RESUMEN
Objective:To evaluate the performance of an artificial intelligent (AI)-based automated digital cell morphology analyzer (hereinafter referred as AI morphology analyzer) in detecting peripheral white blood cells (WBCs).Methods:A multi-center study. 1. A total of 3010 venous blood samples were collected from 11 tertiary hospitals nationwide, and 14 types of WBCs were analyzed with the AI morphology analyzers. The pre-classification results were compared with the post-classification results reviewed by senior morphological experts in evaluate the accuracy, sensitivity, specificity, and agreement of the AI morphology analyzers on the WBC pre-classification. 2. 400 blood samples (no less than 50% of the samples with abnormal WBCs after pre-classification and manual review) were selected from 3 010 samples, and the morphologists conducted manual microscopic examinations to differentiate different types of WBCs. The correlation between the post-classification and the manual microscopic examination results was analyzed. 3. Blood samples of patients diagnosed with lymphoma, acute lymphoblastic leukemia, acute myeloid leukemia, myelodysplastic syndrome, or myeloproliferative neoplasms were selected from the 3 010 blood samples. The performance of the AI morphology analyzers in these five hematological malignancies was evaluated by comparing the pre-classification and post-classification results. Cohen′s kappa test was used to analyze the consistency of WBC pre-classification and expert audit results, and Passing-Bablock regression analysis was used for comparison test, and accuracy, sensitivity, specificity, and agreement were calculated according to the formula.Results:1. AI morphology analyzers can pre-classify 14 types of WBCs and nucleated red blood cells. Compared with the post-classification results reviewed by senior morphological experts, the pre-classification accuracy of total WBCs reached 97.97%, of which the pre-classification accuracies of normal WBCs and abnormal WBCs were more than 96% and 87%, respectively. 2. The post-classification results reviewed by senior morphological experts correlated well with the manual differential results for all types of WBCs and nucleated red blood cells (neutrophils, lymphocytes, monocytes, eosinophils, basophils, immature granulocytes, blast cells, nucleated erythrocytes and malignant cells r>0.90 respectively, reactive lymphocytes r=0.85). With reference, the positive smear of abnormal cell types defined by The International Consensus Group for Hematology, the AI morphology analyzer has the similar screening ability for abnormal WBC samples as the manual microscopic examination. 3. For the blood samples with malignant hematologic diseases, the AI morphology analyzers showed accuracies higher than 84% on blast cells pre-classification, and the sensitivities were higher than 94%. In acute myeloid leukemia, the sensitivity of abnormal promyelocytes pre-classification exceeded 95%. Conclusion:The AI morphology analyzer showed high pre-classification accuracies and sensitivities on all types of leukocytes in peripheral blood when comparing with the post-classification results reviewed by experts. The post-classification results also showed a good correlation with the manual differential results. The AI morphology analyzer provides an efficient adjunctive white blood cell detection method for screening malignant hematological diseases.
RESUMEN
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.
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 evaluate the influence of hematocrit(HCT),vitamin C(Vc)and galactose on three portable blood glucose meters to provide some reference for clinical selection of appropriate blood glucose me-ter.Methods 20 heparin anticoagulant venous blood samples in the clinical laboratory department of Nanfang Hospital were selected for verifying the accuracy of blood glucose meter.2 healthy volunteers were selected for collecting 5 w hole blood samples in interferent test.Referring to the detection results of Roche automatic bio-chemical analyzer,the Nova StatStrip Xpress glucometer,Bayer Contour Plus glucometer and Roche Accu-chek Performa blood glucose meter were performed the accuracy verification.The influence of HCT,Vc and galac-tose on the detection results of above three portable blood glucose meters were evaluated.Results The detec-tion accuracy of Nova StatStrip Xpress and the Roche Accu-Chek glucometers all conformed to the require-ments of ISO15197:2013 standards.The detection accuracy of Bayer Contour Plus glucometer only conformed to the requirements of ISO15197:2003 standards.Under the interference of different levels of HCT,Vc and galactose,the detection results of Nova StatStrip Xpress glucometer conformed to the requirements of ISO15197:2013 standards;w hen detecting low concentration of blood glucose,the Bayer Contour Plus glucom-eter was interfered by 10 mg/dL Vc,and other detection results conformed to the requirements of ISO15197:2003 standards;the anti-interference performance of Roche Accu-chek Performa glucometer conformed to the
RESUMEN
Objective To investigate and analysis the clinical effect of pramipexole in Parkinson's disease with depression.Methods The patients with Parkinson disease patients with depression were selected in a total of 100 as the research object,and were randomly divided into two groups,the observation group and the control group with 50 cases in each group.The control group was taken conventional treatment,the observation group was given pramipexole based on the conventional treatment methods,the the effects of treatment were observed and compared. Results The MIHD score of the observation group after treated for 12 month (8.26 ±1.96)was lower than the score before treatment (24.91 ±4.6),and the score of the control group after treated for 12 month (11.15 ±2.10)was also lower than the score before treatment (24.48 ±5.34),the difference were all statistically significant(P<0.05). After treated for 12 month,the score in the observation group was lower than that in the control group,and the total effective rate in the two group were 94% and 80% respectively(P<0.05 ).The UPDRS score of the observation group was lower than in the control group,but the difference was not significant(χ2 =14.756,P<0.05).Conclusion Give pramipexole has notable curative effect on the depression disease in patients with Parkinson disease on the basis of conventional therapy method,and has the value of popularization.
RESUMEN
Objective To improve the reliability and accuracy of WBC counting in cerebrospinal fluid (CSF) ,this article is stud-ying the improved method of WBC counting in CSF by finding out the optimum percentage of CSF specimen with the most suitable concentration of acetic acid .Methods CSF specimen was mixed with different acetic acid at different ratio respectively .WBC counts were performed in 5 minutes on diluted samples of various concentrations .A series of 20 CSF specimens were analyzed via the proposed assay and conventional method .The average value and coefficient of variation (CV) of WBC count of each sample were c compared and analyzed .Results The optimum percentage of CSF sample was obtained at 60∶40 ratio .In this percentage , the maximal WBC count (189/μL) was obtained compared that of conventional method (161/μL) .Moreover ,the CV of the WBC counts in this percentage (7% ) was also lower than that of the conventional method (18% ) .Conclusion The reliability and accur-ancy of WBC counting in CSF was the optimum percentage of CSF specimen and 5% acetic acid was 60 :40 .It may lead to a more reliable ,accurate and standard way of WBC counts in CSF .