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Mouatcho, Joel C., and J. P. Dean Goldring. "Malaria rapid diagnostic tests: challenges and prospects." Journal of Medical Microbiology 62, no. 10 (2013): 1491–505. http://dx.doi.org/10.1099/jmm.0.052506-0.
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In the last decade, there has been an upsurge of interest in developing malaria rapid diagnostic test (RDT) kits for the detection of Plasmodium species. Three antigens – Plasmodium falciparum histidine-rich protein 2 (PfHRP2), plasmodial aldolase and plasmodial lactate dehydrogenase (pLDH) – are currently used for RDTs. Tests targeting HRP2 contribute to more than 90 % of the malaria RDTs in current use. However, the specificities, sensitivities, numbers of false positives, numbers of false negatives and temperature tolerances of these tests vary considerably, illustrating the difficulties and challenges facing current RDTs. This paper describes recent developments in malaria RDTs, reviewing RDTs detecting PfHRP2, pLDH and plasmodial aldolase. The difficulties associated with RDTs, such as genetic variability in the Pfhrp2 gene and the persistence of antigens in the bloodstream following the elimination of parasites, are discussed. The prospect of overcoming the problems associated with current RDTs with a new generation of alternative malaria antigen targets is also described.
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Kidwai, Aneela Altaf, Jamal Ara, Samina Ghaznawi, Shumaila Abdul Rasheed, Saleemullah Paracha, and Tahir Hussain. "DENGUE RAPID DIAGNOSTIC TESTS;." Professional Medical Journal 24, no. 08 (2017): 1216–23. http://dx.doi.org/10.29309/tpmj/2017.24.08.995.
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Objectives: To determine the point of care role of dengue IgA and Dengue IgM/ IgG rapid diagnostic tests (RDTs) in a tertiary care setting in terms of day of onset of illness atpresentation and frequency of positive RDTs in dengue hemorrhagic fever (DHF) and dengueshock syndrome (DSS). Study Design: Cross-sectional study. Setting: Abbasi ShaheedHospital, Karachi. Period: August-2014 to January-2016. Method: Patients aged 13years andabove with acute febrile illness, fulfilling the WHO case definition criteria of probable DF andDHF were included. Two immunochromatograpic (ICT) based RDTs, Assure dengue IgA andPanbio Dengue Duo Cassette (IgM / IgG) were used. Dengue IgA was employed in all patientsfrom day 2 of illness whereas IgM / IgG was employed after day 4 of onset of fever. Result:Among 174 probable cases, 108 (62%) presented between 2 – 5 days of onset of fever, amongwhom 87 (80.5%) were found to be dengue IgA positive. Sixty-nine (39.65%) patients had DHF,among whom 97.1% were seropositive for IgA. Of 118 patients presented after 4 days of onsetof illness, 59.3% were positive by IgM / IgG rapid assay. Conclusion: Considering the higherfrequency of secondary dengue and DHF in dengue endemic-hyperendemic regions, IgAbased ICT might be a helpful diagnostic assay for early diagnosis of dengue infection.
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Zeleke, Melkamu Tiruneh, Kassahun Alemu Gelaye, Adugna Abera Hirpa, et al. "Diagnostic performance of PfHRP2/pLDH malaria rapid diagnostic tests in elimination setting, northwest Ethiopia." PLOS Global Public Health 3, no. 7 (2023): e0001879. http://dx.doi.org/10.1371/journal.pgph.0001879.
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Accurate diagnosis of malaria is vital for the effectiveness of parasite clearance interventions in elimination settings. Thus, evaluating the diagnostic performance of rapid diagnostic tests (RDTs) used in malaria parasite clearance interventions in elimination settings is essential. Therefore, this study aimed to evaluate the diagnostic performance of rapid diagnostic tests recently used in detecting malaria parasites in northwest Ethiopia. A facility-based cross-sectional study was conducted from November 2020 to February 2021 comparing PfHRP2/pLDH CareStart malaria RDTs with light microscopy and polymerase chain reaction (PCR). Blood samples were collected from 310 febrile patients who attended the outpatient department and examined using CareStart RDTs, light microscopy, and PCR. Statistical analyses were performed using STATA/SE version 17.0. The sensitivity of PfHRP2/pLDH CareStart malaria RDTs, regardless of species, was 81.0% [95% CI, 75.3, 86.7] and 75.8% [95% CI, 69.6, 82.0] compared to light microscopy and PCR, while the specificity was 96.8% [95% CI, 93.7, 99.9] and 93.2% [95% CI, 88.6, 97.8], respectively. The false-negative rate of CareStart malaria RDTs in comparison with light microscopy and PCR was 19.0% and 24.2%, respectively. The level of agreement beyond chance between tests was substantial, RDT versus microscopy was 75.0% and RDT versus PCR was 65.1%. The diagnostic performance of PfHRP2/pLDH CareStart RDTs in detecting malaria parasites among febrile patients in the study area was below the recommended WHO standard. The limited diagnostic performance of RDTs in the malaria elimination area undoubtedly affects the impact of malaria parasite clearance interventions. Therefore, parasite clearance intervention like targeted mass drug administration with antimalarial drugs is recommended to back up the limited diagnostic performance of the RDT or replace the existing malaria RDTs with more sensitive, field-deployable, and affordable diagnostic tests.
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Moreira, José, Patrícia Brasil, Sabine Dittrich, and André M. Siqueira. "Mapping the global landscape of chikungunya rapid diagnostic tests: A scoping review." PLOS Neglected Tropical Diseases 16, no. 7 (2022): e0010067. http://dx.doi.org/10.1371/journal.pntd.0010067.
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Background Chikungunya (CHIKV) is a reemerging arboviral disease and represents a global health threat because of the unprecedented magnitude of its spread. Diagnostics strategies rely heavily on reverse transcriptase-polymerase chain reaction (RT-PCR) and antibody detection by enzyme-linked Immunosorbent assay (ELISA). Rapid diagnostic tests (RDTs) are available and promise to decentralize testing and increase availability at lower healthcare system levels. Objectives We aim to identify the extent of research on CHIKV RDTs, map the global availability of CHIKV RDTs, and evaluate the accuracy of CHIKV RDTs for the diagnosis of CHIKV. Eligibility criteria We included studies reporting symptomatic individuals suspected of CHIKV, tested with CHIKV RDTs, against the comparator being a validated laboratory-based RT-PCR or ELISA assay. The primary outcome was the accuracy of the CHIKV RDT when compared with reference assays. Sources of evidence Medline, EMBASE, and Scopus were searched from inception to 13 October 2021. National regulatory agencies (European Medicines Agency, US Food and Drug Administration, and the Brazilian National Health Surveillance Agency) were also searched for registered CHIKV RDTs. Results Seventeen studies were included and corresponded to 3,222 samples tested with RDTs between 2005 and 2018. The most development stage of CHIKV RDTs studies was Phase I (7/17 studies) and II (7/17 studies). No studies were in Phase IV. The countries that manufacturer the most CHIKV RDTs were Brazil (n = 17), followed by the United States of America (n = 7), and India (n = 6). Neither at EMA nor FDA-registered products were found. Conversely, the ANVISA has approved 23 CHIKV RDTs. Antibody RDTs (n = 43) predominated and demonstrated sensitivity between 20% and 100%. The sensitivity of the antigen RDTs ranged from 33.3% to 100%. Conclusions The landscape of CHIKV RDTs is fragmented and needs coordinated efforts to ensure that patients in CHIKV-endemic areas have access to appropriate RDTs. Further research is crucial to determine the impact of such tests on integrated fever case management and prescription practices for acute febrile patients.
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Martiáñez-Vendrell, Xavier, Malia Skjefte, Ruhi Sikka, and Himanshu Gupta. "Factors Affecting the Performance of HRP2-Based Malaria Rapid Diagnostic Tests." Tropical Medicine and Infectious Disease 7, no. 10 (2022): 265. http://dx.doi.org/10.3390/tropicalmed7100265.
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The recent COVID-19 pandemic has profoundly impacted global malaria elimination programs, resulting in a sharp increase in malaria morbidity and mortality. To reduce this impact, unmet needs in malaria diagnostics must be addressed while resuming malaria elimination activities. Rapid diagnostic tests (RDTs), the unsung hero in malaria diagnosis, work to eliminate the prevalence of Plasmodium falciparum malaria through their efficient, cost-effective, and user-friendly qualities in detecting the antigen HRP2 (histidine-rich protein 2), among other proteins. However, the testing mechanism and management of malaria with RDTs presents a variety of limitations. This paper discusses the numerous factors (including parasitic, host, and environmental) that limit the performance of RDTs. Additionally, the paper explores outside factors that can hinder RDT performance. By understanding these factors that affect the performance of HRP2-based RDTs in the field, researchers can work toward creating and implementing more effective and accurate HRP2-based diagnostic tools. Further research is required to understand the extent of these factors, as the rapidly changing interplay between parasite and host directly hinders the effectiveness of the tool.
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Murray, Clinton K., Robert A. Gasser, Alan J. Magill, and R. Scott Miller. "Update on Rapid Diagnostic Testing for Malaria." Clinical Microbiology Reviews 21, no. 1 (2008): 97–110. http://dx.doi.org/10.1128/cmr.00035-07.
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SUMMARY To help mitigate the expanding global impact of malaria, with its associated increasing drug resistance, implementation of prompt and accurate diagnosis is needed. Malaria is diagnosed predominantly by using clinical criteria, with microscopy as the current gold standard for detecting parasitemia, even though it is clearly inadequate in many health care settings. Rapid diagnostic tests (RDTs) have been recognized as an ideal method for diagnosing infectious diseases, including malaria, in recent years. There have been a number of RDTs developed and evaluated widely for malaria diagnosis, but a number of issues related to these products have arisen. This review highlights RDTs, including challenges in assessing their performance, internationally available RDTs, their effectiveness in various health care settings, and the selection of RDTs for different health care systems.
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Baumgartner, Erin T., Kendra N. Williams, Emee Rai, et al. "Enhancing national cholera surveillance using rapid diagnostic tests (RDTs): A mixed methods evaluation." PLOS Neglected Tropical Diseases 19, no. 5 (2025): e0013019. https://doi.org/10.1371/journal.pntd.0013019.
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Cholera rapid diagnostic tests (RDTs) can strengthen existing surveillance systems by offering a cost-effective screening method that improves understanding of cholera burden allowing for targeted prevention and control efforts. The RDT Implementation Strategy and Evaluation (RISE) project is the pilot study for Gavi’s innovative Diagnostic Procurement Platform which provides cholera RDTs to enhance national surveillance. Implementation of cholera RDTs was evaluated following their distribution in 2023 to facilities within Nepal’s Early Warning and Reporting System (EWARS). Quantitative data was collected through EWARS surveillance reports, national-level and individual-level REDCap surveys from select facilities in Kathmandu. Key-informant interviews were also conducted in Kathmandu with personnel involved in cholera surveillance and response. Interviews were conducted using a semi-structured interview guide and analyzed according to inductively identified themes. Qualitative findings indicated generally positive perceptions of cholera RDTs, highlighting their speed and ease of use, and suitability for deployment in under-resourced areas by unskilled personnel. However, a lack of awareness of the RDTs, limited training, and concerns about the RDTs’ quality, availability, and costs were challenges raised consistently. Quantitative findings revealed underreporting of acute gastroenteritis (AGE) and cholera in EWARS and an underutilization of the cholera RDTs, with only 2.6% of reported AGE cases screened using an RDT. This field evaluation demonstrated that RDTs can have an important role in cholera surveillance but highlighted significant challenges with cholera lab capacity, reporting, and training. Both the qualitative and quantitative findings showed gaps in surveillance reporting, which were exacerbated by the complexity of adding RDTs without strong guidance as well as beliefs about the RDTs’ poor validity. These misconceptions and challenges need to be addressed at the local and national level to successfully scale-up cholera RDTs in Nepal and beyond.
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Marchiol, Andrea, Astrid Carolina Florez Sanchez, Andrés Caicedo, et al. "Laboratory evaluation of eleven rapid diagnostic tests for serological diagnosis of Chagas disease in Colombia." PLOS Neglected Tropical Diseases 17, no. 8 (2023): e0011547. http://dx.doi.org/10.1371/journal.pntd.0011547.
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Background Chagas disease is a public health challenge in Colombia, where only an estimated 1.2% of people at risk have accessed diagnosis, while less than 0.5% of affected people have obtained treatment. The development of simplified diagnostic algorithms would enable progress in access to diagnosis; however, the current diagnostic algorithm relies on at least two laboratory-based tests that require qualified personnel, processing equipment, and infrastructure, which are still generally lacking at the primary care level. Rapid diagnostic tests (RDTs) for Chagas disease could simplify diagnosis, but their performance in the epidemiological context of Colombia is not well known. Methodology A retrospective analytical observational study of RDTs was performed to estimate the operational characteristics of 11 commercially available RDTs designed for in vitro detection of anti-T. cruzi IgG antibodies. The study was performed under controlled laboratory conditions using human serum samples. Principal findings Eleven RDTs were assessed, ten using 585 serum samples and one using 551 serum samples. Employing the current national diagnostic algorithm as a reference standard for serological diagnosis of chronic infection, the sensitivity of the assessed RDTs ranged from 75.5% to 99.0% (95% CI 70.5–100), while specificity ranged from 70.9% to 100% (95% CI 65.3–100). Most tests (7/11, 63.6%) had sensitivity above 90%, and almost all (10/11, 90.9%) had specificity above 90%. Five RDTs had both sensitivity and specificity above 90%. Conclusions/Significance The evaluation of these 11 commercially available RDTs under controlled laboratory conditions is a first step in the assessment of the diagnostic performance of RDTs in Colombia. As a next step, field studies will be conducted on available RDTs with sensitivity and specificity greater than 90% in this study, to evaluate performance in real world conditions, with the final goal to allow simplified diagnostic algorithms.
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Ogboi, Johnbull S., Polycarp U. Agu, Adeniyi F. Fagbamigbe, Onyemocho Audu, and al. et. "Misdiagnosis of malaria using wrong buffer substitutes for rapid diagnostic tests in poor resource setting in Enugu, southeast Nigeria." MalariaWorld Journal 5, no. 6 (2014): 1–6. https://doi.org/10.5281/zenodo.10878928.
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<strong>Background.</strong> A key to the effective management of malaria is prompt and accurate diagnosis, and the use of malaria rapid diagnostic tests (mRDTs) is becoming relevant in the absence of reliable microscopy. This study explored the phenomenon of using the wrong buffer vial (often a kit from another brand or buffer from HIV rapid test kits), dextrose, saline or distilled water among health care providers who used RDTs for malaria diagnosis in resource poor settings in Enugu South East, Nigeria. <strong>Materials and Methods.</strong> Laboratory personnel (medical laboratory scientists, technicians, assistants, nurses, community health extension workers (CHEW), community health officers (CHO) and doctors) were interviewed using structured questionnaires and results were checked using the SOP checklist. The selection criterion was a prior experience with using RDTs, and any facility that did not use RDTs was excluded. <strong>Results.</strong> Of the 80 study participants that completed their questionnaires, 56.3% reported that malaria diagnosis was positive using non-buffer RDTs detection while others reported negative results. Among the various professionals who used RDTs, 76.2% reported to have run out of RDT buffer stock at least once. Of the study participants that ran out of RDT buffer solution, 73% declared to have used non-RDT alternatives (physiological saline, 0.9% NaCl), distilled water, HIV buffer or ordinary water). Only 30% had received formal training on the proper usage and application of RDTs while 70% had never received any formal training on RDTs but learnt the technique of using RDT on the job. <strong>Conclusions.</strong> This study demonstrated that at least three quarters of health care workers in a resource poor setting had run out of buffer when using malaria RDTs and that the majority of them had used buffer substitutes, which are known to generate inaccurate tests results. This has the consequence of misdiagnosis, thus potentially damaging the credibility of malaria control.
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Amartey, AO, KO Buabeng, A. Mohammed, SM Maru, R. Peeling, and S. Tengey. "Quality of Malaria and HIV Rapid Diagnostic Test kits (RDTs) in health facilities and medicines outlets in the Greater Accra Region of Ghana." INTERNATIONAL JOURNAL OF MULTIDISCIPLINARY RESEARCH AND ANALYSIS 04, no. 05 (2021): 520–29. https://doi.org/10.47191/ijmra/v4-i5-04.
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Background: Questions remain on the quality of malaria and HIV Rapid Diagnostic Test kits (RDTs) stocked and used in health facilities in Ghana. The Food and Drugs Authority (FDA) in Ghana is mandated to regulate RDTs for quality. By this, all RDTs must be registered, and each brand given a unique registration number. This study aimed to assess the quality of malaria and HIV RDTs in health facilities in the Greater Accra Region of Ghana, using FDA standards. Method: Data was obtained using structured questionnaire from 400 facilities in three districts in the Greater Accra region. A multi-stage sampling procedure was used to select the health facilities including retail medicine outlets. Information on the registration status of the RDTs and conditions under which they were stored were gathered. RDTs kept in air conditioned or wellventilated rooms were considered as being stored under good condition. RDTs, registered by the FDA and appropriately stored were considered to be of good quality. Data was coded, stored, and analyzed using STATA version 15. Results: About 17% of the malaria RDTs stocked in the pharmacies were unregistered, 85.7% in hospitals were registered. Also, 83.3% of HIV RDTs in the Policlinics were registered. Registration status of the RDTs were associated with the districts in which the health facilities were located (p = 0.006). The RDTs were generally stored under good conditions (99.5%). Over forty percent (41.9%) of user practitioners interviewed rated the quality of the malaria RDTs as good and 59.2% rated HIV RDTs as very good. Conclusion: Though there were some unregistered RDTs whose quality cannot be ascertained, the quality of malaria and HIV RDTs in the facilities assessed were rated as good and likely to produce good results for malaria and HIV case detection.
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Mendicino, Diego, Carlina Colussi, and Edgardo Moretti. "Simultaneous use of two rapid diagnostic tests for the diagnosis of Chagas disease." Tropical Doctor 49, no. 1 (2018): 23–26. http://dx.doi.org/10.1177/0049475518813792.
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The sensitivity of rapid diagnostic tests (RDT) for Chagas disease is not great enough for their single use. The aim of this paper was to evaluate the performance of two RDTs for Chagas disease, used simultaneously. Two different RDTs (A and B) were performed in 64 and 42 serum samples that were negative and positive, respectively, by conventional serological techniques. Validity and reliability of both tests were evaluated individually and simultaneously. Sensitivity was 90.5% and 97.6%, and specificity was 100% and 93.8%, for RDT A and B, respectively. The κ statistic was 0.96. When both RDTs were used simultaneously, sensitivity was 97.4%, specificity was 100% and the discordance percentage 6.6%. The combined use of two RDTs with serum samples is an acceptable application in healthcare centres.
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Garg, Atul, Jaya Garg, Dharam Singh, and TN Dhole. "Can rapid dengue diagnostic kits be trusted? A comparative study of commercially available rapid kits for serodiagnosis of dengue fever." Journal of Laboratory Physicians 11, no. 01 (2019): 063–67. http://dx.doi.org/10.4103/jlp.jlp_140_18.
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Abstract BACKGROUND: Dengue virus infection is an important emerging disease of the tropical and subtropical regions and is mainly diagnosed by serological detection of NS1 antigen and IgM antidengue antibodies. Since enzyme-linked immunosorbent assay (ELISA) facilities are not easily available at most diagnostic centers, so most of them use various commercially available rapid diagnostic tests (RDTs) kits. AIMS AND OBJECTIVES: This study was designed to access the diagnostic accuracy of four commercially available and widely used RDTs for serodiagnosis of dengue virus infection in Indian laboratories. SUBJECTS AND METHODS: The study was conducted at Department of Microbiology, G.S.V.M Medical College, Kanpur, India, to estimate the sensitivity and specificity of following RDTs: (1) Dengue Cassette (Panbio, Australia), (2) Bioline Dengue Duo (SD Diagnostics, Korea), (3) Dengue Day 1 test (J Mitra and Co., India), and (4) Dengucheck Duo (Tulip Diagnostics, India) on 72 confirmed dengue serum samples that were positive by dengue reverse transcription-polymerase chain reaction, dengue NS1, and IgM ELISA along with 80 serum samples from nondengue febrile illness patients. RESULTS: The majority of the RDTs demonstrated low sensitivity but good specificity for detecting NS1 antigen. Detection of antidengue IgM antibodies by RDTs demonstrated low sensitivity ranging from 27.8% to 77.7%. However, specificity was generally higher (50%–86.2%) and more consistent across the assays. CONCLUSION: The study results differed markedly from the RDTs manufacturers’ claimed performance characteristics. Therefore, the RDT results should be interpreted cautiously and ELISA should be performed as far as possible for serodiagnosis of dengue virus infection.
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Kalgo, Mustapha Umar, B. O. P. Musa, H. I. Inabo, and Laila Hassan. "Diagnosis of Malaria among Children in Sokoto: A Comparison of Microscopy and Rapid Diagnostic Tests." UMYU Journal of Microbiology Research (UJMR) 9, no. 1 (2024): 272–78. http://dx.doi.org/10.47430/ujmr.2491.029.
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Study’s Novelty/Excerpt This study compares the utility, sensitivity, specificity, and predictive values of microscopy with that of Rapid Diagnostic Tests (RDTs) in diagnosing malaria among children in Specialist Hospital Sokoto. The novelty lies in its focus on a specific pediatric population in a resource-limited setting, providing valuable data on the comparative effectiveness of these diagnostic methods in real-world clinical practice. The findings highlight the higher positivity rate of microscopy, advocating for its continued use alongside RDTs to ensure accurate malaria diagnosis and optimal patient care in similar environments. Full Abstract Malaria is a life-threatening disease primarily found in tropical countries, and it is the leading cause of morbidity and mortality among children. Diagnosis of malaria depends largely on clinical presentations and laboratory diagnosis. Microscopy is the gold standard for laboratory malaria diagnosis but requires adequate training and time compared to Rapid Diagnostic Tests (RDTs). The study compared the utility, sensitivity, specificity, and predictive values between microscopy and RDTs in diagnosing malaria among children accessing care in Specialist Hospital Sokoto. A total of 367 blood samples of consented children who met the study inclusion criteria were examined. All samples were screened for malaria using RDT thin and thick blood films. Of the 367 samples assessed, RDT was positive for 202 (55.0%) and negative for 165 (45.0%), while microscopy was positive for 235 (64.1%) and negative for 132 (35.9%), a non-statistically significant (χ2 = 0.090, P = 0.922) difference was observed when both positive tests were compared. The Rapid diagnostic tests (RDTs) showed a sensitivity of 85.95% and a specificity of 83.33%. This study confirms the higher positivity rate of microscopy to RDTs in diagnosing malaria. As such, RDTs are useful for rapid malaria diagnosis, especially in resource-limited settings; microscopy should be encouraged as much as possible for children to avoid missing any positive cases.
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Feleke, Sindew M., Emily N. Reichert, Hussein Mohammed, et al. "Plasmodium falciparum is evolving to escape malaria rapid diagnostic tests in Ethiopia." Nature Microbiology 6, no. 10 (2021): 1289–99. http://dx.doi.org/10.1038/s41564-021-00962-4.
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AbstractIn Africa, most rapid diagnostic tests (RDTs) for falciparum malaria recognize histidine-rich protein 2 antigen. Plasmodium falciparum parasites lacking histidine-rich protein 2 (pfhrp2) and 3 (pfhrp3) genes escape detection by these RDTs, but it is not known whether these deletions confer sufficient selective advantage to drive rapid population expansion. By studying blood samples from a cohort of 12,572 participants enroled in a prospective, cross-sectional survey along Ethiopia’s borders with Eritrea, Sudan and South Sudan using RDTs, PCR, an ultrasensitive bead-based immunoassay for antigen detection and next-generation sequencing, we estimate that histidine-rich protein 2-based RDTs would miss 9.7% (95% confidence interval 8.5–11.1) of P. falciparum malaria cases owing to pfhrp2 deletion. We applied a molecular inversion probe-targeted deep sequencing approach to identify distinct subtelomeric deletion patterns and well-established pfhrp3 deletions and to uncover recent expansion of a singular pfhrp2 deletion in all regions sampled. We propose a model in which pfhrp3 deletions have arisen independently multiple times, followed by strong positive selection for pfhrp2 deletion owing to RDT-based test-and-treatment. Existing diagnostic strategies need to be urgently reconsidered in Ethiopia, and improved surveillance for pfhrp2 deletion is needed throughout the Horn of Africa.
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Getahun Strobel, Aneley, Stephanie Airs, Cattram Nguyen, et al. "Assessment of Rapid Diagnostic Tests for Typhoid Diagnosis and Assessment of Febrile Illness Outbreaks in Fiji." American Journal of Tropical Medicine and Hygiene 106, no. 2 (2022): 543–49. http://dx.doi.org/10.4269/ajtmh.21-0771.
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ABSTRACT. Typhoid is an endemic in Fiji with increases observed since the early 2000s and frequent outbreaks reported. We assessed the diagnostic accuracy of currently available typhoid rapid diagnostic tests (RDTs) (TUBEX, Typhidot Rapid, and Test-It assay) to establish their performance against blood culture in Fiji and to examine their suitability for rapid typhoid outbreak identification. The performance of RDTs was assessed in the public health reference laboratory in Suva, Fiji, according to the manufacturers’ instructions. A simulation was used to examine the potential use of RDTs for attribution of a febrile illness outbreak to typhoid. For the diagnostic evaluation, 179 patients were included; 49 had blood culture–confirmed typhoid, 76 had fever as a result of non-typhoid etiologies, and 54 were age-matched community controls. The median (interquartile range) age was 29 (20–46) years. Of the participants, 92 (51.4%) were male and 131 (73.2%) were indigenous Fijians. The sensitivities of the tests were 77.6% for TUBEX, 75.5% for Typhidot Rapid, and 57.1% for Test-It assay. The Test-It assay had the highest specificity of 93.4%, followed by Typhidot Rapid 85.5% and TUBEX 60.5%. Typhidot Rapid had the best performance in the simulation for attribution of a febrile illness outbreak to typhoid. Typhoid RDTs performed suboptimally for individual patient diagnosis due to low sensitivity and variable specificity. We demonstrate that RDTs could be useful in the field for rapid attribution of febrile illness outbreaks to typhoid. Typhidot Rapid had the best combination of sensitivity, specificity, positive and negative predictive values, cost, and ease of use for this purpose.
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Oyeniyi, Jonathan Ayobami, Ibrahim Sebutu Bello, Olanrewaju Oloyede Oyegbade, Azeez Oyemomi Ibrahim, Oyeladun Funmi Okunromade, and Oladipupo Omolade Fakoya. "Agreement among rapid diagnostic tests, urine malaria tests, and microscopy in malaria diagnosis of adult patients in southwestern Nigeria." Journal of International Medical Research 50, no. 9 (2022): 030006052211227. http://dx.doi.org/10.1177/03000605221122740.
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Objective We determined the malaria prevalence and ascertained the degree of agreement among rapid diagnostic tests (RDTs), urine malaria tests, and microscopy in malaria diagnosis of adults in Nigeria. Methods This was a cross-sectional study among 384 consenting patients recruited at a tertiary health facility in southwestern Nigeria. We used standardized interviewer-administered questionnaires to collect patients’ sociodemographic information. Venous blood samples were collected and processed for malaria parasite detection using microscopy, RDTs, and urine malaria tests. The degree of agreement was determined using Cohen’s kappa statistic. Results The malaria prevalence was 58.3% (95% confidence interval [CI]: 53.0–63.1), 20.6% (95% CI: 16.6–25.0), and 54.2% (95% CI: 49.0–59.2) for microscopy, RDTs, and urine malaria test, respectively. The percent agreement between microscopy and RDTs was 50.8%; the expected agreement was 45.1% and Cohen’s kappa was 0.104. The percent agreement between microscopy and urine malaria tests was 52.1%; the expected agreement was 50.7% and Cohen’s kappa was 0.03. Conclusion The malaria prevalence was dependent on the method of diagnosis. This study revealed that RDTs are a promising diagnostic tool for malaria in resource-limited settings. However, urine malaria test kits require further improvement in sensitivity prior to field use in malaria-endemic settings.
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Dinhuzen, Janejira, Umaporn Limothai, Sasipha Tachaboon, et al. "A prospective study to evaluate the accuracy of rapid diagnostic tests for diagnosis of human leptospirosis: Result from THAI-LEPTO AKI study." PLOS Neglected Tropical Diseases 15, no. 2 (2021): e0009159. http://dx.doi.org/10.1371/journal.pntd.0009159.
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Background Rapid diagnostic tests (RDTs) have become widely used in low-resource settings for leptospirosis diagnostic. This study aims to evaluate the diagnostic performance of the five commercially available RDTs to detect human IgM against Leptospira spp. in Thai population. Methodology/Principal findings Ninety-nine serum samples from Leptospirosis suspicious patients were tested with five RDTs, including Medical Science Public Health, Leptocheck-WB, SD bioline, TRUSTline, and J.Mitra. The case definition was based on MAT, qPCR, and culture results. Diagnostic accuracy was determined based on the first day of enrollment in an overall analysis and stratified according to days post-onset of fever. The five RDTs had overall sensitivity ranging from 1.8% to 75% and specificity ranging from 52.3% to 97.7%. Leptocheck-WB had high sensitivity of 75.0%. The sensitivity of five RDTs increased on days 4–6 post-onset of fever, while the specificity of all tests remained relatively stable at different days post-onset of fever. Conclusions/Significance The tested RDTs showed low sensitivity. Therefore, based on the present study, five commercially available RDTs might not be an appropriate test for acute leptospirosis screening in the Thai population.
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Rezaei, Zahra, Bahman Pourabbas, Vera Kühne, Parham Pourabbas, and Philippe Büscher. "Diagnostic Performance of Three rK39 Rapid Diagnostic Tests and Two Direct Agglutination Tests for the Diagnosis of Visceral Leishmaniasis in Southern Iran." Journal of Tropical Medicine 2022 (April 11, 2022): 1–5. http://dx.doi.org/10.1155/2022/3569704.
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To evaluate the diagnostic performance of five alternative serodiagnostic tests, serum samples from 100 confirmed visceral leishmaniasis (VL) patients, 197 healthy endemic individuals, and 58 non-VL patients living in southern Iran were compared. The VL patients were defined as individuals with a positive result of the immunofluorescent antibody test (IFAT), having clinical signs and symptoms and appropriate response to treatment. The index tests were two direct agglutination tests, DAT-ITM (Institute of Tropical Medicine, Antwerp, Belgium) and DAT-KIT (Royal Tropical Institute, Amsterdam, The Netherlands), and three rapid diagnostic tests (RDTs), Kalazar Detect (InBios International Inc., USA), IT Leish (Bio-Rad, catalog 710124), and Leishmania test (Cypress Diagnostic Company, Belgium). Sensitivities of DAT-ITM and DAT-KIT were low, respectively, 56% and 59%, while specificities were acceptable, respectively, 98% and 93%. Observed sensitivities and specificities of RDTs were higher (71%, 81%, 70% and 99%, 99%, 98% for Kalazar Detect, IT Leish, and Leishmania test, respectively). Even with a maximum sensitivity of 81%, RDTs missed almost one-fifth of VL patients that were positive in IFAT. We conclude that RDTs in VL patients do not possess adequate performance in southern Iran and require some improvement, but they can still be helpful in the diagnosis and screening of the disease in this region due to their high specificity and speed.
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Arkell, Paul, Maria Tanesi, Nelia Gomes, et al. "Field evaluation of rapid diagnostic tests to determine dengue serostatus in Timor-Leste." PLOS Neglected Tropical Diseases 16, no. 11 (2022): e0010877. http://dx.doi.org/10.1371/journal.pntd.0010877.
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The live attenuated tetravalent CYD-TDV vaccine (Dengvaxia) is effective but has scarcely been used due to safety concerns among seronegative recipients. Rapid diagnostic tests (RDTs) which can accurately determine individual dengue serostatus are needed for use in pre-vaccination screening. This study aimed to determine the performance of existing RDTs (which have been designed to detect levels of immunoglobulin G, IgG, associated with acute post-primary dengue) when repurposed for detection of previous dengue infection (where concentrations of IgG are typically lower). A convenience sample of four-hundred-and-six participants (including 217 children) were recruited in the community. Whole blood was collected by phlebotomy and tested using Bioline Dengue IgG/IgM (Abbott) and Standard Q Dengue IgM/IgG (SD Biosensor) RDTs in the field. Serum samples from the same individuals were also tested at National Health Laboratory. The Panbio indirect IgG ELISA was used as a reference test. Reference testing determined that 370 (91.1%) participants were dengue IgG seropositive. Both assays were highly specific (100.0%) but had low sensitivity (Bioline = 21.1% and Standard Q = 4.6%) when used in the field. Sensitivity was improved when RDTs were used under laboratory conditions, and when assays were allowed to run beyond manufacturer recommendations (and read at a delayed time-point), but specificity was reduced. Efforts to develop RDTs with high sensitivity and specificity for prior dengue infection which can be operationalised for pre-vaccination screening are ongoing. Performance of forthcoming candidate assays should be tested under field conditions with blood samples, as well as in the laboratory.
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Perez, Freddy, Debbie Vermeij, Roberto Salvatella, Luis Gerardo Castellanos, and Andrea Silvestre de Sousa. "The use of rapid diagnostic tests for chronic Chagas disease: An expert meeting report." PLOS Neglected Tropical Diseases 18, no. 8 (2024): e0012340. http://dx.doi.org/10.1371/journal.pntd.0012340.
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Chagas disease, caused by Trypanosoma cruzi, affects millions of people globally and is associated with significant underdiagnosis and undertreatment. Current diagnostic algorithms face challenges in remote regions. We aimed to review the potential of rapid diagnostic tests (RDTs) for screening or diagnosing chronic Chagas disease in endemic areas. An expert panel representing scientific and academic institutions from the Americas convened with the aim of discussing the use of RDTs. The study employed the nominal group technique, gathering insights from diverse experts during a 3-day meeting. Panel discussions covered RDT application, research protocols, and regulatory mechanisms. The results indicate that RDTs play a crucial role in surveillance and screening, although limitations in sensitivity and specificity exist. The expert group recommends standardized protocols, emphasizes the importance of cost-effectiveness assessments, and highlights the need to consider geographic validation. Despite these challenges, RDTs present a promising avenue for improving Chagas disease diagnosis in resource-limited settings. Future research and a collaborative approach are deemed essential for effective implementation.
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Rachlin, Audrey, Lee M. Hampton, Paul A. Rota, et al. "Use of Measles and Rubella Rapid Diagnostic Tests to Improve Case Detection and Targeting of Vaccinations." Vaccines 12, no. 8 (2024): 823. http://dx.doi.org/10.3390/vaccines12080823.
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Efforts to control and eliminate measles and rubella are aided by high-quality surveillance data—supported by laboratory confirmation—to guide decision-making on routine immunization strategies and locations for conducting preventive supplementary immunization activities (SIAs) and outbreak response. Important developments in rapid diagnostic tests (RDTs) for measles and rubella present new opportunities for the global measles and rubella surveillance program to greatly improve the ability to rapidly detect and respond to outbreaks. Here, we review the status of RDTs for measles and rubella Immunoglobulin M (IgM) testing, as well as ongoing questions and challenges regarding the operational use and deployment of RDTs as part of global measles and rubella surveillance. Efforts to develop IgM RDTs that can be produced at scale are underway. Once validated RDTs are available, clear information on the benefits, challenges, and costs of their implementation will be critical for shaping deployment guidance and informing country plans for sustainably deploying such tests. The wide availability of RDTs could provide new programmatic options for measles and rubella elimination efforts, potentially enabling improvements and flexibility for testing, surveillance, and vaccination.
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Joji, Ronni Mol, and Mohammad Shahid. "The Role of Antigen Rapid Diagnostic Test in COVID-19 Diagnosis." Open COVID Journal 1, no. 1 (2021): 108–11. http://dx.doi.org/10.2174/2666958702101010108.
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Since the emergence of a novel infection due to the SARS-CoV-2 virus (COVID-19), the World Health Organization has urged countries to develop diagnostic tests to combat the pandemic. Molecular assays were developed following the release of the gene sequence of the virus in January 2020. Reverse transcription-quantitative PCR (RT-qPCR) is taken as the gold standard for the diagnosis of COVID-19. However, due to its limitations, highly sensitive methods for detecting antigens (antigen rapid diagnostic tests) have been developed that would help in a timely and accurate diagnosis. Antigen rapid diagnostic tests (Ag-RDTs) can help guide patient management at the point of care by random screening, re-testing, and timely decision-making in the field of public health. When the affordability and validity of the diagnostic assay are involved, no assay can show 100% correct results. Further studies need to be done to better understand the response of the Ag-RDTs in different settings. Nevertheless, Ag-RDTs can play a complementary role in the response and case management of COVID-19.
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Pokharel, Sunil, Lisa J. White, Ricardo Aguas, Olivier Celhay, Karell G. Pellé, and Sabine Dittrich. "Algorithm in the Diagnosis of Febrile Illness Using Pathogen-specific Rapid Diagnostic Tests." Clinical Infectious Diseases 70, no. 11 (2019): 2262–69. http://dx.doi.org/10.1093/cid/ciz665.
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Abstract Background In the absence of proper guidelines and algorithms, available rapid diagnostic tests (RDTs) for common acute undifferentiated febrile illnesses are often used inappropriately. Methods Using prevalence data of 5 common febrile illnesses from India and Cambodia, and performance characteristics (sensitivity and specificity) of relevant pathogen-specific RDTs, we used a mathematical model to predict the probability of correct identification of each disease when diagnostic testing occurs either simultaneously or sequentially in various algorithms. We developed a web-based application of the model so as to visualize and compare output diagnostic algorithms when different disease prevalence and test performance characteristics are introduced. Results Diagnostic algorithms with appropriate sequential testing predicted correct identification of etiology in 74% and 89% of patients in India and Cambodia, respectively, compared with 46% and 49% with simultaneous testing. The optimally performing sequential diagnostic algorithms differed in India and Cambodia due to varying disease prevalence. Conclusions Simultaneous testing is not appropriate for the diagnosis of acute undifferentiated febrile illnesses with presently available tests, which should deter the unsupervised use of multiplex diagnostic tests. The implementation of adaptive algorithms can predict better diagnosis and add value to the available RDTs. The web application of the model can serve as a tool to identify the optimal diagnostic algorithm in different epidemiological settings, while taking into account the local epidemiological variables and accuracy of available tests.
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Yow, Kok-Siang, Joel Aik, Eugene Yong-Meng Tan, Lee-Ching Ng, and Yee-Ling Lai. "Rapid diagnostic tests for the detection of recent dengue infections: An evaluation of six kits on clinical specimens." PLOS ONE 16, no. 4 (2021): e0249602. http://dx.doi.org/10.1371/journal.pone.0249602.
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Introduction Early and rapid confirmation of dengue infections strengthens disease surveillance program and are critical to the success of vector control measures. Rapid diagnostics tests (RDTs) are increasingly used to confirm recent dengue infections due to their ease of use and short turnaround time for results. Several studies undertaken in dengue-endemic Southeast Asia have reported the performance of RDTs against enzyme-linked immunosorbent assay (ELISA), reverse transcriptase polymerase chain reaction (RT-PCR) and virus isolation methods. However, few studies have compared multiple RDTs for the detection of dengue NS1 antigen and IgM antibody in a single combo cassette. We evaluated six RDTs in Singapore for their utility in routine clinical testing to detect recent dengue infections. Methods The evaluation comprised two phases. The first phase sought to determine each RDT’s specificity to dengue NS1 and IgM using zika and chikungunya virus supernatant and zika convalescent samples. RDTs that cross-reacted with zika or chikungunya were not further tested in phase 2. The second phase sought to determine the sensitivity and specificity of the remaining RDTs to dengue NS1 and IgM using pre-characterised dengue specimens and non-dengue/chikungunya febrile clinical specimens. Results None of the RDTs cross-reacted with zika IgM in Phase 1. Truquick and Quickprofile cross reacted with zika and chikungunya viruses and were not evaluated thereafter. Standard Q had the highest dengue NS1 and IgM sensitivity at 87.0% and 84.3% respectively whereas Bioline (68.5%) and Multisure (58.3%) had the lowest dengue NS1 and IgM sensitivity respectively. Combining dengue NS1/IgM detection results greatly improved the RDT ability to detect recent dengue infection; Standard Q had the highest sensitivity at 99.1% while Multisure had the lowest at 92.6%. All the RDTs were highly specific for dengue NS1 and IgM (96.7% to 100%). All the RDTs had high positive predictive values (98.4% to 100%) for NS1, IgM and combined NS1/IgM parameters whereas Standard Q had the highest negative predictive values at 68.2% (NS1), 63.8% (IgM) and 96.8% (NS1/IgM). For the RDTs, detection of NS1 declined from acute to convalescent phase of illness whereas IgM detection rate gradually increased over time. Conclusion In our study, several RDTs were evaluated for their diagnostic accuracy and capability in detecting recent dengue infection. Standard Q demonstrated a high degree of diagnostic accuracy and capability in the detection of NS1 and IgM biomarkers. RDTs can provide rapid and accurate confirmation of recent dengue infections and augment dengue surveillance and control programmes. Further studies are required to assess the usefulness of these RDTs in other epidemiology settings.
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Beganovic, Maya, Erin K. McCreary, Monica V. Mahoney, Brandon Dionne, Daniel A. Green, and Tristan T. Timbrook. "Interplay between Rapid Diagnostic Tests and Antimicrobial Stewardship Programs among Patients with Bloodstream and Other Severe Infections." Journal of Applied Laboratory Medicine 3, no. 4 (2019): 601–16. http://dx.doi.org/10.1373/jalm.2018.026450.
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Abstract Background Antimicrobial stewardship programs (ASPs) aim to provide optimal antimicrobial therapy to patients quickly to improve the likelihood of overcoming infection while reducing the risk of adverse effects. Rapid diagnostic tests (RDTs) for infectious diseases have become an integral tool for ASPs to achieve these aims. Content This review explored the demonstrated clinical value of longer-standing technologies and implications of newer RDTs from an antimicrobial stewardship perspective. Based on available literature, the focus was on the use of RDTs in bloodstream infections (BSIs), particularly those that perform organism identification and genotypic resistance detection, phenotypic susceptibility testing, and direct specimen testing. Clinical implications of rapid testing among respiratory, central nervous system, and gastrointestinal infections are also reviewed. Summary Coupling RDTs with ASPs facilitates the appropriate and timely use of test results, translating into improved patient outcomes through optimization of antimicrobial use. These benefits are best demonstrated in the use of RDT in BSIs. Rapid phenotypic susceptibility testing offers the potential for early pharmacokinetic/pharmacodynamic optimization, and direct specimen testing on blood may allow ASPs to initiate appropriate therapy and/or tailor empiric therapy even sooner than other RDTs. RDTs for respiratory, central nervous system, and gastrointestinal illnesses have also shown significant promise, although more outcome studies are needed to evaluate their full impact.
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Muzembo, Basilua Andre, Kei Kitahara, Ayumu Ohno, Anusuya Debnath, Keinosuke Okamoto, and Shin-Ichi Miyoshi. "Cholera Rapid Diagnostic Tests for the Detection of Vibrio cholerae O1: An Updated Meta-Analysis." Diagnostics 11, no. 11 (2021): 2095. http://dx.doi.org/10.3390/diagnostics11112095.
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The rapid diagnosis of cholera contributes to adequate outbreak management. This meta-analysis assesses the diagnostic accuracy of cholera rapid tests (RDTs) to detect Vibrio cholerae O1. Methods: Systematic review and meta-analysis. We searched four databases (Medline, EMBASE, Google Scholar, and Web of Science up to 8 September 2021) for studies that evaluated cholera RDTs for the detection of V. cholerae O1 compared with either stool culture or polymerase chain reaction (PCR). We assessed the studies’ quality using the QUADAS-2 criteria. In addition, in this update, GRADE approach was used to rate the overall certainty of the evidence. We performed a bivariate random-effects meta-analysis to calculate the pooled sensitivity and specificity of cholera RDTs. Results: Overall, 20 studies were included in this meta-analysis. Studies were from Africa (n = 11), Asia (n = 7), and America (Haiti; n = 2). They evaluated eight RDTs (Crystal VC-O1, Crystal VC, Cholkit, Institut Pasteur cholera dipstick, SD Bioline, Artron, Cholera Smart O1, and Smart II Cholera O1). Using direct specimen testing, sensitivity and specificity of RDTs were 90% (95% CI, 86 to 93) and 86% (95% CI, 81 to 90), respectively. Cholera Sensitivity was higher in studies conducted in Africa [92% (95% CI, 89 to 94)] compared with Asia [82% (95% CI, 77 to 87)]. However, specificity [83% (95% CI, 71 to 91)] was lower in Africa compared with Asia [90% (95% CI, 84 to 94)]. GRADE quality of evidence was estimated as moderate. Conclusions: Against culture or PCR, current cholera RDTs have moderate sensitivity and specificity for detecting Vibrio cholerae O1.
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Lubell-Doughtie, Peter, Shiven Bhatt, Roger Wong, and Anuraj H. Shankar. "Transforming Rapid Diagnostic Tests for Precision Public Health: Open Guidelines for Manufacturers and Users." JMIR Biomedical Engineering 7, no. 2 (2022): e26800. http://dx.doi.org/10.2196/26800.
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Background Precision public health (PPH) can maximize impact by targeting surveillance and interventions by temporal, spatial, and epidemiological characteristics. Although rapid diagnostic tests (RDTs) have enabled ubiquitous point-of-care testing in low-resource settings, their impact has been less than anticipated, owing in part to lack of features to streamline data capture and analysis. Objective We aimed to transform the RDT into a tool for PPH by defining information and data axioms and an information utilization index (IUI); identifying design features to maximize the IUI; and producing open guidelines (OGs) for modular RDT features that enable links with digital health tools to create an RDT-OG system. Methods We reviewed published papers and conducted a survey with experts or users of RDTs in the sectors of technology, manufacturing, and deployment to define features and axioms for information utilization. We developed an IUI, ranging from 0% to 100%, and calculated this index for 33 World Health Organization–prequalified RDTs. RDT-OG specifications were developed to maximize the IUI; the feasibility and specifications were assessed through developing malaria and COVID-19 RDTs based on OGs for use in Kenya and Indonesia. Results The survey respondents (n=33) included 16 researchers, 7 technologists, 3 manufacturers, 2 doctors or nurses, and 5 other users. They were most concerned about the proper use of RDTs (30/33, 91%), their interpretation (28/33, 85%), and reliability (26/33, 79%), and were confident that smartphone-based RDT readers could address some reliability concerns (28/33, 85%), and that readers were more important for complex or multiplex RDTs (33/33, 100%). The IUI of prequalified RDTs ranged from 13% to 75% (median 33%). In contrast, the IUI for an RDT-OG prototype was 91%. The RDT open guideline system that was developed was shown to be feasible by (1) creating a reference RDT-OG prototype; (2) implementing its features and capabilities on a smartphone RDT reader, cloud information system, and Fast Healthcare Interoperability Resources; and (3) analyzing the potential public health impact of RDT-OG integration with laboratory, surveillance, and vital statistics systems. Conclusions Policy makers and manufacturers can define, adopt, and synergize with RDT-OGs and digital health initiatives. The RDT-OG approach could enable real-time diagnostic and epidemiological monitoring with adaptive interventions to facilitate control or elimination of current and emerging diseases through PPH.
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Andrey, Diego O., Patrick Cohen, Benjamin Meyer, et al. "Head-to-Head Accuracy Comparison of Three Commercial COVID-19 IgM/IgG Serology Rapid Tests." Journal of Clinical Medicine 9, no. 8 (2020): 2369. http://dx.doi.org/10.3390/jcm9082369.
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Background: Comparative data of SARS-CoV-2 IgM/IgG serology rapid diagnostic tests (RDTs) is scarce. We thus performed a head-to-head comparison of three RDTs. Methods: In this unmatched case-control study, blood samples from 41 RT-PCR-confirmed COVID-19 cases and 50 negative controls were studied. The diagnostic accuracy of three commercially available COVID-19 RDTs: NTBIO (RDT-A), Orient-Gene (RDT-B), and MEDsan (RDT-C), against both a recombinant spike-expressing immunofluorescence assay (rIFA) and Euroimmun IgG ELISA, was assessed. RDT results concordant with the reference methods, and between whole blood and plasma, were established by the Kendall coefficient. Results: COVID-19 cases’ median time from RT-PCR to serology was 22 days (interquartile range (IQR) 13–31 days). Whole-blood IgG detection with RDT-A, -B, and -C showed 0.93, 0.83, and 0.98 concordance with rIFA. Against rIFA, RDT-A sensitivity (SN) was 92% (95% CI: 78–98) and specificity (SP) 100% (95% CI: 91–100), RDT-B showed 87% SN (95% CI: 72–95) and 98% SP (95% CI: 88–100), and RDT-C 100% SN (95% CI: 88–100) and 98% SP (95% CI: 88–100). Against ELISA, SN and SP were above 90% for all three RDTs. Conclusions: RDT-A and RDT-C displayed IgG detection SN and SP above 90% in whole blood. These RDTs could be considered in the absence of routine diagnostic serology facilities.
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Haspreet, Kaur Gill, Kumari Swarnim, and Jaiswal C.P. "A Hospital Based Assessment of the Diagnostic Efficacy of Two Different Approaches in the Diagnosis of Malaria." International Journal of Current Pharmaceutical Review and Research 16, no. 05 (2024): 644–47. https://doi.org/10.5281/zenodo.12886193.
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AbstractAim: Evaluation of Rapid diagnostic tests compared to peripheral smear in the diagnosis of malaria.Methods and Materials: This is a retrospective hospital-based study was conducted in the Department ofpathology, NMCH, Patna, Bihar, India for 9 months. During this period, 1835 blood samples were received formalaria diagnosis from clinically suspected cases. Blood samples were collected in EDTA vacutainer tube.Peripheral smears were made on a clean glass slide with a drop of blood, air dried and stained with Leishmanstain. Smears were thoroughly examined under oil immersion for the presence of malaria parasite. Of 1835samples, 600 samples were randomly selected and Rapid Diagnostic test was performed using Antigen based Pf(HRP-II) and PV (pLDH) specific kit. Procedure was performed as per manufacturer’s instructions.Results: Of the 600 Peripheral smears studied, 175 showed positive for malarial parasite. Plasmodium Vivax (Pv)was diagnosed in 173 Cases, Plasmodium Falciparum (Pf) was identified in one case and one smear showed mixedinfection with both Plasmodium Vivax and Plasmodium Falciparum. Rapid Diagnostic test showed 189 positivecases, of which 178 were plasmodium Vivax, four cases were Plasmodium Falciparum and seven cases showedmixed infection with Falciparum and Vivax. Sensitivity, specificity, Positive Predictive Value and NegativePredictive value were 100%, 96.7%, 92.5% and 100% respectively.Conclusions: Peripheral smears are considered to be gold standard for diagnosis of malaria. RDTs can be moresensitive and specific than peripheral smears. Newer Pf /Pv specific antigen card can distinguish mixed and PFinfections. However further studies are required to assess cost effectiveness and efficiency of different RDTs.
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García Luna, Jonny Alejandro, Nelson Romero-Rosas, Sebastian Alejandro Silva Peña, et al. "Diagnostic performance of two rapid tests for syphilis screening in people living with HIV in Cali, Colombia." PLOS ONE 18, no. 3 (2023): e0282492. http://dx.doi.org/10.1371/journal.pone.0282492.
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Introduction There is insufficient evidence supporting the use of rapid diagnostic tests (RDTs) for syphilis in people living with HIV (PLWH). We evaluated the diagnostic performance of two commercially available RDTs (Bioline and Determine) in PLWH in Cali, Colombia. Methods A cross-sectional field validation study on consecutive adults with confirmed HIV diagnosis attending three outpatient clinics. Both RDTs were performed on capillary blood (CB), obtained by finger prick, and sera, by venipuncture. A combination of treponemal enzyme linked immunosorbent assay (ELISA) and Treponema pallidum haemagglutination assay (TPHA) on serum samples was the reference standard. Rapid plasma reagin (RPR) and clinical criteria were added to define active syphilis. Sensitivity and specificity, predictive values and likelihood ratios (LR) of RDTs were estimated with their corresponding 95% confidence interval (95% CI). Stratified analyses by sample type, patient characteristics, non-treponemal titers, operator and re-training were performed. Results 244 PLWH were enrolled, of whom 112 (46%) had positive treponemal reference tests and 26/234 (11.1%) had active syphilis. The sensitivities of Bioline on CB and sera were similar (96.4% vs 94.6%, p = 0.6). In contrast, Determine had a lower sensitivity on CB than sera (87.5% vs 99.1%, p<0.001). Sensitivities were lower in PLWH not receiving ART (Bioline 87.1% and Determine 64.5%, p<0.001) and for one of the operators (Bioline 85% and Determine 60%, p<0.001). Specificities of the RDTs were > 95% in most analyses. Predictive values were 90% or higher. For active syphilis, the RDTs showed a similar performance pattern but with decreased specificities. Conclusion The studied RDTs have an excellent performance in PLWH to screen for syphilis and potentially for active syphilis, yet Determine performs better on sera than CB. Patient characteristics and potential difficulties operators may face in acquiring enough blood volume from finger pricks should be considered for the implementation and the interpretation of RDTs.
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Mendels, David-A., Laurent Dortet, Cécile Emeraud, et al. "Using artificial intelligence to improve COVID-19 rapid diagnostic test result interpretation." Proceedings of the National Academy of Sciences 118, no. 12 (2021): e2019893118. http://dx.doi.org/10.1073/pnas.2019893118.
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Serological rapid diagnostic tests (RDTs) are widely used across pathologies, often providing users a simple, binary result (positive or negative) in as little as 5 to 20 min. Since the beginning of the COVID-19 pandemic, new RDTs for identifying SARS-CoV-2 have rapidly proliferated. However, these seemingly easy-to-read tests can be highly subjective, and interpretations of the visible “bands” of color that appear (or not) in a test window may vary between users, test models, and brands. We developed and evaluated the accuracy/performance of a smartphone application (xRCovid) that uses machine learning to classify SARS-CoV-2 serological RDT results and reduce reading ambiguities. Across 11 COVID-19 RDT models, the app yielded 99.3% precision compared to reading by eye. Using the app replaces the uncertainty from visual RDT interpretation with a smaller uncertainty of the image classifier, thereby increasing confidence of clinicians and laboratory staff when using RDTs, and creating opportunities for patient self-testing.
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Rivero, Rocío, M. Soledad Santini, Constanza López-Albizu, et al. "Comparative evaluation of four rapid diagnostic tests that detect human Trypanosoma cruzi-specific antibodies to support diagnosis of Chagas Disease in urban population of Argentina." PLOS Neglected Tropical Diseases 18, no. 3 (2024): e0011997. http://dx.doi.org/10.1371/journal.pntd.0011997.
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Background Chagas disease (CD), caused by the parasite Trypanosoma cruzi, is the most important endemic anthropozoonosis in Argentina. Since 2010, the World Health Organization has highlighted the urgent need to validate diagnostic systems that allow rapid detection of T. cruzi, infection in primary healthcare centers. Serological rapid diagnostic tests (RDTs) for T. cruzi, infection could be used to improve case management, as RDTs do not require specialized laboratories or highly trained staff to use them. We aimed to generate unbiased performance data of RDTs in Argentina, to evaluate their usefulness for improving T. cruzi, diagnosis rates. Methods and principal findings This is a retrospective, laboratory-based, diagnostic evaluation study to estimate the clinical sensitivity/specificity of four commercially available RDTs for T. cruzi, using the Chagas disease diagnostic algorithm currently used in Argentina as the reference standard. In total, 400 serum samples were tested, 200 from individuals with chronic T. cruzi infection and 200 from individuals not infected with T. cruzi. All results were registered as the agreement of at least two operators who were blinded to the reference standard results. The sensitivity estimates ranged from 92.5–100% (95% confidence interval (CI) lower bound 87.9–98.2%); for specificity, the range was 76–96% (95% CI lower bound 69.5–92.3%). Most RDTs evaluated showed performances comparable with the reference standard method, showing almost perfect concordance (Kappa 0.76–0.92). Conclusions Our study demonstrates that, under controlled laboratory conditions, commercially available RDTs for CD have a performance comparable to the Argentinian diagnostic algorithm, which is based on laboratory-based serological tests. For the next stage of our work, the RDTs will be evaluated in real-world settings.
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Castillo-León, Jaime, Ramona Trebbien, John J. Castillo, and Winnie E. Svendsen. "Commercially available rapid diagnostic tests for the detection of high priority pathogens: status and challenges." Analyst 146, no. 12 (2021): 3750–76. http://dx.doi.org/10.1039/d0an02286a.
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Rapid diagnostic tests (RDTs) will provide a key element of disease surveillance. Their rapid turnaround, low cost, and accessibility in resource limited areas will help increase public health reporting and facilitate outbreak containment.
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Kojom Foko, Loick Pradel, Veena Pande, and Vineeta Singh. "Field Performances of Rapid Diagnostic Tests Detecting Human Plasmodium Species: A Systematic Review and Meta-Analysis in India, 1990–2020." Diagnostics 11, no. 4 (2021): 590. http://dx.doi.org/10.3390/diagnostics11040590.
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Rapid diagnostic tests (RDTs) have become a mainstay of malaria diagnosis in endemic countries since their implementation in the 1990s. We conducted a 30-year systematic review and meta-analysis on malaria RDTs performance in India. Outcomes of interest were sensitivity (Se), specificity (Sp), positive/negative likelihood ratio (PLR/NLR), and diagnostic odd ratio (DOR). Among the 75 studies included, most of the studies were cross-sectional (65.3%), hospital-based (77.3%), and targeted febrile patients (90.6%). Nearly half of RDTs were designed for detecting Plasmodium falciparum only (47.5%) while the rest were for P. falciparum and P. vivax (11.9%), and P. falciparum/Pan-Plasmodium except for P. knowlesi (32.3%). When compared to light microscopy (gold standard), pooled estimates of performances were: Se = 97.0%, Sp = 96.0%, PLR = 22.4, NLR = 0.02 and DOR = 1080. In comparison to polymerase chain reaction, the RDTs showed Se = 89.0% and Sp = 99.0%. Performance outcomes (Se and Sp) were similar for RDT targeting P. falciparum only, but decreased for mixed and non-falciparum infections. Performances of malaria RDTs are still high India. However, there is a need for developing RDTs with regard to targeting minor malarial species, individuals carrying only mature gametocytes, and pfhrp2-deleted parasites.
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Jean Louis, Frantz, Marie Lina Excellent, Renette Anselme, et al. "External quality assessment for HIV rapid tests: challenges and opportunities in Haiti." BMJ Global Health 3, no. 6 (2018): e001074. http://dx.doi.org/10.1136/bmjgh-2018-001074.
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HIV rapid diagnostic tests (RDTs) are instrumental in scaling-up HIV testing services (HTS) in low-income and middle-income countries (LMICs). HIV misdiagnosis is a growing concern in the era of expanded and decentralised access to HTS. External quality assurance (EQA) programme including proficiency testing (PT) for HIV RDTs is a priority to guarantee the accuracy and reliability of the patients’ result. Here we are sharing Haiti’s 11 years’ experience in implementing HIV RDTs EQA programme to help address some of the challenges faced by other LMICs. HTS is expanding beyond laboratory walls and HIV RDTs are increasingly performed by non-laboratory personnel and closer to the community. EQA programmes for HIV RDTs in Haiti have faced significant challenges. In expanded HTS settings, non-laboratory personnel (nurses, aid-nurses) involved in HIV RDT are usually undertrained and participate poorly in PT programs. In more than half of the lab enrolled in the PT programme in Haiti, the panels are always tested by the most experienced technician, defying the purpose of the program which is to evaluate the performance of the technician performing the test daily. EQA programme in Haiti and other LMICs are usually not tailored to address community HIV testing challenges. With decreased funding and absence of government financial commitment to HIV RDTs EQA programmes, more innovative and cost-efficient strategies are sought to ensure the quality of HIV diagnosis in LMICs. Qualified human resources, continuous training, supervision and community-tailored PT programmes remain key components for the success of HIV RDT quality management.
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Blacksell, Stuart D. "Commercial Dengue Rapid Diagnostic Tests for Point-of-Care Application: Recent Evaluations and Future Needs?" Journal of Biomedicine and Biotechnology 2012 (2012): 1–12. http://dx.doi.org/10.1155/2012/151967.
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Dengue fever, dengue haemorrhagic fever, and dengue shock syndrome (DF/DHF/DSS) are tropical diseases that cause significant humanitarian and economic hardship. It is estimated that more than 2.5 billion people are at risk of infection and more than 100 countries have endemic dengue virus transmission. Laboratory tests are essential to provide an accurate diagnosis of dengue virus infection so that appropriate treatment and patient management may be administered. In many dengue endemic settings, laboratory diagnostic resources are limited and simple rapid diagnostic tests (RDTs) provide opportunities for point-of-care diagnosis. This paper addresses current issues relating to the application of commercial dengue RDTs for the diagnosis of acute dengue virus infection, recent diagnostic evaluations, and identifies future needs.
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Haritsa, Kanthishree B., and P. Sangeetha. "Systematic Review of Rapid Typhoid Diagnostic Kits." Journal of the Scientific Society 51, no. 2 (2024): 165–76. http://dx.doi.org/10.4103/jss.jss_144_23.
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Typhoid fever is a bacterial infection that can be fatal and a major concern globally. Due to the infection’s high morbidity and fatality rates, there is an urgent need for precise and quick diagnostic tests to help with disease management and prevention. The purpose of the current review is to evaluate the specificity and sensitivity of the currently commercially available typhoid fever rapid diagnostic kits (RDTs). Publicly available English databases, such as PubMed and Google Scholar, were used to screen the research papers. We mined a total of 371 research documents, of which 18 articles were selected based on the inclusion and exclusion criteria. Studies from 10 different developing countries evaluated the diagnostic performance of Typhidot, Typhidot-M, and Tubex. The average sensitivity and specificity were approximately 80%–90% and 65%–78% for Typhidot, 85%–94% and 77%–89% for Typhidot-M, and 94.7% and 80.4% for Tubex. The sensitivity and specificity of these diagnostics varied with the geographical location. In comparison to the widely used Widal test, the observed performance cannot support the exclusive use of a particular RDT. Hence, there is a need to develop affordable, antigen-based RDTs.
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Okangba, C. C., R. I. Funwei, A. O. Solanke, et al. "Performance and Comparison of two Malaria Rapid Diagnostic Tests among Symptomatic Patients in Lagos, Southwest Nigeria." International Journal of Research and Innovation in Applied Science IX, no. V (2024): 122–34. http://dx.doi.org/10.51584/ijrias.2024.905011.
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Malaria remains a public health problem in Sub Saharan Africa. Microscopic identification of Plasmodium spp. is the gold standard for malaria diagnosis. However, malaria rapid diagnostic test kits are also available for prompt diagnosis, effective treatment and are important in reducing morbidity and mortality associated with malaria especially among high-risk groups. The use of malaria rapid diagnostic tests (RDTs) has improved Plasmodium falciparum diagnosis, especially in settings where quality microscopy is not available. Field evaluation of RDTs would assist in confirming the potency, performance of the RDTs and in ruling out or confirming malaria parasite. In this study, the performance of two RDTs were assessed for malaria diagnosis, using thick and thin blood smears as the gold standard. A total of 1,271 patients suspected to have malaria who gave consent were enrolled in the study within six months at St Matthew”s Primary Health Center Amukoko in Ajeromi Ifelodun LGA of Lagos state. The study population age range between 2-67years. This is a cross-sectional study involving patients with history of malaria symptoms. The SD Bioline and First Response HRP2 based MRDTs were evaluated in this study. Of the patients 1,271 screened for malaria, 185 were slide positive for malaria parasites. Blood smears and HRP2 First response RDT showed malaria prevalence rate of 14.6%, while the HRP2 SD Bioline RDT showed prevalence rate of 15.5%. The SD Bioline HRP2 RDTs showed a sensitivity of 61.1%, specificity of 92.3%, PPV of 57.4% and NPV of 93.3%, while the First response RDT showed a sensitivity of 58.9%, specificity of 93.1%, PPV of 59.6% and NPV of 92.9%. In this study, the sensitivity of the RDT increased with parasite density (>1000p/µl showed sensitivity >90%). All the malaria rapid diagnostic test kits performed relatively well and can be used in emergencies. Concerning cost-effectiveness, using the malaria RDTs at the hospital is cheaper than light microscopy for diagnosing malaria. However, for malaria diagnosis, malaria RDT kits cannot be relied upon alone; hence, microscopic confirmation is always required.
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CHIODINI, PETER L. "Malaria diagnostics: now and the future." Parasitology 141, no. 14 (2014): 1873–79. http://dx.doi.org/10.1017/s0031182014001371.
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SUMMARYLight microscopy of stained blood films is still the mainstay of malaria diagnosis in many regions, but its pre-eminence is threatened by accurate and sensitive rapid diagnostic tests (RDTs) based on immunochromatography which are now widely used in the field. In well-resourced regions, nucleic acid detection easily out performs microscopy and RDTs. This paper reviews the main in vitro methods for parasite detection and considers future trends in diagnostics, both for sophisticated laboratory settings and for field use.
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Yimer, Solomon Abebe, Birgitte Boonstra Booij, Gwen Tobert, et al. "Rapid diagnostic test: a critical need for outbreak preparedness and response for high priority pathogens." BMJ Global Health 9, no. 4 (2024): e014386. http://dx.doi.org/10.1136/bmjgh-2023-014386.
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Rapid diagnostic tests (RDTs) are critical for preparedness and response against an outbreak or pandemic and have been highlighted in the 100 Days Mission, a global initiative that aims to prepare the world for the next epidemic/pandemic by driving the development of diagnostics, vaccines and therapeutics within 100 days of recognition of a novel Disease X threat.RDTs play a pivotal role in early case identification, surveillance and case management, and are critical for initiating deployment of vaccine and monoclonal antibodies. Currently available RDTs, however, have limited clinical sensitivity and specificity and inadequate validation. The development, validation and implementation of RDTs require adequate and sustained financing from both public and private sources. While the World Health Assembly recently passed a resolution on diagnostic capacity strengthening that urges individual Member States to commit resources towards this, the resolution is not binding and implementation will likely be impeded by limited financial resources and other competing priorities, particularly in low-income countries. Meanwhile, the diagnostic industry has not sufficiently invested in RDT development for high priority pathogens.Currently, vaccine development projects are getting the largest funding support among medical countermeasures. Yet vaccines are insufficient tools in isolation, and pandemic preparedness will be incomplete without parallel investment in diagnostics and therapeutics.The Pandemic Fund, a global financing mechanism recently established for strengthening pandemic prevention, preparedness and response, may be a future avenue for supporting diagnostic development.In this paper, we discuss why RDTs are critical for preparedness and response. We also discuss RDT investment challenges and reflect on the way forward.
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Kim, Jung Ho, Jiyeon Suh, Woon Ji Lee, et al. "Modelling the impact of rapid diagnostic tests on Plasmodium vivax malaria in South Korea: a cost–benefit analysis." BMJ Global Health 6, no. 2 (2021): e004292. http://dx.doi.org/10.1136/bmjgh-2020-004292.
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BackgroundRapid diagnostic tests (RDTs) are widely used for diagnosing Plasmodium vivax malaria, especially in resource-limited countries. However, the impact of RDTs on P. vivax malaria incidence and national medical costs has not been evaluated. We assessed the impact of RDT implementation on P. vivax malaria incidence and overall medical expenditures in South Korea and performed a cost–benefit analysis from the payer’s perspective.MethodsWe developed a dynamic compartmental model for P. vivax malaria transmission in South Korea using delay differential equations. Long latency and seasonality were incorporated into the model, which was calibrated to civilian malaria incidences during 2014–2018. We then estimated averted malaria cases and total medical costs from two diagnostic scenarios: microscopy only and both microscopy and RDTs. Medical costs were extracted based on data from a hospital in an at-risk area for P. vivax malaria and were validated using Health Insurance Review and Assessment Service data. We conducted a cost–benefit analysis of RDTs using the incremental benefit:cost ratio (IBCR) considering only medical costs and performed a probabilistic sensitivity analysis to reflect the uncertainties of model parameters, costs and benefits.ResultsThe results showed that 55.3% of new P. vivax malaria cases were averted, and $696 214 in medical costs was saved over 10 years after RDT introduction. The estimated IBCR was 2.5, indicating that RDT implementation was beneficial, compared with microscopy alone. The IBCR was sensitive to the diagnosis time reduction, infectious period and short latency period, and provided beneficial results in a benefit over $10.6 or RDT cost under $39.7.ConclusionsThe model simulation suggested that RDTs could significantly reduce P. vivax malaria incidence and medical costs. Moreover, cost–benefit analysis demonstrated that the introduction of RDTs was beneficial over microscopy alone. These results support the need for widespread adoption of RDTs.
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Freire, Mariana Lourenço, Daniel Moreira de Avelar, Mariana Junqueira Pedras, et al. "Impact of age and immune status on the accuracy of rapid diagnostic tests for visceral leishmaniasis in Brazil." PLOS Neglected Tropical Diseases 19, no. 6 (2025): e0013087. https://doi.org/10.1371/journal.pntd.0013087.
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Background Visceral leishmaniasis (VL) represents a significant public health concern due to its high case-fatality, which poses the challenge of a timely and accurate diagnosis. Antibody-based rapid diagnostic tests (RDTs) have emerged as a disruptive innovation in recent years, by offering a diagnosis in the field, at low cost, easy to perform and with results in a few minutes. However, their performance can vary across regions and different subgroups, particularly in immunocompromised individuals. This study aimed to assess the accuracy of VL RDTs registered with the Brazilian national regulatory agency, or available through the PAHO strategic fund, considering diverse patient profiles. Methodology/principal findings Three commercially RDTs were identified LSH Ab Eco Teste, Leishmaniasis VH Bio, and Kalazar Detect and evaluated using a well characterized panel of serum samples (n = 300) from suspected VL patients from different Brazilian regions. Sensitivity, specificity, and accuracy were determined for different patient’s ages and HIV coinfection status. Overall, RDTs exhibited lower sensitivity in children under 3 years old and HIV co-infected individuals compared to those over 3 years without HIV co-infection (p < 0.05). The agreement (Cohen’s kappa coefficient) between observers (reproducibility) and intra-test (repeatability) for all three commercial kits was excellent. Conclusions/significance While RDTs offer desirable advantages in terms of access to diagnoses, variation on their performance imposes limits on their implementation. The performance of RDTs for VL exhibits significant differences related to age and immune status.
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Dembele, Bamory, Roseline Affi-Aboli, Mathieu Kabran, et al. "Evaluation of Four Rapid Tests for Detection of Hepatitis B Surface Antigen in Ivory Coast." Journal of Immunology Research 2020 (June 26, 2020): 1–6. http://dx.doi.org/10.1155/2020/6315718.
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Background. Hepatitis B virus (HBV) infection is a leading cause of liver disease worldwide. Hepatitis B surface antigen (HBsAg) rapid diagnostic tests (RDTs) could be an ideal tool for a large-scale HBV screening in settings with high endemicity but limited infrastructure. The aim of this study was to evaluate the diagnosis performance of such RDTs for screening HBV infection in Ivory Coast. Methods. From September 2018 to January 2019, a cross-sectional phase I evaluation study of RDTs was conducted in three laboratories of Abidjan (CeDReS, CNTS and IPCI), on a panel of 405 whole blood samples and 699 plasmas. Four HBsAg RDTs (Determine™ HBsAg, SD Bioline HBsAg WB®, Standard Q HBsAg® and Vikia HBsAg®) were evaluated. The diagnostic performance (sensitivity and specificity) was calculated in comparison to the reference sequential algorithms of two EIA tests (Dia.Pro HBsAg® one version ULTRA and Monolisa™ HBsAg ULTRA). Results. The Determine™ HBsAg and Vikia HBsAg® tests performed well, with 100% of sensitivity, specificity both on plasma and on whole blood. For SD Bioline HBsAg WB® and Standard Q HBsAg®, the specificities were 99.8% and the sensitivities 99.3% and 97.1% respectively. Finally, there were a total of 19 false negative results: 3 with SD Bioline HBsAg WB® and 16 with Standard Q HBsAg®. Conclusion. Determine HBsAg® from Alere and Vikia HBsAg® from Biomérieux are the most suitable RDTs for screening for HBV in Ivory Coast. A phase II evaluation must be initiated.
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Naz, Ruby, Sameena khan, Mohammad Khalid Farooqui, Ruchi Girotra, and A. K. Malik. "Comparison of Microscopic Determination and Rapid Diagnostic Tests (RDTs) in the Detection of Plasmodium Infection." Scholars Journal of Applied Medical Sciences 4, no. 7 (2016): 2539–43. http://dx.doi.org/10.21276/sjams.2016.4.7.49.
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Omonkhua, Akhere A., Adedayo Faneye, Kazeem S. Akinwande, et al. "Performance evaluation of SARS-CoV-2 rapid diagnostic tests in Nigeria: A cross-sectional study." PLOS Global Public Health 4, no. 7 (2024): e0003371. http://dx.doi.org/10.1371/journal.pgph.0003371.
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The COVID-19 pandemic challenged health systems globally. Reverse transcription polymerase chain reaction (RT-PCR) is the gold standard for detecting the presence of SARS-CoV-2 in clinical samples. Rapid diagnostic test (RDT) kits for COVID-19 have been widely used in Nigeria. This has greatly improved test turnover rates and significantly decreased the high technical demands of RT-PCR. However, there is currently no nationally representative evaluation of the performance characteristics and reliability of these kits. This study assessed the sensitivity, specificity, and predictive values of ten RDT kits used for COVID-19 testing in Nigeria. This large multi-centred cross-sectional study was conducted across the 6 geo-political zones of Nigeria over four months. Ten antigen (Ag) and antibody (Ab) RDT kits were evaluated, and the results were compared with RT-PCR. One thousand, three hundred and ten (1,310) consenting adults comprising 767 (58.5%) males and 543 (41.5%) females participated in the study. The highest proportion, 757 (57.7%), were in the 20–39 years’ age group. In terms of diagnostic performance, Lumira Dx (61.4, 95% CI: 52.4–69.9) had the highest sensitivity while MP SARS and Panbio (98.5, 95% CI: 96.6–99.5) had the highest specificity. For predictive values, Panbio (90.7, 95% CI: 79.7–96.9) and Lumira Dx (81.2, 95% CI: 75.9–85.7) recorded the highest PPV and NPV respectively. Ag-RDTs had better performance characteristics compared with Ab-RDTs; however, the sensitivities of all RDTs in this study were generally low. The relatively high specificity of Ag-RDTs makes them useful for the diagnosis of infection in COVID-19 suspected cases where positive RDT may not require confirmation by molecular testing. There is therefore the need to develop RDTs in-country that will take into consideration the unique environmental factors, interactions with other infectious agents, and strains of the virus circulating locally. This may enhance the precision of rapid and accurate diagnosis of COVID-19 in Nigeria.
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Camara, Oumou, Justin Windingoudi Kaboré, Aïssata Soumah, et al. "Conducting active screening for human African trypanosomiasis with rapid diagnostic tests: The Guinean experience (2016–2021)." PLOS Neglected Tropical Diseases 18, no. 2 (2024): e0011985. http://dx.doi.org/10.1371/journal.pntd.0011985.
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Strategies to detect Human African Trypanosomiasis (HAT) cases rely on serological screening of populations exposed to trypanosomes. In Guinea, mass medical screening surveys performed with the Card Agglutination Test for Trypanosomiasis have been progressively replaced by door-to-door approaches using Rapid Diagnostic Tests (RDTs) since 2016. However, RDTs availability represents a major concern and medical teams must often adapt, even in the absence of prior RDT performance evaluation. For the last 5 years, the Guinean HAT National Control Program had to combine three different RDTs according to their availability and price: the SD Bioline HAT (not available anymore), the HAT Sero-K-SeT (most expensive), and recently the Abbott Bioline HAT 2.0 (limited field evaluation). Here, we assess the performance of these RDTs, alone or in different combinations, through the analysis of both prospective and retrospective data. A parallel assessment showed a higher positivity rate of Abbott Bioline HAT 2.0 (6.0%, n = 2,250) as compared to HAT Sero-K-SeT (1.9%), with a combined positive predictive value (PPV) of 20.0%. However, an evaluation of Abbott Bioline HAT 2.0 alone revealed a low PPV of 3.9% (n = 6,930) which was surpassed when using Abbott Bioline HAT 2.0 in first line and HAT Sero-K-SeT as a secondary test before confirmation, with a combined PPV reaching 44.4%. A retrospective evaluation of all 3 RDTs was then conducted on 189 plasma samples from the HAT-NCP biobank, confirming the higher sensitivity (94.0% [85.6–97.7%]) and lower specificity (83.6% [76.0–89.1%]) of Abbott Bioline HAT 2.0 as compared to SD Bioline HAT (Se 64.2% [52.2–74.6%]—Sp 98.4% [94.2–99.5%]) and HAT Sero-K-SeT (Se 88.1% [78.2–93.8%]—Sp 98.4% [94.2–99.5%]). A comparison of Abbott Bioline HAT 2.0 and malaria-RDT positivity rates on 479 subjects living in HAT-free malaria-endemic areas further revealed that a significantly higher proportion of subjects positive in Abbott Bioline HAT 2.0 were also positive in malaria-RDT, suggesting a possible cross-reaction of Abbott Bioline HAT 2.0 with malaria-related biological factors in about 10% of malaria cases. This would explain, at least in part, the limited specificity of Abbott Bioline HAT 2.0. Overall, Abbott Bioline HAT 2.0 seems suitable as first line RDT in combination with a second HAT RDT to prevent confirmatory lab overload and loss of suspects during referral for confirmation. A state-of-the-art prospective comparative study is further required for comparing all current and future HAT RDTs to propose an optimal combination of RDTs for door-to-door active screening.
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Bhumika, Baria, Agravat Amit, Dhruva Gauravi, and Pujara Krupal. "A Study on Different Techniques of Laboratory Detection of Malaria in a Tertiary Care Hospital in Western India." International Journal of Pharmaceutical and Clinical Research 16, no. 7 (2024): 1553–60. https://doi.org/10.5281/zenodo.13336763.
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<strong>Background:</strong> Malaria is one of the most prevalent parasitic infections in the world including India. It is a tropical, endemic protozoal infection. In most countries, its diagnosis is challenging. Microscopy is the gold standard method for its diagnosis in clinical practice as well as for research purpose. However, it is laborious, requiring significant skills and time, causing therapeutic delays. Rapid malaria diagnostic tests (RDTs) have made possible to obtain quick results from the blood examination. Various fast, reliable and easy to use RDTs are available which can detect Plasmodium falciparum and non-falciparum infections or both. <strong>Objective:</strong> To study about different techniques for detection of malaria in a tertiary care hospital in Western India. <strong>Materials and Methods:</strong> Study was conducted in the Central Clinical Laboratory (CCL), Department of Pathology, PDU Medical College, Rajkot, Gujarat, India over one year period between June 2023 to May 2024. Peripheral blood smear stained by Hematoxylin and Eosin Stain, Leishman stain and Field stain technique for conventional smear and thick smear preparation and commercially available rapid antigen detection kits were used for the diagnosis of malaria. <strong>Results: </strong>During the 1-year period, rapid card test method showed 150 positives for malarial parasite. Of these, 127 cases were positive for P. vivax and 20 cases for P. falciparum. Peripheral blood smear method showed 139 cases positive for malarial parasite. Of these, 120 cases were positive for P. vivax and 17 cases for P. falciparum and 2 cases of co-infection. 24 cases were reported with thick smear preparation. 11 cases reported were peripheral blood smear negative. Among the cases, there were 46 females and 104 males. 20 – 29 years is the most affected age group which is followed by 30 – 39 years. Maximum samples were from the month of September with a positivity rate of 26%. <strong>Conclusion:</strong> RDTs based on detection of malaria antigen from whole blood are as specific as and more sensitive than microscopy (being considered as the gold standard method). However, peripheral blood smear method remains superior for accurate species differentiation, quantitation of parasite and maintenance of a permanent record. Other tests such as Flow cytometry, PCR, ELISA can be considered.
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Mohd Hatta, Hazlienor, Nik Mohd Hafiz Mohd Fuzi, Suhaiza Sulaiman, Abdul Haris Muhammad, and Zaini Hussin. "The Performance of Antigen-detecting Rapid Diagnostic Test Among COVID-19 Outbreaks in North-Eastern Peninsular Malaysia." Epidemiology and Health System Journal 9, no. 4 (2022): 164–70. http://dx.doi.org/10.34172/ehsj.2022.30.
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Background and aims: Accurate and timely diagnosis is crucial for coronavirus disease 2019 (COVID-19) outbreaks. Antigen-detecting rapid diagnostic tests (Ag-RDTs) are easily accessible and affordable, producing rapid results. They are an alternative to the limited gold-standard real-time reverse-transcription polymerase chain reaction (rRT-PCR) tests. This study assessed the performance of Ag-RDTs for COVID-19 outbreaks in institutional settings with high disease prevalence in Kelantan State, Malaysia. Methods: This study analyzed a total of 303 individuals from five institutional outbreaks with paired nasopharyngeal specimens tested for COVID-19 by Ag-RDTs and rRT-PCR. The diagnostic performance of Ag-RDTs was evaluated through rRT-PCR as the gold standard based on cycle threshold (Ct) value, disease prevalence, and manufacturers. Results: There was a moderate agreement between Ag-RDTs and RT-PCR (κ=0.603; 95% CI: 0.520- 0.686; P<0.001). The overall specificity was 97.9% (95% CI: 94.1%-99.6%), sensitivity was 63.3% (95% CI: 55.3%-70.8%), accuracy Ag-RDTs was 81.2% (95% CI: 76.4%-85.5%), while positive and negative predictive value was 96.6% (95% CI: 90.2%-98.9%) and 74.1% (95% CI: 70.0%-77.9%), respectively. Further, lower median Ct was reported in 100 (33.0%) true-positive cases compared to 58 (19.1%) false-negative cases (20.3 vs 31.4, P<0.001). The sensitivity was higher (P<0.001) in those with high viral load (Ct value≤25.0) with better performance and a prevalence>10%. In addition, no significant difference was observed between the studied manufacturers. Conclusion: The Ag-RDTs performed well in diagnosing COVID-19 among outbreaks with higher viral load and disease prevalence. High-risk cases tested negative by Ag-RDTs may have low viral load and require confirmation by rRT-PCR.
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Dembélé, Pascal, Mady Cissoko, Adama Zan Diarra, et al. "Evaluation of the Performance of Rapid Diagnostic Tests for Malaria Diagnosis and Mapping of Different Plasmodium Species in Mali." International Journal of Environmental Research and Public Health 21, no. 2 (2024): 228. http://dx.doi.org/10.3390/ijerph21020228.
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Background: The first-line diagnosis of malaria in Mali is based on the use of rapid diagnostic tests (RDT) that detect the Histidin Rich Protein 2 (HRP2) antigen specific to Plasmodium falciparum. Our study, based on a real-time polymerase chain reaction (qPCR) gold standard, aimed to describe the distribution of the Plasmodium species in each administrative region of Mali and to assess the performance of RDTs. Methods: We randomly selected 150 malaria-negative and up to 30 malaria-positive RDTs in 41 sites distributed in 9 regions of Mali. DNA extracted from the RDT nitrocellulose strip was assayed with a pan-Plasmodium qPCR. Positive samples were then analyzed with P. falciparum-, P. malariae-, P. vivax-, or P. ovale-specific qPCRs. Results: Of the 1496 RDTs, 258 (18.6%) were positive for Plasmodium spp., of which 96.9% were P. falciparum. The P. vivax prevalence reached 21.1% in the north. RDT displayed acceptable diagnostic indices; the lower CI95% bounds of Youden indices were all ≥0.50, except in the north (Youden index 0.66 (95% CI [0.44–0.82]) and 0.63 (95% CI [0.33–0.83]. Conclusions: Overall, RDT diagnostic indices are adequate for the biological diagnosis of malaria in Mali. We recommend the use of RDTs detecting P. vivax-specific antigens in the north.
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Park, Chunjong, Hung Ngo, Libby Rose Lavitt, et al. "The Design and Evaluation of a Mobile System for Rapid Diagnostic Test Interpretation." Proceedings of the ACM on Interactive, Mobile, Wearable and Ubiquitous Technologies 5, no. 1 (2021): 1–26. http://dx.doi.org/10.1145/3448106.
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Rapid diagnostic tests (RDTs) provide point-of-care medical screening without the need for expensive laboratory equipment. RDTs are theoretically straightforward to use, yet their analog colorimetric output leaves room for diagnostic uncertainty and error. Furthermore, RDT results within a community are kept isolated unless they are aggregated by healthcare workers, limiting the potential that RDTs can have in supporting public health efforts. In light of these issues, we present a system called RDTScan for detecting and interpreting lateral flow RDTs with a smartphone. RDTScan provides real-time guidance for clear RDT image capture and automatic interpretation for accurate diagnostic decisions. RDTScan is structured to be quickly configurable to new RDT designs by requiring only a template image and some metadata about how the RDT is supposed to be read, making it easier to extend than a data-driven approach. Through a controlled lab study, we demonstrate that RDTScan's limit-of-detection can match, and even exceed, the performance of expert readers who are interpreting the physical RDTs themselves. We then present two field evaluations of smartphone apps built on the RDTScan system: (1) at-home influenza testing in Australia and (2) malaria testing by community healthcare workers in Kenya. RDTScan achieved 97.5% and 96.3% accuracy compared to RDT interpretation by experts in the Australia Flu Study and the Kenya Malaria Study, respectively.