Evaluation of GeneXpert and advanced biological laboratories UltraGene HCV diagnostic detection and performance against Roche real time PCR in Myanmar
Copyright © 2024. Published by Elsevier B.V..
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.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2024 |
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| Erschienen: |
2024 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:171 |
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| Enthalten in: |
Journal of clinical virology : the official publication of the Pan American Society for Clinical Virology - 171(2024) vom: 15. Apr., Seite 105653 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Pisa, Pedro [VerfasserIn] |
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| Links: |
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| Themen: |
GeneXpert |
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| Anmerkungen: |
Date Completed 18.03.2024 Date Revised 02.04.2024 published: Print-Electronic Citation Status MEDLINE |
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| doi: |
10.1016/j.jcv.2024.105653 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
NLM368983846 |
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| 100 | 1 | |a Pisa, Pedro |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Evaluation of GeneXpert and advanced biological laboratories UltraGene HCV diagnostic detection and performance against Roche real time PCR in Myanmar |
| 264 | 1 | |c 2024 | |
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| 500 | |a Date Completed 18.03.2024 | ||
| 500 | |a Date Revised 02.04.2024 | ||
| 500 | |a published: Print-Electronic | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a Copyright © 2024. Published by Elsevier B.V. | ||
| 520 | |a 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 | ||
| 520 | |a 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 | ||
| 520 | |a 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 | ||
| 520 | |a 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 | ||
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Research Support, Non-U.S. Gov't | |
| 650 | 4 | |a GeneXpert | |
| 650 | 4 | |a HCV RNA | |
| 650 | 4 | |a Hepatitis c virus | |
| 650 | 4 | |a Myanmar | |
| 650 | 4 | |a Near to real–time testing | |
| 650 | 4 | |a PCR | |
| 650 | 4 | |a Viral load | |
| 650 | 7 | |a RNA, Viral |2 NLM | |
| 700 | 1 | |a Kinge, Constance Wose |e verfasserin |4 aut | |
| 700 | 1 | |a Chasela, Charles |e verfasserin |4 aut | |
| 700 | 1 | |a Mothibi, Eula |e verfasserin |4 aut | |
| 700 | 1 | |a Thaung, Yin Min |e verfasserin |4 aut | |
| 700 | 1 | |a Thwin, Hnin T |e verfasserin |4 aut | |
| 700 | 1 | |a Aung, Nay M |e verfasserin |4 aut | |
| 700 | 1 | |a Chew, Kara W |e verfasserin |4 aut | |
| 700 | 1 | |a Gandhi, Malini M |e verfasserin |4 aut | |
| 700 | 1 | |a Clint, Cavenaugh |e verfasserin |4 aut | |
| 700 | 1 | |a Minior, Thomas |e verfasserin |4 aut | |
| 700 | 1 | |a Lwin, Aye A |e verfasserin |4 aut | |
| 700 | 1 | |a Freiman, Morgan J |e verfasserin |4 aut | |
| 700 | 1 | |a Kyi, Khin P |e verfasserin |4 aut | |
| 700 | 1 | |a Sein, Yi Y |e verfasserin |4 aut | |
| 700 | 1 | |a Marange, Fadzai |e verfasserin |4 aut | |
| 700 | 1 | |a van der Horst, Charles |e verfasserin |4 aut | |
| 700 | 1 | |a Mohamed, Sofiane |e verfasserin |4 aut | |
| 700 | 1 | |a Barralon, Matthieu |e verfasserin |4 aut | |
| 700 | 1 | |a Sanne, Ian |e verfasserin |4 aut | |
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