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.
ABSTRACT
Objective To investigate diagnostic value of GP73 in alcoholic disease .Methods GP73 was measured by ELISA in 44 alcoholic fatty liver ,43 alcoholic hepatitis ,32 alcoholic cirrhosis ,67 non‐alcoholic fatty liver patients and 120 healthy control per‐sons .Meanwhile ALT ,AST ,ALP ,GGT ,Alb ,TBil ,AFP were measured .Results GP73 of alcoholic fatty liver ,alcoholic hepatitis , alcoholic cirrhosis ,non‐alcoholic fatty liver patients and healthy control group were (84 .22 ± 26 .22) ,(157 .98 ± 39 .71) ,(201 .23 ± 61 .14) ,(62 ± 14 .02) ,(47 .08 ± 22 .75)ng/mL respectively .The GP73 differences between patients and healthy control group had statistical significance(P<0 .05) .Before and after therapy of alcoholic hepatitis and alcoholic cirrhosis patients had statistical signif‐icance(P<0 .05) .Sensitivity of diagnostic value of GP73 in ALD was 71 .4% and specification was 95 .2% .Conclusion Serum GP73 elevates in types of alcoholic liver disease and show significant diagnostic value .Decrease of GP73 could be applied to assess treatment of alcoholic hepatitis and alcoholic cirrhosis .