Quality index monitoring and application evaluation of nucleic acid pooling detection mode in blood stations
10.13303/j.cjbt.issn.1004-549x.2025.02.015
- VernacularTitle:血站核酸混检模式质量指标监测及应用评价
- Author:
Fei DONG
1
;
Yang LIU
1
;
Guoliang DONG
1
;
Weiwei ZHAI
1
;
Weimin LIU
1
;
Xuemei LI
1
Author Information
1. Weifang Blood Center, Weifang 261041, China
- Publication Type:Journal Article
- Keywords:
nucleic acid testing (NAT);
pooling NAT;
quality monitoring index;
self-comparison;
horizontal comparison
- From:
Chinese Journal of Blood Transfusion
2025;38(2):251-256
- CountryChina
- Language:Chinese
-
Abstract:
[Objective] To explore the influencing factors of quality monitoring index on the nucleic acid pooling detection mode and continuously improve the detection quality of nucleic acid laboratory. [Methods] The quality monitoring indicators (NAT reactive rate, NAT resolution reactive rate, NAT invalid batch rate, NAT invalid result rate, equipment failure rate) and causes of invalidity in our laboratory from January 1, 2020 to December 31, 2022 were retrospectively analyzed. The quality monitoring indicators of the laboratory during 2020 to 2022 were compared longitudinally. The quality monitoring indicators of the laboratory in 2022 were compared horizontally with the overall level in Shandong for the same period to find the differences. [Results] From 2020 to 2022, a total of 218 686 samples were detected, the NAT reactive rate was 0.15‰ (32 samples in total), the resolution reactive rate was 39.02%, the invalid batch rate was 1.06%, the invalid result rate was 1.18%, and the equipment failure rate was 3.58%. There were no differences in the NAT reactive rate, NAT resolution reactive rate and NAT invalid batch rate among different years (P>0.05), but there were differences in the invalid result rate (P<0.05). Equipment failure was the main cause of invalid results (56.53%). Compared with other laboratories in Shandong, there were differences in the NAT reactive rate and invalid result rate (P<0.05). There were differences in the reaction rate, resolution rate and invalid result rate among different reagents (P<0.05). Compared with other two laboratories using the same manufacturer's reagent, there were differences in the reactive rate and invalid result rate (P<0.05), but no difference in the resolution rate and invalid batch rate (P>0.05). [Conclusion] Establishing quality indexes for process control and regular analysis can timely detect potential risks in laboratory operation. The use of quality indicators to implement self-comparison and inter-laboratory comparison can help the laboratory systematically and scientifically evaluate its own operating status and formulate corresponding quality management strategies, thereby improving the laboratory's testing capacity and ensure the safety of blood use.
