Evidence map›Paper›PMID 29499042›Full record

ArticlePloS one2018

Multidisease testing for HIV and TB using the GeneXpert platform: A feasibility study in rural Zimbabwe.

Zibusiso Ndlovu, Emmanuel Fajardo, Elton Mbofana, Tatenda Maparo, Daniela Garone, Carol Metcalf, Helen Bygrave, Kekeletso Kao, Sekesai Zinyowera

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Article in PloS one, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 67 papers, 7 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
67citing papers in PubMed, 7 pooled it
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1 · What the graph read from 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.

2 · The registry

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.

3 · Its place in the literature

Who cites it

67 citing papers in PubMed, 7 syntheses or guidelines pooled it.

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7 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors.

Zibusiso NdlovuMedecins Sans Frontières, Southern Africa Medical Unit, Cape Town, South Africa.ORCID 0000-0003-0386-8641
Emmanuel FajardoMedecins Sans Frontières, Access Campaign, Geneva, Switzerland.
Elton MbofanaMedecins Sans Frontières, Harare, Zimbabwe.
Tatenda MaparoMedecins Sans Frontières, Harare, Zimbabwe.
Daniela GaroneMedecins Sans Frontières, Harare, Zimbabwe.
Carol MetcalfMedecins Sans Frontières, Southern Africa Medical Unit, Cape Town, South Africa.
Helen BygraveMedecins Sans Frontières, Southern Africa Medical Unit, Cape Town, South Africa.
Kekeletso KaoFoundation for Innovative New Diagnostics, Geneva, Switzerland.
Sekesai ZinyoweraNational Microbiology Reference Laboratory, Ministry of Health and Child Care, Harare, Zimbabwe.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundHIV Viral Load and Early Infant Diagnosis technologies in many high burden settings are restricted to centralized laboratory testing, leading to long result turnaround times and patient attrition. GeneXpert (Cepheid, CA, USA) is a polyvalent near point-of-care platform and is widely implemented for Xpert MTB/RIF diagnosis. This study sought to evaluate the operational feasibility of integrated HIV VL, EID and MTB/RIF testing in new GeneXpert platforms.

methodsWhole blood samples were collected from consenting patients due for routine HIV VL testing and DBS samples from infants due for EID testing, at three rural health facilities in Zimbabwe. Sputum samples were collected from all individuals suspected of TB. GeneXpert testing was reserved for all EID, all TB suspects and priority HIV VL at each site. Blood samples were further sent to centralized laboratories for confirmatory testing. GeneXpert polyvalent testing results and patient outcomes, including infrastructural and logistical requirements are reported. The study was conducted over a 10-month period.

resultsThe fully automated GeneXpert testing device, required minimal training and biosafety considerations. A total of 1,302 HIV VL, 277 EID and 1,581 MTB/RIF samples were tested on a four module GeneXpert platform in each study site. Xpert HIV-1 VL testing was prioritized for patients who presented with advanced HIV disease, pregnant women, adolescents and suspected ART failures patients. On average, the study sites had a GeneXpert utilization rate of 50.4% (Gutu Mission Hospital), 63.5% (Murambinda Mission Hospital) and 17.5% (Chimombe Rural Health Centre) per month. GeneXpert polyvalent testing error rates remained lower than 4% in all sites. Decentralized EID and VL testing on Xpert had shorter overall median TAT (1 day [IQR: 0-4] and 1 day [IQR: 0-1] respectively) compared to centralized testing (17 days [IQR: 13-21] and 26 days [IQR: 23-32] respectively). Among patients with VL >1000 copies/ml (73/640; 11.4%) at GMH health facility, median time to enhanced adherence counselling was 8 days and majority of those with documented outcomes had re-suppressed VL (20/32; 62.5%). Median time to ART initiation among Xpert EID positive infants at GMH was 1 day [IQR: 0-1].

conclusionImplementation of near point-of-care GeneXpert platform for integrated multi-disease testing within district and sub-district healthcare settings is feasible and will increase access to VL, and EID testing to priority populations. Quality management systems including monitoring of performance indicators, together with regular on-site supervision are crucial, and near-POC test results must be promptly actioned-on by clinicians for patient management.

Indexed as

Point-of-Care SystemsAdultAnti-Retroviral AgentsAutomationFeasibility StudiesFemaleHIV-1HIV InfectionsHumansMaleSputumTuberculosisViral LoadZimbabweAnti-Retroviral Agents

Identifiers

PMID29499042
PMCPMC5834185

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Registered trials

None linked

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.