ABSTRACT
BACKGROUND: To verify and evaluate the performance characteristics of an enzyme-linked immunosorbent assay (ELISA) assay kit (Hangzhou Cancer probe Biotech Company) for seven autoantibodies (7-AABS), including p53, GAGE7, PGP9.5, CAGE, MAGEA1, SOX2, and GBU4-5. METHODS: Evaluation was carried out according to "Guidelines for performance evaluation of in vitro diagnostic reagent". The performance parameters included detection limit, reportable range, precision, accuracy, and method comparison. RESULTS: The detection limit was less than 3.75 U/mL. Reportable range was from 3.75 U/mL to 60 U/mL. The coefficient of variations (CVs) of within-run of 7-AABS were 5.15% - 10.13%, and between-run of CVs were 3.41% - 8.80%. For accuracy verification, the relative deviations (Bias) were all lower than 15% in the indicated concentration range. The sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and ac-curacy were 35.9%, 90.0%, 80.3%, 55.3%, 61.3%, respectively. CONCLUSIONS: Overall, the verification study demonstrated the performance of the kit meets the testing requirements. It is qualified for clinical applications.
