Performance evaluation of the Vitros anti-hepatitis C virus antibody assay for use in clinical laboratories

Yongjung Park; Yoonmi Seok; Jonghyeon Choi; Hyon Suk Kim

doi:10.1016/j.clinbiochem.2011.10.020

Performance evaluation of the Vitros anti-hepatitis C virus antibody assay for use in clinical laboratories

Yongjung Park, Yoonmi Seok, Jonghyeon Choi, Hyon Suk Kim

Department of Laboratory Medicine

Research output: Contribution to journal › Article › peer-review

6 Citations (Scopus)

Abstract

Objectives: We evaluated the performance of Vitros anti-HCV assay. Design and methods: Precision performance was assessed for 20. days. A total of 1011 sera were tested for anti-HCV with Vitros and Elecsys assays. Specimens positive for any of the two assays were retested with Architect assay. Discrepant results were evaluated with recombinant immunoblot assay (RIBA) and HCV RNA quantification. Results: Total imprecision of Vitros assay was 11.6% and 3.3% CV for negative and positive QC. Among the 1011 sera, 17 showed discrepant results between the three assays. Six were positive and three negative for RIBA. HCV RNA was not detected from all discrepant cases. Sensitivity and specificity were 99.5% and 99.5% for the Vitros, and 100.0% and 99.9% for the Elecsys assay. Conclusions: Sensitivities and specificities of the anti-HCV assays were sufficiently high for use in clinical laboratories, but retesting of weak positive results may be necessary.

Original language	English
Pages (from-to)	175-177
Number of pages	3
Journal	Clinical Biochemistry
Volume	45
Issue number	1-2
DOIs	https://doi.org/10.1016/j.clinbiochem.2011.10.020
Publication status	Published - 2012 Jan

All Science Journal Classification (ASJC) codes

Clinical Biochemistry

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title = "Performance evaluation of the Vitros anti-hepatitis C virus antibody assay for use in clinical laboratories",

abstract = "Objectives: We evaluated the performance of Vitros anti-HCV assay. Design and methods: Precision performance was assessed for 20. days. A total of 1011 sera were tested for anti-HCV with Vitros and Elecsys assays. Specimens positive for any of the two assays were retested with Architect assay. Discrepant results were evaluated with recombinant immunoblot assay (RIBA) and HCV RNA quantification. Results: Total imprecision of Vitros assay was 11.6% and 3.3% CV for negative and positive QC. Among the 1011 sera, 17 showed discrepant results between the three assays. Six were positive and three negative for RIBA. HCV RNA was not detected from all discrepant cases. Sensitivity and specificity were 99.5% and 99.5% for the Vitros, and 100.0% and 99.9% for the Elecsys assay. Conclusions: Sensitivities and specificities of the anti-HCV assays were sufficiently high for use in clinical laboratories, but retesting of weak positive results may be necessary.",

author = "Yongjung Park and Yoonmi Seok and Jonghyeon Choi and Kim, {Hyon Suk}",

year = "2012",

month = jan,

doi = "10.1016/j.clinbiochem.2011.10.020",

language = "English",

volume = "45",

pages = "175--177",

journal = "Clinical Biochemistry",

issn = "0009-9120",

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AU - Park, Yongjung

AU - Seok, Yoonmi

AU - Choi, Jonghyeon

AU - Kim, Hyon Suk

PY - 2012/1

Y1 - 2012/1

N2 - Objectives: We evaluated the performance of Vitros anti-HCV assay. Design and methods: Precision performance was assessed for 20. days. A total of 1011 sera were tested for anti-HCV with Vitros and Elecsys assays. Specimens positive for any of the two assays were retested with Architect assay. Discrepant results were evaluated with recombinant immunoblot assay (RIBA) and HCV RNA quantification. Results: Total imprecision of Vitros assay was 11.6% and 3.3% CV for negative and positive QC. Among the 1011 sera, 17 showed discrepant results between the three assays. Six were positive and three negative for RIBA. HCV RNA was not detected from all discrepant cases. Sensitivity and specificity were 99.5% and 99.5% for the Vitros, and 100.0% and 99.9% for the Elecsys assay. Conclusions: Sensitivities and specificities of the anti-HCV assays were sufficiently high for use in clinical laboratories, but retesting of weak positive results may be necessary.

AB - Objectives: We evaluated the performance of Vitros anti-HCV assay. Design and methods: Precision performance was assessed for 20. days. A total of 1011 sera were tested for anti-HCV with Vitros and Elecsys assays. Specimens positive for any of the two assays were retested with Architect assay. Discrepant results were evaluated with recombinant immunoblot assay (RIBA) and HCV RNA quantification. Results: Total imprecision of Vitros assay was 11.6% and 3.3% CV for negative and positive QC. Among the 1011 sera, 17 showed discrepant results between the three assays. Six were positive and three negative for RIBA. HCV RNA was not detected from all discrepant cases. Sensitivity and specificity were 99.5% and 99.5% for the Vitros, and 100.0% and 99.9% for the Elecsys assay. Conclusions: Sensitivities and specificities of the anti-HCV assays were sufficiently high for use in clinical laboratories, but retesting of weak positive results may be necessary.

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