Original articles

Performance verification of a full automatic enzyme immunoassay analyzer for the detecting of HAV-IgM antibody

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  • 1. Department of Laboratory, Qingpu Hospital of Traditional Chinese Medicine, Shanghai 201799, China
    2. Department of Clinical Laboratory, Huashan Hospital Affiliated to Fudan University, Shanghai 200040, China

Received date: 2019-11-20

  Online published: 2020-02-25

Abstract

Objective: To verify and evaluate the performance of a full automatic enzyme immunoassay analyzer (Tecan) for the detecting of hepatitis A virus(HAV)-IgM. Methods: According to the EP5-A2 document of Clinical and Laboratory Standards Institute(CLSI)and related documents of China National Accreditation Service for Conformity Assessment-CL39(CNAL-CL39) in combination with the condition of our laboratory, the precision, detection limit, accuracy and cut off value of the full automatic enzyme immunoassay analyzer Tecan for the detecting of HAV-IgM were eva-luated.Results: The intra-and inter-batch coefficient of variation (CV) of Tecan for detecting HAV-IgM were 7.77% and 11.17%, respectively, and the coincidence rates of both positive and negative results were 100%. The detection limit was 1.0 NCU/mL, which met the requirement of laboratory and was close to the statement of manufacturer (2.0 NCU/mL). In the validation experiment for cut-off value, the light absorption value ($\bar{x}$+3SD)=0.032 was less than the value 0.105 provided by the kit. Conclusions: The precision, accuracy, detection limit and cutoff value of the automatic enzyme immunoassay analyzer Tecan for detecting HAV-IgM meet the requirements of manufacturer's standards and clinical needs.

Cite this article

WANG Fenglei, WU Xiaoyan, WANG Zhicheng . Performance verification of a full automatic enzyme immunoassay analyzer for the detecting of HAV-IgM antibody[J]. Journal of Diagnostics Concepts & Practice, 2020 , 19(1) : 84 -87 . DOI: 10.16150/j.1671-2870.2020.01.017

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