Establishing and Verifing Detection Limit for the Eight Items before Blood Transfusion with Enzyme-Linked Immunosorbent Assay by the WS/T 514-2017 Industry Standard Documents / 现代检验医学杂志

ABSTRACT

Objective To evaluate the limit of detection of eight enzyme-linked immunosorbent assay (ELISA) according to hospital grade assessment and ISO151892012.Methods According to the new health industry standard WS/T 514-2017"Establishment and verification of detection capability for clinical laboratory measurement procedures",the limit of detection (LoD) was established,in the sameset of detection system,using two reagent lot,each lot for 5 consecutive days 4 consecutive days to assess the value of the concentration of five specimens were detected repeatedly,calculated the corresponding hit rate,then transform into probability units,and the corresponding concentration value production regression model,the hit rate of 95 ％ corresponds to the probability unit 1.645 substituted into the equation,the resulting concentration value was LoD estimates.The detection limit values were tested for 3 consecutive days of detection of two LoD concentrations near the declared concentration of the sample (diluted by the standard material) was detected 4 times repeatedly to calculate the positive result was greater than or equal to the percentage of LoD statement,greater than or equal to the critical value of 87％,then verified success.Results HBsAg0.100 IU/ml,HBsAb9.642 mIU/ml,HBeAg0.666 NCU/ml,HBeAb3.700 NCU/ml,HBcAb0.786 IU /ml,HCV0.506 NCU/ml,TP2.236 mIU/ml and HIV0.135 NCU/ml.The detection limit estimates were passed.Conclusion The verification limit of the verification project in the testing method and detection system of the laboratory meet the requirements Objective.