Pedro Pisa , Constance Wose Kinge , Charles Chasela , Eula Mothibi , Yin Min Thaung , Hnin T. Thwin , Nay M. Aung , Kara W. Chew , Malini M. Gandhi , Cavenaugh Clint , Thomas Minior , Aye A. Lwin , Morgan J. Freiman , Khin P. Kyi , Yi Y. Sein , Fadzai Marange , Charles van der Horst , Sofiane Mohamed , Matthieu Barralon , Ian Sanne
{"title":"在缅甸评估 GeneXpert 和 Advanced Biological Laboratories UltraGene HCV 诊断仪的检测结果以及与罗氏实时 PCR 相比的性能","authors":"Pedro Pisa , Constance Wose Kinge , Charles Chasela , Eula Mothibi , Yin Min Thaung , Hnin T. Thwin , Nay M. Aung , Kara W. Chew , Malini M. Gandhi , Cavenaugh Clint , Thomas Minior , Aye A. Lwin , Morgan J. Freiman , Khin P. Kyi , Yi Y. Sein , Fadzai Marange , Charles van der Horst , Sofiane Mohamed , Matthieu Barralon , Ian Sanne","doi":"10.1016/j.jcv.2024.105653","DOIUrl":null,"url":null,"abstract":"<div><h3>Background</h3><p>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.</p></div><div><h3>Methods</h3><p>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.</p></div><div><h3>Results</h3><p>There was a strong positive correlation coefficient between all three methods with GeneXpert and Roche having the strongest, <em>r</em> = 0.96, (<em>p</em><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.</p></div><div><h3>Conclusion</h3><p>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.</p></div>","PeriodicalId":15517,"journal":{"name":"Journal of Clinical Virology","volume":"171 ","pages":"Article 105653"},"PeriodicalIF":4.0000,"publicationDate":"2024-02-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S1386653224000155/pdfft?md5=09f425e484bdfe4e15922e598f5c3960&pid=1-s2.0-S1386653224000155-main.pdf","citationCount":"0","resultStr":"{\"title\":\"Evaluation of GeneXpert and advanced biological laboratories UltraGene HCV diagnostic detection and performance against Roche real time PCR in Myanmar\",\"authors\":\"Pedro Pisa , Constance Wose Kinge , Charles Chasela , Eula Mothibi , Yin Min Thaung , Hnin T. Thwin , Nay M. Aung , Kara W. Chew , Malini M. Gandhi , Cavenaugh Clint , Thomas Minior , Aye A. Lwin , Morgan J. Freiman , Khin P. Kyi , Yi Y. Sein , Fadzai Marange , Charles van der Horst , Sofiane Mohamed , Matthieu Barralon , Ian Sanne\",\"doi\":\"10.1016/j.jcv.2024.105653\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<div><h3>Background</h3><p>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.</p></div><div><h3>Methods</h3><p>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.</p></div><div><h3>Results</h3><p>There was a strong positive correlation coefficient between all three methods with GeneXpert and Roche having the strongest, <em>r</em> = 0.96, (<em>p</em><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.</p></div><div><h3>Conclusion</h3><p>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.</p></div>\",\"PeriodicalId\":15517,\"journal\":{\"name\":\"Journal of Clinical Virology\",\"volume\":\"171 \",\"pages\":\"Article 105653\"},\"PeriodicalIF\":4.0000,\"publicationDate\":\"2024-02-12\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.sciencedirect.com/science/article/pii/S1386653224000155/pdfft?md5=09f425e484bdfe4e15922e598f5c3960&pid=1-s2.0-S1386653224000155-main.pdf\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Journal of Clinical Virology\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://www.sciencedirect.com/science/article/pii/S1386653224000155\",\"RegionNum\":3,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q2\",\"JCRName\":\"VIROLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Journal of Clinical Virology","FirstCategoryId":"3","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S1386653224000155","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q2","JCRName":"VIROLOGY","Score":null,"Total":0}
Evaluation of GeneXpert and advanced biological laboratories UltraGene HCV diagnostic detection and performance against Roche real time PCR in Myanmar
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.
期刊介绍:
The Journal of Clinical Virology, an esteemed international publication, serves as the official journal for both the Pan American Society for Clinical Virology and The European Society for Clinical Virology. Dedicated to advancing the understanding of human virology in clinical settings, the Journal of Clinical Virology focuses on disseminating research papers and reviews pertaining to the clinical aspects of virology. Its scope encompasses articles discussing diagnostic methodologies and virus-induced clinical conditions, with an emphasis on practicality and relevance to clinical practice.
The journal publishes on topics that include:
• new diagnostic technologies
• nucleic acid amplification and serologic testing
• targeted and metagenomic next-generation sequencing
• emerging pandemic viral threats
• respiratory viruses
• transplant viruses
• chronic viral infections
• cancer-associated viruses
• gastrointestinal viruses
• central nervous system viruses
• one health (excludes animal health)