Point-of-Care Cepheid Xpert HIV-1 Viral Load Test in Rural African Communities Is Feasible and Reliable

Moyo, Sikhulile; Mohammed, Terence; Wirth, Kathleen E.; Prague, Mélanie; Bennett, Kara; Holme, Molly Pretorius; Mupfumi, Lucy; Sebogodi, Philemon; Moraka, Natasha O.; Boleo, Corretah; Maphorisa, Comfort; Seraise, Boitumelo; Gaseitsiwe, Simani; Musonda, Rosemary; Widenfelt, Erik van; Powis, Kathleen M.; Gaolathe, Tendani; Tchetgen, Eric J. Tchetgen; Makhema, Joseph; Essex, Max; Lockman, Shahin; Novitsky, Vladimir

doi:10.1128/jcm.01594-16

Cited by 69 publications

(70 citation statements)

References 26 publications

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“…Its performance and utility have also been tested in a rural community-based project in Botswana, reporting a sensitivity of 98.6%. 34 More recently, Cepheid have launched a hepatitis B VL assay, which may contribute a much-needed tool to aid treatment deci- However, in our study one-third of patients required re-testing owing to test errors, which were attributed to both inadequate sample volume and also loss of electrical supply while samples were being analysed. The rate of error appears to be fair greater than that has previous been reported in the literature (1%-3%).…”

Section: Discussionmentioning

confidence: 74%

“…For example, the WHO have prequalified the Xpert ® HIV VL assay, which has a lower limit of detection of 38 IU/mL. Its performance and utility have also been tested in a rural community‐based project in Botswana, reporting a sensitivity of 98.6% . More recently, Cepheid have launched a hepatitis B VL assay, which may contribute a much‐needed tool to aid treatment decision‐making and monitoring in resource‐limited settings.…”

Section: Discussionmentioning

confidence: 99%

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In‐field evaluation of Xpert® HCV viral load Fingerstick assay in people who inject drugs in Tanzania

Mohamed

Mbwambo

Rwegasha

et al. 2019

Liver International

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Background Although novel hepatitis C virus (HCV) RNA point‐of‐care technology has the potential to enhance the diagnosis in resource‐limited settings, very little real‐world validation of their utility exists. We evaluate the performance of HCV RNA quantification using the Xpert® HCV viral load Fingerstick assay (Xpert® HCV VL Fingerstick assay) as compared to the World Health Organisation pre‐qualified plasma Xpert® HCV VL assay among people who inject drugs (PWID) attending an opioid agonist therapy (OAT) clinic in Dar‐es‐Salaam, Tanzania. Methods Between December 2018 and February 2019, consecutive HCV seropositive PWID attending the OAT clinic provided paired venous and Fingerstick samples for HCV RNA quantification. These were processed onsite using the GeneXpert® platform located at the Central tuberculosis reference laboratory. Results A total of 208 out of 220 anti‐HCV‐positive participants recruited (94.5%) had a valid Xpert® HCV VL result available; 126 (61%; 95% CI 53.8‐67.0) had detectable and quantifiable HCV RNA. About 188 (85%) participants had paired plasma and Fingerstick whole blood samples; the sensitivity and specificity for the quantification of HCV RNA levels were 99.1% and 98.7% respectively. There was an excellent correlation (R2 = .95) and concordance (mean difference 0.13 IU/mL, (95% CI −0.9 to 0.16 IU/mL) in HCV RNA levels between plasma samples and Fingerstick samples. Conclusion This study found excellent performance of the Xpert® HCV VL Fingerstick assay for HCV RNA detection and quantification in an African‐field setting. Its clinical utility represents an important watershed in overcoming existing challenges to HCV diagnosis, which should play a crucial role in HCV elimination in Africa.

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Section: Discussionmentioning

confidence: 74%

Section: Discussionmentioning

confidence: 99%

In‐field evaluation of Xpert® HCV viral load Fingerstick assay in people who inject drugs in Tanzania

Mohamed

Mbwambo

Rwegasha

et al. 2019

Liver International

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“…Our results are consistent with similar validation studies in other countries. [8][9][10][11][12][13][14] After a detailed investigation by the company, the high invalid and error rate was primarily attributed to a suboptimal cartridge lot. We also identified supply chain issues, such as broken cartridges during shipping and a defect that caused plasma sample leakage within the cartridge.…”

Section: Use Of the Genexpert Tuberculosis System For Hiv Viral Load mentioning

confidence: 99%

Use of the GeneXpert tuberculosis system for HIV viral load testing in India

Nash

Ramapuram

Kaiya

et al. 2017

The Lancet Global Health

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“…Investing in a national integrated RoR system that accommodates both clinical and surveillance results will be important as countries expand viral load monitoring capacity. In addition, use of point of care VL test instruments, including Alere™ q HIV‐1/2 Detect assay and Cepheid Xpert HIV‐1 VL assay, may offer advantages in future surveys to minimize TAT and avoid the complexities arising from specimen transport, handling and data management issues described above . However, these instruments are best suited for decentralized health facilities that are remote, allowing for rural HIV positive patients without access to central laboratories to be clinically monitored in their disease progression.…”

Section: Discussionmentioning

confidence: 99%

Returning HIV‐1 viral load results to participant‐selected health facilities in national Population‐based HIV Impact Assessment (PHIA) household surveys in three sub‐Saharan African Countries, 2015 to 2016

et al. 2017

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IntroductionLogistical complexities of returning laboratory test results to participants have precluded most population‐based HIV surveys conducted in sub‐Saharan Africa from doing so. For HIV positive participants, this presents a missed opportunity for engagement into clinical care and improvement in health outcomes. The Population‐based HIV Impact Assessment (PHIA) surveys, which measure HIV incidence and the prevalence of viral load (VL) suppression in selected African countries, are returning VL results to health facilities specified by each HIV positive participant within eight weeks of collection. We describe the performance of the specimen and data management systems used to return VL results to PHIA participants in Zimbabwe, Malawi and Zambia.MethodsConsenting participants underwent home‐based counseling and HIV rapid testing as per national testing guidelines; all confirmed HIV positive participants had VL measured at a central laboratory on either the Roche CAP/CTM or Abbott m2000 platform. On a bi‐weekly basis, a dedicated data management team produced logs linking the VL test result with the participants’ contact information and preferred health facility; project staff sent test results confidentially via project drivers, national courier systems, or electronically through an adapted short message service (SMS). Participants who provided cell phone numbers received SMS or phone call alerts regarding availability of VL results.Results and discussionFrom 29,634 households across the three countries, 78,090 total participants 0 to 64 years in Zimbabwe and Malawi and 0 to 59 years in Zambia underwent blood draw and HIV testing. Of the 8391 total HIV positive participants identified, 8313 (99%) had VL tests performed and 8245 (99%) of these were returned to the selected health facilities. Of the 5979 VL results returned in Zimbabwe and Zambia, 85% were returned within the eight‐week goal with a median turnaround time of 48 days (IQR: 33 to 61). In Malawi, where exact return dates were unavailable all 2266 returnable results reached the health facilities by 11 weeks.ConclusionsThe first three PHIA surveys returned the vast majority of VL results to each HIV positive participant's preferred health facility within the eight‐week target. Even in the absence of national VL monitoring systems, a system to return VL results from a population‐based survey is feasible, but it requires developing laboratory and data management systems and dedicated staff. These are likely important requirements to strengthen return of results systems in routine clinical care.

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Point-of-Care Cepheid Xpert HIV-1 Viral Load Test in Rural African Communities Is Feasible and Reliable

Cited by 69 publications

References 26 publications

In‐field evaluation of Xpert® HCV viral load Fingerstick assay in people who inject drugs in Tanzania

In‐field evaluation of Xpert® HCV viral load Fingerstick assay in people who inject drugs in Tanzania

Use of the GeneXpert tuberculosis system for HIV viral load testing in India

Returning HIV‐1 viral load results to participant‐selected health facilities in national Population‐based HIV Impact Assessment (PHIA) household surveys in three sub‐Saharan African Countries, 2015 to 2016

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