More Than a Decade of GeneXpert<sup>®</sup> <i>Mycobacterium tuberculosis</i>/Rifampicin (Ultra) Testing in South Africa: Laboratory Insights from Twenty-Three Million Tests

This study seeks to describe the rollout and current state of South Africa’s GeneXpert molecular diagnostic program for tuberculosis (TB). Xpert MTB/RIF was introduced in 2011 with a subsequent expansion to include extra-pulmonary and paediatric testing, followed by Xpert MTB/RIF Ultra in 2017. Thro...

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Main Authors: Manuel Pedro da Silva, Naseem Cassim, Silence Ndlovu, Puleng Shiela Marokane, Mbuti Radebe, Anne Shapiro, Lesley Erica Scott, Wendy Susan Stevens
Format: Article
Language:English
Published: MDPI AG 2023-10-01
Series:Diagnostics
Subjects:
Online Access:https://www.mdpi.com/2075-4418/13/20/3253
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author Manuel Pedro da Silva
Naseem Cassim
Silence Ndlovu
Puleng Shiela Marokane
Mbuti Radebe
Anne Shapiro
Lesley Erica Scott
Wendy Susan Stevens
author_facet Manuel Pedro da Silva
Naseem Cassim
Silence Ndlovu
Puleng Shiela Marokane
Mbuti Radebe
Anne Shapiro
Lesley Erica Scott
Wendy Susan Stevens
author_sort Manuel Pedro da Silva
collection DOAJ
description This study seeks to describe the rollout and current state of South Africa’s GeneXpert molecular diagnostic program for tuberculosis (TB). Xpert MTB/RIF was introduced in 2011 with a subsequent expansion to include extra-pulmonary and paediatric testing, followed by Xpert MTB/RIF Ultra in 2017. Through a centralised laboratory information system and the use of a standardised platform for more than a decade, over 23 million tests were analysed, describing the numbers tested, <i>Mycobacterium tuberculosis</i> complex detection, rifampin resistance, and the unsuccessful test rates. The stratification by province, specimen type, age, and sex identified significant heterogeneity across the program and highlighted testing gaps for men, low detection yield for paediatric pulmonary TB, and the effects of inadequate specimen quality on the detection rate. The insights gained from these data can aid in the monitoring of interventions in support of the national TB program beyond laboratory operational aspects.
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spelling doaj.art-526114ef8adf40ae87870517eeeb7af82023-11-19T16:13:28ZengMDPI AGDiagnostics2075-44182023-10-011320325310.3390/diagnostics13203253More Than a Decade of GeneXpert<sup>®</sup> <i>Mycobacterium tuberculosis</i>/Rifampicin (Ultra) Testing in South Africa: Laboratory Insights from Twenty-Three Million TestsManuel Pedro da Silva0Naseem Cassim1Silence Ndlovu2Puleng Shiela Marokane3Mbuti Radebe4Anne Shapiro5Lesley Erica Scott6Wendy Susan Stevens7National Health Laboratory Service (NHLS), Johannesburg 2192, South AfricaNational Health Laboratory Service (NHLS), Johannesburg 2192, South AfricaNational Health Laboratory Service (NHLS), Johannesburg 2192, South AfricaNational Health Laboratory Service (NHLS), Johannesburg 2192, South AfricaNational Health Laboratory Service (NHLS), Johannesburg 2192, South AfricaDepartment of Biostatistics, Boston University School of Public Health, Boston, MA 02118, USAWits Diagnostics Innovation Hub (DIH), Faculty of Health Sciences, University of Witwatersrand, Johannesburg 2193, South AfricaNational Health Laboratory Service (NHLS), Johannesburg 2192, South AfricaThis study seeks to describe the rollout and current state of South Africa’s GeneXpert molecular diagnostic program for tuberculosis (TB). Xpert MTB/RIF was introduced in 2011 with a subsequent expansion to include extra-pulmonary and paediatric testing, followed by Xpert MTB/RIF Ultra in 2017. Through a centralised laboratory information system and the use of a standardised platform for more than a decade, over 23 million tests were analysed, describing the numbers tested, <i>Mycobacterium tuberculosis</i> complex detection, rifampin resistance, and the unsuccessful test rates. The stratification by province, specimen type, age, and sex identified significant heterogeneity across the program and highlighted testing gaps for men, low detection yield for paediatric pulmonary TB, and the effects of inadequate specimen quality on the detection rate. The insights gained from these data can aid in the monitoring of interventions in support of the national TB program beyond laboratory operational aspects.https://www.mdpi.com/2075-4418/13/20/3253GeneXpert MTB/RIFGeneXpert MTB/RIF Ultramolecular diagnosticstuberculosispulmonary tuberculosisextra-pulmonary tuberculosis
spellingShingle Manuel Pedro da Silva
Naseem Cassim
Silence Ndlovu
Puleng Shiela Marokane
Mbuti Radebe
Anne Shapiro
Lesley Erica Scott
Wendy Susan Stevens
More Than a Decade of GeneXpert<sup>®</sup> <i>Mycobacterium tuberculosis</i>/Rifampicin (Ultra) Testing in South Africa: Laboratory Insights from Twenty-Three Million Tests
Diagnostics
GeneXpert MTB/RIF
GeneXpert MTB/RIF Ultra
molecular diagnostics
tuberculosis
pulmonary tuberculosis
extra-pulmonary tuberculosis
title More Than a Decade of GeneXpert<sup>®</sup> <i>Mycobacterium tuberculosis</i>/Rifampicin (Ultra) Testing in South Africa: Laboratory Insights from Twenty-Three Million Tests
title_full More Than a Decade of GeneXpert<sup>®</sup> <i>Mycobacterium tuberculosis</i>/Rifampicin (Ultra) Testing in South Africa: Laboratory Insights from Twenty-Three Million Tests
title_fullStr More Than a Decade of GeneXpert<sup>®</sup> <i>Mycobacterium tuberculosis</i>/Rifampicin (Ultra) Testing in South Africa: Laboratory Insights from Twenty-Three Million Tests
title_full_unstemmed More Than a Decade of GeneXpert<sup>®</sup> <i>Mycobacterium tuberculosis</i>/Rifampicin (Ultra) Testing in South Africa: Laboratory Insights from Twenty-Three Million Tests
title_short More Than a Decade of GeneXpert<sup>®</sup> <i>Mycobacterium tuberculosis</i>/Rifampicin (Ultra) Testing in South Africa: Laboratory Insights from Twenty-Three Million Tests
title_sort more than a decade of genexpert sup r sup i mycobacterium tuberculosis i rifampicin ultra testing in south africa laboratory insights from twenty three million tests
topic GeneXpert MTB/RIF
GeneXpert MTB/RIF Ultra
molecular diagnostics
tuberculosis
pulmonary tuberculosis
extra-pulmonary tuberculosis
url https://www.mdpi.com/2075-4418/13/20/3253
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