ABSTRACT
【Objective】 To analyze the influencing factors of the repeat reactive (RR) rates of minipools implicated in minipool (MP) nucleic acid testing(NAT) in Xiamen Blood Center, in order to provide reference for NAT. 【Methods】 Samples of blood donors from January 1, 2019 to October 31, 2022 were collected in Xiamen Blood Center and tested by MP-NAT(pools of six). Statistical analysis and comparison of MP-NAT RR rates was performed among different years, testers, reagent batches, instrument combinations, CT values of MP-NAT reactive pools and sample backgrounds. 【Results】 A total of 234 715 blood samples were tested by MP-NAT, and 428 pools were reactive, in which 248 pools were individual-donor NAT reactive, with a MP-NAT RR rate of 57.9%. The difference of MP-NAT RR rates were not statistically significant among different years, testers, reagent batches, instrument combinations, and sample backgrounds (P> 0.05). The difference of MP-NAT RR rates among different CT values of MP-NAT reactive pools was statistically significant (χ2=69.587, P<0.05). Significantly abnormal RR rate accurred in two months in 2022, and returned to normal after timely handling. 【Conclusion】 The MP-NAT RR rates is one of the important indicators to monitor the quality of NAT. Once there is a significant change in the MP-NAT RR rates, comprehensive analysis and timely handling should be carried out to ensure the quality of blood detection.
ABSTRACT
【Objective】 To study the screening and confirmatory test of human T-lymphotropic virus(HTLV) in blood donors. 【Methods】 Anti HTLV-1 / 2 screening was conducted on voluntary blood donors from 9 cities in Fujian province betweenJan. 12016toDec. 312018.Plasma samples ofanti-HTLV-1/2 reactive donors werecollected and sent to Xiamen Blood Center for confirmatory test. The influence of different screening reagents and confirmatory test methods on the test results were analyzed. 【Results】 A total of 741 anti-HTLV-1/2 reactivesamples were collected, among which 252 were positiveby Western Blot, 15undetermined, and 474negative, withthe overall positive rate at 34.0% (252/741). The yielding rate of domestic reagent A was significantly differentbyregions, withthe highest in Ningde(73.9%, 88/119) and the lowest in Zhangzhou(4.0%, 4/99). The confirmedpositive rates of anti-HTLV-1/2 screening reagent A(domestic) and B(imported)were 33.3%(13/39) and 57.1%(56/98), respectively, and the difference was statistically significant(P5, the reagent Ayielding rate was 76.5%(13/17), significantly lower than that of imported reagent Bas 100%(56/56) (P<0.01). A total of 652 anti-HTLV-1 / 2 reactive samples were confirmed by Western Blot and nucleic acid test in parallel, among which 638 results were concordant, 14 were not, with the overall concordance rate at 97.85%. 【Conclusion】 Comparable differences in the yielding rate of twoanti-HTLV screening reagents were observed.There was over allhighconcordance, but also complementarity, between Western Blot and nucleic acid test.