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.

Key words: Hepatitis A virus (HAV)-IgM, Full automatic enzyme immunoassay analyzer, Performance verification