RÉSUMÉ
【Objective】 To evaluate the effectiveness of random quality control sampling in blood sample detetion by ELISA. 【Methods】 Blood samples of 5 mL specification of blood donors from our blood station from May to July 2022 were selected for routine operation on a fully automated sampler. J standard substances(3 mL specification) as daily samples were added to A1 well, H12 well and random wells of HBsAg, anti-HCV, anti-HIV, and -TP, and then placed in a fully automated enzyme immunoassay analyzer for testing. With random well quality control as the internal quality control judgment standard, 20 consecutive tests were conducted and were divided into A1 (well) group, H12 (well) group and random (well) group according to different well positions. Quality control maps were drawn using Levey-Jennings quality control chart with random group as the framework, and were compared with the quality control map of A1 well and H12 well results in the same day. 【Results】 The mean quality control levels of infectious indicators of blood transfusion in blood donors by ELISA were: HBsAg 3.87±0.28, anti-HCV 3.79±0.38, anti-HIV 3.64±0.30 and anti-TP 4.53±0.51. 【Comparison】 of HBsAg, anti-HCV, anti-HIV and anti-TP, between random group, A1 group and H12 group were HBsAg 3.87± 0.28 vs 4.09±0.30 vs 3.64±0.26, anti-HCV 3.78±0.37 vs 3.96±0.38 vs 3.63±0.38, anti-HIV 3.63±0.31 vs 3.82±0.32 vs 3.48±0.28 and anti-TP 4.51±0.51 vs 4.71±0.52 vs 4.36±0.51, The S/CO value of each indicator were H12 group<random group<Al group (P<0.05), and the mean quality control levels of random group were similar to each detection indicator (P>0.05) . Using random group as the quality control framework standard, 5 points in group A1 fell outside of +2s, and 1 point in group H12 fell outside of -2s, resulting in a total of 6 alarms. With the quality control substance placed in A1 well of the ELISA plate, the judgment of detection results of the entire ELISA plate could be inevitably affected, especially the last row of low concentration virus marker samples on the ELISA plate. 【Conclusion】 The application of random quality control sampling method in donor blood by ELISA is scientific and reasonable, which can reduce the systematic error caused by artificial setting of ELISA plate fixed well positions and can also discover edge effects that affect the detection results.
RÉSUMÉ
The most new ultrasensitive chemiluminescent photographic detectiondot-ELISA (CPD-Dot-ELISA) technique was developed by combining the chemiluminescence technique with Dot-ELISA. The sensitivity of testing for pure HBsAg by CPD-Dot-ELISA was 30 and 60 times higher than by general Dot-ELISA and plate ELISA, respectively. 243 clinical serum specimens had been tested for HBsAg by both plate ELISA and CPD-Dot-ELISA, indicating that of 243 specimens tested for HBsAg by the former, 149 were positive, while of 243 specimens tested for HBsAg by the latter, 194 were positive. Of 149 positive specimmens tested by the former, only Ⅰ wasn't detected by the latter. 14 specimens randomly sampled from the additional 45 positive serum specimens detected by the latter, and 2 serum specimens which proved to be positive by both methods, had then been subject to neutralized test for HBIG, indicating that all 16 mentioned above specimens were positive. The results showed that the CPD-Dot-ELISA technique not only had its high sensitivity, good specificity and repro-ducibility, but also it was simple in manipulation, economically practical and worthy to be widely spread.