Point -of -care testing (POCT) in molecular diagnostics: Performance evaluation of GeneXpert HCV RNA test in diagnosing and monitoring of HCV infection

Gupta, Ekta; Agarwala, Pragya; Kumar, Guresh; Maiwall, Rakhi; Sarin, Shiv Kumar

doi:10.1016/j.jcv.2017.01.006

Cited by 64 publications

(62 citation statements)

References 16 publications

Supporting

Mentioning

Contrasting

Unclassified

Order By: Relevance

“…In our study, the sensitivity of Xpert compared to Roche was 100% (95% CI 99.2, 100.0). This finding is similar to two previous studies that compared the performance of Xpert against Abbott RealTime among mostly GT1 and GT3 patients: Gupta et al found a sensitivity of 94.4% (95% CI 88.8, 97.7) and McHugh et al 98.0% (95% CI 96.1, 99.1) . While both Gupta and McHugh reported false negatives, none occurred in our study.…”

Section: Discussionsupporting

confidence: 92%

“…Our LOA was greater than the predefined clinical agreement limit for the maximum allowed difference of 0.5 log 10 IU/mL, and 13.9% (=63/454) of samples fell outside this limit. Our LOA was also wider compared to previous studies by: Gupta (mean difference of 0.04 log 10 IU/mL and LOA of −0.42 and 0.49), McHugh (mean difference of 0.03 log 10 IU/mL and LOA of −0.41 to 0.47), and Grebely (mean difference of −0.036 log 10 IU/mL and LOA of −0.28 to 0.35) . This may be attributable to differences in sample preparation procedures and the differences in the comparator platforms.…”

Section: Discussioncontrasting

confidence: 58%

“…Evidence used to demonstrate clinical performance in the WHO Prequalification Programme relied predominantly on results from GT1 patients, with the inclusion of only 23 non‐GT1 samples . Previous studies evaluating the performance of the Xpert assay have also been conducted in resource‐rich countries where the majority of the samples tested were GT1/GT3 . Non‐GT1/GT3 HCV is prevalent in low‐ and middle‐income countries in East and Southeast Asia, North Africa, the Middle East, and Southern sub‐Saharan Africa and is disproportionately under‐represented in the literature .…”

Section: Introductionmentioning

confidence: 99%

See 2 more Smart Citations

Field evaluation of GeneXpert^® (Cepheid) HCV performance for RNA quantification in a genotype 1 and 6 predominant patient population in Cambodia

Iwamoto

Calzia

Dublineau³

et al. 2018

Journal of Viral Hepatitis

View full text Add to dashboard Cite

GeneXpert (Cepheid) is the only WHO prequalified platform for hepatitis C virus (HCV) nucleic acid amplification testing that is suitable for point-of-care use in resource-limited contexts. However, its application is constrained by the lack of evidence on genotype 6 (GT6) HCV. We evaluated its field performance among a patient population in Cambodia predominantly infected with GT6. Between August and September 2017, we tested plasma samples obtained from consenting patients at Médecins Sans Frontières' HCV clinic at Preah Kossamak Hospital for HCV viral load (VL) using GeneXpert and compared its results to those obtained using COBAS AmpliPrep/Cobas TaqMan HCV Quantitative Test, v2.0 (Roche) at the Institut Pasteur du Cambodge. Among 769 patients, 77% of the seropositive patients (n = 454/590) had detectable and quantifiable VL using Roche and 43% (n = 195/454) were GT6. The sensitivity and specificity of GeneXpert against Roche were 100% (95% CI 99.2, 100.0) and 98.5% (95% CI 94.8, 99.8). The mean VL difference was -0.01 (95% CI -0.05, 0.02) log IU/mL for 454 samples quantifiable on Roche and -0.07 (95% CI -0.12, -0.02) log IU/mL for GT6 (n = 195). The limit of agreement (LOA) was -0.76 to 0.73 log IU/mL for all GTs and -0.76 to 0.62 log IU/mL for GT6. Twenty-nine GeneXpert results were outside the LOA. Frequency of error and the median turnaround time (TAT) for GeneXpert were 1% and 0 days (4 days using Roche). We demonstrated that the GeneXpert HCV assay has good sensitivity, specificity, quantitative agreement, and TAT in a real-world, resource-limited clinical setting among GT6 HCV patients.

show abstract

Section: Discussionsupporting

confidence: 92%

Section: Discussioncontrasting

confidence: 58%

Section: Introductionmentioning

confidence: 99%

See 1 more Smart Citation

Field evaluation of GeneXpert^® (Cepheid) HCV performance for RNA quantification in a genotype 1 and 6 predominant patient population in Cambodia

Iwamoto

Calzia

Dublineau³

et al. 2018

Journal of Viral Hepatitis

View full text Add to dashboard Cite

show abstract

“…Our study adds to the limited literature addressing the use of HCV NAT point‐of‐care tests in sub‐Saharan Africa, raising the potential for Xpert ® HCV VL Fingerstick assay to provide a further simplified solution to existing issues related to HCV diagnosis. In addition, we add our findings to the limited data supporting the use of the Xpert ® platform in HCV genotype 4 …”

Section: Discussionmentioning

confidence: 75%

“…Secondly, the Xpert ® HCV VL assay was used as the gold standard as there was no local access to conventional laboratory‐based NAT testing. However, it is unlikely that this would have introduced any significant discrepancy as this assay is WHO pre‐qualified and has demonstrated excellent performance in previous validation studies . Thirdly, as local genotyping was not available, only those with historic genotypes were reported in this study.…”

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

View full text Add to dashboard Cite

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.

show abstract

A Rapid Graphene Sensor Platform for the Detection of Viral Proteins in Low Volume Samples

Walters

Burwell

Mitchell

et al. 2022

Advanced NanoBiomed Research

View full text Add to dashboard Cite

Infectious disease outbreaks remain an ever-prevalent global issue, with increasing global travel and trade increasing the risk of rapid disease spread to pandemic levels. [1] This is exemplified by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic from 2019. One specific issue that has been highlighted by the pandemic is the need for methods to achieve rapid, accurate diagnostics for infectious diseases, not just for coronaviruses, but for other major diseases as well. Rapid diagnostics and onsite testing will therefore play a critical role in facilitating early intervention and treatment [2] of diseases. Large-scale testing and rapid onsite diagnostic decisions are crucial for surveillance monitoring of disease outbreaks and infection spread. In future, this data will enable swift decision-making and management to help prevent the spread of epidemic and pandemic infectious disease outbreaks. [1,3,4] In this work, we use the chronic hepatitis C virus (HCV) as a model infectious disease to demonstrate a viral detection platform sensor. HCV is still endemic in populations around the world and is a major cause of liver cirrhosis and hepatocellular carcinoma, affecting around 71 million people worldwide. [5] HCV deaths exceed annual deaths due to HIV, malaria, and tuberculosis. [6] Consequently, the World Health Organization (WHO) aims to eliminate HCV by 2030, [7,8] with a strategy to target an increase in HCV

show abstract

Point -of -care testing (POCT) in molecular diagnostics: Performance evaluation of GeneXpert HCV RNA test in diagnosing and monitoring of HCV infection

Cited by 64 publications

References 16 publications

Field evaluation of GeneXpert^® (Cepheid) HCV performance for RNA quantification in a genotype 1 and 6 predominant patient population in Cambodia

Field evaluation of GeneXpert^® (Cepheid) HCV performance for RNA quantification in a genotype 1 and 6 predominant patient population in Cambodia

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

A Rapid Graphene Sensor Platform for the Detection of Viral Proteins in Low Volume Samples

Contact Info

Product

Resources

About

Point -of -care testing (POCT) in molecular diagnostics: Performance evaluation of GeneXpert HCV RNA test in diagnosing and monitoring of HCV infection

Cited by 64 publications

References 16 publications

Field evaluation of GeneXpert® (Cepheid) HCV performance for RNA quantification in a genotype 1 and 6 predominant patient population in Cambodia

Field evaluation of GeneXpert® (Cepheid) HCV performance for RNA quantification in a genotype 1 and 6 predominant patient population in Cambodia

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

A Rapid Graphene Sensor Platform for the Detection of Viral Proteins in Low Volume Samples

Contact Info

Product

Resources

About

Field evaluation of GeneXpert^® (Cepheid) HCV performance for RNA quantification in a genotype 1 and 6 predominant patient population in Cambodia

Field evaluation of GeneXpert^® (Cepheid) HCV performance for RNA quantification in a genotype 1 and 6 predominant patient population in Cambodia