What is required from HCV point-of-care tests to reduce the burden of hepatitis C infection? ‘<i>Development and clinical validation of the genedrive point-of-care test for qualitative detection of hepatitis C virus</i>’

Lemoine, Maud; Tillmann, Hans L.

doi:10.1136/gutjnl-2018-316438

Cited by 8 publications

(6 citation statements)

References 8 publications

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“…Although HCV RNA point-of-care assays have been designed for LMICs, a lack of in-field validation data in such environments exists and addressing this has recently been highlighted as crucial. 18 For example, the urgent need to scale-up resources to address the risk of blood-borne viruses (BBVs) among PWID engaged in harm reduction in Tanzania has previously been highlighted, including the pressing need for locally available HCV RNA confirmation as part of the cascade of care. 19,20 In addition, a lack of access for temperature regulated sample transport and storage, particularly in a tropical climate, provide further justification for the need to confirm the performance of the Xpert ® HCV VL Fingerstick assay in this resource-limited African setting.…”

Section: Backg Rou N Dmentioning

confidence: 99%

“…Although HCV RNA point‐of‐care assays have been designed for LMICs, a lack of in‐field validation data in such environments exists and addressing this has recently been highlighted as crucial . For example, the urgent need to scale‐up resources to address the risk of blood‐borne viruses (BBVs) among PWID engaged in harm reduction in Tanzania has previously been highlighted, including the pressing need for locally available HCV RNA confirmation as part of the cascade of care .…”

Section: Introductionmentioning

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: Backg Rou N Dmentioning

confidence: 99%

Section: Introductionmentioning

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

Self Cite

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“…Nevertheless, this test still requires a venous puncture for the collection of plasma samples and needs centrifugation, which is not easily accessible in remote areas [47]. Therefore, in this current situation, Xpert VL test could be an option to support the 'one-step diagnosis strategy' that testing HCV viremia can be performed at any level of patient care to achieve elimination of HCV by non-laboratory trained individuals such as physicians, nurses, and nursing assistants [38,48].…”

Section: Discussionmentioning

confidence: 99%

Improving linkage to care of hepatitis C: Evaluation of GeneXpert® HCV Viral Load Point-of-Care Assay in Indonesia

Thedja

Wibowo

El-Khobar

et al. 2020

Preprint

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Background: Lack of simple, rapid, and reliable point-of-care (POC) test hampers large-scale diagnosis and treatment of hepatitis C virus (HCV) infection and pose a challenge for its elimination as a public health threat. This study aimed to evaluate Cepheid Xpert® HCV Viral Load performance in comparison to Roche Cobas® TaqMan® HCV Test using HCV-samples with various genotypes in Indonesia.Methods: Viral load (VL) quantification was performed on 243 anti-HCV positive patients’ samples using both Xpert and Roche HCV tests, followed by HCV genotyping by reverse hybridization. Strength of relationship between the assays was measured by Pearson correlation coefficient, while level of agreement was analyzed by Deming regression and Bland-Altman plot analysis using log10-transformed VL values.Results: Quantifiable VL was detected in 180/243 (74.1%), with Xpert sensitivity of 100% (95% CI 0.98, 1.00) and specificity of 98.41% (95% CI 0.91, 0.99), while HCV genotypes were determined in 172/180 (95.6%) samples. There was a very good correlation between both assays (r = 0.97, P < 0.001), overall and per genotype, with good concordance by Deming regression and mean difference of −0.25 log10 IU/mL (95% CI −0.33, −0.18) by Bland-Altman plot analysis.Conclusion: Good performance of Xpert HCV Viral Load test was demonstrated as a POC platform for HCV diagnosis and treatment decision, which would be beneficial for decentralized service in resource-limited areas.

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“…Genedrive detects HCV RNA in a small volume of plasma (30 µL) using reverse transcription polymerase chain reaction (RT-PCR). The system provides a simple, qualitative result without the need for specialist knowledge or data interpretation [ 9 ]. The Genedrive instrument is small and can be easily operated in a range of decentralized laboratory settings with limited requirements for ancillary equipment or test materials.…”

Section: Introductionmentioning

confidence: 99%

Diagnostic Performance and Usability of the Genedrive® HCV ID Kit in Two Decentralized Settings in Cameroon and Georgia

et al. 2021

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Point-of-care diagnostics have the potential to increase diagnosis and linkage to care and help reach the WHO targets to eliminate hepatitis C virus (HCV) by 2030. Here, we evaluated the diagnostic accuracy of Genedrive HCV ID assay for the qualitative detection of HCV RNA in decentralized settings in two low- and middle-income countries using fresh plasma specimens from 426 participants. The Abbott RealTime HCV assay was used as the gold standard. Genedrive HCV ID assay was conducted by different users. Users also completed questionnaires to assess the usability of Genedrive. At detection thresholds of 12 IU/mL or 30 IU/mL, 1000 IU/mL, and 2362 IU/mL, the sensitivity was 96.2% (95% CI: 92.7–98.4), 100% (98.2–100), and 100% (98.2–100), respectively; the specificity was 99.5% (95% CI: 97.4–100), 99.5% (97.5–100), and 98.7% (96.1–100), respectively. All genotypes detected using the gold-standard assay were also detected with Genedrive. Users found Genedrive easy to use. Genedrive is a simple and accurate test to confirm chronic HCV infection in decentralized, real-life, resource-limited settings. This novel diagnostic tool could contribute to closing the current gap in HCV diagnosis.

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What is required from HCV point-of-care tests to reduce the burden of hepatitis C infection? ‘Development and clinical validation of the genedrive point-of-care test for qualitative detection of hepatitis C virus’

Cited by 8 publications

References 8 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

Improving linkage to care of hepatitis C: Evaluation of GeneXpert® HCV Viral Load Point-of-Care Assay in Indonesia

Diagnostic Performance and Usability of the Genedrive® HCV ID Kit in Two Decentralized Settings in Cameroon and Georgia

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