RESUMO
【Objective】 To investigate the related viral markers of HBV DNA reactive samples among voluntary blood donors in Shiyan area, so as to provide some reference for donor re-entry. 【Methods】 From August 2019 to June 2021, 78 samples with HBV DNA reactivity from voluntary blood donors in our blood station were collected, and they were further detected for HBV viral markers(using chemiluminescence assays), nucleic acid testing(NAT) of virus quantification and sequencing analysis. 【Results】 Forty-seven (60.3%)out of 78 HBV DNA reactive samples were from repeated blood donors, and 56.4%(44/78)of them were over 45 years old. Among the five viral markers of hepatitis B, 37.2%(29/78) were positive for anti-HBs alone, 19.2%(15/78) were positive for anti-HBe+ anti-HBc and anti-HBs+ anti-HBe+ anti-HBc, and 11.5% (9/78) were all items negative.A total of 62.8%(49/78) of samples were detected by NAT quantification and seven samples had been successfully sequenced for HBV. 【Conclusion】 NAT can effectively minimize the missed detection of HBsAg methodology and reduce the risk of HBV transmission through blood. The re-entry of HBV DNA reactive blood donors should be treated with care.
RESUMO
Objective To confirm the performance of rate method for detecting ALT in blood donors to verify that it meets the requirements of ISO15189 .Methods according to the requirements of CNSA‐CL02 :2012 the Medical Laboratory Quality and Abili‐ty Recognized Standards and the Blood Station Technical Operation Regulations(edition 2012) ,the precision ,accuracy ,sensitivity , reportable range ,biology reference interval and measurement uncertainty of the detection system were verified .Results The intra‐batch imprecision for the ALT quality control serum and 2 concentrations of blood donor sample detected for 20 times and 20 d was<5 .0% and the inter‐batch imprecision was <6 .7% ;the correct estimates passed the external quality assessment results of the original Ministry of Public Health in 2014 and calibration results analysis .The relative bias was less than 1/2 of CLIA′88 permissi‐ble error;the regression equation of reportable range obtained by the linear regression was Y =0 .995 1X -5 .618 4 ,r=0 .999 7 (R2 =0 .999 4) ,the results within the detection range were correct ;the biological reference interval was 0 .0 -32 .7 U/L and the measurement uncertainty was (74 .90 ± 3 .32)U/L .Conclusion The performance indexes of ALT detection method conform to the expected requirements of ISO15189 .This method can be used as a blood screening test method in laboratory .