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Nicol, Mark, Andrew Whitelaw, and Wendy Stevens. "Using Xpert MTB/RIF." Current Respiratory Medicine Reviews 9, no. 3 (September 1, 2013): 187–92. http://dx.doi.org/10.2174/1573398x113099990015.
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Yin, Qing-Qin, Wei-Wei Jiao, Rui Han, An-Xia Jiao, Lin Sun, Jian-Ling Tian, Yu-Yan Ma, et al. "Rapid Diagnosis of Childhood Pulmonary Tuberculosis by Xpert MTB/RIF Assay Using Bronchoalveolar Lavage Fluid." BioMed Research International 2014 (2014): 1–6. http://dx.doi.org/10.1155/2014/310194.
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In order to evaluate the diagnostic accuracy of the Xpert MTB/RIF assay on childhood pulmonary tuberculosis (PTB) using bronchoalveolar lavage fluid (BALF), we evaluated the sensitivity, specificity, positive predictive value, and negative predictive value of Xpert MTB/RIF assay using BALF in comparison with acid-fast bacilli (AFB) microscopy andMycobacterium tuberculosis(MTB) culture for diagnosing childhood PTB using Chinese “composite clinical reference standard” (CCRS) as reference standard. Two hundred fifty-five children with suspected PTB were enrolled at Beijing Children’s Hospital from September 2010 to July 2013. Compared with Chinese CCRS, the sensitivity of AFB microscopy, MTB culture, and Xpert MTB/RIF assay was 8.4%, 28.9%, and 53.0%, respectively. The specificity of three assays was all 100%. Xpert MTB/RIF assay could detect 33.9% of cases with negative MTB culture, and 48.7% of cases with negative AFB microscopy. Younger age (<3 years), absence of BCG scar, and contact with TB patient were found significantly associated with a positive result of Xpert MTB/RIF assay. In conclusion, Xpert MTB/RIF assay using BALF can assist in diagnosing childhood PTB much faster when fiberoptic bronchoscopy is necessary according to the chest radiograph.
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Cuong, Nguyen Kim, Nguyen Bao Ngoc, Nguyen Binh Hoa, Vu Quoc Dat, and Nguyen Viet Nhung. "GeneXpert on patients with human immunodeficiency virus and smear-negative pulmonary tuberculosis." PLOS ONE 16, no. 7 (July 6, 2021): e0253961. http://dx.doi.org/10.1371/journal.pone.0253961.
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Objectives Vietnam is a high-prevalence country for tuberculosis (TB). Xpert MTB/RIF is a novel PCR-based diagnostic test that is substantially more sensitive for detecting M. tuberculosis than traditional smear-based techniques. However, locally-derived evidence of Xpert MTB/RIF in HIV-infected people is limited. This study evaluates the performance of the Xpert MTB/RIF in HIV-infected patients with smear-negative pulmonary TB (SNTB). Methods This was a cross-sectional study in 3 hospitals. The performance of Xpert MTB/RIF was compared with the reference standard of liquid culture and phenotypic drug-susceptibility testing for rifampicin (RIF) resistance. Results Out of 123 patients, the median age was 37.0 (IQR: 32.0–41.0) and 81.3% were male. The area under the receiver operating characteristic curve, sensitivity (Se) and specificity (Sp) of Xpert MTB/RIF for pulmonary TB diagnosis were 0.72 (95% confidence interval [CI]: 0.63–0.81), 66.7% (95%CI: 54.8–77.1) and 77.1% (95%CI: 62.7–88.0), respectively, while Se and Sp of Xpert MTB/RIF in detecting RIF resistance were 50.0 (11.8–88.2) and 86.4% (95%CI: 72.7–94.8). Conclusion The performance of Xpert MTB/RIF in HIV-infected patients with SNTB for the diagnosis of TB and RIF-resistance was low. Further studies are required to evaluate the results of Xpert MTB/RIF assay in HIV-infected patients with SNTB and the role of Xpert repetition on the same specimens.
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Chhajed, Prashant N., Preyas J. Vaidya, Neha P. Mandovra, Vinod B. Chavhan, Tejashree T. Lele, Rekha Nair, Jörg D. Leuppi, and Avinandan Saha. "EBUS-TBNA in the rapid microbiological diagnosis of drug-resistant mediastinal tuberculous lymphadenopathy." ERJ Open Research 5, no. 4 (October 2019): 00008–2019. http://dx.doi.org/10.1183/23120541.00008-2019.
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This study aimed to examine the use of endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) in the rapid diagnosis of mediastinal tuberculous lymphadenitis and drug-resistant mediastinal tuberculous lymphadenitis.A diagnosis of TB was confirmed by a positive Xpert MTB/RIF test or Mycobacterium tuberculosis culture. Rifampicin-resistant TB (RR-TB) or multidrug-resistant TB (MDR-TB) was diagnosed upon the detection of rifampicin resistance by Xpert MTB/RIF or resistance to rifampicin and isoniazid by phenotypic drug susceptibility testing (DST).Xpert MTB/RIF was positive in 43 of 56 patients (77%) and TB culture was positive in 31 of 56 patients (55%). Of these 56 patients, 25 (45%) were Xpert MTB/RIF positive and TB culture negative, 13 (23%) were Xpert MTB/RIF negative and TB culture positive, and 18 (32%) were Xpert MTB/RIF positive and TB culture positive. 11 patients (20%) had drug-resistant TB: seven with RR/MDR-TB, one with pre-extensively drug-resistant (XDR) TB, two with XDR-TB and one with isoniazid mono-resistance.An Xpert MTB/RIF assay carried out on EBUS-TBNA specimens provides rapid diagnosis of TB. Xpert MTB/RIF testing appears to have additional and more rapid sensitivity compared with culture alone. Culture-based DST provides an additional exclusive yield and the full resistance profile in addition to or instead of rifampicin resistance.
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Diel, Roland, Albert Nienhaus, Doris Hillemann, and Elvira Richter. "Cost–benefit analysis of Xpert MTB/RIF for tuberculosis suspects in German hospitals." European Respiratory Journal 47, no. 2 (December 2, 2015): 575–87. http://dx.doi.org/10.1183/13993003.01333-2015.
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Our objective was to assess the cost–benefit of enhancing or replacing the conventional sputum smear with the real-time PCR Xpert MTB/RIF method in the inpatient diagnostic schema for tuberculosis (TB).Recent data from published per-case cost studies for TB/multidrug-resistant (MDR)-TB and from comparative analyses of sputum microscopy, mycobacterial culture, Xpert MTB/RIF and drug susceptibility testing, performed at the German National Reference Center for Mycobacteria, were used. Potential cost savings of Xpert MTB/RIF, based on test accuracy and multiple cost drivers, were calculated for diagnosing TB/MDR-TB suspects from the hospital perspective.Implementing Xpert MTB/RIF as an add-on in smear-positive and smear-negative TB suspects saves on average €48.72 and €503, respectively, per admitted patient as compared with the conventional approach. In smear-positive and smear-negative MDR-TB suspects, cost savings amount to €189.56 and €515.25 per person, respectively. Full replacement of microscopy by Xpert MTB/RIF saves €449.98. In probabilistic Monte-Carlo simulation, adding Xpert MTB/RIF is less costly in 46.4% and 76.2% of smear-positive TB and MDR-TB suspects, respectively, but 100% less expensive in all smear-negative suspects. Full replacement by Xpert MTB/RIF is also consistently cost-saving.Using Xpert MTB/RIF as an add-on to and even as a replacement for sputum smear examination may significantly reduce expenditures in TB suspects.
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Yu, Guocan, Fangming Zhong, Yanqin Shen, and Hong Zheng. "Diagnostic accuracy of the Xpert MTB/RIF assay for tuberculous pericarditis: A systematic review and meta-analysis." PLOS ONE 16, no. 9 (September 10, 2021): e0257220. http://dx.doi.org/10.1371/journal.pone.0257220.
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Objective The purpose of this study was to evaluate the diagnostic efficacy of Xpert MTB/RIF for tuberculous pericarditis (TBP). Methods We searched relevant databases for Xpert MTB/RIF for TBP diagnosis until April 2021 and screened eligible studies for study inclusion. We evaluated the effectiveness of Xpert MTB/RIF when the composite reference standard (CRS) and mycobacterial culture were the gold standards, respectively. We performed meta-analyses using a bivariate random-effects model, and when the heterogeneity was obvious, the source of heterogeneity was further discussed. Results We included seven independent studies comparing Xpert MTB/RIF with the CRS and six studies comparing it with culture. The pooled sensitivity, specificity, and area under the curve of Xpert MTB/RIF were 65% (95% confidence interval, 59–72%), 99% (97–100%), and 0.99 (0.97–0.99) as compared with the CRS, respectively, and 75% (53–88%), 99% (90–100%), and 0.94 (0.92–0.96) as compared with culture, respectively. There was no significant heterogeneity between studies when CRS was the gold standard, whereas heterogeneity was evident when culture was the gold standard. Conclusions The sensitivity of Xpert MTB/RIF for diagnosing TBP was moderate and the specificity was good; thus, Xpert MTB/RIF can be used in the initial diagnosis of TBP.
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Tadesse, Mulualem, Gemeda Abebe, Danie Yilma, Ludwig Apers, Bouke De Jong, and Leen Rigouts. "PO 8168 CLINICAL UTILITY OF XPERT MTB/RIF ASSAY FOR THE DIAGNOSIS OF EXTRAPULMONARY TUBERCULOSIS IN ETHIOPIA." BMJ Global Health 4, Suppl 3 (April 2019): A20.2—A20. http://dx.doi.org/10.1136/bmjgh-2019-edc.50.
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BackgroundThe diagnosis of extrapulmonary tuberculosis (EPTB) is often made on clinical suspicion alone, and many people receive the wrong diagnosis leading to unnecessary TB treatment or poor outcomes from untreated EPTB. In this study, we evaluated the clinical utility of the Xpert MTB/RIF assay on routinely collected extra-pulmonary specimens in Ethiopia.MethodsThis study was carried out at Jimma University Specialized Hospital, Southwest Ethiopia from September 2015 to June 2017. Extra-pulmonary specimens were collected from 572 patients clinically suspected of suffering from EPTB. All specimens were tested for TB by smear-microscopy, culture and Xpert MTB/RIF. The diagnostic accuracy of Xpert MTB/RIF was calculated compared to a composite reference standard (CRS), composed of liquid culture and anti-TB treatment response.ResultsIn total, 572 extra-pulmonary specimens (279 lymph node, 159 pleural, 80 peritoneal, 45 cerebrospinal and 9 pericardial fluids) were tested. The pooled sensitivity and specificity of Xpert MTB/RIF were calculated to be 91% and 90.6% respectively when compared to culture. The pooled sensitivity of Xpert MTB/RIF was decreased to 75% and the specificity was improved to 98% when Xpert MTB/RIF was compared to the CRS. The sensitivities among the specimen types differed markedly. The highest sensitivity was documented for lymph node (90%), moderate sensitivity for cerebrospinal (53%), while the sensitivity was lowest for pleural (30%) and peritoneal (32%) fluids. Xpert MTB/RIF, in addition, detected rifampicin resistance in 13 patients in perfect agreement with line probe assay.ConclusionOur study showed that Xpert MTB/RIF is likely to be of greatest utility when testing lymph node specimens. A negative Xpert MTB/RIF result on fluid specimens does not exclude the diagnosis of EPTB and patients with a high clinical probability of EPTB should be started on anti-TB treatment.
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Lee, Han Na, Jung Im Kim, and Yee Hyung Kim. "Clinical and CT characteristics of Xpert MTB/RIF-negative pulmonary tuberculosis." PLOS ONE 16, no. 5 (May 3, 2021): e0250616. http://dx.doi.org/10.1371/journal.pone.0250616.
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Purpose To determine the diagnostic accuracy of the Xpert MTB/RIF assay in patients with smear-negative pulmonary tuberculosis (TB) and to assess clinical and CT characteristics of Xpert-negative pulmonary TB. Material and methods We retrospectively reviewed the records of 1,400 patients with suspected pulmonary TB for whom the sputum Xpert MTB/RIF assay was performed between September 1, 2014 and February 28, 2020. Clinical and CT characteristics of smear-negative pulmonary TB patients with negative Xpert MTB/RIF results were compared with positive results. Results Of 1,400 patients, 365 (26.1%) were diagnosed with pulmonary TB and 190 of 365 patients (52.1%) were negative for sputum acid-fast bacilli. The diagnosis of pulmonary TB was based on a positive culture, positive Xpert MTB/RIF or the clinical diagnoses of patients treated with an anti-TB medication. The sensitivity, specificity, positive predictive and negative predictive values of sputum Xpert MTB/RIF for smear-negative pulmonary TB were 41.1%, 100%, 100%, and 90.1%, respectively. Finally, 172 patients with smear-negative pulmonary TB who underwent chest CT within 2 weeks of diagnosis were included to compare Xpert-positive (n = 66) and Xpert- negative (n = 106) groups. Patients with sputum Xpert-negative TB showed lower positive rates for sputum culture (33.0% vs. 81.8%, p<0.001) and bronchoalveolar lavage culture (53.3% vs. 84.6%, p = 0.042) than in Xpert-positive TB. Time to start TB medication was longer in patients with Xpert-negative TB than in Xpert-positive TB (11.3±16.4 days vs. 5.0±8.7 days, p = 0.001). On chest CT, sputum Xpert-negative TB showed significantly lower frequency of consolidation (21.7% vs. 39.4%, p = 0.012), cavitation (23.6% vs. 37.9%, p = 0.045), more frequent peripheral location (50.9% vs. 21.2 p = 0.001) with lower area of involvement (4.3±4.3 vs. 7.6±6.4, p<0.001). Multivariate analysis revealed peripheral location (odds ratios, 2.565; 95% confidence interval: 1.157–5.687; p = 0.020) and higher total extent of the involved lobe (odds ratios, 0.928; 95% confidence interval: 0.865–0.995; p = 0.037) were significant factors associated with Xpert MTB/RIF-negative TB. Regardless of Xpert positivity, more than 80% of all cases were diagnosed of TB on chest CT by radiologists. Conclusion The detection rate of sputum Xpert MTB/RIF assay was relatively low for smear negative pulmonary TB. Chest CT image interpretation may play an important role in early diagnosis and treatment of Xpert MTB/RIF-negative pulmonary TB.
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McMillen, Tracy, Shauna C. Usiak, Liang Hua Chen, Luz Gomez, Peter Ntiamoah, Meera R. Hameed, Indre Budvytiene, Niaz Banaei, Mini Kamboj, and N. Esther Babady. "Evaluation of the Xpert MTB/RIF Performance on Tissues: Potential Impact on Airborne Infection Isolation at a Tertiary Cancer Care Center." Infection Control & Hospital Epidemiology 39, no. 4 (February 15, 2018): 462–66. http://dx.doi.org/10.1017/ice.2018.7.
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OBJECTIVESIn this study, we sought to evaluate the performance of the Xpert MTB/RIF (Cepheid) assay for the detection of Mycobacterium tuberculosis (MTB) complex DNA on fresh and formalin-fixed, paraffin-embedded (FFPE) tissue specimens from oncology patients in an area with a low prevalence of tuberculosis. We also aimed to retrospectively assess the potential impact of Xpert MTB/RIF on the duration of airborne infection isolation (AII).SETTINGA 473-bed, tertiary-care cancer center in New York City.DESIGNA total of 203 tissue samples (101 FFPE and 102 fresh) were tested using Xpert MTB/RIF, including 133 pulmonary tissue samples (65.5%) and 70 extrapulmonary tissue samples (34.5%). Acid-fast bacilli (AFB) culture was used as the diagnostic gold standard. The limit of detection (LOD) and reproducibility were also evaluated for both samples types using contrived specimens. The potential impact of the Xpert MTB PCR assay on tissue samples from AII patients on AII duration was retrospectively assessed.RESULTSUsing the Xpert MTB/RIF for fresh tissue specimens, the sensitivity was 50% (95% CI, 1.3%–98.7%) and the specificity was 99% (95% CI, 94.5%–99.9%). For FFPE tissue specimens, the sensitivity was 100% (95% CI, 63.1%–100%) and the specificity was 98.3% (95% CI, 95.5%–100%. The LOD was 103 colony-forming units (CFU)/mL for both fresh and FFPE tissue specimens, and the Xpert MTB/RIF was 100% reproducible at concentrations 10 times that of the LOD. With an expected turnaround time of 24 hours, the Xpert MTB PCR could decrease the duration of AII from a median of 8 days to a median of 1 day.CONCLUSIONSThe Xpert MTB/RIF assay offers a valid option for ruling out Mycobacterium tuberculosis complex (MTBC) on tissue samples from oncology patients and for minimizing AII resource utilization.Infect Control Hosp Epidemiol 2018;39:462–466
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Fakey Khan, Dilshaad, Moosa Suleman, Prinita Baijnath, Rubeshan Perumal, Vedanthi Moodley, Zoey Mhlane, Taryn Naidoo, Thumbi Ndung'u, and Emily B. Wong. "Multiple microbiologic tests for tuberculosis improve diagnostic yield of bronchoscopy in medically complex patients." AAS Open Research 2 (July 16, 2019): 25. http://dx.doi.org/10.12688/aasopenres.12980.1.
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Background: Bronchoalveolar lavage (BAL) is indicated for medical evaluation of complex cases of lung disease. There is limited data on the performance of tuberculosis (TB) microbiologic tests on BAL in such patients, particularly in human immunodeficiency virus (HIV) and TB endemic areas. Methods: We evaluated the performance of Mycobacterium tuberculosis (Mtb) culture and up to two simultaneous Xpert MTB/RIF tests on BAL fluid against a consensus clinical diagnosis in 98 medically complex patients undergoing bronchoscopy over a two-year period in Durban, South Africa. Results: TB was the most frequently diagnosed lung disease, found in 19 of 98 participants (19%) and was microbiologically proven in 14 of these (74%); 9 (47%) were culture positive and 5 were positive on at least one Xpert MTB/RIF assay. Immunosuppression prevalence was high (26% HIV-infected, 29% on immunosuppressive therapy and 4% on chemotherapy). Xpert MTB/RIF had low sensitivity (45%) and high specificity (99%) when assessed against the consensus clinical diagnosis. Compared to TB culture, a single Xpert MTB/RIF increased the diagnostic yield by 11% and a second Xpert MTB/RIF by a further 16%. Conclusion: Although Xpert MTB/RIF had a low sensitivity, sending two tests improved the microbiologically-proven diagnostic yield of bronchoscopy from 47% to 74% compared to culture alone.
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Zhou, Yue-Ying, Ji-Chan Shi, Ning Pan, Zheng-Xing Wu, Ai-Qiong Cheng, Yan-Hong Mei, Lian-Peng Wu, and Xian-Gao Jiang. "The value of GeneXpert MTB/RIF in bronchoalveolar lavage fluid in the diagnosis of smear-negative pulmonary tuberculosis." Investigación Clínica 62, no. 1 (March 1, 2021): 28–36. http://dx.doi.org/10.22209/ic.v62n1a03.
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This study aims to evaluate the diagnostic value of Xpert MTB/ RIF assay in bronchoalveolar lavage fluid (BALF) in subjects with smear-negative pulmonary tuberculosis. From January 2019 to December 2019, 197 patients with suspected pulmonary tuberculosis were recruited, and bronchoalveolar lavage fluid was collected for acid-fast staining smear, liquid culture of Mycobacterium combined drug sensitivity and Xpert MTB/RIF detection. The sensitivity, specificity, positive predictive value and negative predictive value of Xpert MTB/RIF in bronchoalveolar lavage fluid (BALF) were calculated with smear-negative pulmonary tuberculosis as the reference standard. The consistency of xpert MTB/RIF in the diagnosis of rifampicin resistance was evaluated, with the results of Mycobacterium liquid culture drug sensitivity test and drug sensitivity test as the gold standards. The results showed that among 197 suspected tuberculosis patients, 55 patients were not diagnosed with tuberculosis and 142 patients were diagnosed with smear-negative pulmonary tuberculosis. One hundred and twenty three cases (86.62%) were positive for Xpert MTB/ RIF in bronchoalveolar lavage fluid, 15 cases (10.56%) were positive by acid-fast staining smear method, and 88 cases (61.97%) were positive by the liquid culture method. The positive rate of Xpert MTB / RIF was 93.18% (82 / 88), which was higher than that of 75.93% (41 / 54) of the negative BALF mycobacterium culture (χ 2 = 8.598, P<0.01). The sensitivity and specificity of Xpert MTB/RIF for rifampicin resistance were 100.00% and 97.30%, respectively. Therefore, the diagnostic value of Xpert MTB/RIF in bronchoalveolar lavage fluid for bacterialnegative pulmonary tuberculosis is superior to the acid-fast staining smear of lavage fluid and the mycobacterium culture method.
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Rufai, Syed Beenish, Amit Singh, Parveen Kumar, Jitendra Singh, and Sarman Singh. "Performance of Xpert MTB/RIF Assay in Diagnosis of Pleural Tuberculosis by Use of Pleural Fluid Samples." Journal of Clinical Microbiology 53, no. 11 (August 26, 2015): 3636–38. http://dx.doi.org/10.1128/jcm.02182-15.
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Prospectively, 162 pleural fluid samples from patients with probable tuberculous pleural effusion were tested by the Xpert MTB/RIF assay and the Bactec MGIT-960 culture system. Of these, 43 (26.5%) were positive in the MGIT-960 culture, and 23 (14.2%), in the Xpert MTB/RIF assay. The sensitivity and specificity of the Xpert MTB/RIF compared with the MGIT-960 culture were 54.8% and 100%, respectively.
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Simarmata, Oster Suriani, and Dina Bisara Lolong. "Evaluasi Keunggulan Tes Cepat Molekuler dengan Xpert MTB/ RIF Dibanding dengan Uji Mikroskopis dalam Mendiagnosis Tuberkulosis di Indonesia Tahun 2018." Buletin Penelitian Kesehatan 48, no. 2 (September 22, 2020): 109–16. http://dx.doi.org/10.22435/bpk.v48i2.2875.
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Abstract
Tuberculosis (TB) remains a severe health issue worldwide which is one of the death leading causes, particularly in developing countries including Indonesia. The purpose of this study is to evaluate the superiority of the molecular diagnostic test with Xpert MTB/RIF compared to the microscopic test in 44 health facilities in Indonesia in 2018. The results revealed that the Xpert MTB/RIF test could detect 31,9% positive TB from 33,630 suspected cases. The Xpert MTB/RIF were also able to detect 16.7% positive samples from 5.491 samples which were previously negative tested by microscopic technique. The positive TB was dominated by the male in the age group of 15 to 54 years. Moreover, Xpert MTB/RIF test could examine the not-sputum samples of 0.16% (52 of 33,630 samples), which 9 samples of them were positive TB (17.3%). These positive TB samples were derived from gastric fluid (77.8%), pleural fluid (11.1%), and lymph node aspiration (11.1%), which majority were from children under 15 years old. This study concluded that the superiority of TCM test included its sensitivity to detect positive TB in resistant rifampicin cases, to identify the existence of MTB resistant to rifampicin drugs simultaneously and to detect the MTB with the non-sputum samples.
Keywords: evaluation, TB, Xpert MTB/RIF test
Abstrak
Tuberkulosis (TB) masih merupakan masalah kesehatan global yang serius dan penyebab utama kematian di seluruh dunia terutama di negara berkembang termasuk Indonesia. Tujuan dari penelitian ini adalah mengevaluasi keunggulan pemeriksaan diagnostik Tes Cepat Molekuler (TCM) Xpert MTB/RIF dibanding dengan pemeriksaan mikroskopis di 44 fasilitas kesehatan di Indonesia tahun 2018. Hasil pemeriksaan TCM dengan Xpert MTB/RIF dari 33.630 terduga TB terdapat TB positif sebesar 31,9%. Pemeriksaan mikroskopis dengan hasil negatif sebanyak 5.491 terduga TB yang juga diperiksa TCM dengan Xpert MTB/RIF terdapat hasil TB positif sebesar 16,7%. Hasil TB positif tersebut didominasi kelompok umur 15-54 tahun dan laki-laki. Pemeriksaan TCM ini juga mampu memeriksa spesimen bukan sputum sebesar 0,16% dan hasilnya 9 di antaranya adalah TB positif (17,3%). Spesimen TB positif ini berasal dari bilasan/ aspirasi cairan lambung 77,8% (7 dari 9 spesimen), cairan pleura 11,1% (1 dari 9 spesimen) dan aspirasi limfonodus 11,1% (1 dari 9 spesimen). Dilihat dari kelompok umur lebih dari separuh spesimen bukan sputum ini berasal dari anak <15 tahun. Penelitian ini menyimpulkan bahwa TCM dengan Xpert MTB/RIF lebih unggul daripada pemeriksaan mikroskopis karena sensitivitasnya pada rifampisin sensitif maupun resisten, mampu mengidentifikasi keberadaan MTB yang resisten obat rifampisin secara bersamaan serta sampel bukan-sputum.
Kata kunci: Evaluasi, TB, Tes Cepat Molekuler dengan Xpert MTB/RIF
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Feliciano, Cinara Silva, Lucas José Bazzo Menon, Livia Maria Pala Anselmo, Anzaan Dippenaar, Robin Mark Warren, Wilson Araújo Silva, and Valdes Roberto Bollela. "Xpert MTB/RIF performance to diagnose tuberculosis and rifampicin resistance in a reference centre in southern Brazil." ERJ Open Research 5, no. 3 (July 2019): 00043–2019. http://dx.doi.org/10.1183/23120541.00043-2019.
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Effective treatment of tuberculosis (TB) remains a serious public health problem in many countries, including Brazil, especially when considering drug-resistant disease. Xpert MTB/RIF has been implemented in many countries to reduce the time to TB diagnosis and to rapidly detect rifampicin resistance. The study aimed to describe and evaluate Xpert MTB/RIF performance in diagnosing pulmonary TB and rifampicin resistance in a tertiary healthcare facility in Brazil.A cross-sectional study was performed, which included all isolates of confirmed pulmonary TB patients from 2015 to 2018. Both Xpert MTB/RIF and GenoType MTBDRplus assays were performed to detect rifampicin and isoniazid resistance. In addition, isolates with detected resistance to rifampicin and/or isoniazid were analysed by phenotypic testing using MGIT-960 SIRE kit and whole-genome sequencing (WGS) using Illumina MiSeq Sequencing System.2148 respiratory specimens tested with Xpert MTB/RIF were included: n=1556 sputum, n=348 bronchoalveolar lavage and n=244 gastric washing. The overall Xpert MTB/RIF sensitivity in sputum was 94% and the overall specificity was 98%. The negative predictive value in sputum of all the patients was 99% with a positive predictive value of 89%. The concordance between Xpert MTB/RIF and phenotypic susceptibility test was 94.1%, while its concordance with WGS was 78.9%.Xpert MTB/RIF is a rapid and accurate diagnostic strategy for pulmonary TB, which can contribute to improvement in TB control. However, detection of rifampicin resistance might be associated with false-positive results.
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Sehgal, Inderpaul Singh, Sahajal Dhooria, Ashutosh Nath Aggarwal, Digambar Behera, and Ritesh Agarwal. "Diagnostic Performance of Xpert MTB/RIF in Tuberculous Pleural Effusion: Systematic Review and Meta-analysis." Journal of Clinical Microbiology 54, no. 4 (January 27, 2016): 1133–36. http://dx.doi.org/10.1128/jcm.03205-15.
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A systematic review investigating the role of Xpert MTB/RIF in the diagnosis of tuberculous pleural effusion (TPE) was conducted. The pooled sensitivities and specificities of Xpert MTB/RIF were 51.4% and 98.6%, respectively, with culture used as a reference standard and 22.7% and 99.8%, respectively, with a composite reference standard (CRS) used as the benchmark. Xpert MTB/RIF has low sensitivity but excellent specificity in the diagnosis of TPE.
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Pinto, Márcia, Aline Piovezan Entringer, Ricardo Steffen, and Anete Trajman. "Cost analysis of nucleic acid amplification for diagnosing pulmonary tuberculosis, within the context of the Brazilian Unified Health Care System." Jornal Brasileiro de Pneumologia 41, no. 6 (December 2015): 536–38. http://dx.doi.org/10.1590/s1806-37562015000004524.
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ABSTRACT We estimated the costs of a molecular test for Mycobacterium tuberculosis and resistance to rifampin (Xpert MTB/RIF) and of smear microscopy, within the Brazilian Sistema Único de Saúde (SUS, Unified Health Care System). In SUS laboratories in the cities of Rio de Janeiro and Manaus, we performed activity-based costing and micro-costing. The mean unit costs for Xpert MTB/RIF and smear microscopy were R$35.57 and R$14.16, respectively. The major cost drivers for Xpert MTB/RIF and smear microscopy were consumables/reagents and staff, respectively. These results might facilitate future cost-effectiveness studies and inform the decision-making process regarding the expansion of Xpert MTB/RIF use in Brazil.
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Velasco, John Mark, Noel Gaurano, Maria Theresa Valderama, Kathyleen Nogrado, Paula Corazon Diones, Ma Nila Lopez, Cynthia Liao, et al. "Multidrug Resistant Mycobacterium tuberculosis Among Military and Civilian Personnel seen at a Tertiary Military Hospital, Manila, Philippines (2015–2018)." Military Medicine 185, no. 7-8 (January 9, 2020): e1106-e1111. http://dx.doi.org/10.1093/milmed/usz456.
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Abstract Introduction: About one third of the world population is estimated to be infected with Mycobacterium tuberculosis (MTB), and this proportion is expected to be higher in countries with a high tuberculosis (TB) burden. The Philippines is both a high tuberculosis burden and a high multidrug resistant tuberculosis (MDR-TB) burden country. Though TB has been extensively described in the civilian population, there is limited data on TB in the military population. The objectives are: (1) To determine MTB/MDR-TB prevalence among military and civilian patients in the Philippines presenting with clinically suspected TB in a tertiary military hospital and (2) To determine performance of direct sputum smear microscopy (DSSM) using Ziehl-Neelsen (ZN) staining compared to Xpert MTB/RIF real-time reverse transcriptase polymerase chain reaction. Materials and Methods: Sputum samples were obtained from patients, clinically suspected with TB, and/or with TB associated signs/symptoms. Sputum specimens were tested using DSSM with ZN staining and Xpert MTB/RIF assay (Cepheid, Sunnyvale, California) and patient demographic and clinical data were collected. Results: From March 2015 to December 2018, a total of 795 (173 military personnel [164 active duty and 9 retired]; 618 civilians; and 4 with no data on military/civilian status) patients with TB associated symptoms or clinically suspected with TB were tested. Overall, MTB prevalence was 81/795 (10%). MTB prevalence among active duty and retired military personnel were 27/164 (16%) and 4/9 (44%), respectively while MTB prevalence for civilian patients was 50/618 (8%) (p value = 0.0003; OR = 2.48 [95% C.I. 1.5–4]). Among active and retired military personnel who tested positive for MTB, rifampin resistance was 4/27 (15%) and 1/4 (25%), respectively, while rifampin resistance for civilian patients was 9/50 (18%) (p value = 1; OR = 0.88 [95% C.I. 0.26–2.90]). For active duty military personnel, average MTB prevalence (based on Xpert MTB/RIF) covering years 2015–2018 was 21% and ranged from 13% to 35%, while average rifampin resistance among MTB positive active duty military personnel was 15% and ranged from 0% to 25%. Overall sensitivity and specificity of DSSM compared to Xpert MTB/RIF were 70% and 96%, respectively. Positive and negative predictive values of DSSM to accurately categorize MTB in symptomatic cases (with Xpert MTB/RIF as “true positive” reference) were 74% and 95%, respectively. Performance of DSSM varied according to MTB load detected by Xpert MTB/RIF with increasing DSSM sensitivity observed as the MTB load detected by Xpert MTB/RIF increased (p = 0.02). Conclusion: This report describes high MTB and MDR-TB prevalence rates among symptomatic military patients with military personnel having higher odds of MTB infection compared to the civilian patients in the study. Since DSSM (ZN) sensitivity greatly varied depending on MTB load, the Xpert MTB/RIF should be used as a first-line diagnostic tool to identify MTB and detect rifampin resistance among presumptive TB cases instead of DSSM (ZN) microscopy.
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Han, Yi, Ning Xiao, Shaojung Huang, Ming Qin, Nanying Che, and Zhidong Liu. "The Application of Xpert Mycobacterium tuberculosis/Rifampicin, Quantitative Polymerase Chain Reaction and High Resolution Melting Curve in the Diagnosis of Superficial Lymph Node TB." Current Pharmaceutical Biotechnology 20, no. 12 (October 18, 2019): 1044–54. http://dx.doi.org/10.2174/1389201020666190716104131.
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Objective: The diagnostic sensitivity and specificity of conventional methods for superficial lymph node tuberculosis (LNTB) are not ideal. We evaluated several novel methods including Xpert Mycobacterium tuberculosis/rifampicin (Xpert MTB/RIF) technology, quantitative fluorescence Polymerase Chain Reaction (qPCR) and High-Resolution Melting Curve (HRMC) in the diagnosis of superficial lymph node TB. Methods: Specimens from eighty-one consecutive patients with suspected LNTB and thirteen cases with other lymph node disease were analyzed by Xpert MTB/RIF, qPCR, and HRMC. Results: Among 81 patients with clinical suspicion of LNTB, there were 74 (91.4%) cases positive Mycobacterium tuberculosis Complex (MTBC) of Xpert MTB/RIF, 60 (74%) positive of qPCR, 24 (29.6%) of positive of BACTEC MGIT960 culture, and 13 (16%) cases positive of Roche culture. 38 cases (46.9%) were diagnosed with LNTB. All test methods showed a diagnostic specificity of 100% for LNTB. The sensitivity of molecular biology techniques was significantly higher than that of the traditional diagnostic methods, and Xpert MTB/RIF was the most sensitive diagnostic assay. On Rifampinresistant detection, Xpert MTB/RIF detected three cases (3.7%) with rpoB gene mutation, and Mycobacterium tuberculosis susceptibility testing detected 2 rifampicin-resistant cases (2.4%) which were consistent with Xpert MTB/RIF results. In the Isoniazid-resistant, 7 cases (8.1) of isoniazid resistance mutations (8.1%) were detected by HNC and 1 case was confirmed by Isoniazid susceptibility test. Conclusion: Molecular detection increased the diagnostic sensitivity of LNTB and improved the detection sensitivity for rifampin and isoniazid resistance strain.
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Tiamiyu, Abdulwasiu Bolaji, Garba Iliyasu, Farouq Muhammad Dayyab, Zaiyad Garba Habib, Sirajo Haliru Tambuwal, Habibu Galadanci, Sunday A. Bwala, Lovett Lawson, and Abdulrazaq Garba Habib. "Evaluation of GeneXpert MTB/RIF as a diagnostic tool in patients with sputum smear-negative TB in a high HIV burden region in Nigeria." Transactions of The Royal Society of Tropical Medicine and Hygiene 114, no. 9 (April 17, 2020): 697–99. http://dx.doi.org/10.1093/trstmh/traa019.
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Abstract Background There are challenges in the diagnosis of TB in people with smear-negative pulmonary TB (SNPTB) in resource-limited settings. We evaluated the diagnostic usefulness of Xpert MTB/RIF compared with TB culture among SNPTB. Methods The study was a cross-sectional study among patients with SNPTB. The Xpert MTB/RIF tests and sputum culture (using Lowenstein-Jensen medium) were performed. Sensitivity and specificity were calculated. Results Of 150 patients studied, the sensitivity and specificity of GeneXpert MTB/RIF were 81.8 and 97.4%, respectively. Conclusion The sensitivity and specificity of Xpert MTB/RIF assay was comparative with culture in SNPTB patients.
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Triasih, Rina, Amalia Setyati, Dwikisworo Setyowireni, Titik Nuryastuti, Rachma Dewi Isnaini Putri, and Emi Rusdiyati. "Use of Xpert MTB/RIF for diagnosis of pediatric tuberculosis in Indonesia." Paediatrica Indonesiana 60, no. 4 (July 17, 2020): 198–204. http://dx.doi.org/10.14238/pi60.4.2020.198-204.
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Background The Xpert MTB/RIF assay demonstrated a better diagnostic value than sputum smear for TB in adults and children.
Objective To evaluate the use of Xpert MTB/RIF for TB diagnosis in children.
Methods We conducted a prospective study in Yogyakarta, Indonesia, involving 19 primary health centers (PHCs) and one provincial hospital. Children aged 0-14 years with suspected TB who visited the study sites were screened. Subjects underwent history-taking, physical examination, tuberculin skin test, chest X-ray, as well as sputum induction for Xpert MTB/RIF assay, sputum smear, and TB culture. The diagnosis of TB was made by doctors based on the results of investigations, as follows: certain TB (bacteriological confirmation), probable TB, and possible TB.
Results Of 80 subjects, 21 (26%) were diagnosed with TB disease (4 certain TB and 17 probable TB). Sputum induction was successfully performed in 79 children. None of the children had positive sputum smears. Mycobacterium tuberculosis was detected by Xpert MTB/RIF in 4 children, accounting for 5% of all children with suspected TB, or 19% among children with TB disease. The 4 Xpert MTB/RIF-positive subjects had severe TB disease and were rifampicin-sensitive.
Conclusion Xpert MTB/RIF may improve case finding among children with severe TB disease with negative sputum smear.
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Rendell, Nicole L., Solongo Bekhbat, Gantungalag Ganbaatar, Munkhjargal Dorjravdan, Madhukar Pai, and Claudia C. Dobler. "Implementation of the Xpert MTB/RIF assay for tuberculosis in Mongolia: a qualitative exploration of barriers and enablers." PeerJ 5 (July 14, 2017): e3567. http://dx.doi.org/10.7717/peerj.3567.
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Objective The aim of our study was to identify barriers and enablers to implementation of the Xpert MTB/RIF test within Mongolia’s National Tuberculosis Program. Methods Twenty-foursemi-structured interviews were conducted between June and September 2015 with laboratory staff and tuberculosis physicians in Mongolia’s capital Ulaanbaatar and regional towns where Xpert MTB/RIF testing had been implemented. Interviews were recorded, transcribed, translated and analysed thematically using NVIVO qualitative analysis software. Results Eight laboratory staff (five from the National Tuberculosis Reference Laboratory in Ulaanbaatar and three from provincial laboratories) and sixteen tuberculosis physicians (five from the Mongolian National Center for Communicable Diseases in Ulaanbaatar, four from district tuberculosis clinics in Ulaanbaatar and seven from provincial tuberculosis clinics) were interviewed. Major barriers to Xpert MTB/RIF implementation identified were: lack of awareness of program guidelines; inadequate staffing arrangements; problems with cartridge supply management; lack of local repair options for the Xpert machines; lack of regular formal training; paper based system; delayed treatment initiation due to consensus meeting and poor sample quality. Enablers to Xpert MTB/RIF implementation included availability of guidelines in the local language; provision of extra laboratory staff, shift working arrangements and additional modules; capacity for troubleshooting internally; access to experts; opportunities for peer learning; common understanding of diagnostic algorithms and decentralised testing. Conclusion Our study identified a number of barriers and enablers to implementation of Xpert MTB/RIF in the Mongolian National Tuberculosis Program. Lessons learned from this study can help to facilitate implementation of Xpert MTB/RIF in other Mongolian locations as well as other low-and middle-income countries.
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Habeenzu, Charity, Chie Nakajima, Eddie Solo, Precious Bwalya, Kiichi Kajino, Mari Miller, Youichi Kurosawa, et al. "Evaluation of in-house loop-mediated isothermal amplification for tuberculosis diagnosis compared with Xpert MTB/RIF." Journal of Infection in Developing Countries 11, no. 06 (June 27, 2017): 440–44. http://dx.doi.org/10.3855/jidc.7730.
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Introduction: To evaluate the diagnostic performances of an in-house loop-mediated isothermal amplification (LAMP) kit and the Xpert MTB/RIF test for the diagnosis of pulmonary tuberculosis in a resource-limited setting, this study was performed at the University Teaching Hospital, Ministry of Health, the Republic of Zambia.
Methodology: Two hundred sputum specimens obtained from new tuberculosis (TB) suspects were used for the evaluation of the diagnostic performance of an in-house LAMP kit in comparison with the Xpert MTB/RIF kit.
Results: The sensitivity of in-house LAMP and Xpert MTB/RIF was 96.9% and 95.4% in smear-positive samples, 96.8% and 100% in smear-positive/culture-positive samples, and 39.1% and 73.9% in smear-negative/culture-positive samples, respectively. The specificity of in-house LAMP and MTB/RIF kits with culture was 96.5% and 94.5%, respectively. This indicated the superiority of the Xpert MTB/RIF kit; however, mechanical errors during sample processing and the insufficient quantity of samples by Xpert MTB/RIF kit occurred at 2.0% and 19.7%, respectively, comparing to the 100% accessibility of in-house LAMP.
Conclusions: Considering the results obtained in this study together with the easy setup with much simpler equipment, such as an aluminum heat block or water bath, in in-house LAMP compared with real-time polymerase chain reaction equipment in Xpert MTB/RIF kit, the applicability of in-house LAMP for the screening of tuberculosis directly from sputum in resource-limited setting seemed to be high.
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Worku, Mesfin, Mulualem Agonafir, Mubarek A. Yassin, Mohammed A. Yassin, Daniel G. Datiko, Sally Theobald, and Luis E. Cuevas. "Use of Xpert MTB/RIF for the Identification of TB and Drug Resistance Among Smear-Negative and Re-Treatment Cases in Rural Areas of Ethiopia." Open Microbiology Journal 13, no. 1 (June 30, 2019): 188–92. http://dx.doi.org/10.2174/1874285801913010188.
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Introduction: Tuberculosis (TB) remains a leading infectious cause of morbidity and mortality worldwide. A key contributor to this burden is poor diagnosis as only 60% of new pulmonary tuberculosis (TB) cases in Africa are ever detected. Therefore, this study aimed to assess the feasibility of Xpert MTB/RIF test implementation in the region, and the performance of the assay to increase case detection on the selected rural health care setting. Objective: To assess the feasibility of Xpert MTB/RIF test implementation in the rural health care setting in Southern Ethiopia. Methods: Two Xpert MTB/RIF machines were brought in 2012 through TB REACH project. It was placed at Yirgalem hospital and at Aletawondo health centre. The instruments were installed after formal training was provided to laboratory technologists for three days. We collected sputum sample from participants who repeatedly had negative smear microscopy and those who had not responded to first-line anti-TB drugs. Result: Of the total participants tested, 1828 have valid result (MTB-, MTB+/RIF-, MTB+/RIF+, MTB+/RIF Indeterminate). From the participants with valid results, 217 (11.9%) were Xpert-positive of which were 165 (9.0%) RIF-negative, 6 (0.3%) RIF-indeterminate and 46 (2.5%) RIF-positive. Among TB suspects with previous treatment history and positive by Xpert, RIF resistance was detected in 10 (2.2%). From the new TB suspects with positive Xpert, RIF resistance was detected in 29 (2.7%). All cases identified were linked with TB/MDR-TB treatment centers. Conclusion: Xpert provides an additional tool for the diagnosis of TB and drug resistance, with almost 12% of new and retreatment cases obtaining information that is useful for clinical management. To enhance its efficient utilisation, operational challenges should be minimized particularly in relation to availing robust alternative power source.
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Andrianto, Andrianto, Ni Made Mertaniasih, Parama Gandi, Makhyan Jibril Al-Farabi, Yusuf Azmi, Michael Jonatan, and Stevanus Immanuel Silahooij. "Diagnostic test accuracy of Xpert MTB/RIF for tuberculous pericarditis: a systematic review and meta-analysis." F1000Research 9 (July 22, 2020): 761. http://dx.doi.org/10.12688/f1000research.22770.1.
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Introduction: Xpert MTB/RIF is a rapid diagnostic instrument for pulmonary tuberculosis (TB). However, studies reported varied accuracy of Xpert MTB/RIF in detecting Mycobacterium tuberculosis in pericardial effusion. Methods: We performed a systematic review of literature in PubMed, published up to February 1, 2020, according to PRISMA guidelines. We screened cross-sectional studies, observational cohort studies, and randomized control trials that evaluated the accuracy of Xpert MTB/RIF in diagnosing TB pericarditis. Papers with noninterpretable results of sensitivity and specificity, non-English articles, and unpublished studies were excluded. The primary outcomes were the sensitivity and specificity of Xpert MTB/RIF. We conducted a quality assessment using QUADAS-2 to evaluate the quality of the studies. A bivariate model pooled the overall sensitivity, specificity, positive likelihood ratios (PLRs), and negative likelihood ratios (NLRs) of included studies. Results: In total, 581 subjects from nine studies were analyzed in this meta-analysis. Our pooled analysis showed that the overall sensitivity, specificity, PLRs and NLRs of included studies were 0.676 (95% CI: 0.580–0.759), 0.994 (95% CI: 0.919–1.000), 110.11 (95% CI: 7.65–1584.57) and 0.326 (95% CI: 0.246–0.433), respectively. Conclusions: Xpert MTB/RIF had a robust specificity but unsatisfactory sensitivity in diagnosing TB pericarditis. These findings indicated that although positive Xpert MTB/RIF test results might be valuable in swiftly distinguishing the diagnosis of TB pericarditis, negative test results might not be able to rule out TB pericarditis. Registration: PROSPERO CRD42020167480 28/04/2020
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Yu, Guocan, Fangming Zhong, Bo Ye, Xudong Xu, Da Chen, and Yanqin Shen. "Diagnostic Accuracy of the Xpert MTB/RIF Assay for Lymph Node Tuberculosis: A Systematic Review and Meta-Analysis." BioMed Research International 2019 (May 19, 2019): 1–12. http://dx.doi.org/10.1155/2019/4878240.
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Objectives. To evaluate the performance of Xpert MTB/RIF for lymph node tuberculosis (LNTB). Methods. We searched databases for published reports. We reviewed the studies and identified the performance of Xpert MTB/RIF with respect to a composite reference standard (CRS) and culture. We used a bivariate random-effects model to perform meta-analyses and used metaregression to analyze sources of heterogeneity. Results. 15 independent studies compared Xpert MTB/RIF with CRS while 21 comparing it with culture were included. The pooled sensitivity and specificity of Xpert MTB/RIF were 79% and 98% compared to that of CRS, respectively, and 84% and 91% compared to that of culture, respectively. The pooled sensitivity and specificity using fine needle aspiration (FNA) samples versus CRS were 80% and 96%, whereas those against culture were 90% and 89%, respectively. The percentages while working with tissue samples versus CRS were 76% and 100%, respectively, whereas those against culture were 76% and 92%, respectively. There was no significant difference in diagnostic efficiency among the types of specimen. Conclusions. Xpert MTB/RIF demonstrates good diagnostic efficiency for LNTB and is not related to the type of specimen, obtained via different routes.
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Casela, Marilda, Silvânia Maria Andrade Cerqueira, Thais de Oliveira Casela, Mariana Araújo Pereira, Samanta Queiroz dos Santos, Franco Andres Del Pozo, Songeli Menezes Freire, and Eliana Dias Matos. "Rapid molecular test for tuberculosis: impact of its routine use at a referral hospital." Jornal Brasileiro de Pneumologia 44, no. 2 (April 2018): 112–17. http://dx.doi.org/10.1590/s1806-37562017000000201.
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ABSTRACT Objective: To evaluate the impact of the use of the molecular test for Mycobacterium tuberculosis and its resistance to rifampin (Xpert MTB/RIF), under routine conditions, at a referral hospital in the Brazilian state of Bahia. Methods: This was a descriptive study using the database of the Mycobacteriology Laboratory of the Octávio Mangabeira Specialized Hospital, in the city of Salvador, and georeferencing software. We evaluated 3,877 sputum samples collected from symptomatic respiratory patients, under routine conditions, between June of 2014 and March of 2015. All of the samples were submitted to sputum smear microscopy and the Xpert MTB/RIF test. Patients were stratified by gender, age, and geolocation. Results: Among the 3,877 sputum samples evaluated, the Xpert MTB/RIF test detected M. tuberculosis in 678 (17.5%), of which 60 (8.8%) showed resistance to rifampin. The Xpert MTB/RIF test detected M. tuberculosis in 254 patients who tested negative for sputum smear microscopy, thus increasing the diagnostic power by 59.9%. Conclusions: The use of the Xpert MTB/RIF test, under routine conditions, significantly increased the detection of cases of tuberculosis among sputum smear-negative patients.
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Shetye, Shamma, P. Chheda, A. Lad, and S. Matkar. "PERFORMANCE OF XPERT MTB/RIF ASSAY FOR DETECTION OF M.TB IN PULMONARY AND EXTRA-PULMONARY SAMPLES IN INDIAN PATIENTS." SAARC Journal of Tuberculosis, Lung Diseases and HIV/AIDS 14, no. 1 (July 12, 2017): 7–13. http://dx.doi.org/10.3126/saarctb.v14i1.17720.
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Introduction: Conventional methods like Ziehl-Neelsen (ZN) staining and liquid culture have been the mainstay for diagnosis of Tuberculosis (TB). The gold standard Liquid Culture method has a longer turnaround time. In the wake of the TB catastrophe, newer rapid and easily accessible methods of detection are the need of the hour. A molecular method like the Xpert MTB/RIF assay has revolutionized the early and rapid diagnosis of TB. Objective of the current study was to assess the performance and utility of Xpert MTB/RIF assay for the diagnosis of M. tuberculosis in pulmonary and extra-pulmonary clinical specimens in a large Indian reference laboratory.Methodology: The reference methods used were MGIT Liquid Culture system and ZN smear microscopy. Our study was performed in Global Reference Laboratory, Metropolis Healthcare, Mumbai, India for a period of 18 months with consecutive one thousand and forty two (518 Pulmonary + 524 extra-pulmonaryspecimens) clinical specimens obtained from the patients with clinical suspicion of tuberculosis. Diagnostic performance (sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) of the three methods were calculated with standard formulae.Results: In comparison to MGIT Liquid culture, sensitivity of Xpert MTB/RIF assay for pulmonary and extra pulmonary specimens were 87.18% and 68.92%, respectively while in comparison to ZN smear microscopy the sensitivity of Xpert MTB/RIF assay for pulmonary and extra pulmonary specimens were 92.67% and 83.81%, respectively.Conclusion: Our study concludes that in combination with the MGIT culture, Xpert MTB/RIF assay will significantly improve the detection rate of MTB bacteria.SAARC J TUBER LUNG DIS HIV/AIDS, 2017; XIV(1), page: 7-13
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Magar, Sanam Thapa, Gokarna Ghimire, and Pradeep Kumar Shah. "Comparison of Led Fluorescent Microscopy and the Gene Xpert MTB/RIF Assay in Diagnosis of Pulmonary and Extrapulmonary Tuberculosis." Tribhuvan University Journal of Microbiology 6 (December 7, 2019): 127–32. http://dx.doi.org/10.3126/tujm.v6i0.26596.
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Objectives: The objective of this study was to evaluate Gene Xpert MTB/RIF Assay and anid fast staining (AFB) for rapid detection of Mycobacterium tuberculosis in specimen of patients suspected of pulmonary tuberculosis (PTB) and extra pulmonary tuberculosis (EPTB).
Methods: A comparative cross-sectional study of 400 samples (PTB-365 and EPTB-35) of patients visiting National Tuberculosis Centre (NTC) was conducted from July 2018 to December 2018. Gene Xpert MTB/ RIF Assay, smear microscopy were performed under standard guideline inside biosafety cabinet class II. The result obtained from both the tests were analyzed using SPSS 20.0 software and Excel 2019.
Results: Of the total samples, 18% (72/400) and 39% (156/400) were positive by AFB smear microscopy and Xpert MTB/RIF assay respectively. Prevalence of MTB positive was highest in the age group 35-44 years, 33 cases (17.74%) were detected in total, with a male to female ratio of 2.3:1. Pleural fluid, pus, and CSF fluid also yielded positive results with the Gene Xpert MTB/RIF assay accounting 1.28%, 0.64% and 1.28% of MTB positive case respectively. Rifampicin resistance was observed in 1.28% of the cases.
Conclusion: The key findings of this study suggest that Gene Xpert test should be implemented as primary diagnostic test for PTB and EPTB.
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Rufai, Syed Beenish, Sarman Singh, Amit Singh, Parveen Kumar, Jitendra Singh, and Anand Vishal. "Performance of Xpert MTB/RIF on Ascitic Fluid Samples for Detection of Abdominal Tuberculosis." Journal of Laboratory Physicians 9, no. 01 (January 2017): 047–52. http://dx.doi.org/10.4103/0974-2727.187927.
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ABSTRACT Background: Diagnosis of abdominal tuberculosis (TB) from ascitic fluid samples using routinely available diagnostic methods is challenging due to its paucibacillary nature. Although performance of Xpert MTB/RIF assay has been evaluated extensively on pulmonary samples, its performance on extrapulmonary samples is still under evaluation. Objectives: The objective of this study was to find out the performance of Xpert MTB/RIF on ascitic fluid samples obtained from suspected cases of abdominal TB. Performance was compared with Mycobacterium growth indicator tube-960 (MGIT-960) culture and in-house multiplex polymerase chain reaction (PCR). The latter detects and differentiates Mycobacterium tuberculosis and nontuberculous mycobacteria simultaneously. Materials and Methods: Sixty-seven patients suspected of probable/possible abdominal TB were included in this observational, prospective study. All samples were tested by Ziehl–Neelsen staining, MGIT-960 culture, in-house multiplex PCR, and Xpert MTB/RIF assay. Results: All 67 samples were smear negative. Seventeen (25.4%) were MGIT-960 culture positive while 12 (17.9%) were detected positive by the Xpert MTB/RIF assay and 9 (13.4%) by in-house multiplex PCR. Sensitivity and specificity of the Xpert MTB/RIF assay compared with the MGIT-960 culture were 70.6% (95%, confidence interval [CI]: 44.1–89.7) and 100% (95%, CI: 92.8–100) and that of in-house multiplex PCR were 52.9% (95%, CI: 30.9–73.8) and 100% (95%, CI: 92.8–100), respectively. Conclusions: Diagnostic yield of Xpert MTB/RIF assay on ascitic fluid samples was lower than MGIT-960 culture. We thus emphasize on the need for urgent discovery of new biomarkers for paucibacillary TB.
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Li, Hou-He, Zhi-Jian He, Jia-Qi Liang, Gui-Lin Li, Tian-Ao Xie, Ye-Ling Liu, Zhong-Wei Li, Xuan-Cheng Feng, Yong Xia, and Xu-Guang Guo. "Evaluation of Xpert MTB/RIF for the Diagnosis of Lymphatic Tuberculosis." BioMed Research International 2020 (June 28, 2020): 1–11. http://dx.doi.org/10.1155/2020/1968487.
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Background. The World Health Organization approved the use of Xpert MTB/RIF for the detection of Mycobacterium tuberculosis DNA, which has significantly improved the diagnosis of tuberculosis. In this study, our main objective was to evaluate the diagnostic efficacy of Xpert MTB/RIF for lymphoid tuberculosis to determine whether Xpert MTB/RIF could be used as a routine detection method. Materials and Methods. We searched four databases for the relevant literature published from May 2007 to December 2019. The quality of the literature was evaluated with reference to the evaluation criteria. Data that were extracted from the literature on Xpert MTB/RIF diagnosis of lymphatic tuberculosis were used to plot the summary receiver operating characteristic (SROC) curve, after which the software was used to combine and analyze the accuracy of these data. Results. A total of 27 studies were included. The sensitivity of Xpert MTB/RIF for detecting lymphatic tuberculosis was 0.79 (95% CI (0.77, 0.81)), the specificity was 0.88 (95% CI (0.87, 0.90)), and the positive likelihood ratio (PLR) was 7.21 (95% CI (4.93, 10.55)). In addition, the negative likelihood ratio (NLR) was 0.25 (95% CI (0.19, 0.32)) and the diagnostic odds ratio (DOR) was 40.23 (95% CI (24.53, 65.98)). At the same time, we used the extracted data to make the SROC curve, obtaining the following parameters: area under the curve AUC=0.9144, Q=0.8470 (SE=0.0163). Conclusion. Xpert MTB/RIF has high accuracy in detecting lymphatic tuberculosis, and it can be used to quickly and easily diagnose lymphatic tuberculosis at an early stage as a general method.
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Cazabon, Danielle, Tripti Pande, Sandra Kik, Wayne Van Gemert, Hojoon Sohn, Claudia Denkinger, Zhi Zhen Qin, Brenda Waning, and Madhukar Pai. "Market penetration of Xpert MTB/RIF in high tuberculosis burden countries: A trend analysis from 2014 - 2016." Gates Open Research 2 (September 18, 2018): 35. http://dx.doi.org/10.12688/gatesopenres.12842.2.
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Background: Xpert® MTB/RIF, a rapid tuberculosis (TB) molecular test, was endorsed by the World Health Organization in 2010. Since then, 34.4 million cartridges have been procured under concessional pricing. Although the roll out of this diagnostic is promising, previous studies showed low market penetration. Methods: To assess 3-year trends of market penetration of Xpert MTB/RIF in the public sector, smear and Xpert MTB/RIF volumes for the year 2016 were evaluated and policies from 2014-2016 within 22 high-burden countries (HBCs) were studied. A structured questionnaire was sent to representatives of 22 HBCs. The questionnaires assessed the total smear and Xpert MTB/RIF volumes, number of modules and days of operation of GeneXpert machines in National TB Programs (NTPs). Data regarding the use of NTP GeneXpert machines for other diseases and GeneXpert procurement by other disease control programs were collected. Market penetration was estimated by the ratio of total sputum smear volume for initial diagnosis divided by the number of Xpert MTB/RIF tests procured in the public sector. Results: The survey response rate was 21/22 (95%). Smear/Xpert ratios decreased in 17/21 countries and increased in four countries, since 2014. The median ratio decreased from 32.6 (IQR: 44.6) in 2014 to 6.0 (IQR: 15.4) in 2016. In 2016, the median GeneXpert utilization was 20%, however seven countries (7/19; 37%) were running tests for other diseases on their NTP-procured GeneXpert systems in 2017, such as HIV, hepatitis-C virus (HCV), Chlamydia trachomatis, and Neisseria gonorrhoeae. Five (5/15; 33%) countries reported GeneXpert procurement by HIV or HCV programs in 2016 and/or 2017. Conclusions: Our results show a positive trend for Xpert MTB/RIF market penetration in 21 HBC public sectors. However, GeneXpert machines were under-utilized for TB, and inadequately exploited as a multi disease technology.
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Seth, Bhavna, John Bernardo, and Carol Sulis. "793. Diagnostic Accuracy of Single vs. Multiple Gene Xpert for Discontinuation of Airborne Infection Isolation in Suspected Pulmonary Tuberculosis Patients at a US Safety-Net Hospital." Open Forum Infectious Diseases 5, suppl_1 (November 2018): S284—S285. http://dx.doi.org/10.1093/ofid/ofy210.800.
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Abstract Background Patients suspected to have pulmonary tuberculosis (PTB) undergo serial sputum analysis under airborne infection isolation (AII). The US FDA approved the Cepheid GeneXpert-MTB-Rif® to support removing patients from AII. The FDA requires that “either one or two” separate sputum specimens be examined. To clarify this statement, the National Tuberculosis Controllers’ Association and the Association of Public Health Laboratories published guidelines that recommend that two sputum specimens be used and recommend that each institution examine their own data to determine whether one specimen is sufficient. Most patients in low prevalence settings do not have PTB yet are tested several times; an optimal testing strategy will reduce unnecessary isolation and related expenses. We sought to determine the diagnostic accuracy of a single vs. two sputum samples for Xpert MTB/RIF in discharging suspected PTB patients from AII. Methods Retrospective review of patients admitted between September 2016 to January 2018 was undertaken to identify sensitivity, specificity, positive and negative predictive values, for MTB gene Xpert in comparison to Mycobacterial culture as the gold standard. We further analyzed whether a larger number of such tests improved diagnostic yield for PTB. Results One hundred seventy-one patients, 17.5% of whom were HIV+, mostly of non-US origins (64%), provided 312 samples for Xpert MTB/RIF, of which 26 were Xpert-positive. These 26 samples came from 15 patients, 14 of whom were diagnosed using the first sample tested with Xpert MTB/RIF. Sensitivity and specificity of the first sample tested with Xpert MTB/RIF were more than those for the first two samples considered together or for all tested samples. Of these 15 positive cases, 13 were confirmed on sputum culture; 10 were positive from the first, one from the second, and two from the third sputum samples cultured. Conclusion Patients suspected to have PTB at our facility can be rapidly and accurately discharged from AII after testing a single sputum sample for MTB/RIF Xpert. Disclosures All authors: No reported disclosures.
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Theron, Grant, Jonny Peter, and Keertan Dheda. "Xpert MTB/RIF test for tuberculosis." Lancet 378, no. 9790 (August 2011): 481. http://dx.doi.org/10.1016/s0140-6736(11)61242-7.
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Salvo, Fulvio, Tsetan Dorjee Sadutshang, Giovanni Battista Migliori, Alimuddin Zumla, and Daniela Maria Cirillo. "Xpert MTB/RIF test for tuberculosis." Lancet 378, no. 9790 (August 2011): 481–82. http://dx.doi.org/10.1016/s0140-6736(11)61243-9.
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Ferrara, Giovanni, Justin O'Grady, Alimuddin Zumla, and Markus Maeurer. "Xpert MTB/RIF test for tuberculosis." Lancet 378, no. 9790 (August 2011): 482. http://dx.doi.org/10.1016/s0140-6736(11)61244-0.
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Taddese, Boja D., Daniel M. Desalegn, Abay S. Misganaw, Kumera T. Kitila, Tinsae Kidanemariam Hailu, and Abraham T. Bika. "Diagnostic Performance of Xpert MTB/RIF Assay Versus Ziehl-Neelsen Method for the Diagnosis of Pulmonary Tuberculosis in Addis Ababa, Ethiopia." Open Microbiology Journal 12, no. 1 (November 30, 2018): 390–96. http://dx.doi.org/10.2174/1874285801812010390.
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Background: Worldwide Tuberculosis (TB) is the ninth leading cause of death from a single infectious agent, positioning on top of Human Immuno Deficiency Virus (HIV) and it is still an eminently serious public health problem. In developing countries, Ziehl-Neelsen (ZN)-stained sputum smear microscopy is the most widely used diagnostic method in diagnosing Pulmonary Tuberculosis (PTB). This study was aimed to compare the diagnostic performances of ZN-method with Xpert MTB/RIF assay for the diagnosis of PTB in Addis Ababa, Ethiopia. Methods: Facility-based cross-sectional study design was conducted from September 2016 to June 2017 on a total of 244 sputum samples collected from presumptive TB patients. The L-J sputum culture was used as a gold standard to compare the diagnostic performances of Xpert MTB/RIF assay and ZN-methods. Kappa values were analyzed by using statistical package for Social Science (SPSS) version 20 software at 95% Confidence Interval (CI). The Sensitivity, Specificity, Positive Predictive Value (PPV) and Negative Predictive Value (NPV) of ZN-stained sputum smear microscopy and Xpert MTB/RIF assay were calculated against the gold standard. Results: The Sensitivity, Specificity, PPV and NPV of ZN-stained sputum smear microscopy were 68.38%, 95.28%, 93.02% and 76.58% respectively, while for Xpert MTB/ RIF assay were 88.89%, 81.89%, 81.89% and 88.89% respectively. The results of the two diagnostic approaches were concordant with the gold standard with a kappa value of ZN 0.650 and 0.743 for Xpert MTB/RIF assay. Conclusion: This study concludes that the sensitivity of Xpert MTB/RIF assay was better than ZN-stained direct sputum smear microscopy for the diagnosis of pulmonary tuberculosis.
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Scott, Lesley, Anura David, Lara Noble, Matilda Nduna, Pedro Da Silva, Andrew Black, Francois Venter, and Wendy Stevens. "Performance of the Abbott RealTi m e MTB and MTB RIF/INH Assays in a Setting of High Tuberculosis and HIV Coinfection in South Africa." Journal of Clinical Microbiology 55, no. 8 (June 7, 2017): 2491–501. http://dx.doi.org/10.1128/jcm.00289-17.
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ABSTRACT South Africa is a country with a high incidence of tuberculosis (TB), complicated by coinfection with human immunodeficiency virus (HIV). The Xpert MTB/RIF (Cepheid, Sunnyvale, CA, USA) is used in South Africa as the test for the initial diagnosis of TB, and other molecular platforms such as the m 2000 (Abbott Molecular, Des Plaines, IL, USA) are widely used for molecular monitoring of HIV load. The latter platform is now also equipped with the RealTi m e (RT) MTB and RealTi m e MTB RIF/INH assays for TB and first-line drug resistance screening but has not been evaluated in settings of HIV and TB coinfection. A prospective clinical validation study was conducted at a community health center in Johannesburg, South Africa, and consenting individuals with presumptive pulmonary TB were enrolled. The performance of the Abbott assays was compared with those of the Xpert MTB/RIF, liquid culture, drug susceptibility testing, and clinical case definitions. A statistical analysis was performed on 206 individuals (73% were HIV positive). The sensitivity and specificity of the RT MTB were 82.5% (confidence interval [CI], 67.2 to 92.7) and 93.1% (CI, 86.2 to 97.2) on raw sputum and 77.5% (CI, 61.5 to 89.2) and 95.1% (CI, 88.9 to 98.4) on concentrated sputum, respectively, compared with those from liquid culture. The RT MTB correctly identified 17/35 more smear-negative culture-positive specimens than the Xpert MTB/RIF. Both the RT MTB and the Xpert MTB/RIF displayed sensitivities >70% and specificities >90% in HIV-positive individuals. The available drug resistance results concurred with MTBDR plus and drug susceptibility profiles. The RT MTB assay has similar diagnostic performance to the Xpert MTB/RIF and is suited to testing presumptive TB patients coinfected with HIV. The existing laboratory information system connectivity, training, and technical support make this a viable polyvalent option to scale up TB alongside HIV laboratory testing services in South Africa.
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Akhter, Nousheen, Kamran Khan Sumalani, Dimple Chawla, and Nadeem Ahmed Rizvi. "Comparison between the diagnostic accuracy of Xpert MTB/Rif assay and culture for pleural tuberculosis using tissue biopsy." ERJ Open Research 5, no. 3 (July 2019): 00065–2019. http://dx.doi.org/10.1183/23120541.00065-2019.
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BackgroundEarly diagnosis of pleural tuberculosis is difficult as it is a paucibacillary disease and a combination of tests is required to diagnose it, which have varied diagnostic accuracy and increase the cost. The aim of this study was to evaluate the diagnostic performance of the Xpert MTB/Rif assay on thoracoscopic pleural biopsy specimens.MethodsA total of 201 patients with exudative pleural effusion and normal lung parenchyma were included in the study. All patients underwent thoracoscopic pleural biopsy under local anaesthesia. Biopsy samples were sent for Xpert MTB/Rif assay and culture, along with histopathology. Chronic granulomatous inflammation on histopathology and response to antituberculous treatment was taken as the reference standard for diagnosis of tuberculous pleurisy.ResultsOf the 198 patients included in the final analysis, 134 had pleural tuberculosis. The sensitivity of the Xpert assay was 52.2% and specificity was 100%, and that of pleural biopsy cultures were 41% and 100% respectively.ConclusionThe sensitivity and specificity of Xpert MTB/Rif assay scores were high, hence escalating the speed of diagnosis and imparting marked impact on patient outcomes. The Xpert MTB/Rif assay is a potential game changer in diagnosing pleural tuberculosis.
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Mollel, Edson, Isack Lekule, Lutgarde Lynen, and Tom Decroo. "Effect of reliance on Xpert MTB/RIF on time to treatment and multidrug-resistant tuberculosis treatment outcomes in Tanzania: a retrospective cohort study." International Health 11, no. 6 (February 26, 2019): 520–27. http://dx.doi.org/10.1093/inthealth/ihz005.
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Abstract Background During 2009–2013, Xpert MTB/RIF testing was decentralized in Tanzania. Standardized treatment of multidrug-resistant/rifampicin-resistant tuberculosis (MDR/RR-TB) was centralized at the Kibong’oto Infectious Diseases Hospital. Initially, Xpert MTB/RIF results were confirmed and complemented with phenotypic drug susceptibility testing before MDR-TB treatment was started. Since 2013, the decision to start MDR-TB treatment in patients with RR-TB relied on Xpert MTB/RIF results. Methods A retrospective cohort study of predictors of unsuccessful treatment outcomes (including death, lost to follow-up and treatment failure) was carried out. Results During the study period, 201 patients started MDR-TB treatment. The number of patients starting MDR-TB treatment increased over time. Out of 201 patients, 48 (23.9%) had an unsuccessful treatment outcome. The median time between sample collection and MDR-TB treatment initiation was reduced from 155 d (IQR 40–228) in the 2009–2012 period to 26 d (IQR 13–64) in 2013. Patients who started MDR-TB treatment in 2013 were more likely (adjusted OR 2.3; 95% CI 1.1–4.7; p=0.02) to have an unsuccessful treatment outcome. Conclusions Xpert MTB/RIF testing increased enrolment on MDR-TB treatment. Reliance on Xpert MTB/RIF results to start MDR-TB treatment reduced time to treatment. However, treatment outcomes did not improve.
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Pink, F., T. J. Brown, K. Kranzer, and F. Drobniewski. "Evaluation of Xpert MTB/RIF for Detection of Mycobacterium tuberculosis in Cerebrospinal Fluid." Journal of Clinical Microbiology 54, no. 3 (January 13, 2016): 809–11. http://dx.doi.org/10.1128/jcm.02806-15.
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Studies investigating Xpert MTB/RIF diagnostic performance on cerebrospinal fluid (CSF) samples are lacking in resource-rich settings. Xpert MTB/RIF results for 740 CSF samples from 698 patients across England were retrospectively compared with the results of culture of the same and contemporary samples. The overall sensitivity was calculated at 55%.
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Ochodo, Eleanor A., Nelson Kalema, Samuel Schumacher, Karen Steingart, Taryn Young, Susan Mallett, Jon Deeks, et al. "Variation in the observed effect of Xpert MTB/RIF testing for tuberculosis on mortality: A systematic review and analysis of trial design considerations." Wellcome Open Research 4 (November 12, 2019): 173. http://dx.doi.org/10.12688/wellcomeopenres.15412.1.
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Background: Most studies evaluating the effect of Xpert MTB/RIF testing for tuberculosis (TB) concluded that it did not reduce overall mortality compared to usual care. We conducted a systematic review to assess whether key study design and execution features contributed to earlier identification of patients with TB and decreased pre-treatment loss to follow-up, thereby reducing the potential impact of Xpert MTB/RIF testing. Methods: We searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, and Scopus for literature published from 1st January 2009 to February 2019. We included all primary intervention studies that had evaluated the effect of Xpert MTB/RIF on mortality compared to usual care in participants with presumptive pulmonary TB. We critically reviewed features of included studies across: Study setting and context, Study population, Participant recruitment and enrolment, Study procedures, and Study follow-up. Results: We included seven randomised and one non-randomised study. All included studies demonstrated relative reductions in overall mortality in the Xpert MTB/RIF arm ranging from 6% to 40%. However, mortality reduction was reported to be statistically significant in two studies. Study features that could explain the lack of observed effect on mortality included: the higher quality of care at study sites; inclusion of patients with a higher pre-test probability of TB leading to higher than expected empirical rates; performance of additional diagnostic testing not done in usual care leading to increased TB diagnosis or empiric treatment initiation; the recruitment of participants likely to return for follow-up; and involvement of study staff in ensuring adherence with care and follow-up. Conclusion: Most studies of Xpert MTB/RIF were designed and conducted in a manner that resulted in more patients being diagnosed and treated for TB, minimising the potential difference in mortality Xpert MTB/RIF testing could have achieved compared to usual care.
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Ochodo, Eleanor A., Nelson Kalema, Samuel Schumacher, Karen Steingart, Taryn Young, Susan Mallett, Jon Deeks, et al. "Variation in the observed effect of Xpert MTB/RIF testing for tuberculosis on mortality: A systematic review and analysis of trial design considerations." Wellcome Open Research 4 (August 17, 2020): 173. http://dx.doi.org/10.12688/wellcomeopenres.15412.2.
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Background: Most studies evaluating the effect of Xpert MTB/RIF testing for tuberculosis (TB) concluded that it did not reduce overall mortality compared to usual care. We conducted a systematic review to assess whether key study design and execution features contributed to earlier identification of patients with TB and decreased pre-treatment loss to follow-up, thereby reducing the potential impact of Xpert MTB/RIF testing. Methods: We searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, and Scopus for literature published from 1st January 2009 to February 2019. We included all primary intervention studies that had evaluated the effect of Xpert MTB/RIF on mortality compared to usual care in participants with presumptive pulmonary TB. We critically reviewed features of included studies across: Study setting and context, Study population, Participant recruitment and enrolment, Study procedures, and Study follow-up. Results: We included seven randomised and one non-randomised study. All included studies demonstrated relative reductions in overall mortality in the Xpert MTB/RIF arm ranging from 6% to 40%. However, mortality reduction was reported to be statistically significant in two studies. Study features that could explain the lack of observed effect on mortality included: the higher quality of care at study sites; inclusion of patients with a higher pre-test probability of TB leading to higher than expected empirical rates; performance of additional diagnostic testing not done in usual care leading to increased TB diagnosis or empiric treatment initiation; the recruitment of participants likely to return for follow-up; and involvement of study staff in ensuring adherence with care and follow-up. Conclusion: Most studies of Xpert MTB/RIF were designed and conducted in a manner that resulted in more patients being diagnosed and treated for TB, minimising the potential difference in mortality Xpert MTB/RIF testing could have achieved compared to usual care.
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Khumsri, Jiraporn, Narin Hiransuthikul, Piya Hanvoravongchai, and Charoen Chuchottaworn. "Effectiveness of Tuberculosis Screening Technology in the Initiation of Correct Diagnosis of Pulmonary Tuberculosis at a Tertiary Care Hospital in Thailand: Comparative Analysis of Xpert MTB/RIF Versus Sputum AFB Smear." Asia Pacific Journal of Public Health 30, no. 6 (September 2018): 542–50. http://dx.doi.org/10.1177/1010539518800336.
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Pulmonary tuberculosis (PTB) is one of the top 10 causes of mortality worldwide in 2016. Early detection is very important, as it can help early treatment. This study compared 2 separate methods of diagnosing PTB among suspected patients, specifically examining correct diagnosis and the duration of receiving a correct diagnosis. It was carried out in a tertiary care public hospital in Bangkok, Thailand. Ninety patients were randomly assigned to 2 groups, one with the Xpert MTB/RIF ( Mycobacterium tuberculosis/rifampicin) and the other with sputum AFB (acid-fast bacilli) smear. The proportion of correct diagnosis was 90.9% and 83.7% for the Xpert MTB/RIF and the comparison group, respectively. The difference was not statistically significant ( P > .05). However, the time to correct diagnosis in the Xpert MTB/RIF group was significantly shorter than the comparison group (2.23 days). This could lead to early diagnosis and lower transmission rate of PTB cases. Results support the provision of Xpert MTB/RIF as the initial diagnostic test for PTB in Thailand.
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Lebina, Limakatso, Nigel Fuller, Tolu Osoba, Lesley Scott, Katlego Motlhaoleng, Modiehi Rakgokong, Pattamukkil Abraham, Ebrahim Variava, and Neil Alexander Martinson. "The Use of Xpert MTB/Rif for Active Case Finding among TB Contacts in North West Province, South Africa." Tuberculosis Research and Treatment 2016 (2016): 1–6. http://dx.doi.org/10.1155/2016/4282313.
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Introduction.Tuberculosis is a major cause of morbidity and mortality especially in high HIV burden settings. Active case finding is one strategy to potentially reduce TB disease burden. Xpert MTB/Rif has recently been recommended for diagnosis of TB.Methods.Pragmatic randomized trial to compare diagnosis rate and turnaround time for laboratory testing for Xpert MTB/Rif with TB microscopy and culture in household contacts of patients recently diagnosed with TB.Results.2464 household contacts enrolled into the study from 768 active TB index cases. 1068 (44%) were unable to give sputum, but 24 of these were already on TB treatment. 863 (53%) participants sputum samples were tested with smear and culture and 2.7% (23/863; CI: 1.62–3.78) were diagnosed with active TB. Xpert MTB/Rif was used in 515 (21%) participants; active TB was diagnosed in 1.6% (8/515; CI: 0.52–2.68).Discussion and Conclusions.Additional 31 cases were diagnosed with contact tracing of household members. When Xpert MTB/Rif is compared with culture, there is no significant difference in diagnostic yield.
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Yu, Guocan, Fangming Zhong, Yanqin Shen, and Hong Zheng. "Diagnostic accuracy of the Xpert MTB/RIF assay for tuberculous pericarditis: A protocol of systematic review and meta-analysis." PLOS ONE 16, no. 5 (May 26, 2021): e0252109. http://dx.doi.org/10.1371/journal.pone.0252109.
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Background Tuberculous pericarditis (TBP) can lead to serious consequences. Early diagnosis and treatment are very important for TBP, but early diagnosis is still very challenging. This study aims to evaluate the diagnostic accuracy of Xpert MTB/RIF for TBP using meta-analysis method. Methods We will search Embase, PubMed, the Cochrane Library, China National Knowledge Infrastructure (CNKI), and the Wanfang database for researches assessing the diagnostic accuracy of Xpert MTB/RIF for TBP until April 2021. Any types of study design with full text will be selected and included. The Quality Assessment of Diagnostic Accuracy Studies (QUADAS-2) tool will be used to assess the risk of bias. We will use version 15.0 of the STATA software with the midas command packages to carry out meta-analyses. Results Evidence for diagnostic accuracy of Xpert MTB/RIF for TBP will be provided through the study, and this protocol will be submitted to a peer-reviewed journal for publication. Conclusion This study will provide evidence of Xpert MTB/RIF for TBP.
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Cazabon, Danielle, Tripti Pande, Sandra Kik, Wayne Van Gemert, Hojoon Sohn, Claudia Denkinger, Zhi Zhen Qin, Brenda Waning, and Madhukar Pai. "Market penetration of Xpert MTB/RIF in high tuberculosis burden countries: A trend analysis from 2014 - 2016." Gates Open Research 2 (July 25, 2018): 35. http://dx.doi.org/10.12688/gatesopenres.12842.1.
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Background: Xpert® MTB/RIF, a rapid tuberculosis (TB) molecular test, was endorsed by the World Health Organization in 2010. Since then, 34.4 million cartridges have been procured under concessional pricing. Although the roll out of this diagnostic is promising, previous studies showed low market penetration. Methods: To assess 3-year trends of market penetration of Xpert MTB/RIF in the public sector, smear and Xpert MTB/RIF volumes for the year 2016 were assessed and policies from 2014-2016 within 22 high-burden countries (HBCs) were studied. A structured questionnaire was sent to representatives of 22 HBCs. The questionnaires assessed the total smear and Xpert MTB/RIF volumes, number of modules and days of operation of GeneXpert machines in National TB Programs (NTPs). Data regarding the use of NTP GeneXpert machines for other diseases and GeneXpert procurement by other disease control programs were collected. Market penetration was estimated by the ratio of total sputum smear volume for initial diagnosis divided by the number of Xpert MTB/RIF tests procured in the public sector. Results: The survey response rate was 21/22 (95%). Smear/Xpert ratios decreased in 17/21 countries and increased in four countries, since 2014. The median ratio decreased from 32.6 (Q1:14.3, Q3: 58.9) in 2014 to 6.0 (Q1: 1.6, Q3: 17.0) in 2016. Nineteen countries (19/19; 100%) were not using GeneXpert machines to their full capacity, however seven countries (7/19; 37%) were running tests for other diseases on their NTP-procured GeneXpert systems in 2017, such as HIV, hepatitis-C virus (HCV), Chlamydia trachomatis, and Neisseria gonorrhoeae. Five (5/15; 33%) countries reported GeneXpert procurement by HIV or HCV programs in 2016 and/or 2017. Conclusions: Our results show a positive trend for Xpert MTB/RIF market penetration in 21 HBC public sectors. However, GeneXpert machines were under-utilized for TB, and inadequately exploited as a multi disease technology.
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Bellam, Balaji L., Harshal S. Mandavdhare, Kusum Sharma, Siddharth Shukla, Hariom Soni, Praveen Kumar-M, Harjeet Singh, Kaushal K. Prasad, Usha Dutta, and Vishal Sharma. "Utility of tissue Xpert-Mtb/Rif for the diagnosis of intestinal tuberculosis in patients with ileocolonic ulcers." Therapeutic Advances in Infectious Disease 6 (January 2019): 204993611986393. http://dx.doi.org/10.1177/2049936119863939.
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Introduction: Data on the use of Xpert Mtb/Rif for the diagnosis of intestinal tuberculosis is sparse. We report on the utility of Xpert Mtb/Rif testing for diagnosis of intestinal tuberculosis (ITB) in patients with ileocecal ulcers Methodology: We performed a retrospective analysis of patients with ileocecal ulcers and suspected to have ITB and in whom testing of intestinal tissue for Xpert Mtb/Rif was performed. The patients were divided into two groups: those with a final diagnosis of intestinal tuberculosis and those with other diagnosis. These patients were compared for clinical features and presentation. The sensitivity, specificity, positive predictive value, and negative predictive value of Xpert Mtb/Rif for the diagnosis of ITB were calculated. Results: Of the 40 patients studied, 23 were women and the mean age was 32.92 ± 12.78 years. Abdominal pain was present in 33 (88.5%) patients and diarrhea in 12 (30%). A total of 25 patients had underlying ITB whereas 15 patients had other diagnoses (Crohn’s disease, amebiasis, nonspecific ileitis, etc.). The sensitivity, specificity, negative predictive value, positive predictive value, and accuracy of GeneXpert-Mtb/Rif was 32% (CI: 14.95–53.50%), 100% (78.2–100), 46.88% (40.27–53.59%), 100 & 57.50 (40.89–72.89%) respectively. Conclusion: A positive GeneXpert-Mtb/Rif helps in the diagnosis of ITB, but the sensitivity is low.
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Cox, Janneke A., Robert L. Lukande, Sam Kalungi, Eric Van Marck, Martin Lammens, Koen Van de Vijver, Andrew Kambugu, Ann M. Nelson, Robert Colebunders, and Yukari C. Manabe. "Accuracy of Lipoarabinomannan and Xpert MTB/RIF Testing in Cerebrospinal Fluid To Diagnose Tuberculous Meningitis in an Autopsy Cohort of HIV-Infected Adults." Journal of Clinical Microbiology 53, no. 8 (June 10, 2015): 2667–73. http://dx.doi.org/10.1128/jcm.00624-15.
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Point-of-care tests for tuberculous meningitis (TBM) are needed. We studied the diagnostic accuracy of the lipoarabinomannan (LAM) lateral flow assay (LFA), LAM enzyme-linked immunosorbent assay (ELISA), and Xpert MTB/RIF in cerebrospinal fluid (CSF) in an autopsy cohort of Ugandan HIV-infected adults. We obtained written informed consent postmortem from the next of kin. A complete autopsy was done and CSF obtained. We performed LAM LFA (on unprepared and supernatant CSF after heating and spinning), LAM ELISA, and Xpert MTB/RIF on the CSF samples. Accuracy parameters were calculated for histopathological TBM and also for the composite standard, including Xpert MTB/RIF-positive cases. We tested CSF of 91 patients. LAM LFA had a sensitivity of 75% for definite histopathological TBM, ELISA a sensitivity of 43%, and Xpert MTB/RIF a sensitivity of 100% and specificities of 87%, 91%, and 87%, respectively. LAM LFA had a sensitivity of 50% for definite and probable histopathological TBM, ELISA a sensitivity of 38%, and Xpert MTB/RIF a sensitivity of 86% and specificities of 70%, 91%, and 87%, respectively. LAM LFA had a sensitivity of 68% for the composite standard and ELISA a sensitivity of 48% and specificities of 78% and 98%, respectively. The rapid diagnostic tests detected TBM in 22% to 78% of patients not on anti-TB treatment. Point-of-care tests have high accuracy in diagnosis of TBM in deceased HIV-infected adults. LAM LFA in CSF is a useful additional diagnostic tool.
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Sharma, Pratibha, Abhishek Kumar, Mamatha S., and Ranganath T. Ganga. "Diagnostic Performance of Xpert MTB/RIF in Bronchoalveolar Lavage of Sputum-Scarce Recurrent Pulmonary Tuberculosis Cases." Journal of Health and Allied Sciences NU 10, no. 02 (August 2020): 74–78. http://dx.doi.org/10.1055/s-0040-1714650.
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Abstract Introduction Xpert MTB/RIF has greater sensitivity and specificity than smear microscopy. Bronchoalveolar lavage (BAL) is safe and valuable tool in sputum-scarce and sputum-negative tuberculosis (TB) patients. Our study evaluated the performance of Xpert in BAL specimen of sputum-scarce recurrent TB cases exclusively. Materials and Methods Sputum-scarce recurrent TB patients who underwent BAL between July 2018 and July 2019 were included. The diagnostic performance of Xpert and acid-fast bacilli (AFB) smear examination in BAL specimen was compared with liquid culture Mycobacterium TB (MTB) and composite reference standard. Results A total of 126 patients were included in the study. MTB culture was positive in 70 cases and nontuberculous mycobacteria were seen in five cases. Xpert was positive was in 63 patients. Sensitivity of Xpert and AFB smear was 84.29% (95% confidence interval [CI]: 73.62–91.89) and 18.57% (95% CI: 10.28–29.66), respectively, with p < 0.001 proving the superiority of Xpert. Xpert had a specificity of 97.96 (89.15–99.95), positive predictive value of 93.65% (95% CI 85.19–97.42), and negative predictive value of 80.36% (95% CI: 70.26–87.63). Smear had a specificity of 91.84% (95% CI: 80.21–97.58) against 97.96 (89.15–99.95) of Xpert, and smear was positive in nontuberculous mycobacterium cases as well. Xpert showed no cross-reactivity between mycobacterial species. Rifampicin resistance was seen in 8 (12.69%) cases, and 21 patients had other diagnoses. Conclusion Xpert has greater sensitivity in comparison to AFB smear in BAL specimen. Sputum-scarce recurrent TB cases have a similar chance of rifampicin resistance as sputum smear-positive cases should undergo BAL for Xpert analysis routinely.
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Кошак, Ю. Ф. "ВИКОРИСТАННЯ Xpert MTB/RIF У МОЛЕКУЛЯРНІЙ ДІАГНОСТИЦІ ТУБЕРКУЛЬОЗНОЇ ЕМПІЄМИ ПЛЕВРИ." Medical Informatics and Engineering, no. 4 (June 4, 2020): 55–61. http://dx.doi.org/10.11603/mie.1996-1960.2019.4.11019.
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Представлено перший аналіз тестової діагностики пацієнтів із туберкульозною емпіємою плеври від застосування Xpert MTB/RIF у відеоторакоскопічних дослідженнях органів грудної клітини. Проаналізовано торакоскопічні особливості стадійності, локалізації у діагностиці туберкульозної емпієми плеври в залежності від статі, віку, початку, перебігу та поширеності нагноєння. Показано експрес можливості Xpert MTB/RIF у ранній діагностиці туберкульозу плеври для проведення мінімального інвазивного хірургічного лікування (VTS, VATS) пацієнтів.