Application of serum plate in the grey area setting of HBsAg ELISA
Journal Title: Chinese Journal of Blood Transfusion - Year 2022, Vol 35, Issue 11
Abstract
Objective To evaluate the necessity and rationality of setting 0.7 CO of the gray area of HBV surface antigen reagent (ELISA) in our laboratory, and to provide the basis for the grey area setting. Methods A total of 60 samples of serum plate were repeatability tested by two kinds of ELISA HBsAg reagents. Based on the test results, C50, C5, C95 concentrations and corresponding S / CO values were calculated, and whether C5 and C95 were within C50±20% was verified. At the same time, the true positive rate and the confirmed positive rate of gray area samples revealed by two reagents were calculated. Results The confirmation results of serum plate were as follows: The C50, C5 and C95 concentrations of reagent A were 0.090 IU/mL, 0.075 IU/mL, 0.105 IU/mL. The true positive rate was 99.1%(436/440), the confirmed positive rate of grey area was37.8%(136/360). The C50, C5 and C95 concentrations of reagent B were 0.112 IU/mL, 0.091 IU/mL, and 0.133 IU/mL; the true positive detection rate was 97.1%(233/240); the confirmed positive rate of grey area was 35.8%(129/360). It was verified that C5 and C95 of reagent A and reagent B were within their respective C50±20%, and the gray areas of the HBsAg ELISA were verified to be effective. Conclusion It is necessary to set the gray area for these two HBsAg ELISA reagents in our laboratory, but the gray area value setting to 0.7 CO is unreasonable. The best gray area value was 0.75 CO in reagent A and 0.63 CO in reagent B.
Authors and Affiliations
Dan SHENG, Kecheng WANG
Keywords
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- EP ID EP738415
- DOI 10.13303/j.cjbt.issn.1004-549x.2022.11.020
- Views 49
- Downloads 0
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