A multicenter study on the establishment and validation of autoverification rules for coagulation tests
10.3760/cma.j.cn114452-20200326-00305
- VernacularTitle:凝血检验结果自动审核规则建立与验证的多中心研究
- Author:
Linlin QU
1
;
Jun WU
;
Wei WU
;
Beili WANG
;
Xiangyi LIU
;
Hong JIANG
;
Xunbei HUANG
;
Dagan YANG
;
Yongzhe LI
;
Yandan DU
;
Wei GUO
;
Dehua SUN
;
Yuming WANG
;
Wei MA
;
Mingqing ZHU
;
Xian WANG
;
Hong SUI
;
Weiling SHOU
;
Qiang LI
;
Lin CHI
;
Shuang LI
;
Xiaolu LIU
;
Zhuo WANG
;
Jun CAO
;
Chunxi BAO
;
Yongquan XIA
;
Hui CAO
;
Beiying AN
;
Fuyu GUO
;
Houmei FENG
;
Yan YAN
;
Guangri HUANG
;
Wei XU
Author Information
1. 吉林大学第一医院检验科，长春 130021
- From:
Chinese Journal of Laboratory Medicine
2020;43(8):802-811
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To establish autoverification rules for coagulation tests in multicenter cooperative units, in order to reduce workload for manual review of suspected results and shorten turnaround time (TAT) of test reports, while ensure the accuracy of results.Methods:A total of 14 394 blood samples were collected from fourteen hospitals during December 2019 to March 2020. These samples included: Rules Establishment Group 11 230 cases, including 1 182 cases for Delta check rules; Rules Validation Group 3 164 cases, including 487cases for Delta check; Clinical Application Trial Group 77 269 cases. Samples were analyzed for coagulation tests using Sysmex CS series automatic coagulation analyzers, and the clinical information, instrument parameters, test results, clinical diagnosis, medication history of anticoagulant and other relative results such as HCT, TG, TBIL, DBIL were summarized; on the basis of historical data, the 2.5 and 97.5 percentile of all data arranged from low to high were initially accumulated; on the basis of clinical suggestions, critical values and specific drug use as well as relative guidelines, autoverification rules and limits were established.The rules were then input into middleware, in which Stage I/Stage II validation was done. Positive coincidence, negative coincidence, false negative, false positive, autoverification pass rate, passing accuracy (coincidence of autoverification and manual verification) were calculated. Autoverification rules underwent trial application in coagulation results reports.Results:(1) The autoverification algorisms involve 33 rules regarding PT/INR, APTT, FBG, D-dimer, FDP,Delta check, reaction curve and sample abnormalities; (2)Autoverification Establishment Group showed autoverification pass rate was 68.42% (7 684/11 230), the false negative rate was 0%(0/11230), coincidence of autoverification and manual verification was 98.51%(11 063/11 230), in which positive coincidence and negative coincidence were respectively 30.09% (3 379/11 230) and 68.42%(7 684/11 230); Autoverification Validation Group showed autoverification pass rate was 60.37%(1 910/3 164), the false negative rate was 0%(0/11 230), coincidence of autoverification and manual verification was 97.79%(3 094/3 164), in which positive coincidence and negative coincidence were respectively 37.42%(1 184/3 164) and 60.37%(1 910/3 164); (3) Trialed implementation of these autoverification rules on 77 269 coagulation samples showed that the average TAT shortened by 8.5 min-83.1 min.Conclusions:This study established 33 autoverification rules in coagulation tests. Validation showedthese rules could ensure test quality while shortening TAT and lighten manual workload.
