Diagnostic Accuracy of the Truenat MTB Plus Assay and Comparison with the Xpert MTB/RIF Assay to Detect Tuberculosis among Hospital Outpatients in Cameroon

Mbuli, Cyrille; Neh, Angela; Nshom, Emmanuel; Koudjou, Armand; Palmer, Dennis; Ndi, Norah Nyah; Qin, Zhi Zhen; Creswell, Jacob; Mbassa, Vincent; Vuchas, Comfort; Sander, Melissa

doi:10.1128/jcm.00155-22

Cited by 17 publications

(14 citation statements)

References 23 publications

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“…The speci city of Truenat was 94% (159/169) among culture-negative patients. This was comparable to the speci city documented in the previous studies [7][8][9]. Culture is considered the gold standard for TB diagnosis, however, there remain unresolved discordances when compared with molecular diagnostics.…”

Section: Discussionsupporting

confidence: 88%

“…In our study only 4/10 Truenat positive but culture negative participants had history of previous TB. This observation is also seen in the previous studies comparing culture and molecular tests [9,[11][12][13]. Management of such patients is dependent on the clinician's decision combined with other clinical evaluation in line with TB disease.…”

Section: Discussionsupporting

confidence: 57%

“…Performing the Truenat, GeneXpert Ultra and culture on the same sample, eliminated potential sample handling bias which makes our ndings stronger for test performance comparison. We compared the performance of Truenat with GeneXpert Ultra, which is not the case with most of the previous Truenat evaluation studies [7][8][9]14]. Our study had a bigger sample size of PLHIV (44%) which makes the results more generalizable.…”

Section: Discussionmentioning

confidence: 99%

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Performance Evaluation of Truenat Mtb and Truenat Mtb-rif Dx Assays in Comparison to Gene Xpert Mtb/rif Ultra for the Diagnosis of Pulmonary Tuberculosis in Uganda

Ssengooba,

Katamba,

Sserubiri

et al. 2023

Preprint

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Background The World Health Organization endorsed Truenat MTB rapid molecular assay in 2020 and recommended additional in-country evaluation studies before uptake. We evaluated the accuracy and operational feasibility of Truenat MTB assay (Truenat) in comparison with GeneXpert Ultra and culture. Methods In a cross-sectional study of 250 presumptive TB patients, participants were requested to provide a sputum sample on the day of their visit to the clinic. The sputum sample was homogenized and a portion was tested using GeneXpert Ultra as per the routine standard procedure and the other portion was tested using Truenat assay at the clinic laboratory. The second sample portion was processed for Concentrated Fluorescent smear Microscopy (CFM), LJ, and MGIT cultures. Truenat sensitivity and specificity were compared to GeneXpert Ultra and culture. Test performance characteristics were also collected and summarized as proportions and percentages. Results Of the 250 participants recruited in the study, the sensitivity and specificity of Truenat was n/N (%, 95%CI); 66/82 (80.5, 70.2–88.4) and 156/159 (98.1, 94.5–99.6) when compared with Ultra, 50/64 (89.3, 66.0-87.4) and 166/180 (92.2, 87.2–95.6) when compared with LJ, 58/71 (81.7,70.7–89.8) and 131/138 (94.9, 89.8–97.9) when compared to MGIT culture and 59/73 (80.8, 69.9–89.1) and 159/169 (94.1,89.3–97.1) when compared to LJ and/or MGIT culture. The sensitivity of Truenat was lower, 14/23 (60.9, 40.6–82.8) among smear-negative compared to 45/50 (90.0, 78.1–96.6) among smear-positive participants but not different by HIV status. There were no special training needs especially among laboratory personnel with previous GeneXpert /molecular test experience, 19/242 (7.8%) error/invalid, and 17,4% uninterpretable/indeterminate results mainly for rifampicin resistance determination. Conclusion Among presumptive TB patients in Uganda, the Truenat assay has high sensitivity and specificity. The Truenat assay has acceptable operational feasibility attributes when compared with the GeneXpert Assay.

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Section: Discussionsupporting

confidence: 88%

Section: Discussionsupporting

confidence: 57%

Section: Discussionmentioning

confidence: 99%

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Performance Evaluation of Truenat Mtb and Truenat Mtb-rif Dx Assays in Comparison to Gene Xpert Mtb/rif Ultra for the Diagnosis of Pulmonary Tuberculosis in Uganda

Ssengooba,

Katamba,

Sserubiri

et al. 2023

Preprint

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“…To address the existing gap in decentralized rabies diagnostics within India and other rabies endemic countries, the Truenat rabies assay emerges as a fitting and practical solution for deployment at peripheral laboratories. The Truenat platform is already widely used for diagnosis of tuberculosis, 22,25,26 COVID‐19, 16 and other infectious diseases 27,28 . Hence rabies testing can be seamlessly integrated into the pre‐existing diagnostic services with minimal additional expenditure on infrastructure or training of human resources.…”

Section: Discussionmentioning

confidence: 99%

Evaluation of a rapid, chip‐based, micro‐PCR assay for detection of rabies virus in human and canine specimens

Lodha,

Ananda,

Ramachandran

et al. 2023

Journal of Medical Virology

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Rabies, a lethal zoonotic encephalitis, remains a significant global health concern, causing an estimated 60 000 annual fatalities worldwide. Dogs serve as the primary reservoirs and vectors for transmitting this infection to humans. Definitive diagnosis of rabies in both human and animal cases necessitates laboratory testing involving various clinical specimens. However, the complexity of laboratory infrastructure and the need for skilled personnel, along with the challenge of maintaining cold‐chain integrity during sample referral, hinder the decentralization of diagnostic facilities. This study aimed to assess the efficacy of the Truenat rabies assay, a rapid, portable, semiautomated, and closed PCR‐based system, for the diagnosis of rabies in both humans and animals. The Truenat assay demonstrated a sensitivity of 100% and a specificity of 86.96% when compared with the fluorescent antibody test (FAT), as the reference standard, on 147 canine brain samples tested. Notably, the Truenat assay exhibited a sensitivity and specificity of 100% when tested on 48 human brain specimens. Furthermore, an examination of 148 human antemortem samples (cerebrospinal fluid, saliva, and skin biopsy) using both the Truenat assay and a validated real‐time reverse transcriptase PCR assay revealed a κ value of 0.505, indicative of a moderate level of agreement between the two tests. Thus, the Truenat assay offers a robust, reliable, and affordable point‐of‐care solution to enhance rabies diagnostic capacity in endemic areas.

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“…Recently, the WHO has endorsed Truenat as another molecular test to be used in ATB and rifampicin resistance diagnosis. Different studies have found Truenat to have a similar accuracy compared to GeneXpert MTB/RIF (Nikam et al, 2014;Penn-Nicholson et al, 2021;Ngangue et al, 2022), though Truenat has the advantage of being supplied by a batterypowered system, thus requiring less infrastructure (Lee et al, 2019).…”

Section: Pathogen Biomarkersmentioning

confidence: 99%

Diagnostic biomarkers for active tuberculosis: progress and challenges

et al. 2022

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Tuberculosis (TB) is a leading cause of morbidity and mortality from a single infectious agent, despite being preventable and curable. Early and accurate diagnosis of active TB is critical to both enhance patient care, improve patient outcomes, and break Mycobacterium tuberculosis (Mtb) transmission cycles. In 2020 an estimated 9.9 million people fell ill from Mtb, but only a little over half (5.8 million) received an active TB diagnosis and treatment. The World Health Organization has proposed target product profiles for biomarker‐ or biosignature‐based diagnostics using point‐of‐care tests from easily accessible specimens such as urine or blood. Here we review and summarize progress made in the development of pathogen‐ and host‐based biomarkers for active TB diagnosis. We describe several unique patient populations that have posed challenges to development of a universal diagnostic TB biomarker, such as people living with HIV, extrapulmonary TB, and children. We also review additional limitations to widespread validation and utilization of published biomarkers. We conclude with proposed solutions to enhance TB diagnostic biomarker validation and uptake.

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Diagnostic Accuracy of the Truenat MTB Plus Assay and Comparison with the Xpert MTB/RIF Assay to Detect Tuberculosis among Hospital Outpatients in Cameroon

Cited by 17 publications

References 23 publications

Performance Evaluation of Truenat Mtb and Truenat Mtb-rif Dx Assays in Comparison to Gene Xpert Mtb/rif Ultra for the Diagnosis of Pulmonary Tuberculosis in Uganda

Performance Evaluation of Truenat Mtb and Truenat Mtb-rif Dx Assays in Comparison to Gene Xpert Mtb/rif Ultra for the Diagnosis of Pulmonary Tuberculosis in Uganda

Evaluation of a rapid, chip‐based, micro‐PCR assay for detection of rabies virus in human and canine specimens

Diagnostic biomarkers for active tuberculosis: progress and challenges

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