ABSTRACT
【Objective】 To retrospectively analyze the key performance indicators of two hepatitis B surface antigen (HBsAg) ELISA reagents used in blood stations, so as to provide basis for reagent selection from the perspective of laboratory performance. 【Methods】 The test results, reactive rate of initial/repeat test, concordance rate of initial and repeat test, and the NAT-yield implicated in ELISA-reactive samples with one assay from 2016 to 2019 were analyzed to compare the detection performance of two ELISA reagents. 【Results】 The total ELISA reactive rate of HBsAg was 0.39%(1 863/480 741), with 0.31% and 0.29% in two reagents, respectively. The initial reactive rate were 0.44% and 0.39%, concordance rate of initial and repeat test was 70.21% and 74.55%, respectively. 43 NAT-yield samples were implicated in ELISA-reactive samples with one assay. 【Conclusion】 There are differences underlying in the detection performance of the two reagents. In order to avoid blood waste and ensure blood safety, the key performance indexes and test results should be taken into consideration when selecting reagents.
ABSTRACT
【Objective】 To explore the status of HBV infection and low viral load of HBV DNA in blood donor samples implicated in TMA triplex reactive but discriminatory test non-reactive samples. 【Methods】 A total of 51 996 samples were detected by Procleix Panther nucleic acid detection(NAT) system from January 2020 to March 2021, and 86 of them were TMA triplex reactive but discriminatory test non-reactive. HBV serological markers (HBsAg, anti-HBs, HBeAg, anti-HBe, anti-HBc) were detected by electrochemiluminescence. Single-donation(ID) NAT was conducted in some TMA triplex + /discriminatory test-samples using Roche NAT. 【Results】 Out of 86 TMA triplex + /discriminatory test-samples, anti-HBc were positive in 89.53% (77/86), anti-HBe positive in 27.90% (24/86) and anti-HBs positive in 65.12% (56/86). 15 donors carried anti-HBs, anti-HBe and anti-HBc, 34 both anti-HBs and anti-HBc, 1 both anti-HBs/anti-HBe, 8 both anti-HBe/anti-HBc, 6 solo anti-HBs, and 20 solo anti-HBc. The positive rate of HBV serological markers was 97.67% (84/86). HBV DNA in 5 out of the 10 samples was qualitatively detected by Roche ID NAT, and one of them presented HBV DNA < 20 IU/mL. 【Conclusion】 Most TMA triplex + /discriminatory test-samples were occult hepatitis B infection.
ABSTRACT
Objective To understand the HIV infection status and epidemic characteristics among blood donors in Hefei area to provide the basis for recruiting the blood donors and establishing the blood detection scheme.Methods Two kinds of serological re-agent were adopted for screening the blood donors.HRV RNA in the detection samples of the nucleic acid test system and positive serological samples were simultaneously sent to the municipal Center for Disease Control for conducting the confirmation detection from 2012.Results 495 279 blood donors were performed the serological screening,44 cases were confirmed HIV positive with the detection positive rate of 0.9;112 940 samples were performed the NAT detection,20 cases were confirmed HIV positive,all were the serological dual reagent positive samples.Conclusion The HIV infection among unpaid blood donors in Hefei area shows the increasing trend year by year.Effective measures must be taken to ensure the safety of blood.
ABSTRACT
Objective To discuss the role of nucleic acid test(NAT)in blood screening to provide the scientific basis for the se-lection of blood screening strategies.Methods The serological detection and NAT were simultaneously performed on 68 662 speci-mens of voluntary blood donation from January 2012 to April 2013;29 samples of HBV DNA positive with serological HBsAg nega-tive were performed the serum HBV markers detection.Partial samples of anti-HIV antibody positive were sent to CDC for conduc-ting the confirmation test.Results Among 68 662 samples,120 cases of single NAT positive were detected out,the residual risk of blood transfusion was 0.175%.In the serum HBV markers detection,the mode of HBcAb was predominant.11 cases of HIV posi-tive were confirmed and all were the NAT positive samples.Conclusion NAT can reduce the residual risk of blood transfusion,en-sure the safety of blood transfusion.NAT and the serological detection are mutual complementation and not replaced by each other. The suitable screening strategy shold be selected.