ArticleBMC infectious diseases2015
Performance evaluation of three commercial molecular assays for the detection of Mycobacterium tuberculosis from clinical specimens in a high TB-HIV-burden setting.
Article in BMC infectious diseases, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers, 2 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
12 citing papers in PubMed, 2 syntheses or guidelines pooled it, 31 citations in OpenAlex.
- Xpert Ultra versus Xpert MTB/RIF for pulmonary tuberculosis and rifampicin resistance in adults with presumptive pulmonary tuberculosis.The Cochrane database of systematic reviews · 2021Pooled it
- Xpert MTB/RIF and Xpert MTB/RIF Ultra for pulmonary tuberculosis and rifampicin resistance in adults.The Cochrane database of systematic reviews · 2019Pooled it
- Diagnostic yield of polymerase chain reaction on induced sputum for pulmonary tuberculosis: A single-center retrospective cross-sectional study.Infectious medicine · 2025Article
- Article
- Comparative Performance of Line Probe Assay (Version 2) and Xpert MTB/RIF Assay for Early Diagnosis of Rifampicin-Resistant Pulmonary Tuberculosis.Tuberculosis and respiratory diseases · 2021Article
- Diagnostic utility of GeneXpert MTB/RIF assay versus conventional methods for diagnosis of pulmonary and extra-pulmonary tuberculosis.BMC microbiology · 2021Article
- Evaluation of GeneXpert MTB/RIF system performances in the diagnosis of extrapulmonary tuberculosis.BMC infectious diseases · 2019Article
- Rapid Extraction Method ofDiagnostics (Basel, Switzerland) · 2019Article
- Diagnostic Performance of the GenoType MTBDRChinese medical journal · 2017Article
- Diagnosis of opportunistic infections: HIV co-infections - tuberculosis.Current opinion in HIV and AIDS · 2017Review
- [Role of GeneXpert MTB/RIF test in the screening for pulmonary tuberculosis at the General Referral Provincial Hospital of Bukavu, in the East of the Democratic Republic of the Congo: balance after 10 months of use].The Pan African medical journal · 2017Article
- Impact of the GeneXpert MTB/RIF Technology on Tuberculosis Control.Microbiology spectrum · 2017Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
6 authors at 3 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundA major challenge faced by countries with a high burden of tuberculosis (TB) is early detection especially in individuals with paucibacillary disease which is common in HIV endemic settings. Remarkable efforts have been made globally to accelerate the development and expansion of new diagnostic technologies that allow better and earlier diagnosis of active tuberculosis particularly directly from clinical specimens with a few commercial options available. These include GenoType MTBDRplus Version 2.0 (Hain Lifescience), Xpert® MTB/RIF (Cepheid) and Anyplex™ plus MTB/NTM/DR-TB Real-time detection (Seegene). We evaluated the diagnostic performance of these three commercial molecular assays for the detection of Mycobacterium tuberculosis complex from clinical specimens in a high TB-HIV-burden setting.
methodsThis was a retrospective laboratory-based study using stored remnant sediments from clinical specimens of presumptive pulmonary TB cases. A stratified sample of smear positive TB, smear negative TB and TB culture negatives was included. All the samples were tested on the three molecular assays following the manufacturers' instructions; except for Anyplex™plus, for which DNA extraction was performed using the NucliSENS® easyMAG® platform (bioMerieux). Samples were also processed for liquid TB culture and time-to-culture positivity was recorded.
resultsOf the 90 sediments processed, 81 were analyzable across all three systems. The overall sensitivity was highest for Xpert® MTB/RIF (89.1%) followed by GenoType MTBDRplus (70.9%) and Anyplex™ plus (65.5%). The specificity and sensitivity in smear positive cases was comparable across all systems. There was a significant difference in sensitivity between Xpert® MTB/RIF and the other two assays for smear-negative cases (P < 0.05). The performance in cases where the time-to-culture positivity was ≥ 20 days was also significantly poorer for both Anyplex™ plus and GenoType MTBDRplus compared to Xpert® MTB/RIF (P < 0.05). Xpert® MTB/RIF achieved 100% specificity, while Anyplex™ plus and GenoType MTBDRplus achieved 96.2 and 92.3% respectively.
conclusionThe Xpert® MTB/RIF was superior to the other two assays for the detection of TB in smear negative specimens notably when bacterial loads are very low in sputum. It is important that studies reporting on test performance stratify their results by time-to-culture positivity to accurately assess clinical performance especially in high HIV settings.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.