ABSTRACT
【Objective】 To analyze the effect of sample hemolysis on ELISA test results in blood screening laboratory, so as to determine the acceptable tolerance of hemolysis specific to laboratory test items and detection system, and provide reference for the formulation of tolerance standard of sample hemolysis. 【Methods】 Negative and weakly positive (S/CO was about 2) samples with different hemolysis degrees were tested by several commonly used domestic reagents for HBsAg, HIV Ag/Ab, anti-HCV and anti-TP, respectively. The effects of various degrees of hemolysis on the test results of negative and weakly positive samples for each item were analyzed. 【Results】 1) Hemolysis had no effect on the test results (reactive/non-reactive) of negative and weakly positive samples for HBsAg, anti-HCV and anti-TP ELISA items; 2) Hemolysis affected the test results (reactive/non-reactive) of negative and weakly positive samples for HIV Ag/Ab ELISA item. A tolerance of Hb 2 g/L was taken as the acceptable hemolysis degree for HIV Ag/Ab ELISA item. 【Conclusion】 In this study, the acceptable tolerance of hemolytic samples for corresponding test items and detection system in our laboratory were determined. The influence of hemolysis on ELISA test result is related to the reagent, equipment, environment and other factors, therefore the acceptable tolerance of hemolysis should be determined scientifically and reasonably based on the specific evaluation of each laboratory.