HBsAg high S/CO negative samples : A comparative analysis between nucleic acid minipool test and individual test
10.13303/j.cjbt.issn.1004-549x.2021.05.022
- VernacularTitle:30例献血者ELISA检测HBsAg高S/CO值阴性标本在血液核酸混检与单检中的结果分析
- Author:
Shaobin CHEN
1
;
Qingkai CHEN
1
;
Ziyi HE
1
;
Lin YU
1
;
Qing WANG
1
Author Information
1. Dongguan Blood Center, Dongguan 523000, China
- Publication Type:Journal Article
- Keywords:
HBsAg;
negative samples with high S/CO value;
nucleic acid testing;
minipool detection;
individual detection;
blood donors
- From:
Chinese Journal of Blood Transfusion
2021;34(5):528-531
- CountryChina
- Language:Chinese
-
Abstract:
【Objective】 To compare the results by minipool and individual NAT on blood samples with HBsAg detection S/CO value between 0.25-0.90 by ELISA, in order to re-evaluate the safety of NAT for such negative samples with high HBsAg S/CO value and provide references for the optimization of detection process. 【Methods】 A total of 30 blood samples which were non-reactive for HBsAg by ELISA twice and with the S/CO value of any reagent between 0.25-0.90 (defined as " high S/CO value negative" ) from our center from February to October 2020 were collected, and minipool test of 6 samples and individual test were performed in parallel. 11 samples which were negative by minipool tests but positive by individual test were submitted to repeated NAT minipool tests, and the results of each test were recorded and analyzed. 【Results】 The median S/CO values of the 30 samples by two ELISA reagents were 0.565 and 0.320, respectively, and the differences were statistically significant (P<0.01). The NAT yield of primary minipool and individual NAT was 13.33% (4/30) and 76.67% (23/30), respectively, and the differences were statistically significant (P<0.05). Eleven samples, minipool NAT negative but individual NAT positive, were subjected to repeated minipool NAT. One remained negative throughout the 10 times of repeated minipool NAT test, and 10 (90.91%) presented positive results at least once. The repeated positive rate was 5.88% (1 /17) -70.00% (7/10). The Ct value of NAT ranged 34.4-38.5 (median 36.76) in the primary minipool test, 29.6-42.8 (median 36.50) in the individual test, and 36.1-56.0 (median 37.75) in repeated minipool test afterwards. The Ct value was significantly different between repeated minipool tests and individual tests (P<0.01), but not between repeated minipool tests and primary ones (P> 0.05). 【Conclusion】 The NAT-yield of samples with high ELISA HBsAg S/CO value was high in individual test and low in minipool test, and the NAT-yield in minipool test could be improved by repetitive test. Therefore, the safety of NAT for samples with high HBsAg S/CO value should be re-evaluated as minipool test is dominant in blood stations. Individual NAT test is recommended for such samples currently as there is no any other more sensitive detection approaches.
