Performance of the Abbott RealTime MTB and RIF/INH resistance assays for the detection of Mycobacterium Tuberculosis and resistance markers in sputum specimens

Araya, Bezalem Tesfaye; Ali, Kirubel Eshetu; Geleta, Dereje Assefa; Tekele, Saba Gebremichael; Tulu, Kassu Desta

doi:10.1371/journal.pone.0251602

Cited by 6 publications

(8 citation statements)

References 17 publications

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“…6 The sensitivity and specificity of the Abbott RealTime MTB and INH/RIF assays for detection of Mtb and detection of INH resistance were 92.4% (95% CI 83.6-96.9) and 95.4% (95% CI 91.1-97.7) and 84.2% (95% CI 60.4-96.6) and 100% (95% CI 89.7-100), respectively. In the case of RIF resistance, no discrepant results were observed, 73 a finding supported by several other studies. [74][75][76][77] The multiplexed real-time PCR (MAX MDR-TB) (Becton Dickinson) NAAT platform using five-colour detection enables direct detection of Mtb in raw sputum or concentrated sputum sediments.…”

Section: Moderate Complexity Automated Naatssupporting

confidence: 86%

Rapid Molecular Assays for the Diagnosis of Drug-Resistant Tuberculosis

Nandlal¹,

Perumal²,

Naidoo³

2022

IDR

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The recognition that drug-resistant tuberculosis (DR-TB) poses a major threat to global tuberculosis (TB) control efforts has catalysed the development of new and urgently needed TB diagnostics. The full beneficial impact of the subsequent flood of new TB diagnostic tests into the market can only be realised if these diagnostic tests are readily accessible to TB programs and contribute to improved patient outcomes. Although phenotypic drug-susceptibility testing remains the gold standard, an improved understanding of the relationship between mutations and different levels of drug resistance coupled with the advantages of molecular diagnostics could result in rapid molecular diagnostic tests replacing phenotypic drug-susceptibility testing. Successful diagnostics need to diagnose all forms of drugresistant TB prevalent in each geographic region. Given the finite number and often limited availability of effective drugs for DR-TB, the diagnostic test must be able to detect all clinically important types of resistance to available anti-TB drugs. However, less comprehensive resistance profiling may be sufficient in settings where extensively drug-resistant TB (XDR-TB) and pre-XDR are absent. Rapid molecular diagnostic tests for DR-TB detection suitable for DR-TB endemic settings should be accurate, inexpensive, suitable to be performed on an easily accessible sample, detect prevalent circulating drug-resistant strains, and provide results within a short turnaround time to enable timely treatment initiation. In this review, we appraise the wide range of molecular diagnostics for DR-TB endorsed by the World Health Organisation, discuss the challenges in the development and rollout of rapid molecular DR-TB tests in low-and middle-income countries, and highlight user perspectives and cost-effectiveness factors that influence their utility.

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Section: Moderate Complexity Automated Naatssupporting

confidence: 86%

Rapid Molecular Assays for the Diagnosis of Drug-Resistant Tuberculosis

Nandlal¹,

Perumal²,

Naidoo³

2022

IDR

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“…Despite this wide range of performance, our study demonstrated that the overall sensitivity and specificity of the Indigen MTB/DR-TB RT-PCR assay to detect MTB in sputum were 94.1 and 98.1%, respectively, in comparison to the standard TB culture method, along with a kappa value of ≥0.9. Concordant with our results, studies on the performance of a commercial IS6110 sequence-based PCR assay, Abbot Real-Time RIF/INH, reported a sensitivity level of 92.4% (Araya et al, 2021), while another metaanalysis study confirmed that the assay had sensitivity and specificity levels of 96 and 97%, respectively (Wang et al, 2019). Moreover, another comparison study between the IS6110-Taq Man-based PCR assay and GeneXpert RIF/INH reported that IS6110-Taq Man-based had better sensitivity (84% vs. 79%, respectively, 19).…”

Section: Discussionsupporting

confidence: 92%

“…Moreover, another comparison study between the IS6110-Taq Man-based PCR assay and GeneXpert RIF/INH reported that IS6110-Taq Man-based had better sensitivity (84% vs. 79%, respectively, 19). All these findings support that multicopy target IS6110, which is present at 10 to 15 copies in most genomes of MTB, contributes to the better sensitivity of the TB PCR-based assay (Eisenach et al, 1990;Araya et al, 2021).…”

Section: Discussionsupporting

confidence: 62%

“…To achieve those requirements, one of the most determining factors is primers specific to target sequences within the MTB genome. Most TB PCR-based assays target IS6110 to detect MTB in pulmonary and extra-pulmonary specimens (Noordhoek et al, 1994;Lee et al, 2014;Araya et al, 2021). It has been reported that the sensitivity and specificity of IS6110 sequence-based PCR for the detection of MTB differ among trials, ranging from 50 to 90% and 60 to 100%, respectively, compared to culture (Noordhoek et al, 1994).…”

Section: Discussionmentioning

confidence: 99%

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Evaluation of a real-time PCR assay performance to detect Mycobacterium tuberculosis, rifampicin, and isoniazid resistance in sputum specimens: a multicenter study in two major cities of Indonesia

Parwati,

Chaidir,

Yunus

et al. 2024

Front. Microbiol.

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BackgroundTuberculosis (TB) is one of the major global health issues due to its high mortality rate, especially in low- and middle-income countries. One of the key success points of the TB eradication program is early TB diagnosis, which requires rapid and accurate diagnostic testing. This study aimed to evaluate the performance of a newly developed RT-PCR kit (Indigen MTB/DR-TB RT-PCR) in a routine TB clinical setting.MethodA multi-fluorescence RT-PCR assay was designed and developed to detect regions within IS6110, rpoB, katG, and inhA of the Mycobacterium tuberculosis (MTB) genes. Sputum specimens were obtained from suspected TB patients who visited TB healthcare facilities in two major cities of Indonesia from September 2022 to May 2023. Specimens were assessed using Indigen MTB/DR-TB RT-PCR, acid-fast bacillus (AFB) smear microscopy, MTB culture, and drug susceptibility testing (DST) methods. Fisher’s exact test (χ2) was used to analyze the Indigen performance relative to culture methods.ResultThe performance of Indigen MTB/DR-TB RT-PCR to detect MTB was assessed using 610 sputum specimens obtained from suspected patients. The overall sensitivity and specificity were 94.12% (95% CI: 90.86–96.48%) and 98.32% (95% CI: 96.20–99.46%), respectively. When the analysis was performed on AFB smear-negative TB subjects (386 subjects), a lower sensitivity level was found at 78.57% (95% CI: 68.26–86.78%), while the specificity level remained similar at 98.34% (95% CI: 96.18–99.46%). The overall performance of Indigen MTB/DR-TB RT-PCR to detect MTB showed substantial agreement with the MTB culture method (kappa value 0.93). In comparison to DST, the sensitivity and specificity levels of Indigen to detect RIF resistance or INH resistance were 78.2% (95% CI: 61.8–90.2%) and 82.8% (95% CI: 64.2–94.2%), respectively, while the specificity level for both groups was at 100% (95% CI, 87.7–100%).ConclusionIndigen MTB/DR-TB RT-PCR demonstrated reliable performance for TB molecular diagnostic testing and can be implemented in routine TB diagnostic settings.

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“…Los cultivos utilizados en nuestra institución son realizados por medio sólido Ogawa Kuddo; la prueba molecular se realizó mediante el ensayo Abbott RealTime MTB RIF/ INH Resistance m2000 ® . El ensayo Abbott RealTime MTB RIF/INH Resistance m2000 ® , permite la determinación de M. tuberculosis a partir de la secuencia de inserción 6110 (IS6110) y el antígeno proteínico b (PAB) en muestras de esputo o lavado bronco alveolar, con un límite de detección de 60 UFC/ml, adicionalmente permite la detección cualitativa de resistencia a rifampicina e isoniazida (7).…”

Section: Métodosunclassified

Experiencia en diagnóstico de tuberculosis meníngea por pruebas moleculares comparado con cultivo en un hospital de alta complejidad en Cali, Colombia

et al. 2021

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Introducción: La tuberculosis es una de las enfermedades infecciosas de mayor distribución mundial y la tuberculosis meníngea es una de sus manifestaciones más devastadoras. Su diagnóstico y confirmación microbiológica no siempre es fácil. Objetivo: Describir la experiencia en el diagnóstico de tuberculosis meníngea por pruebas moleculares comparado con cultivo, caracterizando las principales manifestaciones clínicas y determinar los factores asociados a mortalidad. Métodos: Identificamos retrospectivamente a los pacientes adultos con diagnóstico de tuberculosis meníngea, mediante técnicas de pruebas moleculares y/o cultivo para M. tuberculosis, que ingresaron en nuestra institución entre enero de 2018 y marzo de 2020, se realizó un análisis estadístico descriptivo. Se excluyeron mujeres gestantes, pacientes que no contaran con prueba molecular para M. tuberculosis. Resultados: Se obtuvo una muestra de 33 pacientes, los hallazgos más relevantes en el citoquímico de líquido cefalorraquídeo (LCR) fue la presencia de hipoglucorraquia, con una mediana de 34,2 mg/dl (RIQ 2,0-95,0 mg/dl) y de hiperproteinorraquia, con mediana de 265 mg/dl (RIQ 24,0-600 mg/dl). El resultado más significativo fue la presencia de proteína C reactiva elevada en suero en todos los casos, con una mediana de 53,3 mg/L (RIQ 22,9 - 89,6 mg/L) y neutrofilia en 75.8% (25). La mortalidad fue de 54.5% (18), la sensibilidad de la prueba molecular en LCR fue del 38,46% y el valor predictivo positivo de 58,82%. Conclusiones: El diagnóstico de TB meníngea sigue siendo todo un reto, aunque las pruebas moleculares pueden ayudar en el diagnóstico temprano, su sensibilidad es baja en formas extrapulmonares.

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Performance of the Abbott RealTime MTB and RIF/INH resistance assays for the detection of Mycobacterium Tuberculosis and resistance markers in sputum specimens

Cited by 6 publications

References 17 publications

Rapid Molecular Assays for the Diagnosis of Drug-Resistant Tuberculosis

Rapid Molecular Assays for the Diagnosis of Drug-Resistant Tuberculosis

Evaluation of a real-time PCR assay performance to detect Mycobacterium tuberculosis, rifampicin, and isoniazid resistance in sputum specimens: a multicenter study in two major cities of Indonesia

Experiencia en diagnóstico de tuberculosis meníngea por pruebas moleculares comparado con cultivo en un hospital de alta complejidad en Cali, Colombia

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