Establishment of a multi-rule quality control mechanism for blood nucleic acid screening results based on Poisson distribution
10.13303/j.cjbt.issn.1004-549x.2024.08.011
- VernacularTitle:核酸单反应性质量控制多规则的建立
- Author:
Junmou XIE
1
;
Lanyin LAN
;
Rongsong DU
;
Aiqiong HUANG
;
Xuying LIU
;
Fenfang LIAO
;
Hao WANG
Author Information
1. 广州血液中心 广州市医学重点实验室 血液安全重点实验室,广东 广州 510095
- Keywords:
Poisson distribution;
nucleic acid testing(NAT);
laboratory contamination
- From:
Chinese Journal of Blood Transfusion
2024;37(8):908-913
- CountryChina
- Language:Chinese
-
Abstract:
Objective To establish a quality control mechanism based on the Poisson distribution for monitoring con-tamination in nucleic acid testing(NAT)laboratories.Methods The study collected NAT single-reactivity rates and dis-criminatory test reactivity rates from the Grifols Panther NAT system from 2022 to 2023.The Poisson distribution probability method was used to calculate the daily probability of nucleic acid single reactivity.Sensitivity and specificity of the quality control model were further validated using single-reactivity rates,discriminatory reactivity rates and ROC curve analysis,fol-lowed by proposing corresponding multi-rule quality control strategies.Results Using P=0.05 as the threshold for out-of-control,the Poisson distribution probability quality control model identified 40 out-of-control points with P<0.05.After man-ual verification using discriminatory reactivity rates,20 out-of-control points were confirmed.The sensitivity of determining out-of-control was 60.0%,and the specificity was 95.6%.Due to the high number of out-of-control points,it is recommen-ded to combine discriminatory reactivity rates and employ multi-rule quality control methods for quality monitoring.Under the multi-rule quality control,there were 18 warning points and 2 out-of-control points for NAT single reactivity from 2022 to 2023.Conclusion The multi-rule NAT single-reactivity monitoring mechanism based on the Poisson distribution probability is more suitable for nucleic acid laboratories to monitor and warn of laboratory contamination,thereby enhancing the manage-ment capabilities and detection quality of nucleic acid laboratories.
