RESUMEN
Objective@#To establish a set of rules for autoverification of blood analysis, in order to provide a way to validate autoverification rules for different analytical systems, which can ensure the accuracy of test results as well as shorten turnaround time (TAT) of test reports.@*Methods@#A total of 34 629 EDTA-K2 anticoagulated blood samples were collected from multicenter cooperative units including the First Hospital of Jinlin University during January 2017 to November 2017. These samples included: 3 478 cases in Autoverification Establishment Group, including 288 cases for Delta check rules; 5 362 cases in Autoverification Validation Group, including 2 494 cases for Delta check; 25 789 cases in Clinical Application Trial Group. All these samples were analyzed for blood routine tests using Sysmex XN series automatic blood analyzers.Blood smears, staining and microscopic examination were done for each sample; then the clinical information, instrument parameters, test results and microscopic results were summarized; screening and determination of autoverification conditions including parameters and cutoff values were done using statistical analysis. The autoverification rules were input into Sysmex Laboman software and undergone stage Ⅰ validation using simulated data, and stage Ⅱ validation for post-analytical samples successively. True negative, false negative, true positive, false positive, autoverification pass rate and passing accuracy were calculated. Autoverification rules were applied to autoverification blood routine results and missed detection rates were validated, and also data of autoverification pass rate and TAT were obtained.@*Results@#(1)The selected autoverification conditions and cutoff values included 43 rules involving WBC, RBC, PLT, Delta check and abnormal characteristics. (2)Validation of 3 190 cases in Autoverification Establishment Group showed the false negative rate was 1.94%(62/3 190)(P<0.001), autoverification pass rate was 76.74%, passing accuracy was 97.47%; Validation of 2 868 cases in Autoverification Validation Group, the false negative rate was 3.38%(97/2 868)(P=0.002), autoverification pass rate was 42.26%, passing accuracy was 92.00%; Validation of Delta check on 288 cases in Autoverification Establishment Group and 2 494 cases in Autoverification Validation Group showed the false negative rates were respectively 1.39% and 2.61%(P<0.001). (3)Three hospitals adopted these rules of autoverification for 25 789 blood routine samples, and found that the average TAT of blood routine test reports were shortened by 24min, 32min and 7min respectively, the rate of samples reported within 30min were elevated by 33%, 53% and 7%. The autoverification pass rates were 72%-74%.@*Conclusions@#The application of this set of 43 autoverification rules in blood sample analysis can ensure test quality while shortenTAT and improve work efficiency. It is worth pointing out that for the same analytical systems in this research, validation is necessary before application of this set of rules, and periodic validation is required during application to make necessary adjustment; for different analytical systems, as this research provide a way to establish autoverification rules for blood routine tests.Clinical labs may establish their own suitable autoverification rules on the basis of technological parameters. (Chin J Lab Med, 2018, 41: 601-607)
RESUMEN
Objective To build anautoverification system for hematology analysis system and validate the system based on commercialized labXpert software.Methods Preliminary validation rules was established base on 41 Items of International Consensus Review Rules and instructions for Mindray CAL8000 auto hematology analyzer,and input the rules into labX pert sample validation system.999 clinical samples were collected from Beijing Hospital Ministry of Health to test the preliminary rules and parameters including false positive rate,false negative rate and autoverification pass rate were calculated,based on which to adjust and customize the original protocol.Then 15 934 samples were tested,respectively,for autoverification by calculating the autoverification pass rate,proportion of manual verification and microscopic verification.Autoverification were compared as well as the turnover time (TAT,timefrom receipt of sample to report of result) before and after application of autoverification system.Results Preliminary verification results showed that false negative rates in both hospitals were less than 2％,and the false negative mainly caused by low promyelocytic cells value (blasts and promyelocytes less than 3 ％),abnormal erythrocyte morphology,and abnormal platelet morphology.No sample with excess blasts or percentage of blasts and promyelocytes higher 3％ with tested with false negative result,indicating relatively low clinical risks.Both hospitals reported with relatively high false positive rates,up to nearly 18％,using preliminary programs,which may affect the autoverification rate of the system.Based on the analyzing result of false positive results,the program was adjusted to significantly reduce the false positive rate while remaining the false negative rate low,therefore resulted with 4 remarkable increase of autoverification pass rate.Over 10,000 samples were tested with improved program,and the autoverification pass rates for hospital was 78.4 ％,respectively.Primary reason causing failure of autoverification included increased IMG％,flag for immature cells and WBC exceeding set limit.Application of system reduced the TAT by 5 min (P＜0.05).Conclusion Autoverificationsystem using Mindray CAL8000 auto hematology analyzer andlabXpert has been confirmed effective in reducing TAT and enhancing working efficiency while remaining low false negative rate.The autoverification pass rate tested 75％,which suggested that laboratory workers can spare more time on reexamination of abnormal samples for better blood routine report.