학술논문
Evaluation of GeneXpert and advanced biological laboratories UltraGene HCV diagnostic detection and performance against Roche real time PCR in Myanmar.
Document Type
Academic Journal
Author
Pisa P; Department of Strategic Information, Right to Care, Centurion, South Africa; Department of Human Nutrition, University of Pretoria, Faculty of Health Sciences, Pretoria, South Africa.; Kinge CW; Department of Implementation Science, Right to Care, Centurion, South Africa; Department of Epidemiology and Biostatistics, School of Public Health, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.; Chasela C; Department of Implementation Science, Right to Care, Centurion, South Africa; Department of Epidemiology and Biostatistics, School of Public Health, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa. Electronic address: Charles.Chasela@righttocare.org.; Mothibi E; Department of Implementation Science, Right to Care, Centurion, South Africa.; Thaung YM; Community Partners International, Yangon, Myanmar.; Thwin HT; Community Partners International, Yangon, Myanmar.; Aung NM; Community Partners International, Yangon, Myanmar.; Chew KW; David Geffen School of Medicine at UCLA, Los Angeles, CA, USA.; Gandhi MM; David Geffen School of Medicine at UCLA, Los Angeles, CA, USA.; Clint C; U.S. Agency for International Development, USA.; Minior T; U.S. Agency for International Development, USA.; Lwin AA; U.S. Agency for International Development, USA.; Freiman MJ; Department of Medical Research, Ministry of Health and Sports, Yangon, Myanmar.; Kyi KP; Myanmar Liver Foundation, Yangon, Myanmar.; Sein YY; Department of Medical Research, Ministry of Health and Sports, Yangon, Myanmar.; Marange F; Right to Care, Centurion, South Africa.; van der Horst C; University of North Carolina, Chapel Hill, NC. USA.; Mohamed S; Advanced Biological Laboratories (ABL) SA.17, rue des Jardiniers, Luxembourg 1835.; Barralon M; Advanced Biological Laboratories (ABL) SA.17, rue des Jardiniers, Luxembourg 1835.; Sanne I; Clinical HIV Research Unit, School of Clinical Medicine, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.
Source
Publisher: Elsevier Science Country of Publication: Netherlands NLM ID: 9815671 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1873-5967 (Electronic) Linking ISSN: 13866532 NLM ISO Abbreviation: J Clin Virol Subsets: MEDLINE
Subject
Language
English
Abstract
Background: Developing countries experience limited access to HCV laboratory tests for different reasons. Providing near to real-time HCV testing and results especially to at-risk populations including those in rural settings for timely initiation to treatment is key. Within a rural Myanmar setting, we compared HCV diagnostic detection and quantification of the GeneXpert, and Advanced Biological Laboratories UltraGene-HCV assays against the gold standard and reference method Roche real-time HCV in Myanmar.
Methods: Blood samples from 158 high-risk individuals were assessed using three different methods at baseline. Results were checked for normality and log transformed. Log differences and bias between methods were calculated and correlated. Pearson's correlation coefficient was used to determine the association of HCV viral loads across all methods. The level of agreement with the standard method (Roche real time HCV) was assessed using Bland-Altman analyses.
Results: There was a strong positive correlation coefficient between all three methods with GeneXpert and Roche having the strongest, r = 0.96, (p<0.001). Compared to Roche, ABL (mean difference, 95 % limits of agreement; -0.063 and -1.4 to 1.3 Log10IU/mL) and GeneXpert (mean difference, 95 % limits of agreement; -0.28 and -0.7 to 1.8 Log10IU/mL) showed a good level of agreement with the GeneXpert being slightly superior.
Conclusion: We demonstrate the excellent performance and no-inferiority, in terms of levels of agreements of both GeneXpert and ABL compared to the Roche platform and supporting the use of the POC assays as alternative a cost-effective methods in HCV detection and diagnosis in developing and low resource settings countries.
Competing Interests: Declaration of competing interest All other authors who have taken part in this study have nothing to disclose regarding competing financial or personal interest with respect to the work reported in this manuscript. KWC has received a research grant to the institution from Merck Sharp & Dohme.
(Copyright © 2024. Published by Elsevier B.V.)
Methods: Blood samples from 158 high-risk individuals were assessed using three different methods at baseline. Results were checked for normality and log transformed. Log differences and bias between methods were calculated and correlated. Pearson's correlation coefficient was used to determine the association of HCV viral loads across all methods. The level of agreement with the standard method (Roche real time HCV) was assessed using Bland-Altman analyses.
Results: There was a strong positive correlation coefficient between all three methods with GeneXpert and Roche having the strongest, r = 0.96, (p<0.001). Compared to Roche, ABL (mean difference, 95 % limits of agreement; -0.063 and -1.4 to 1.3 Log10IU/mL) and GeneXpert (mean difference, 95 % limits of agreement; -0.28 and -0.7 to 1.8 Log10IU/mL) showed a good level of agreement with the GeneXpert being slightly superior.
Conclusion: We demonstrate the excellent performance and no-inferiority, in terms of levels of agreements of both GeneXpert and ABL compared to the Roche platform and supporting the use of the POC assays as alternative a cost-effective methods in HCV detection and diagnosis in developing and low resource settings countries.
Competing Interests: Declaration of competing interest All other authors who have taken part in this study have nothing to disclose regarding competing financial or personal interest with respect to the work reported in this manuscript. KWC has received a research grant to the institution from Merck Sharp & Dohme.
(Copyright © 2024. Published by Elsevier B.V.)