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pISSN 2384-2458 eISSN 2288-7261
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Lab Med Qual Assur 2021; 43(1): 37-42

Published online March 31, 2021

https://doi.org/10.15263/jlmqa.2021.43.1.37

Copyright © Korean Association of External Quality Assessment Service.

Influence of Test Parameters on the Performance of Rapid Anti-Hepatitis C Virus Immunochromatographic Assay

Eun Jin Choi1 , Jae Han Kim1 , and Mi-Soon Han2

1Department of Laboratory Medicine, U2 Clinical Laboratories, Jangwon Medical Foundation, Seoul; 2Department of Laboratory Medicine, Seoul Clinical Laboratories, Yongin, Korea

Correspondence to:Mi-Soon Han
Department of Laboratory Medicine, Seoul Clinical Laboratories, Heungdeok IT Valley 25F, 13 Heungdeok 1-ro, Giheung-gu, Yongin 16954, Korea
Tel +82-2-330-2210
Fax +82-2-790-6509
E-mail misoon_han@scllab.co.kr

Received: July 30, 2020; Revised: October 23, 2020; Accepted: November 16, 2020

This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/3.0) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.

Abstract

Anti-hepatitis C virus (HCV) immunochromatographic assay (ICA) is commonly used as an early screening test for HCV infection. This study evaluated the influence of test parameters (technician, assay type, kit lot, temperature, and humidity) on the performance of anti-HCV ICA. The anti-HCV results were collected in 2016–2018 by two ICA assays (Humasis HCV card [Humasis Co. Ltd., Korea] and Asan Easy Test HCV [Asan Pharmaceutical, Korea]) (N=55,919). Anti-HCV ICA-positive samples (N=639) were retested using Architect anti-HCV (Abbott Laboratories, Germany). There were statistically significant differences in the retest signal to cutoff (S/CO) ratios of anti-HCV ICA-positive samples among the groups with different technicians and kit lots (P<0.05). The positive rates of anti-HCV ICA were statistically significantly different according to indoor humidity levels (P=0.0405). These findings suggest that there is a need for clinical laboratories to manage the performance of anti-HCV ICA with acceptable ranges of positive rates and utilize the S/CO ratio to evaluate the influence of test parameters.

Keywords: Hepatitis C virus, Hepatitis C antibodies, Immunochromatographic assay, Performance, Evaluation

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