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Performance evaluation of the DAAN HCV assay for quantification of hepatitis C virus RNA and its comparison with COBAS AmpliPrep/COBAS TaqMan HCV Quantitative Test, v2.0

BACKGROUND: The Daan HCV RNA quantitative assay was a recently developed kit with high sensitivity for the detection of HCV RNA. We aimed to evaluate the analytical performance of the Daan HCV RNA quantitative assay and compare it with the COBAS AmpliPrep/COBAS TaqMan HCV Quantitative Test, v2.0. ME...

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Autores principales: He, Yuting, Wang, Yichong, Chen, Xuefang, Huang, Hao, Deng, Jiankai, Chen, Peisong, Bin, Huang
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley and Sons Inc. 2020
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7370725/
https://www.ncbi.nlm.nih.gov/pubmed/32167624
http://dx.doi.org/10.1002/jcla.23280
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author He, Yuting
Wang, Yichong
Chen, Xuefang
Huang, Hao
Deng, Jiankai
Chen, Peisong
Bin, Huang
author_facet He, Yuting
Wang, Yichong
Chen, Xuefang
Huang, Hao
Deng, Jiankai
Chen, Peisong
Bin, Huang
author_sort He, Yuting
collection PubMed
description BACKGROUND: The Daan HCV RNA quantitative assay was a recently developed kit with high sensitivity for the detection of HCV RNA. We aimed to evaluate the analytical performance of the Daan HCV RNA quantitative assay and compare it with the COBAS AmpliPrep/COBAS TaqMan HCV Quantitative Test, v2.0. METHOD: WHO HCV RNA standard, NIBSC 06/102 standard, and CLSI EP documents were used to evaluate the precision, accuracy, linearity, anti‐interference ability, and cross‐reactivity of the Daan HCV RNA quantitative assay. Overall 198 clinical serum specimens were used to make comparison between the Daan HCV RNA quantitative assay and the Roche Cobas test. RESULTS: The within‐run precision (S(within)), and total precision (S(total)) for 6.11 log IU/mL, 4.22 log IU/mL, and 2.32 log IU/mL HCV RNA were 0.13 and 0.15, 0.07 and 0.09, and 0.11 and 0.10, respectively. The linear range was 20‐10(8) IU/mL, and the limit of detection was 15 IU/mL. It did not display any interference with commonly encountered conditions and cross‐reactivity with some common virus. A good agreement was observed between the Daan HCV RNA quantitative assay and the Roche Cobas test. CONCLUSION: The Daan HCV RNA quantitative assay has shown satisfactory performances and excellent agreement with COBAS HCV Quantitative Test on clinical specimens with lower cost, which provides an alternative choice for the diagnosis and monitoring of HCV infection in developing countries.
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spelling pubmed-73707252020-07-21 Performance evaluation of the DAAN HCV assay for quantification of hepatitis C virus RNA and its comparison with COBAS AmpliPrep/COBAS TaqMan HCV Quantitative Test, v2.0 He, Yuting Wang, Yichong Chen, Xuefang Huang, Hao Deng, Jiankai Chen, Peisong Bin, Huang J Clin Lab Anal Research Articles BACKGROUND: The Daan HCV RNA quantitative assay was a recently developed kit with high sensitivity for the detection of HCV RNA. We aimed to evaluate the analytical performance of the Daan HCV RNA quantitative assay and compare it with the COBAS AmpliPrep/COBAS TaqMan HCV Quantitative Test, v2.0. METHOD: WHO HCV RNA standard, NIBSC 06/102 standard, and CLSI EP documents were used to evaluate the precision, accuracy, linearity, anti‐interference ability, and cross‐reactivity of the Daan HCV RNA quantitative assay. Overall 198 clinical serum specimens were used to make comparison between the Daan HCV RNA quantitative assay and the Roche Cobas test. RESULTS: The within‐run precision (S(within)), and total precision (S(total)) for 6.11 log IU/mL, 4.22 log IU/mL, and 2.32 log IU/mL HCV RNA were 0.13 and 0.15, 0.07 and 0.09, and 0.11 and 0.10, respectively. The linear range was 20‐10(8) IU/mL, and the limit of detection was 15 IU/mL. It did not display any interference with commonly encountered conditions and cross‐reactivity with some common virus. A good agreement was observed between the Daan HCV RNA quantitative assay and the Roche Cobas test. CONCLUSION: The Daan HCV RNA quantitative assay has shown satisfactory performances and excellent agreement with COBAS HCV Quantitative Test on clinical specimens with lower cost, which provides an alternative choice for the diagnosis and monitoring of HCV infection in developing countries. John Wiley and Sons Inc. 2020-03-13 /pmc/articles/PMC7370725/ /pubmed/32167624 http://dx.doi.org/10.1002/jcla.23280 Text en © 2020 The Authors. Journal of Clinical Laboratory Analysis published by Wiley Periodicals, Inc This is an open access article under the terms of the http://creativecommons.org/licenses/by/4.0/ License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited.
spellingShingle Research Articles
He, Yuting
Wang, Yichong
Chen, Xuefang
Huang, Hao
Deng, Jiankai
Chen, Peisong
Bin, Huang
Performance evaluation of the DAAN HCV assay for quantification of hepatitis C virus RNA and its comparison with COBAS AmpliPrep/COBAS TaqMan HCV Quantitative Test, v2.0
title Performance evaluation of the DAAN HCV assay for quantification of hepatitis C virus RNA and its comparison with COBAS AmpliPrep/COBAS TaqMan HCV Quantitative Test, v2.0
title_full Performance evaluation of the DAAN HCV assay for quantification of hepatitis C virus RNA and its comparison with COBAS AmpliPrep/COBAS TaqMan HCV Quantitative Test, v2.0
title_fullStr Performance evaluation of the DAAN HCV assay for quantification of hepatitis C virus RNA and its comparison with COBAS AmpliPrep/COBAS TaqMan HCV Quantitative Test, v2.0
title_full_unstemmed Performance evaluation of the DAAN HCV assay for quantification of hepatitis C virus RNA and its comparison with COBAS AmpliPrep/COBAS TaqMan HCV Quantitative Test, v2.0
title_short Performance evaluation of the DAAN HCV assay for quantification of hepatitis C virus RNA and its comparison with COBAS AmpliPrep/COBAS TaqMan HCV Quantitative Test, v2.0
title_sort performance evaluation of the daan hcv assay for quantification of hepatitis c virus rna and its comparison with cobas ampliprep/cobas taqman hcv quantitative test, v2.0
topic Research Articles
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7370725/
https://www.ncbi.nlm.nih.gov/pubmed/32167624
http://dx.doi.org/10.1002/jcla.23280
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