To see the other types of publications on this topic, follow the link: Rapid Diagnostic Test (RDT).
Journal articles on the topic 'Rapid Diagnostic Test (RDT)'
Create a spot-on reference in APA, MLA, Chicago, Harvard, and other styles
Consult the top 50 journal articles for your research on the topic 'Rapid Diagnostic Test (RDT).'
Next to every source in the list of references, there is an 'Add to bibliography' button. Press on it, and we will generate automatically the bibliographic reference to the chosen work in the citation style you need: APA, MLA, Harvard, Chicago, Vancouver, etc.
You can also download the full text of the academic publication as pdf and read online its abstract whenever available in the metadata.
Browse journal articles on a wide variety of disciplines and organise your bibliography correctly.
1
Ozkan, Haydar, and Osman Semih Kayhan. "A Novel Automatic Rapid Diagnostic Test Reader Platform." Computational and Mathematical Methods in Medicine 2016 (2016): 1–10. http://dx.doi.org/10.1155/2016/7498217.
Full textAbstract:
A novel automatic Rapid Diagnostic Test (RDT) reader platform is designed to analyze and diagnose target disease by using existing consumer cameras of a laptop-computer or a tablet. The RDT reader is useable with numerous lateral immunochromatographic assays and similar biomedical tests. The system has two different components, which are 3D-printed, low-cost, tiny, and compact stand and a decision program named RDT-AutoReader 2.0. The program takes the image of RDT, crops the region of interest (ROI), and extracts the features from the control end test lines to classify the results as invalid, positive, or negative. All related patient’s personal information, image of ROI, and the e-report are digitally saved and transferred to the related clinician. Condition of the patient and the progress of the disease can be monitored by using the saved data. The reader platform has been tested by taking image from used cassette RDTs of rotavirus (RtV)/adenovirus (AdV) and lateral flow strip RDTs ofHelicobacter pylori(H. pylori) before discarding them. The created RDT reader can also supply real-time statistics of various illnesses by using databases and Internet. This can help to inhibit propagation of contagious diseases and to increase readiness against epidemic diseases worldwide.
2
Giantini, Astuti, Dewi Wulandari, and Siskawati Suparmin. "Comparison of Syphilis Rapid Diagnostic Test to Rapid Plasma Reagin, Treponema pallidum Haemagglutination Assay and Fluorescent Treponemal Antibody-Absorption for Syphilis and Yaws Diagnostics." Indonesian Biomedical Journal 12, no. 2 (June 29, 2020): 136–42. http://dx.doi.org/10.18585/inabj.v12i2.1029.
Full textAbstract:
BACKGROUND: Syphilis and yaws are the treponemal infections which have become serious public health problems, and both are serologically indistinguishable. Developed serological tests for syphilis may also be used to diagnose yaws. In remote area, test modality with minimal requirements were needed. This study investigated the diagnostic value of syphilis rapid diagnostic test (RDT) in diagnosing syphilis and yaws.METHODS: For syphilis diagnostic test, serum samples were obtained from patients of outpatient clinic in Dr. Cipto Mangunkusumo National Central General Hospital who were sent for rapid plasma reagin (RPR) and Treponema pallidum haemagglutination assay (TPHA) to clinical laboratory of the hospital. The serum samples were collected and stored at -80°C until the day of testing for syphilis RDT and fluorescent treponemal antibody-absorption (FTA-Abs). For yaws diagnostic test, serum samples were obtained as a part of surveillance study of yaws among children 1-15 years old in West Halmahera. Venous blood samples were used for syphilis RDT and the sera were separated and were sent to Dr. Cipto Mangunkusumo National Central General Hospital for RPR, TPHA, and FTA-Abs tests.RESULTS: For syphilis diagnostic test, among 156 samples, 39 samples were positive with syphilis RDT. The sensitivity of syphilis RDT was similar to RPR and TPHA (100.0%), the specificity was same as TPHA (77.5%), but lower than RPR (84.8%) when compared to FTA-Abs IgM. The sensitivity of syphilis RDT was 62.5% and the specificity was 96.0% when compare to FTA-Abs IgG. For yaws diagnostic test, among 176 samples, 13 samples were positive with syphilis RDT. By using FTA-Abs IgM as gold standard for diagnosing yaws, the RDT have similar sensitivity (50.0%) with RPR and TPHA and syphilis RDT have similar specificity to TPHA (93.1%). If compared to FTA-Abs IgG, the sensitivity of syphilis RDT was 40.0% and the specificity was 98.0%.CONCLUSION: Syphilis RDT gives similar results with TPHA in syphilis and yaws cases. It may be used as a first line screening test latent or untreated syphilis and yaws because of good sensitivity. For yaws diagnosis Syphilis RDT, RPR, and TPHA have low sensitivity, however all those tests have an excellent agreement.KEYWORDS: FTA-Abs, rapid diagnostic test, syphilis, yaws
3
Suarjana, I. Made Dwija, and Muhammad Nauval. "RAPID DIAGNOSTIC TEST (RDT) DALAM DETEKSI MALARIA (Literature Review)." JURNAL KEDOKTERAN 5, no. 1 (November 11, 2019): 179. http://dx.doi.org/10.36679/kedokteran.v5i1.167.
Full textAbstract:
LATAR BELAKANG : Penyakit malaria merupakan infeksi yang disebabkan oleh parasit malaria, suatu protozoa darah genus plasmodium yang ditularkan oleh nyamuk anopheles betina yang terinfeksi. Tes diagnostik cepat untuk malaria berpotensi dapat digunakan di fasilitas ritel obat perifer swasta. Mereka sensitif dan dapat digunakan dengan pelatihan minimal. Di sektor publik formal, menggantikan ini untuk diagnosis klinis (non-tes) dalam pengaturan periferal tanpa akses ke laboratorium umumnya mengarah ke penargetan yang lebih baik. Surveilans epidemiologi terhadap penyakit dapat menentukan penilaian situasi suatu penyakit, di antaranya malaria. Pengamatan yang terus menerus atas distribusi dan kecenderungan penyakit malaria melalui pengumpulan data yang sistematis sangat diperlukan untuk penentuan penanggulangan yang terbaik dan tepat sasaran.
METODE : Pada artikel ini digunakan 2 jurnal Randomize Controll Trial mengenai Uji Rapid Diagnostic Test (RDT) malari untuk mengetahui spseifitas dan sensitivitas dari uji diagnostic tersebut. Penilaian spesifitasdan sensitivitas kami lakukan secara manual menggunakan table tradisional 2x2.
DISKUSI : penelitian uji diagnostic RDT jika dibandingakan dengan standart baku yaitu blood smear, menunjukkan sensitivitas dan spesifitas yang sangayt baik.
4
Vishruti Gandhi, Vishruti Gandhi, Prasad Muley, Niyati Parikh, Hardik Gandhi, and Akash Mehta. "Is rapid diagnostic test (malaria Pv/Pf Ag card test) reliable in diagnosing malaria." International Journal of Contemporary Pediatrics 5, no. 1 (December 21, 2017): 92. http://dx.doi.org/10.18203/2349-3291.ijcp20175565.
Full textAbstract:
Background: Malaria is a protozoan disease transmitted by the bite of infected female anopheles mosquitoes is one of the most important parasitic diseases of human with transmission in 109 countries, affecting more than one billion people worldwide. This study was planned to compare the gold standard i.e. peripheral blood smear examination and the newer rapid diagnostic test (malaria plasmodium falciparum/ plasmodium vivax antigen card) to know the diagnostic accuracy of Rapid Diagnostic Test (RDT) kits. Methods: All the suspected cases of WHO defined malaria between 1month to 18 years of age were enrolled in the study.Results: Out of 96 clinically suspected cases of malaria 63 were confirmed by peripheral smear. The age range of participants ranged from 4 months to 17 years. On peripheral smear examination, out of 96 clinically suspected cases, 37 (38.5%) cases were positive for P. vivax, 23 (23.9%) were positive for P. falciparum and 3 (3.1%) were positive for both parasites by microscopy. Sensitivity and specificity of RDT for Plasmodium Vivax is 92.5% and 96.4% respectively. Sensitivity and specificity of RDT for Plasmodium Falciparum is 96.2% and 90%.Conclusions: The rational use of RDTs as a complement to microscopy might give substantial health benefits through earlier treatment, reduction in morbidity and mortality and more rationalized approach for choosing anti-malarial drugs, which in terms may prevent drug resistance.
5
Wongsrichanalai, Chansuda, Walther H. Wernsdorfer, Sinuon Muth, Awalludin Sutamihardja, and Mazie J. Barcus. "A Review of Malaria Diagnostic Tools: Microscopy and Rapid Diagnostic Test (RDT)." American Journal of Tropical Medicine and Hygiene 77, no. 6_Suppl (December 1, 2007): 119–27. http://dx.doi.org/10.4269/ajtmh.2007.77.119.
Full text
6
Park, Chunjong, Hung Ngo, Libby Rose Lavitt, Vincent Karuri, Shiven Bhatt, Peter Lubell-Doughtie, Anuraj H. Shankar, 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 (March 19, 2021): 1–26. http://dx.doi.org/10.1145/3448106.
Full textAbstract:
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.
7
Mendels, David-A., Laurent Dortet, Cécile Emeraud, Saoussen Oueslati, Delphine Girlich, Jean-Baptiste Ronat, Sandrine Bernabeu, Silvestre Bahi, Gary J. H. Atkinson, and Thierry Naas. "Using artificial intelligence to improve COVID-19 rapid diagnostic test result interpretation." Proceedings of the National Academy of Sciences 118, no. 12 (March 5, 2021): e2019893118. http://dx.doi.org/10.1073/pnas.2019893118.
Full textAbstract:
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.
8
Debes, Amanda K., Kelsey N. Murt, Ethel Waswa, Gerald Githinji, Mamo Umuro, Caroline Mbogori, Mellisa Roskosky, et al. "Laboratory and Field Evaluation of the Crystal VC-O1 Cholera Rapid Diagnostic Test." American Journal of Tropical Medicine and Hygiene 104, no. 6 (June 2, 2021): 2017–23. http://dx.doi.org/10.4269/ajtmh.20-1280.
Full textAbstract:
Abstract.Cholera is a severe acute, highly transmissible diarrheal disease which affects many low- and middle-income countries. Outbreaks of cholera are confirmed using microbiological culture, and additional cases during the outbreak are generally identified based on clinical case definitions, rather than laboratory confirmation. Many low-resource areas where cholera occurs lack the capacity to perform culture in an expeditious manner. A simple, reliable, and low-cost rapid diagnostic test (RDT) would improve identification of cases allowing rapid response to outbreaks. Several commercial RDTs are available for cholera testing with two lines to detect either serotypes O1 and O139; however, issues with sensitivity and specificity have not been optimal with these bivalent tests. Here, we report an evaluation of a new commercially available cholera dipstick test which detects only serotype O1. In both laboratory and field studies in Kenya, we demonstrate high sensitivity (97.5%), specificity (100%), and positive predictive value (100%) of this new RDT targeting only serogroup O1. This is the first field evaluation for the new Crystal VC-O1 RDT; however, with these high-performance metrics, this RDT could significantly improve cholera outbreak detection and improve surveillance for better understanding of cholera disease burden.
9
Sillehu, Sahrir, Heny Arwati, Yoes Prijatna Dachlan, and Sudjajadi Keman. "Sensitivity and Specificity of Rapid Diagnostic Test with Microscopic Gold Standard to Identify Plasmodium Species." International Journal of Public Health Science (IJPHS) 5, no. 4 (October 8, 2016): 354. http://dx.doi.org/10.11591/ijphs.v5i4.4829.
Full textAbstract:
Malaria is a main health problem in islands area which is under developed and isolated. Nation-wide, in 2014 Maluku province was recorded to have Annual Malaria Incident (AMI) value of 30.4%, positive incidents of 13.30%, ABER 3.76%, SPR 21.50%, and Annual Paracite Incident (API) 8.10%, while South Buru Regency has a value of Annual Malaria Incident (AMI) of 14.49%, 494 positive incidents, ABER 1.12%, SPR 60.91%, and Annual Paracite Incident (API) 6.86%. The purpose of this study was to identify Plasmodium species in malaria incidents in NamroleSubdistrict, South Buru Regency, Maluku Province. Observational research with a sample of 64 respondents for symptomatic and asymptomatic malaria. The instrument for the research was Rapid Diagnostic Test (RDT) and microscopic Gold Standard. Result: Malaria examination by using RDT suggested 3 kinds of parasites, i.e., P. falciparum, P. Vivax, and a mix between P. falciparum and P. vivax. Most parasites found were P. falciparum 56.3%. The accuracy of RDT examination was proven with microscopic test and the result suggested that the RDT sensitivity was 100% and the specifivity was 63.3%. Positive predictive value was 92.9% and negative predictive value was 100%, both were for positive likelihood ration of 2.75%. While for negative likelihood ration of 0%, the value of degree of conformity (Kappa) between RDT and microscopic is 0%. RDT has one benefit that it can be use to conduct malaria diagnosis rapidly, particularly in isolated areas. The benefit of Rapid Diagnostic Test (RDT) was that it could be used in remote and isolated areas to conduct diagnosis. RDT is highly effective and efficient.
10
Sillehu, Sahrir, Heny Arwati, Yoes Prijatna Dachlan, and Sudjajadi Keman. "Sensitivity and Specificity of Rapid Diagnostic Test with Microscopic Gold Standard to Identify Plasmodium Species." International Journal of Public Health Science (IJPHS) 5, no. 4 (October 8, 2016): 354. http://dx.doi.org/10.11591/.v5i4.4829.
Full textAbstract:
Malaria is a main health problem in islands area which is under developed and isolated. Nation-wide, in 2014 Maluku province was recorded to have Annual Malaria Incident (AMI) value of 30.4%, positive incidents of 13.30%, ABER 3.76%, SPR 21.50%, and Annual Paracite Incident (API) 8.10%, while South Buru Regency has a value of Annual Malaria Incident (AMI) of 14.49%, 494 positive incidents, ABER 1.12%, SPR 60.91%, and Annual Paracite Incident (API) 6.86%. The purpose of this study was to identify Plasmodium species in malaria incidents in NamroleSubdistrict, South Buru Regency, Maluku Province. Observational research with a sample of 64 respondents for symptomatic and asymptomatic malaria. The instrument for the research was Rapid Diagnostic Test (RDT) and microscopic Gold Standard. Result: Malaria examination by using RDT suggested 3 kinds of parasites, i.e., P. falciparum, P. Vivax, and a mix between P. falciparum and P. vivax. Most parasites found were P. falciparum 56.3%. The accuracy of RDT examination was proven with microscopic test and the result suggested that the RDT sensitivity was 100% and the specifivity was 63.3%. Positive predictive value was 92.9% and negative predictive value was 100%, both were for positive likelihood ration of 2.75%. While for negative likelihood ration of 0%, the value of degree of conformity (Kappa) between RDT and microscopic is 0%. RDT has one benefit that it can be use to conduct malaria diagnosis rapidly, particularly in isolated areas. The benefit of Rapid Diagnostic Test (RDT) was that it could be used in remote and isolated areas to conduct diagnosis. RDT is highly effective and efficient.
11
Osarfo, Joseph, Harry Tagbor, Michael Alifragis, and Pascal Magnuess. "Diagnostic performance of HRP2-only malaria rapid diagnostic test in Ghanaian pregnant women with asymptomatic peripheral blood infection: the case of First Response® test kit." Second Edition in 2020 of the HSI Journal Volume 1 Issue 2 Publication 1, no. 2 (December 22, 2020): 86–92. http://dx.doi.org/10.46829/hsijournal.2020.12.1.2.86-92.
Full textAbstract:
Background: The use of malaria rapid diagnostic test(RDT) enables targeted treatment that mitigates against the development of parasite drug resistance. With detection thresholds at ≥200 parasites/μL, their diagnostic performance in pregnant women may be challenging as asymptomatic infections with low parasite densities are common. Few data exist on the performance of histidine-rich protein-2 (HRP2) RDTs in Ghanaian pregnant women considering commonly occurring low parasite densities. Objective: The study sought to contribute more knowledge on test performance on First Response® test kit to guide the continuous evaluation of HRP2 RDTs in pregnancy. Methods: As part of an antimalarial drug trial in pregnancy, First Response® RDT results were compared to microscopy of peripheral blood slides in 1664 women. The diagnostic performance indicators were computed as proportions with 95% confidence intervals. The risk of having a positive RDT result was computed for age, gravidity and parasite density using binomial regression methods. Results: Parasitaemia prevalence by microscopy was 5.71%(n =95/1664) while that by RDT was 21.57%(n = 359/1664). Sensitivity was 82.11% (n=78/95), specificity was 82.09% (n=1288/1569), positive predictive value was 21.73% (n=78/359), and the likelihood ratio for a positive test was 4.58. False-negative RDT results were recorded for low parasite densities as well as densities ≥ 200/ μL while false-positive results were recorded in 281of 1664 tests. Primigravidae and younger aged women were more likely to have positive RDT results compared to multigravidae and women aged ≥ 30 yr. Conclusion: The moderate sensitivity, specificity and other diagnostic parameters reported suggest the First Response® malaria RDT is useful for detecting peripheral parasitaemia in pregnant women but the use of HRP2-only RDTs is limited by the existence of parasites with HRP2 gene deletion. The use of RDTs based on combined antigens continues to be recommended. Further research is needed on RDT performance in pregnant women with declining malaria transmission.
12
Osarfo, Joseph, Harry Tagbor, Michael Alifragis, and Pascal Magnuess. "Diagnostic performance of HRP2-only malaria rapid diagnostic test in Ghanaian pregnant women with asymptomatic peripheral blood infection: the case of First Response® test kit." Second Edition in 2020 of the HSI Journal Volume 1 Issue 2 Publication 1, no. 2 (December 22, 2020): 86–92. http://dx.doi.org/10.46829/hsijournal.2020.12.1.2.86-92.
Full textAbstract:
Background: The use of malaria rapid diagnostic test(RDT) enables targeted treatment that mitigates against the development of parasite drug resistance. With detection thresholds at ≥200 parasites/μL, their diagnostic performance in pregnant women may be challenging as asymptomatic infections with low parasite densities are common. Few data exist on the performance of histidine-rich protein-2 (HRP2) RDTs in Ghanaian pregnant women considering commonly occurring low parasite densities. Objective: The study sought to contribute more knowledge on test performance on First Response® test kit to guide the continuous evaluation of HRP2 RDTs in pregnancy. Methods: As part of an antimalarial drug trial in pregnancy, First Response® RDT results were compared to microscopy of peripheral blood slides in 1664 women. The diagnostic performance indicators were computed as proportions with 95% confidence intervals. The risk of having a positive RDT result was computed for age, gravidity and parasite density using binomial regression methods. Results: Parasitaemia prevalence by microscopy was 5.71%(n =95/1664) while that by RDT was 21.57%(n = 359/1664). Sensitivity was 82.11% (n=78/95), specificity was 82.09% (n=1288/1569), positive predictive value was 21.73% (n=78/359), and the likelihood ratio for a positive test was 4.58. False-negative RDT results were recorded for low parasite densities as well as densities ≥ 200/ μL while false-positive results were recorded in 281of 1664 tests. Primigravidae and younger aged women were more likely to have positive RDT results compared to multigravidae and women aged ≥ 30 yr. Conclusion: The moderate sensitivity, specificity and other diagnostic parameters reported suggest the First Response® malaria RDT is useful for detecting peripheral parasitaemia in pregnant women but the use of HRP2-only RDTs is limited by the existence of parasites with HRP2 gene deletion. The use of RDTs based on combined antigens continues to be recommended. Further research is needed on RDT performance in pregnant women with declining malaria transmission.
13
Lopez, Aquel Rene. "Reliability of Rapid Diagnostic Tests in the Diagnosis of Malaria amongst Children attending the Outpatient Department of the Tetteh Quarshie Memorial Hospital in the Akuapem North District of the Eastern Region of Ghana." TEXILA INTERNATIONAL JOURNAL OF ACADEMIC RESEARCH 8, no. 2 (April 30, 2021): 36–41. http://dx.doi.org/10.21522/tijar.2014.08.02.art005.
Full textAbstract:
Treatment of malaria, with the appropriate diagnostic tool, helps to reduce morbidity and mortality in children. The absence of resources and inadequate labor in emerging countries like Ghana make malaria microscopy difficult. The Rapid Diagnostic Test kit (RDT) remains unpopular despite its availability and ease of use because of limited research on its effectiveness leading to over prescription of antimalarial drugs. This study shows how reliable the malaria diagnostic test is. Out of 132 children were recruited in all into the study with more females (59.1%) than males (40.9%). 35 (26.5%) of children who were recruited tested positive for Plasmodium falciparum with the Malaria rapid diagnostic test cassette while 97 (73.5%) children tested negative for Plasmodium falciparum with the malaria diagnostic test cassette. In Malaria Microscopy, 35 (26.5%) children tested positive while 97 (73.5%) tested negative for malaria parasites. Out of the 35 children who tested positive, RDT picked 33 as positive and 2 as negative (sensitivity = 94.3%). While out of the 97 that tested negative for microscopy, RDT picked 94 as negative and 3 as positive (specificity= 96.9%). The positive predictive value and negative predictive values are 91.7% and 97.9%, respectively.This clearly shows the Rapid Diagnostic Test (RDT) is an effective diagnostic tool for the testing of malaria in children in the Akuapem North District in the Eastern Region of Ghana.
14
Oyeyemi, Oyetunde T., Akinwale F. Ogunlade, and Isaac O. Oyewole. "Comparative Assessment of Microscopy and Rapid Diagnostic Test (RDT) as Malaria Diagnostic Tools." Research Journal of Parasitology 10, no. 3 (March 1, 2015): 120–26. http://dx.doi.org/10.3923/jp.2015.120.126.
Full text
15
Watson, Oliver J., Kelsey Marie Sumner, Mark Janko, Varun Goel, Peter Winskill, Hannah C. Slater, Azra Ghani, Steven R. Meshnick, and Jonathan B. Parr. "False-negative malaria rapid diagnostic test results and their impact on community-based malaria surveys in sub-Saharan Africa." BMJ Global Health 4, no. 4 (July 2019): e001582. http://dx.doi.org/10.1136/bmjgh-2019-001582.
Full textAbstract:
Surveillance and diagnosis of Plasmodium falciparum malaria relies predominantly on rapid diagnostic tests (RDT). However, false-negative (FN) RDT results are known to occur for a variety of reasons, including operator error, poor storage conditions, pfhrp2/3 gene deletions, poor performance of specific RDT brands and lots, and low-parasite density infections. We used RDT and microscopy results from 85 000 children enrolled in Demographic Health Surveys and Malaria Indicator Surveys from 2009 to 2015 across 19 countries to explore the distribution of and risk factors for FN-RDTs in sub-Saharan Africa, where malaria’s impact is greatest. We sought to (1) identify spatial and demographic patterns of FN-RDT results, defined as a negative RDT but positive gold standard microscopy test, and (2) estimate the percentage of infections missed within community-based malaria surveys due to FN-RDT results. Across all studies, 19.9% (95% CI 19.0% to 20.9%) of microscopy-positive subjects were negative by RDT. The distribution of FN-RDT results was spatially heterogeneous. The variance in FN-RDT results was best explained by the prevalence of malaria, with an increase in FN-RDT results observed at lower transmission intensities, among younger subjects, and in urban areas. The observed proportion of FN-RDT results was not predicted by differences in RDT brand or lot performance alone. These findings characterise how the probability of detection by RDTs varies in different transmission settings and emphasise the need for careful interpretation of prevalence estimates based on surveys employing RDTs alone. Further studies are needed to characterise the cost-effectiveness of improved malaria diagnostics (eg, PCR or highly sensitive RDTs) in community-based surveys, especially in regions of low transmission intensity or high urbanicity.
16
Park, Seo Hye, Seung Jegal, Seong Kyu Ahn, Haneul Jung, Jinyoung Lee, Byoung-Kuk Na, Sung-Jong Hong, Young Yil Bahk, and Tong-Soo Kim. "Diagnostic Performance of Three Rapid Diagnostic Test Kits for Malaria Parasite Plasmodium falciparum." Korean Journal of Parasitology 58, no. 2 (April 30, 2020): 147–52. http://dx.doi.org/10.3347/kjp.2020.58.2.147.
Full textAbstract:
Malaria is a potent burden on public healthcare worldwide due to requiring rapid diagnosis and treatment. Nowadays, prompt diagnosis with rapid diagnostic tests (RDTs) has been widely accepted as an effective diagnostic technique in malaria-endemic countries, primarily due to their easy operation, fast output, and straightforward interpretation. The global availability and use of RDTs have gradually grown over recent decades as field-applicable diagnostic tests for the reliable confirmation of malaria infection and proper case management. This study was conducted to evaluate diagnostic performance of 3 commercially available malaria RDT kits : BIOCREDIT<sup>TM</sup> Malaria Ag Pf(pLDH), Malaria Ag <i>Pf</i>(pLDH/pHRPII), and Malaria Ag <i>Pf/Pv</i>(pLDH/pLDH) (where pLDH and pHRPII stand for plasmodium lactate dehydrogenase and histidine-rich protein 2, respectively) for the specific detection of <i>Plasmodium falciparum</i>. A total of 1,129 blood samples including 95 blood samples, confirmed as vivax malaria infection by microscopic examinations and a nested-PCR method, were tested for falciparum malaria infection. The overall sensitivity and specificity of Malaria Ag <i>Pf</i>(pLDH/pHRPII), Malaria Ag <i>Pf/Pv</i>(pLDH/pLDH), and <i>Pf</i>(pLDH) for <i>P. falciparum</i> were 99.0% and 100%, 95.8% and 100%, and 100% and 100%, respectively. It is proposed that the 3 RDT kits perform reliable level of diagnostic accuracy of detection for <i>P. falciparum</i> parasites.
17
Hunsperger, Elizabeth A., Tyler M. Sharp, Paul Lalita, Kini Tikomaidraubuta, Yolanda Rebello Cardoso, Taina Naivalu, Aalisha Sahu Khan, et al. "Use of a Rapid Test for Diagnosis of Dengue during Suspected Dengue Outbreaks in Resource-Limited Regions." Journal of Clinical Microbiology 54, no. 8 (May 25, 2016): 2090–95. http://dx.doi.org/10.1128/jcm.00521-16.
Full textAbstract:
Dengue is major public health problem, globally. Timely verification of suspected dengue outbreaks allows for public health response, leading to the initiation of appropriate clinical care. Because the clinical presentation of dengue is nonspecific, dengue diagnosis would benefit from a sensitive rapid diagnostic test (RDT). We evaluated the diagnostic performance of an RDT that detects dengue virus (DENV) nonstructural protein 1 (NS1) and anti-DENV IgM during suspected acute febrile illness (AFI) outbreaks in four countries. Real-time reverse transcription-PCR and anti-DENV IgM enzyme-linked immunosorbent assay were used to verify RDT results. Anti-DENV IgM RDT sensitivity and specificity ranged from 55.3 to 91.7% and 85.3 to 98.5%, respectively, and NS1 sensitivity and specificity ranged from 49.7 to 92.9% and 22.2 to 89.0%, respectively. Sensitivity varied by timing of specimen collection and DENV serotype. Combined test results moderately improved the sensitivity. The use of RDTs identified dengue as the cause of AFI outbreaks where reference diagnostic testing was limited or unavailable.
18
Osei-Yeboah, James, Gameli Kwame Norgbe, Sylvester Yao Lokpo, Mohammed Khadijah Kinansua, Loverage Nettey, and Emmanuel Alote Allotey. "Comparative Performance Evaluation of Routine Malaria Diagnosis at Ho Municipal Hospital." Journal of Parasitology Research 2016 (2016): 1–7. http://dx.doi.org/10.1155/2016/5837890.
Full textAbstract:
Differences in quality performance score had been reported for the routinely used diagnostic methods for malaria at different settings. There is therefore a need to evaluate the test performance of the routine diagnostic methods for malaria detection in Ho, a setting with no recorded quality evaluation on malaria diagnosis. The hospital-based cross-sectional study was conducted comprising 299 outpatients. Patients were first seen and presumptively diagnosed with malaria by a clinician and were referred to the laboratory for confirmation (microscopy and Rapid Diagnostic Test). The performance analysis included sensitivity, specificity, receiver operating characteristics (ROC), weighted kappa, Youden index, andpvalue. Out of the 299 patients, 221 patients were positive by presumptive diagnosis, 35 were positive by Rapid Diagnostic Test (RDT), and 25 were positive by microscopy. Using microscopy as the gold standard, RDT had sensitivity of 62.5% and specificity of 92.73%, whilst presumptive diagnosis had a sensitivity of 70.83% and specificity of 25.82%. The RDT recorded ROC of 0.697 withpvalue of 0.0001. The presumptive diagnosis recorded ROC of 0.506 withpvalue of 0.7304. Though none of the test methods evaluated over the gold standard achieved the WHO recommended diagnostic sensitivity and specificity, the RDT achieved an acceptable agreement with the gold standard.
19
Chevaliez, Stéphane, Françoise Roudot-Thoraval, Christophe Hézode, Jean-Michel Pawlotsky, and Richard Njouom. "Performance of rapid diagnostic tests for HCV infection in serum or plasma." Future Microbiology 16, no. 10 (July 2021): 713–19. http://dx.doi.org/10.2217/fmb-2020-0295.
Full textAbstract:
Aim: HCV diagnosis will become the bottleneck in eliminating hepatitis C. Simple, accurate and cost-effective testing strategies are urgently needed to improve hepatitis C screening and diagnosis. Materials & methods: Performance of seven rapid diagnostic tests (RDT) have been assessed in a large series (n = 498) of serum or plasma specimens collected in France and in Cameroon. Results: Specificity varied from 96.1 to 100%. The clinical sensitivity, compared with immunoassays as the reference, was high for all seven RDT (97.2–100%). The Multisure HCV antibody assay and OraQuick HCV rapid antibody test reached sensitivity ≥99%. Conclusion: A number of RDT may be suitable for WHO prequalification and may be implemented in the framework of large-scale low-cost treatment programs to achieve the WHO viral hepatitis objectives by 2030.
20
Dörschug, Anja, Julian Schwanbeck, Andreas Hahn, Anke Hillebrecht, Sabine Blaschke, Uwe Groß, Markus M. Heimesaat, Hagen Frickmann, and Andreas E. Zautner. "Evaluation of the Xiamen AmonMed Biotechnology rapid diagnostic test COVID-19 IgM/IgG test kit (Colloidal gold)." European Journal of Microbiology and Immunology 10, no. 3 (October 14, 2020): 178–85. http://dx.doi.org/10.1556/1886.2020.00029.
Full textAbstract:
AbstractIntroductionTo efficiently monitor the COVID-19 pandemic for surveillance purposes, reliable serological rapid diagnostic tests (RDTs) are desirable for settings where well-established high-throughput bench-top solutions are not available. Here, we have evaluated such an RDT.MethodsWe have assessed the Xiamen AmonMed Biotechnology COVID-19 IgM/IgG test kit (Colloidal gold) and the EUROIMMUN benchtop assay with serum samples from patients with polymerase chain reaction (PCR)-confirmed COVID-19 disease. Samples from patients with Epstein-Barr-virus (EBV) infection and blood donors were used for specificity testing.ResultsFor the colloid gold rapid test and the EUROIMMUN assay, the study indicated overall sensitivity of 15.2% and 67.4%, respectively, while specificity of 99.0% and 97.9% with the blood donor sera, as well as 100% and 96.8% with the EBV-patients, were observed, respectively. An association of the time period between positive PCR results and serum acquisition with serological test positivity could be observed for the immunologlobulin G subclass of the EUROIMMUN assay only.ConclusionsIn spite of acceptable specificity of the assessed RDT, the detected poor sensitivity leaves room for improvement. The test results remain difficult to interpret and therefore the RDT can currently not be recommended for routine diagnostic or surveillance use.
21
Umegbolu, Emmanuel I., and Chinedu N. Madukwe. "Rapid diagnostic test versus microscopy in the diagnosis of acute malaria in a district hospital in Enugu state, Southeast Nigeria." International Journal Of Community Medicine And Public Health 5, no. 1 (December 23, 2017): 54. http://dx.doi.org/10.18203/2394-6040.ijcmph20175762.
Full textAbstract:
Background: Malaria is a systemic disease caused by various species of Plasmodium, transmitted through the bite of a female Anopheles mosquito. According to the World Health Organisation, there were 214 million cases of malaria worldwide in 2015. Nigeria’s burden of malaria is about 51million cases and 207,000 deaths annually, accounting for 60% of outpatient visits to hospitals, 11% of maternal mortality, and 30% of child mortality. The study aimed to compare RDT and microscopy in malaria diagnosis in a District Hospital in Enugu state, Southeast Nigeria. Methods: Blood samples of 300 suspected cases of acute malaria were tested for malaria parasite using RDT and microscopy simultaneously. Results: In 2017, the study found a malaria prevalence of 25% (46.2% in children, and 18.1% in adults) in Awgu. RDT was positive in 38% and microscopy in 70.3% of cases. Both RDT and microscopy were positive in 36.3%, negative in 28.3%, and discordant in 35.4%. Sensitivity of RDT was 50.7% (89.4% in children, and 25.6% in adults). RDT had a specificity of 100% (both children and adults), positive predictive value of 1 (both children and adults), and negative predictive value of 0.6 (0.5 in children, 0.6 in adults). Conclusions: RDT (SD Malaria Ag P. f) had more sensitivity in children (89.4%) than adults (25.6%), and the occurrence of false negative results was more in adults (46.8%) than children (9.5%). All negative RDT results need to be examined microscopically, to rule out false negative cases.
22
Lidia, Kartini. "A Comparative Study of Malaria Diagnosis Using Rapid Diagnostic Tests (RDT) and Microscopy in Fever Patients in East and West Kupang District, Indonesia during the COVID-19 Pandemic." Journal of Communicable Diseases 53, no. 02 (June 30, 2021): 57–61. http://dx.doi.org/10.24321/0019.5138.202126.
Full textAbstract:
Introduction: Malaria is a parasitic infectious disease that is still a world health problem, especially in tropical countries including Indonesia. Itis still a major cause of death in both adults and children. The majority of cases occur in the African region (93%), followed by Southeast Asia including Indonesia (3.4%), and the East Mediterranean region (2.1%). The number of deaths due to malaria globally in 2018 reached 405,000, a decrease compared to416,000 in 2017 and 585,000 in 2010. In the era of theCOVID-19 pandemic. Aim: This study is useful to provide a descriptive picture of the number of malaria casesthat presented with fever, which is also a common symptom of COVID-19. Methods:This research is an interventional descriptive study with the aim of comparing the number of malaria cases with fever symptoms diagnosed through microscopic examination and Rapid Diagnostic Test (RDT) at the Batakte Health Centre located in West Kupang (Group 1) and at the Naibonat Health Centre (Group 2) located in East Kupang. The total sample in this study were 128 people with fever symptoms. In each group, the malaria blood smear was examined and RDT was carried out. Result: The Result of the study revealedthat there were no malaria cases found in both Batakte Health Center and the Naibonat Health Center during the COVID-19 pandemic period. Conclusion: There is no significant difference between the Batakte and Naibonat Health centres in terms of malaria diagnosis using both microscopy and RDT.
23
Lopez, Aquel Rene. "Prevalence of Pfhrp2 and Pfhrp3 Gene Deletions in Plasmodium Falciparum Isolates and their Performance of Hrp2 Based Malaria Rapid Diagnostic Tests in Three Districts of Ghana." TEXILA INTERNATIONAL JOURNAL OF ACADEMIC RESEARCH 8, no. 3 (July 30, 2021): 22–30. http://dx.doi.org/10.21522/tijar.2014.08.03.art003.
Full textAbstract:
Malaria rapid diagnostic tests (MRDTs) are important for malaria disease management. However, the performance of the RDTs is affected when the targeted antigens in the parasite have a variation or are altogether absent. The most common parasite target antigen in RDTs, Plasmodium falciparum histidine-rich protein 2 (HRP2), has been reported to be absent in some P. falciparum parasites. 371 patient samples, from Akuapem North (58.5%), Atiwa East (21.3%), and from New Juaben (20.2%), were used in the study. PCR provided the highest number, 14.8% (55/371), of positive detections for falciparum infections. Microscopy detected parasites in 20/261 (7.7%) samples, and the minimum parasite density by microscopy was 430 parasites/µL. Out of the 371 samples, 27 (7.3%) were positive by RDT. The highest RDT positivity rate, 13.3% (10/75), was observed at New Juaben. False-negative RDT results were obtained in 43/55 (78.2%) of the negative branded RDT kits. Only two microscopies positive sample were RDT positive. Using 18SrDNA PCR, 55 (14.8%) samples were positive for P. falciparum. In Akuapem North, 79.2 % (19/24) of the PCR positive samples had P. falciparum parasites that lacked exon 2 of PFHRP2. An overall RDT positivity rate of 7.3% (27/371) and false-negative rate of 78.2% (43/55) were observed for the study sites. Plasmodium falciparum parasite populations with deletions of the PFHRP2 and PFHRP3 genes are present in Ghana. There is an urgent need to investigate the prevalence and geographic distribution of these parasites. Keywords: Histidine Rich Protien (HRP), Malaria Rapid Diagnostic Test (MRDT), Malaria, Rapid Diagnostic Test (RDT).
24
Ojurongbe, Olusola, Olunike Olayeni Adegbosin, Sunday Samuel Taiwo, Oyebode Armstrong Terry Alli, Olugbenga Adekunle Olowe, Taiwo Adetola Ojurongbe, Oloyede Samuel Bolaji, and Oluwaseyi Adegboyega Adeyeba. "Assessment of Clinical Diagnosis, Microscopy, Rapid Diagnostic Tests, and Polymerase Chain Reaction in the Diagnosis of Plasmodium falciparum in Nigeria." Malaria Research and Treatment 2013 (November 24, 2013): 1–5. http://dx.doi.org/10.1155/2013/308069.
Full textAbstract:
This study compares the performance of clinical diagnosis and three laboratory diagnostic methods (thick film microscopy (TFM), rapid diagnostic test (RDT), and polymerase chain reaction (PCR)) for the diagnosis of Plasmodium falciparum in Nigeria. Using clinical criteria, 217 children were recruited into the study out of which 106 (48.8%) were positive by TFM, 84 (38.7%) by RDT, and 125 (57.6%) by PCR. Using a composite reference method generated from the three diagnostic methods, 71 (32.7%) patients were found to be truly infected and 90 (41.5%) truly uninfected, while 56 (25.8%) were misidentified as infected or noninfected. When each of the 3 diagnostic methods was compared with the composite reference, PCR had sensitivity of 97.3%, specificity of 62.5%, positive predictive value (PPV) of 56.8%, and negative predictive value (NPV) of 97.8%; microscopy had sensitivity of 77.2%, specificity of 72%, PPV of 66.9%, and NPV of 81.1%, while RDT had sensitivity of 62.3%, specificity of 87.4%, PPV of 67.7%, and NPV of 84.5%. PCR test performed best among the three methods followed by TFM and RDT in that order. The result of this study shows that clinical diagnosis cannot be relied upon for accurate diagnosis of P. falciparum in endemic areas.
25
Zainab Sabo Muhammad, Mahmud Yerima Iliyasu, Hassan Shuaibu Musa, Ibrahim Mustapha, and Goni Musa Lawan. "Comparative study on the performance of microscopic and rapid diagnostic test (RDT) for malaria among some patients in Maiduguri metropolis." World Journal of Biology Pharmacy and Health Sciences 3, no. 3 (October 30, 2020): 023–29. http://dx.doi.org/10.30574/wjbphs.2020.3.3.0060.
Full textAbstract:
Malaria remains a major public health problem in Nigeria, that a positive, accurate and reliable microscopy or RDT should preferably be obtained before commencing treatment. High specificity will reduce unnecessary treatment with antimalarial drugs and improve the diagnosis. This study analyze the performance of microscopy and Rapid Diagnostic Techniques (RDT) used in the diagnosis of malaria at the University of Maiduguri Teaching Hospital, Maiduguri, Borno State, Nigeria from September to October, 2019. A total of 118 blood samples was screened for malaria by preparation of thick and thin film, Leishman staining and microscopic examination of the slides under oil immersion objectives. Rapid Diagnostic test (RDT) was performed using NADAL® Malaria 4 species test cassettes, with emphasis on falciparum malaria. The results shows that 65 patients (55.1%) were positive for malaria, out of which 42 (64.6%) were males, mainly (24.6%) within the young age group (1-10 years). Some of the patients 17 (26.2%) have started taking antimalarial drugs before coming to the hospital. Out of the 96 patients presented with acute malaria, only 43 (66.2%) were positive, but all those with severe cases (33.8%) were positive by both microscopic and RDT tests. In general, 53 patients (81.5%) were positive by microscopy, while only 12(18.5%) are RDT-positive. The study revealed a low performance of RDT with high number of false negative tests compared to microscopy on the same samples. It is therefore, necessary to reinforce training in microscopy, improved supplies and ensure proper handling/storage of the rapid test kits in malaria-endemic area, like Nigeria.
26
Agnememel, Alain, François Traincard, Sylvie Dartevelle, Laurence Mulard, Ali Elhaji Mahamane, Odile Ouwe Missi Oukem-Boyer, Mélanie Denizon, et al. "Development and Evaluation of a Dipstick Diagnostic Test for Neisseria meningitidis Serogroup X." Journal of Clinical Microbiology 53, no. 2 (November 19, 2014): 449–54. http://dx.doi.org/10.1128/jcm.02444-14.
Full textAbstract:
The emergence ofNeisseria meningitidisserogroup X (NmX) in the African meningitis belt has urged the development of diagnostic tools and vaccines for this serogroup, especially following the introduction of a conjugate vaccine againstN. meningitidisserogroup A (NmA). We have developed and evaluated a new rapid diagnostic test (RDT) for detecting the capsular polysaccharide (cps) antigen of this emerging serogroup. Whole inactivated NmX bacteria were used to immunize rabbits. Following purification by affinity chromatography, the cpsX-specific IgG antibodies were utilized to develop an NmX-specific immunochromatography dipstick RDT. The test was validated against purified cpsX and meningococcal strains of different serogroups. Its performance was evaluated against that of PCR on a collection of 369 cerebrospinal fluid (CSF) samples obtained from patients living in countries within the meningitis belt (Cameroon, Côte d'Ivoire, and Niger) or in France. The RDT was highly specific for NmX strains. Cutoffs of 105CFU/ml and 1 ng/ml were observed for the reference NmX strain and purified cpsX, respectively. Sensitivity and specificity were 100% and 94%, respectively. A high agreement between PCR and RDT (Kappa coefficient, 0.98) was observed. The RDT gave a high positive likelihood ratio and a low negative likelihood (0.07), indicating almost 100% probability of declaring disease or not when the test is positive or negative, respectively. This unique NmX-specific test could be added to the available set of RDT for the detection of meningococcal meningitis in Africa as a major tool to reinforce epidemiological surveillance after the introduction of the NmA conjugate vaccine.
27
Odio, Bartholomew N., Leonard O. Ajah, Perpetus C. Ibekwe, Monique I. Ajah, George O. Ugwu, Theophilus O. Nwankwo, and Christian C. Anikwe. "Rapid Diagnostic Test Versus Microscopy for Diagnosing Malaria Among Pregnant Women in a Resource-Poor Setting; A Cross-Sectional Comparative Study." Global Journal of Health Science 12, no. 8 (May 29, 2020): 52. http://dx.doi.org/10.5539/gjhs.v12n8p52.
Full textAbstract:
BACKGROUND: Diagnostic challenge of malaria in Nigeria remarkably impedes the World Health Organization (WHO) recommendation of laboratory diagnosis before treatment. Rapid Diagnostic Test (RDT) is easier and cheaper to perform when compared with microscopy especially in resource-poor settings. However there are conflicting results on the accuracy of RDT versus microscopy from previous studies.
AIM: To compare the overall accuracy of microscopy and RDT in detecting peripheral malaria among pregnant women with clinical features of malaria.
MATERIALS & METHODS: This was a cross-sectional comparative studyin whichRDT, microscopy and polymerase chain reaction (PCR) were performed using the peripheral bloodof the eligible study participants at the Alex Ekwueme Federal University Teaching Hospital, Abakaliki between September 1, 2016 and March 31, 2017.The PCR was used as the gold standard in this study. Data was analyzed with the Statistical Package for Social Sciences version 18 (IBM SPSS, Chicago, USA). P value ≤ 0.05 was considered statistically significant.
RESULTS: The actual prevalent rates of malaria based on RDT, microscopy and PCR results among the participants were 58.2%, 59.9% and 61.1% respectively. There was no statistical significant difference among RDT, microscopy and combined RDT and microscopy on overall accuracy. Malaria infestation was associated with self-employed and unemployed women, primigravidity, second trimester, rural residence, non-use of long lasting insecticide treated nets and intermittent preventive therapy for malaria.
CONCLUSION: There was no difference in overall accuracy among RDT, microscopy and combined RDT and microscopy. This underscores the need to scale up RDT for every patient with clinical features of malaria before treatment in this environment.
28
Wahlfeld, Christopher C., Amina Muicha, Paulo Harrison, Aaron M. Kipp, Gael Claquin, Wilson P. Silva, Ann F. Green, C. William Wester, and Troy D. Moon. "HIV Rapid Diagnostic Test Inventories in Zambézia Province, Mozambique: A Tale of 2 Test Kits." International Journal of Health Policy and Management 8, no. 5 (February 26, 2019): 292–99. http://dx.doi.org/10.15171/ijhpm.2019.07.
Full textAbstract:
Background: The first pillar of the UNAIDS 90-90-90 goal seeks to accurately identify persons living with HIV (PLHIV), a process that is predicated on facilities having the necessary HIV tests available to perform the task. In many rural settings, the identification of PLHIV is accomplished through a two-step process involving the sequential use of 2 separate rapid diagnostic tests (RDTs). Inadequate inventory of either test has ramifications for the success of HIV-related programs. The purpose of this study was to evaluate the inventory levels of HIV RDT kits at specific healthcare facilities in Zambézia province, Mozambique. Methods: Using facility-level pharmacy stock surveillance data from October 2015 through September 2016, we assessed the inventory levels of HIV RDTs at 75 health facilities in 8 districts within Zambézia province, Mozambique. Using programmatically established categories (good, sufficient, threatened, or stockout), defined in conjunction with the provincial health authorities, descriptive statistics were performed to determine inventory control of HIV RDTs at the district and health facility levels. Monthly proportions of adequate (good + sufficient) inventory were calculated for each district to identify inventory trends over the evaluation period. To assess whether the proportion of inadequate stocks differed between RDT, a mixed-effects logistic regression was conducted, with inadequate inventory status as the outcome of interest. Results: When viewed as a whole, the inventory of each test kit was reported as being at adequate levels more than 89% of the time across the 75 facilities. However, disaggregated analysis revealed significant variability in the inventory levels of HIV RDTs at the district level. Specifically, the districts of Inhassunge, Namacurra, and Pebane reported inadequate inventory levels (threatened + stockout), of one or both test kits, for more than 10% of the study period. In addition, a disparity between inventory levels of each test kit was identified, with the odds of reporting inadequate inventory levels of the confirmatory test (Uni-Gold™) being approximately 1.8-fold greater than the initial test (Determine™) (odds ratio: 1.82, 95% CI: 1.40-2.38). Conclusion: As Test and Treat programs evolve, a significant emphasis should be placed on the "test" component of the strategy, beginning with assurances that health facilities have the adequate inventory of RDT necessary to meet the needs of their community. As national policy-makers rely predominantly on data from the upstream arm of the supply chain, it is unlikely the disparity between inventory levels of HIV RDTs identified at individual districts and specific health facilities would have been recognized. Moving forward, our findings point to a need for (1) renewed efforts reinforcing appropriate downstream forecasting of essential medicines and diagnostic tests in general and for Uni-Gold™ test kits specifically, and (2) simple metrics that may be routinely collected at all health facilities and which may then easily and quickly flow upstream so that policy-makers may optimally allocate resources.
29
Murungi, Moses, Travis Fulton, Raquel Reyes, Michael Matte, Moses Ntaro, Edgar Mulogo, Dan Nyehangane, et al. "Improving the Specificity of Plasmodium falciparum Malaria Diagnosis in High-Transmission Settings with a Two-Step Rapid Diagnostic Test and Microscopy Algorithm." Journal of Clinical Microbiology 55, no. 5 (March 8, 2017): 1540–49. http://dx.doi.org/10.1128/jcm.00130-17.
Full textAbstract:
ABSTRACT Poor specificity may negatively impact rapid diagnostic test (RDT)-based diagnostic strategies for malaria. We performed real-time PCR on a subset of subjects who had undergone diagnostic testing with a multiple-antigen (histidine-rich protein 2 and pan -lactate dehydrogenase pLDH [HRP2/pLDH]) RDT and microscopy. We determined the sensitivity and specificity of the RDT in comparison to results of PCR for the detection of Plasmodium falciparum malaria. We developed and evaluated a two-step algorithm utilizing the multiple-antigen RDT to screen patients, followed by confirmatory microscopy for those individuals with HRP2-positive (HRP2 + )/pLDH-negative (pLDH − ) results. In total, dried blood spots (DBS) were collected from 276 individuals. There were 124 (44.9%) individuals with an HRP2 + /pLDH + result, 94 (34.1%) with an HRP2 + /pLDH − result, and 58 (21%) with a negative RDT result. The sensitivity and specificity of the RDT compared to results with real-time PCR were 99.4% (95% confidence interval [CI], 95.9 to 100.0%) and 46.7% (95% CI, 37.7 to 55.9%), respectively. Of the 94 HRP2 + /pLDH − results, only 32 (34.0%) and 35 (37.2%) were positive by microscopy and PCR, respectively. The sensitivity and specificity of the two-step algorithm compared to results with real-time PCR were 95.5% (95% CI, 90.5 to 98.0%) and 91.0% (95% CI, 84.1 to 95.2), respectively. HRP2 antigen bands demonstrated poor specificity for the diagnosis of malaria compared to that of real-time PCR in a high-transmission setting. The most likely explanation for this finding is the persistence of HRP2 antigenemia following treatment of an acute infection. The two-step diagnostic algorithm utilizing microscopy as a confirmatory test for indeterminate HRP2 + /pLDH − results showed significantly improved specificity with little loss of sensitivity in a high-transmission setting.
30
Claeys, Kimberly C., Emily Heil, Nora Loughry, Sanjay Chainani, J. Kristie Johnson, and Surbhi Leekha. "141. Use of Rapid Diagnostic Testing in Gram-negative Bloodstream Infections with and without Antimicrobial Stewardship." Open Forum Infectious Diseases 6, Supplement_2 (October 2019): S98—S99. http://dx.doi.org/10.1093/ofid/ofz360.216.
Full textAbstract:
Abstract Background Verigene Blood Culture Gram-Negative (VBC-GN) is a rapid diagnostic test (RDT) that can detect key GNs and resistance within hours from Gram-stain. Numerous studies have shown that RDTs in BSIs improve clinical outcomes, particularly with active antimicrobial stewardship (AMS) intervention. Little is known regarding outcomes in GN BSI without vs. with AMS intervention. Methods A retrospective three-part quasi-experimental study of adult patients with GN BSI from December 2014 to April 2018. VBC-GN was introduced September 2015 and AMS review was implemented October 2017. Antibiotics were appropriate if active in vitro against isolated GN. Optimal antibiotics were not overly broad, accounted for resistance, source of infection, and other infecting organisms. Comparisons were made using Chi-squared for nominal variables and Kaplan–Meier with log-rank for time to event analysis. Results In total, 772 patients met inclusion. The most common source was urinary (30.1%) and E. coli was the most common GN (37.9%). Infectious Disease consults increased with each group (50.6% vs. 67.9% vs. 81.8%, P < 0.001). More patients pre-RDT (37.36%) and RDT+AMS (35.6%) compared with RDT only (24.6%) were critically ill, P = 0.001. Optimal therapy was achieved in more patients in RDT-only (79%) and RDT+AMS (86%) groups compared with pre-RDT (66%), P < 0.001. More patients in the pre-RDT group (44.7%) were appropriately de-escalated compared with RDT only (31.6%) and RDT + AMS (38.7%), P = 0.026. Appropriate escalation occurred most often in the RDT-only group (39.3%) vs. pre-RDT (15.2%) and RDT + AMS (14.2%), P = 0.019. Median post-BSI length of stay (8.2 vs. 7.1 vs. 8.5 days, P = 0.226) and inpatient mortality (10.8% vs. 14.3% vs. 11.4%, P = 0.493) were similar. Conclusion With the implementation of VBC-GN RDT there was a significantly decreased time to optimal therapy, mainly based on necessary antibiotic escalation. Antibiotic de-escalation remained a challenge, even with active AMS review. Disclosures All authors: No reported disclosures.
31
Niyibizi, Jean Baptiste, and Emmanuel Kamana Gatera. "Diagnostic Performance between Histidine-Rich Protein 2 (HRP-2), a Rapid Malaria Diagnostic Test and Microscopic-Based Staining Techniques for Diagnosis of Malaria." Journal of Tropical Medicine 2020 (March 27, 2020): 1–6. http://dx.doi.org/10.1155/2020/5410263.
Full textAbstract:
Malaria presents a diagnostic challenge in most tropical countries such as Rwanda. Microscopy remains the gold standard for diagnosing malaria, but it is labor intensive and depends upon the skill of the examiner. Malaria rapid diagnostic tests (RDTs) have been developed as an easy, convenient alternative to microscopy. This cross-sectional study was conducted at Rukara Health Center which is located in Eastern Province, Kayonza district, Rwanda. One hundred and fifty suspected cases of malaria, who attended Rukara Health Centre, during the period, from 21st June to 30th July 2018, were included in this study. HRP-2 RDTs (CareStart™ Malaria HRP-2 (Access Bio, Inc., Somerset, New Jersey, USA)), for malaria were performed. Thick smears were prepared and Giemsa-stained as recommended; then slides were observed under microscopy and reported quantitatively; RDTs were reported qualitatively (positive or negative). Both RDTs and thick smear results were recorded on data collection sheet. This study included a total of 150 study participants, 87 (58%) females and 63 (42%) males. The patients included in the study did not receive any antimalarial drug. The mean age of the study participants was 31.6 ± 12.4 with the majority of participants being between 25 and 44 years and the minority being above 65 years. The sensitivity of RDT (HRP-2) was calculated and found to be 95.0%, whereas the sensitivity of Giemsa microscopy was 100%. The specificity of RDT (HRP-2) was calculated and found to be 59.2%, whereas the specificity of Giemsa microscopy was 100%. Negative and positive predictive values of RDT are 85.4% and 82.7%, respectively. Negative and positive predictive values of Giemsa microscopy were both 100%. According to the results of the current study, the sensitivity, specificity, and both positive and negative predictive values of Giemsa microscopy are higher than those of histidine-rich protein 2-based rapid diagnostic test for malaria. The results obtained in histidine-rich protein 2-based rapid diagnostic test for malaria parasites should be confirmed with tests with high specificity. Further studies should determine the most appropriate type of rapid diagnostic test of malaria diagnosis to be used in combination with Giemsa microscopy. In addition, sensitivity and specificity of RDT (HRP-2) and Giemsa microscopy should be assessed against molecular biology techniques.
32
Koné, Minayégninrin, Dramane Kaba, Jacques Kaboré, Lian Francesca Thomas, Laura Cristina Falzon, Mathurin Koffi, Cyrille Mambo Kouamé, et al. "Passive surveillance of human African trypanosomiasis in Côte d’Ivoire: Understanding prevalence, clinical symptoms and signs, and diagnostic test characteristics." PLOS Neglected Tropical Diseases 15, no. 8 (August 30, 2021): e0009656. http://dx.doi.org/10.1371/journal.pntd.0009656.
Full textAbstract:
Background Little is known about the diagnostic performance of rapid diagnostic tests (RDTs) for passive screening of human African trypanosomiasis (HAT) in Côte d’Ivoire. We determined HAT prevalence among clinical suspects, identified clinical symptoms and signs associated with HAT RDT positivity, and assessed the diagnostic tests’ specificity, positive predictive value and agreement. Methods Clinical suspects were screened with SD Bioline HAT, HAT Sero-K-Set and rHAT Sero-Strip. Seropositives were parasitologically examined, and their dried blood spots tested in trypanolysis, ELISA/Tbg, m18S-qPCR and LAMP. The HAT prevalence in the study population was calculated based on RDT positivity followed by parasitological confirmation. The association between clinical symptoms and signs and RDT positivity was determined using multivariable logistic regression. The tests’ Positive Predictive Value (PPV), specificity and agreement were determined. Results Over 29 months, 3433 clinical suspects were tested. The RDT positivity rate was 2.83%, HAT prevalence 0.06%. Individuals with sleep disturbances (p<0.001), motor disorders (p = 0.002), convulsions (p = 0.02), severe weight loss (p = 0.02) or psychiatric problems (p = 0.04) had an increased odds (odds ratios 1.7–4.6) of being HAT RDT seropositive. Specificities ranged between 97.8%-99.6% for individual RDTs, and 93.3–98.9% for subsequent tests on dried blood spots. The PPV of the individual RDTs was below 14.3% (CI 2–43), increased to 33.3% (CI 4–78) for serial RDT combinations, and reached 67% for LAMP and ELISA/Tbg on RDT positives. Agreement between diagnostic tests was poor to moderate (Kappa ≤ 0.60), except for LAMP and ELISA/Tbg (Kappa = 0.66). Conclusion Identification of five key clinical symptoms and signs may simplify referral for HAT RDT screening. The results confirm the appropriateness of the diagnostic algorithm presently applied, with screening by SD Bioline HAT or HAT Sero-K-Set, supplemented with trypanolysis. ELISA/Tbg could replace trypanolysis and is simpler to perform. Trial registration ClinicalTrials.gov NCT03356665.
33
Kavanaugh, Michael J., Steven E. Azzam, and David M. Rockabrand. "Malaria Rapid Diagnostic Tests: Literary Review and Recommendation for a Quality Assurance, Quality Control Algorithm." Diagnostics 11, no. 5 (April 25, 2021): 768. http://dx.doi.org/10.3390/diagnostics11050768.
Full textAbstract:
Malaria rapid diagnostic tests (RDTs) have had an enormous global impact which contributed to the World Health Organization paradigm shift from empiric treatment to obtaining a parasitological diagnosis prior to treatment. Microscopy, the classic standard, requires significant expertise, equipment, electricity, and reagents. Alternatively, RDT’s lower complexity allows utilization in austere environments while achieving similar sensitivities and specificities. Worldwide, there are over 200 different RDT brands that utilize three antigens: Plasmodium histidine-rich protein 2 (PfHRP-2), Plasmodium lactate dehydrogenase (pLDH), and Plasmodium aldolase (pALDO). pfHRP-2 is produced exclusively by Plasmodium falciparum and is very Pf sensitive, but an alternative antigen or antigen combination is required for regions like Asia with significant Plasmodium vivax prevalence. RDT sensitivity also decreases with low parasitemia (<100 parasites/uL), genetic variability, and prozone effect. Thus, proper RDT selection and understanding of test limitations are essential. The Center for Disease Control recommends confirming RDT results by microscopy, but this is challenging, due to the utilization of clinical laboratory standards, like the College of American Pathologists (CAP) and the Clinical Lab Improvement Act (CLIA), and limited recourses. Our focus is to provide quality assurance and quality control strategies for resource-constrained environments and provide education on RDT limitations.
34
Mwesigwa, Moses, Jessica L. Webster, Sam Lubwama Nsobya, Alexander Rowan, Mukunda Singh Basnet, Christina R. Phares, Michelle Weinberg, et al. "Prevalence of Malaria Parasite Infections among U.S.-Bound Congolese Refugees with and without Splenomegaly." American Journal of Tropical Medicine and Hygiene 104, no. 3 (March 3, 2021): 996–99. http://dx.doi.org/10.4269/ajtmh.20-0924.
Full textAbstract:
ABSTRACTAll U.S.-bound refugees from sub-Saharan Africa receive presumptive antimalarial treatment before departing for the United States. Among U.S.-bound Congolese refugees, breakthrough malaria cases and persistent splenomegaly have been reported. In response, an enhanced malaria diagnostic program was instituted. Here, we report the prevalence of plasmodial infection among 803 U.S.-bound Congolese refugees who received enhanced diagnostics. Infections by either rapid diagnostic test (RDT) or PCR were detected in 187 (23%) refugees, with 78 (10%) by RDT only, 35 (4%) by PCR only, and 74 (9%) by both. Infections identified by PCR included 103 monoinfections (87 Plasmodium falciparum, eight Plasmodium ovale, seven Plasmodium vivax, and one Plasmodium malariae) and six mixed infections. Splenomegaly was associated with malaria detectable by RDT (odds ratio: 1.8, 95% CI: 1.0–3.0), but not by PCR. Splenomegaly was not strongly associated with parasitemia, indicating that active malaria parasitemia is not necessary for splenomegaly.
35
Cubas-Atienzar, Ana I., Fiona Bell, Rachel L. Byrne, Kate Buist, David J. Clark, Michael Cocozza, Andrea M. Collins, et al. "Accuracy of the Mologic COVID-19 rapid antigen test: a prospective multi-centre analytical and clinical evaluation." Wellcome Open Research 6 (May 28, 2021): 132. http://dx.doi.org/10.12688/wellcomeopenres.16842.1.
Full textAbstract:
Background: The coronavirus disease 2019 (COVID-19) pandemic has highlighted the reliance on antigen detection rapid diagnostic tests (Ag-RDTs). Their evaluation at point of use is a priority. Methods: Here, we report a multi-centre evaluation of the analytical sensitivity, specificity, and clinical accuracy of the Mologic COVID-19 Ag-RDT by comparing to reverse transcriptase polymerase chain reaction (RT-qPCR) results from individuals with and without COVID-19 symptoms. Participants had attended hospitals in Merseyside, hospital and ambulance services in Yorkshire, and drive-through testing facilities in Northumberland, UK. Results: The limit of detection of the Mologic COVID-19 Ag-RDT was 5.0 x 102 pfu/ml in swab matrix with no cross-reactivity and interference for any other pathogens tested. A total of 347 participants were enrolled from 26th of November 2020 to 15th of February 2021 with 39.2% (CI 34.0-44.6) testing RT-qPCR positive for SARS-CoV-2. The overall sensitivity and specificity of the Mologic Ag-RDT compared to the reference SARS-CoV-2 RT-qPCR were 85.0% (95% CI 78.3-90.2) and 97.8% (95.0-99.3), respectively. Sensitivity was stratified by RT-qPCR cycle threshold (Ct) and 98.4% (91.3-100) of samples with a Ct less than 20 and 93.2% (86.5-97.2) of samples with a Ct less than 25 were detected using the Ag-RDT. Clinical accuracy was stratified by sampling strategy, swab type and clinical presentation. Mologic COVID-19 Ag-RDT demonstrated highest sensitivity with nose/throat swabs compared with throat or nose swabs alone; however, the differences were not statistically significant. Conclusions: Overall, the Mologic test had high diagnostic accuracy across multiple different settings, different demographics, and on self-collected swab specimens. These findings suggest the Mologic rapid antigen test may be deployed effectively across a range of use settings.
36
Leathers, James S., Maria Belen Pisano, Viviana Re, Gertine van Oord, Amir Sultan, Andre Boonstra, and Jose D. Debes. "Validation of a point-of-care rapid diagnostic test for hepatitis C for use in resource-limited settings." International Health 11, no. 4 (March 12, 2019): 314–15. http://dx.doi.org/10.1093/inthealth/ihy101.
Full textAbstract:
Abstract Background Treatment of HCV with direct-acting antivirals has enabled the discussion of HCV eradication worldwide. Envisioning this aim requires implementation of mass screening in resource-limited areas, usually constrained by testing costs. Methods We validated a low-cost, rapid diagnosis test (RDT) for HCV in three different continents in 141 individuals. Results The HCV RDT showed 100% specificity and sensitivity across different samples regardless of genotype or viral load (in samples with such information, 90%). Conclusions The HCV test validated in this study can allow for HCV screening in areas of need when properly used.
37
Certoma, Andrea, Ross A. Lunt, Wilna Vosloo, Ina Smith, Axel Colling, David T. Williams, Thao Tran, and Stuart D. Blacksell. "Assessment of a Rabies Virus Rapid Diagnostic Test for the Detection of Australian Bat Lyssavirus." Tropical Medicine and Infectious Disease 3, no. 4 (October 4, 2018): 109. http://dx.doi.org/10.3390/tropicalmed3040109.
Full textAbstract:
Australian bat lyssavirus (ABLV) is closely related to the classical rabies virus and has been associated with three human fatalities and two equine fatalities in Australia. ABLV infection in humans causes encephalomyelitis, resulting in fatal disease, but has no effective therapy. The virus is maintained in enzootic circulation within fruit bats (Pteropid spp.) and at least one insectivorous bat variety (Saccolaimus flaviventris). Most frequently, laboratory testing is conducted on pteropodid bat brains, either following a potential human exposure through bites, scratches and other direct contacts with bats, or as opportunistic assessment of sick or dead bats. The level of medical intervention and post-exposure prophylaxis is largely determined on laboratory testing for antigen/virus as the demonstrable infection status of the in-contact bat. This study evaluates the comparative diagnostic performance of a lateral flow test, Anigen Rabies Ag detection rapid test (RDT), in pteropodid variant of ABLV-infected bat brain tissues. The RDT demonstrated 100% agreement with the reference standard fluorescent antibody test on 43 clinical samples suggesting a potential application in rapid diagnosis of pteropodid variant of ABLV infection. A weighted Kappa value of 0.95 confirmed a high level of agreement between both tests.
38
Kassa, Mekibib, Saïd Abdellati, Lieselotte Cnops, Bruno C. Bremer Hinckel, Arega Yeshanew, Wasihun Hailemichael, Florian Vogt, et al. "Diagnostic accuracy of direct agglutination test, rK39 ELISA and six rapid diagnostic tests among visceral leishmaniasis patients with and without HIV coinfection in Ethiopia." PLOS Neglected Tropical Diseases 14, no. 12 (December 31, 2020): e0008963. http://dx.doi.org/10.1371/journal.pntd.0008963.
Full textAbstract:
Diagnosis of a first-time visceral leishmaniasis (VL) infection in Ethiopia is established by use of a rapid diagnostic test (RDT) detecting antibodies against rK39, direct agglutination test (DAT) and microscopy according to the national algorithm. The performance of individual tests and algorithm is variable and depends on several factors, one being HIV status. Limited data are available on the performance of tests in VL-HIV coinfected patients. Assessment of the performance of DAT (ITM-A), rK39 ELISA (Serion) and six RDT (Onsite Leishmania Ab CTK, Antigen ICT Xinjier, IT Leish Biorad, Kalazar Detect Inbios, rK39 IgG1 Coris, rk28 IgG1 Coris) for the diagnosis of VL was done on a panel of 91 stored serum and plasma samples of ‘first-episode’ suspected VL patients, with HIV coinfection (n = 51) and without (n = 40). A combined reference standard was used: either positive microscopy on tissue aspirates, or in case of negative microscopy, positive PCR results on the aspirate slide. Additionally, endemic healthy controls (n = 20), non-endemic controls (n = 10) and patients with confirmed malaria infection (n = 10) were tested for specificity evaluation. Sensitivities ranged from 69.2% for DAT (applied cut-off ≥ 1/3200) to 92.2% for the Onsite RDT, whereas specificities ranged from 20.0% for Kalazar Antigen ICT to 100% for IT Leish and rK39 IgG1. Sensitivities from all assays decreased upon stratification according to HIV status but was only significantly different for rK39 Serion ELISA (p-value 0.0084) and the Onsite RDT (p-value 0.0159). In conclusion, performance of commercially available assays for VL on samples from Northern-Ethiopian patients varied widely with a substantial decrease in sensitivity in the VL-HIV coinfected group. Clear guidelines on minimal performance criteria of individual tests and algorithms are needed, as well as which reference standard should be used to determine the performance.
39
Mat Jusoh, Tuan Nur Akmalina, and Rafidah Hanim Shueb. "Performance Evaluation of Commercial Dengue Diagnostic Tests for Early Detection of Dengue in Clinical Samples." Journal of Tropical Medicine 2017 (2017): 1–4. http://dx.doi.org/10.1155/2017/4687182.
Full textAbstract:
The shattering rise in dengue virus infections globally has created a need for an accurate and validated rapid diagnostic test for this virus. Rapid diagnostic test (RDT) and reverse transcription-polymerase chain reaction (RT-PCR) diagnostic detection are useful tools for diagnosis of early dengue infection. We prospectively evaluated the diagnostic performance of nonstructural 1 (NS1) RDT and real-time RT-PCR diagnostic kits in 86 patient serum samples. Thirty-six samples were positive for dengue NS1 antigen while the remaining 50 were negative when tested with enzyme-linked immunosorbent assay (ELISA). Commercially available RDTs for NS1 detection, RTK ProDetect™, and SD Bioline showed high sensitivity of 94% and 89%, respectively, compared with ELISA. GenoAmp® Trioplex Real-Time RT-PCR and RealStar® Dengue RT-PCR tests presented a comparable kappa agreement with 0.722. The result obtained from GenoAmp® Real-Time RT-PCR Dengue test showed that 14 samples harbored dengue virus type 1 (DENV-1), 8 samples harbored DENV-2, 2 samples harbored DENV-3, and 1 sample harbored DENV-4. 1 sample had a double infection with DENV-1 and DENV-2. The NS1 RDTs and real-time RT-PCR tests were found to be a useful diagnostic for early and rapid diagnosis of acute dengue and an excellent surveillance tool in our battle against dengue.
40
Mouatcho, Joel C., and J. P. Dean Goldring. "Malaria rapid diagnostic tests: challenges and prospects." Journal of Medical Microbiology 62, no. 10 (October 1, 2013): 1491–505. http://dx.doi.org/10.1099/jmm.0.052506-0.
Full textAbstract:
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.
41
Bhattarai, Narayan Raj, Keshav Rai, Suman Rijal, Anup Ghimire, and Basudha Khanal. "Exploring the Substantial Role of Multiplex Pcr to Diagnose Malaria in Eastern Nepal." Journal of Chitwan Medical College 9, no. 2 (June 23, 2019): 103–10. http://dx.doi.org/10.3126/jcmc.v9i2.24564.
Full textAbstract:
Background: Malaria is still a major health problem in Nepal as 43.3% of population are at risk of infection. However, the national priorities have been given to achieve malaria elimination in Nepal, the question of diagnostic accuracy could jeopardize the elimination target. Among others, multiplex PCR could be the reliable alternative tool to detect the low number of parasitemia and circulating asymptomatic infection in low endemic countries like Nepal. Hence, this paper aims to analyse the diagnostic precision among microscopy, rapid diagnostic test (RDT) and multiplex real time PCR assay.
Methods: A total of 63 archived blood samples obtained from patient with clinical suspicion of malaria were subjected to multiplex PCR and their results were compared with microscopy and rapid diagnostic test. The Latent Class Analysis (LCA) approach was used to compare the diagnostic precision among three different assays.
Results: Our study documented that PCR had 97.4% sensitivity and 83.9% specificity. Among the negative microscopy results, 10 (15.9%) were false negatives whereas 4 (6.3%) RDT results were false negatives based on PCR results.
Conclusions: PCR could be the useful alternative tool to detect the low number of parasite in low endemic settings which could be crucial to rule out the false diagnosis determined by microscopy or RDT.
42
Gomes, Luciano T., Mauro S. Tada, Tony H. Katsuragawa, Marinete M. Povoa, Giselle MR Viana, Maria das Gracas C. Alecrim, Frankllin S. De Santana-Filho, et al. "Low sensitivity of malaria rapid diagnostic tests stored at room temperature in the Brazilian Amazon Region." Journal of Infection in Developing Countries 7, no. 03 (March 14, 2013): 243–52. http://dx.doi.org/10.3855/jidc.2564.
Full textAbstract:
Introduction: In remote areas of the Amazon Region, diagnosis of malaria by microscopy is practically impossible. This study aimed to evaluate the performance of two rapid diagnostic tests (RDTs) targeting different malaria antigens stored at room temperature in the Brazilian Amazon Region. Methodology: Performance of the OptiMal Pf/Pan test and ICT-Now Pf/Pan test was analyzed retrospectively in 1,627 and 1,602 blood samples, respectively. Tests were performed over a 15-month period. Kits were stored at room temperature in five community health centres located in the Brazilian Amazon Region. RDT results were compared with thick blood smear (TBS) results to determine sensitivity, specificity, and accuracy of the RDT. Results: The sensitivities of the OptiMal Pf/Pan test were 79.7% for Plasmodium falciparum malaria diagnosis and 85.7% for non-P. falciparum infections. The results showed a crude agreement of 88.5% for P. falciparum, and 88.3% for non-P. falciparum infections (Kappa index = 0.74 and 0.75, respectively). For the ICT-Now Pf/Pan test (CI 95%), the sensitivities were 87.9% for P. falciparum malaria diagnosis and 72.5% for non-P. falciparum infection. Crude agreement between the ICT-Now Pf/Pan test and TBS was 91.4% for P. falciparum and 79.7% for non-P. falciparum infection. The Kappa index was 0.81 and 0.59 for the final diagnosis of P. falciparum and non-P. falciparum, respectively. Higher levels of parasitaemia were associated with higher crude agreement between RDT and TBS. Conclusions: The sensitivities of RDTs stored at room temperature over a 15-month period and performed in field conditions were lower than those previously reported.
43
Ngo Nsoga, Marie Thérèse, Ilona Kronig, Francisco Javier Perez Rodriguez, Pascale Sattonnet-Roche, Diogo Da Silva, Javan Helbling, Jilian A. Sacks, et al. "Diagnostic accuracy of Panbio rapid antigen tests on oropharyngeal swabs for detection of SARS-CoV-2." PLOS ONE 16, no. 6 (June 24, 2021): e0253321. http://dx.doi.org/10.1371/journal.pone.0253321.
Full textAbstract:
Background Antigen-detecting rapid diagnostic tests (Ag-RDTs) for the detection of SARS-CoV-2 offer new opportunities for testing in the context of the COVID-19 pandemic. Nasopharyngeal swabs (NPS) are the reference sample type, but oropharyngeal swabs (OPS) may be a more acceptable sample type in some patients. Methods We conducted a prospective study in a single screening center to assess the diagnostic performance of the Panbio™ COVID-19 Ag Rapid Test (Abbott) on OPS compared with reverse-transcription quantitative PCR (RT-qPCR) using NPS during the second pandemic wave in Switzerland. Results 402 outpatients were enrolled in a COVID-19 screening center, of whom 168 (41.8%) had a positive RT-qPCR test. The oropharyngeal Ag-RDT clinical sensitivity compared to nasopharyngeal RT-qPCR was 81% (95%CI: 74.2–86.6). Two false positives were noted out of the 234 RT-qPCR negative individuals, which resulted in a clinical specificity of 99.1% (95%CI: 96.9–99.9) for the Ag-RDT. For cycle threshold values ≤ 26.7 (≥ 1E6 SARS-CoV-2 genomes copies/mL, a presumed cut-off for infectious virus), 96.3% sensitivity (95%CI: 90.7–99.0%) was obtained with the Ag-RDT using OPS. Interpretation Based on our findings, the diagnostic performance of the Panbio™ Covid-19 RDT with OPS samples, if taken by a trained person and high requirements regarding quality of the specimen, meet the criteria required by the WHO for Ag-RDTs (sensitivity ≥80% and specificity ≥97%) in a high incidence setting in symptomatic individuals.
44
Kepka, Sabrina, Mickaël Ohana, François Séverac, Joris Muller, Eric Bayle, Yvon Ruch, Elodie Laugel, et al. "Rapid Antigen Test Combined with Chest Computed Tomography to Rule Out COVID-19 in Patients Admitted to the Emergency Department." Journal of Clinical Medicine 10, no. 16 (August 4, 2021): 3455. http://dx.doi.org/10.3390/jcm10163455.
Full textAbstract:
Objective: Correct and timely identification of SARS-CoV-2-positive patients is critical in the emergency department (ED) prior to admission to medical wards. Antigen-detecting rapid diagnostic tests (Ag-RDTs) are a rapid alternative to Reverse-transcriptase polymerase chain reaction (RT-PCR) for the diagnosis of COVID-19 but have lower sensitivity. Methods: We evaluated the performance in real-life conditions of a strategy combining Ag-RDT and chest computed tomography (CT) to rule out COVID-19 infection in 1015 patients presenting in the ED between 16 November 2020 and 18 January 2021 in order to allow non-COVID-19 patients to be hospitalized in dedicated units directly. The combined strategy performed in the ED for patients with COVID-19 symptoms was assessed and compared with RT-PCR. Results: Compared with RT-PCR, the negative predictive value was 96.7% for Ag-RDT alone, 98.5% for Ag-RDT/CT combined, and increased to 100% for patients with low viral load. Conclusion: A strategy combining Ag-RDT and chest CT is effective in ruling out COVID-19 in ED patients with high precision.
45
Hotterbeekx, An, Jolien Perneel, Michel Mandro, Germain Abhafule, Joseph Nelson Siewe Fodjo, Alfred Dusabimana, Steven Abrams, Samir Kumar-Singh, and Robert Colebunders. "Comparison of Diagnostic Tests for Onchocerca volvulus in the Democratic Republic of Congo." Pathogens 9, no. 6 (June 2, 2020): 435. http://dx.doi.org/10.3390/pathogens9060435.
Full textAbstract:
Onchocerciasis is diagnosed by detecting microfilariae in skin snips or by detecting OV16 IgG4 antibodies in blood by either enzyme linked immunosorbent assay (ELISA) or a rapid diagnostic test (RDT). Here, we compare the sensitivity and specificity of these three tests in persons with epilepsy living in an onchocerciasis endemic region in the Democratic Republic of Congo. Skin snips and blood samples were collected from 285 individuals for onchocerciasis diagnosis. Three tests were performed: the OV16 RDT (SD Bioline) and the OV16 ELISA both on serum samples, and microscopic detection of microfilariae in skin snips. The sensitivity and specificity of each test was calculated with the combined other tests as a reference. Microfilariae were present in 105 (36.8%) individuals, with a median of 18.5 (6.5–72.0) microfilariae/skin snip. The OV16 RDT and OV16 ELISA were positive in, respectively, 112 (39.3%) and 143 (50.2%) individuals. The OV16 ELISA had the highest sensitivity among the three tests (83%), followed by the OV16 RDT (74.8%) and the skin snip (71.4%). The OV16 RDT had a higher specificity (98.6%) compared to the OV16 ELISA (84.8%). Our study confirms the need to develop more sensitive tests to ensure the accurate detection of ongoing transmission before stopping elimination efforts.
46
Kingston, Hugh W. F., Stuart D. Blacksell, Ampai Tanganuchitcharnchai, Achara Laongnualpanich, Buddha Basnyat, Nicholas P. J. Day, and Daniel H. Paris. "Comparative Accuracy of the InBios Scrub Typhus Detect IgM Rapid Test for the Detection of IgM Antibodies by Using Conventional Serology." Clinical and Vaccine Immunology 22, no. 10 (August 19, 2015): 1130–32. http://dx.doi.org/10.1128/cvi.00390-15.
Full textAbstract:
ABSTRACTThis study investigated the comparative accuracy of a recombinant 56-kDa type-specific antigen-based rapid diagnostic test (RDT) for scrub typhus for the detection of IgM antibodies by using conventional serology in well-characterized serum samples from undifferentiated febrile illness patients. The RDT showed high specificity and promising comparative accuracy, with 82% sensitivity and 98% specificity for samples defined positive at an IgM indirect immunofluorescence assay positivity cutoff titer of ≥1:1,600 versus 92% and 95% at ≥1:6,400, respectively.
47
Fikri, Bahrul, Andi Dwi Bahagia Febriani, Muhamad Ali, and Nasrum Massi. "Dynamic characteristic of SARS-CoV-2 and its antibody detection." Journal of Medical Research 7, no. 4 (August 15, 2021): 100–101. http://dx.doi.org/10.31254/jmr.2021.7401.
Full textAbstract:
To prevent excess morbidity and mortality of Covid-19, a prompt and accurate diagnosis is crucial. Antibody-based rapid diagnostic test (RDT) is a rapid, fairly reliable, and useful diagnostic testing solution for COVID-19. As a point-of-care test with fast turnaround time, the kit permits quick screening in hospitals to avoid the crowding of specimen collection. However, available RDTs kits have different sensitivity, specificity, and accuracy profiles due to antigen and antibody variability because of the sequence mutation of the SARS-CoV-2 gene. Therefore, it is strongly recommended to either re-measure the accuracy of a rapid test before using it in a different country or use tests developed based on local viral characteristics
48
Berger, Alice, Marie Therese Ngo Nsoga, Francisco Javier Perez-Rodriguez, Yasmine Abi Aad, Pascale Sattonnet-Roche, Angèle Gayet-Ageron, Cyril Jaksic, et al. "Diagnostic accuracy of two commercial SARS-CoV-2 antigen-detecting rapid tests at the point of care in community-based testing centers." PLOS ONE 16, no. 3 (March 31, 2021): e0248921. http://dx.doi.org/10.1371/journal.pone.0248921.
Full textAbstract:
Objectives Determine the diagnostic accuracy of two antigen-detecting rapid diagnostic tests (Ag-RDT) for SARS-CoV-2 at the point of care and define individuals’ characteristics providing best performance. Methods We performed a prospective, single-center, point of care validation of two Ag-RDT in comparison to RT-PCR on nasopharyngeal swabs. Results Between October 9th and 23rd, 2020, 1064 participants were enrolled. The PanbioTM Covid-19 Ag Rapid Test device (Abbott) was validated in 535 participants, with 106 positive Ag-RDT results out of 124 positive RT-PCR individuals, yielding a sensitivity of 85.5% (95% CI: 78.0–91.2). Specificity was 100.0% (95% CI: 99.1–100) in 411 RT-PCR negative individuals. The Standard Q Ag-RDT (SD Biosensor, Roche) was validated in 529 participants, with 170 positive Ag-RDT results out of 191 positive RT-PCR individuals, yielding a sensitivity of 89.0% (95%CI: 83.7–93.1). One false positive result was obtained in 338 RT-PCR negative individuals, yielding a specificity of 99.7% (95%CI: 98.4–100). For individuals presenting with fever 1–5 days post symptom onset, combined Ag-RDT sensitivity was above 95%. Lower sensitivity of 88.2% was seen on the same day of symptom development (day 0). Conclusions We provide an independent validation of two widely available commercial Ag-RDTs, both meeting WHO criteria of ≥80% sensitivity and ≥97% specificity. Although less sensitive than RT-PCR, these assays could be beneficial due to their rapid results, ease of use, and independence from existing laboratory structures. Testing criteria focusing on patients with typical symptoms in their early symptomatic period onset could further increase diagnostic value.
49
Krüger, Lisa J., Mary Gaeddert, Frank Tobian, Federica Lainati, Claudius Gottschalk, Julian A. F. Klein, Paul Schnitzler, et al. "The Abbott PanBio WHO emergency use listed, rapid, antigen-detecting point-of-care diagnostic test for SARS-CoV-2—Evaluation of the accuracy and ease-of-use." PLOS ONE 16, no. 5 (May 27, 2021): e0247918. http://dx.doi.org/10.1371/journal.pone.0247918.
Full textAbstract:
Objectives Diagnostics are essential for controlling the pandemic. Identifying a reliable and fast diagnostic device is needed for effective testing. We assessed performance and ease-of-use of the Abbott PanBio antigen-detecting rapid diagnostic test (Ag-RDT). Methods This prospective, multi-centre diagnostic accuracy study enrolled at two sites in Germany. Following routine testing with reverse-transcriptase polymerase chain reaction (RT-PCR), a second study-exclusive swab was performed for Ag-RDT testing. Routine swabs were nasopharyngeal (NP) or combined NP/oropharyngeal (OP) whereas the study-exclusive swabs were NP. To evaluate performance, sensitivity and specificity were assessed overall and in predefined sub-analyses accordingly to cycle-threshold values, days after symptom onset, disease severity and study site. Additionally, an ease-of-use assessment (EoU) and System Usability Scale (SUS) were performed. Results 1108 participants were enrolled between Sept 28 and Oct 30, 2020. Of these, 106 (9.6%) were PCR-positive. The Abbott PanBio detected 92/106 PCR-positive participants with a sensitivity of 86.8% (95% CI: 79.0% - 92.0%) and a specificity of 99.9% (95% CI: 99.4%-100%). The sub-analyses indicated that sensitivity was 95.8% in Ct-values <25 and within the first seven days from symptom onset. The test was characterized as easy to use (SUS: 86/100) and considered suitable for point-of-care settings. Conclusion The Abbott PanBio Ag-RDT performs well for SARS-CoV-2 testing in this large manufacturer independent study, confirming its WHO recommendation for Emergency Use in settings with limited resources.
50
Laktabai, Jeremiah, Indrani Saran, Yunji Zhou, Ryan A. Simmons, Elizabeth L. Turner, Theodoor Visser, and Wendy O'Meara. "Subsidise the test, the treatment or both? Results of an individually randomised controlled trial of the management of suspected malaria fevers in the retail sector in western Kenya." BMJ Global Health 5, no. 11 (November 2020): e003378. http://dx.doi.org/10.1136/bmjgh-2020-003378.
Full textAbstract:
IntroductionIn many malaria-endemic countries, the private retail sector is a major source of antimalarial drugs. However, the rarity of malaria diagnostic testing in the retail sector leads to overuse of the first-line class of antimalarial drugs known as artemisinin-combination therapies (ACTs). The goal of this study was to identify the combination of malaria rapid diagnostic test (RDT) and ACT subsidies that maximises the proportion of clients seeking care in a retail outlet that choose to purchase an RDT (RDT uptake) and use ACTs appropriately.Methods842 clients seeking care in 12 select retail outlets in western Kenya were recruited and randomised into 4 arms of different combinations of ACT and RDT subsidies, with ACT subsidies conditional on a positive RDT. The outcomes were RDT uptake (primary) and appropriate and targeted ACT use (secondary). Participants’ familiarity with RDTs and their confidence in test results were also evaluated.ResultsRDT uptake was high (over 96%) across the study arms. Testing uptake was 1.025 times higher (98% CI 1.002 to 1.049) in the RDT subsidised arms than in the unsubsidised groups. Over 98% of clients were aware of malaria testing, but only 35% had a previous experience with RDTs. Nonetheless, confidence in the accuracy of RDTs was high. We found high levels of appropriate use and targeting of ACTs, with 86% of RDT positives taking an ACT, and 93.4% of RDT negatives not taking an ACT. The conditional ACT subsidy did not affect the RDT test purchasing behaviour (risk ratio: 0.994; 98% CI 0.979 to 1.009).ConclusionTest dependent ACT subsidies may contribute to ACT targeting. However, in this context, high confidence in the accuracy of RDTs and reliable supplies of RDTs and ACTs likely played a greater role in testing uptake and adherence to test results.