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Objective To investigate the influencing factors on thrombin time (TT) assay to ensure the accuracy of the detection results.Methods Totally 3 out-and in-patients from January to July 2015 with normal results of prothrombin time (PT),activated partial clotting enzyme live time (APTT) and fibrinogen (FIB) were selected,whose detection results were not satisfactory.The specimen underwent re-centrifugation,and then Beckman ACL TOP700 automatic coagulation analyzer was used to detect four coagulation indexes.The detection results were compared with those before re-centrifugation,and the differences between the results were analyzed statically.Results The values of PT,APTT and FIB of the three patients before and after re-centrifugation were (10.8,11.5,9.7 s),(29.5,32.7,25.2 s),(2.49,3.12,2.85 g/L) and (10.9,11.3,10.0 s),(30.4,31.5,25.9 s),(2.31,3.28,2.67 g/L) respectively,and the differences between the results were not significant (with t ranging from 0.627 to 1.719 and P＞0.05).The values of TT of the three patients before and after re-centrifugation were (66.51,127.3,89.62 s) and (12.2,15.7,13.8 s) respectively,and there were obvious differences between the values (with t ranging from 51.743 to 79.167 and P＜0.001).Conclusion Insufficient centrifugation has high influences on the detection result of TT except other coagulation indexes,and re-centrifugation is necessary for the accuracy of TT value to eliminate misdiagnosis.
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Objective To verify the performances and evaluate the reliability of ACL-TOP700 automatic coagulation analyzer. Methods The analyzer had its precision, accuracy, carryover, linear range, reference interval and etc analyzed and verified according to the requirements of Clinical and Laboratory Standards Institute (CLSI) for PT, APTT, FIB, TT, DDHS, FDP and etc. Results The within-and between-array precision was both lower than 5%, which met the requirements of medical laboratory ISO 15189 requirements;the accuracy satisfied the requirements of external quality assessment by Beijing Center for Clinical Laboratory; linear analysis found high linearity (r≥0.975 or r2>0.95) in FIB, DDHS; the carryovers of FIB and DDHS were-0.34%and-0.10%respectively;more than 90%test results were restrained in the reference interval according to normal distribution principle. Conclusion ACL-TOP700 automatic coagulation analyzer has high performances and reliable results, and thus is worthy promoting clinically.
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Objective To verify the analytical performance of fibrin/fibrinogen degradation products(FDP) detection on STAGO STA‐R automatic coagulation analyzer by using the FDP kits made in Sekisui Medical CO .,LTD .Methods In this study ,the vali‐dations of FDP′s precision ,detection limit ,linear range ,accuracy ,the clinical allowable range and reference range were according to a series of files of American clinical laboratory standardization institute(CLSI) and other relevant experimental documents and com‐pared with its quality performance which showed in kit introductions .Results Precision :The within‐run coefficients of variations (CV)were less than 5 .0% ,between‐run coefficients of variations were less than 10 .0% .The detection limit of FDP was 0 .44 mg/L .It was less than that in the kit introductions ,the detection 1imit meets the requirement .The linear equation of FDP was Y=1 .003X+0 .675 ,r2 =0 .995 ,its 1inear range was 0 .44-150 .00 mg/L .Interference test :there was no obvious interference observed when the concentration of total bilirubin <220 μmol/L ,hemoglobin<4 .0 g/L and triglyceride<7 .5 mmol/L in the sample .The relative deviation was <10% .Reference range:the measured results of FDP in 20 normal individuals were a11 in the reference in‐terval of producers .Conclusion The main performance index of FDP kits made in Sekisui Medical CO ,LTD is comply with the re‐quirements on STAGO STA‐R automatic coagulation analyzer .
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Objective To establish normal reference interval for four items of blood coagulation on ACL‐TOP Automatic coagu‐lation analyzer .Methods The fasting anti‐coagulation blood samples were collected from 1 268 inpatients and people conducted physical examination ,all subjects without liver disease ,history of blood disease and coagulation disfunction .The prothrombin time (PT) ,activated partical prothrombin time(APTT) ,thrombin time(TT) and serum levels of fibrinogen(FIB) were determined by u‐sing ACL‐TOP automatic coagulation analyzer which was producted by America IL company .And data of determination results were used to establish the normal reference intervals of indexes in this laboratory .Results The precision and accuracy of this analy‐zer was good .There were differences of normal reference intervals between which established in this laboratory and which provided by the manufacturer .Conclusion Each laboratory should establish its own normal reference interval ,not blindly refer to reference interval provided by regents manual .
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Objective To evaluate the relationship and bias of the Stago-CT and CA1500 automatic coagulation analyzer.Meth-ods The relationship and bias of PT,APTT,INR,FIB,TT,DD examined by the Stago-CT and CA1500 automatic coagulation ana-lyzer by using NCCLS EP9-A2.Results For the six items(PT,APTT,INR,FIB,TT,DD)the r2 were 0.996 9,0.969 1,0.967 7, 0.955 8,0.972 6,0.949 6,respectively,and the bias were 2.9,0.88,5.22,1.16,3.48,20.3.Conclusion The five items (PT, APTT,INR,FIB,TT)at a good relationship(r2 >0.95)by the Stago-CT and CA1500 automatic coagulation analyzer except for the DD(r2 =0.949 6);The bias of the five items(PT,APTT,INR,FIB,TT)were within in the United States of demanding that a third of the clinical laboratory of CLIA 88′bias,except for the DD.
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Objective To analyze the parametric errors during the use of Sysmex CA-1500 automated coagulation analyzer and their treatment measures .Methods Blood samples with test results showing “*”and without figure results were collected .Sysmex CA-1500 automated coagulation analyzer was employed to retest prothrombin time (PT ) ,activated partial thromboplastin time (APTT) and fibrinogen(FIB) .Results FIB ,PT and APTT were found abnormal in 226 cases(95 .77% ) ,5 cases(2 .12% ) and 5 cases(2 .12% ) ,respectively ,with FIB the mainly .ERR008 ,ERR004 ,ERR016 ,ERR002 ,ERR032 and ERR100 were found abnormal in 227 cases(76 .95% ) ,64 cases(21 .69% ) ,one case(0 .34% ) ,one case(0 .34% ) ,one case(0 .34% ) and one case(0 .34% ) ,respec-tively ,with ERR008 the mainly .Difference of no-error results between the initial and repeat test of PT and APTT showed no statis-tical significance(P>0 .05) ,while those of FIB demonstrated statistical significance (P<0 .01) .Conclusion Samples with paramet-ric errors during the use of Sysmex CA-1500 automated coagulation analyzer should be retested to promote the quality of blood co-agulation detection .
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Sysmex CA-1500 is used for in vitro diagnostic fully automatic blood coagulation analyzer, can rapid precision analysis batch sample. It is the use of condensation, yield color and immunoassay methods to detect and analyze data, and the result can be saved, display and print. This article mainly introduces Sysmex CA-1500 Full-Automatic Coagulation Analyzer analysis and fault field analysis and in the use process, share met fault point inspection analysis, for their peers to provide a platform.
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BACKGROUND: Newly developed ACL9000 automatic coagulation analyzer was evaluated in measurement of prothrombin time(PT), activated partial thromboplastin time(aPTT) and fibrinogen. METHODS: We studied precision including withtin-run and between-day precision. Normal reference ranges for PT, aPTT and fibrinogen were obtained in 60 healthy normal controls. The heparin sensitivity for aPTT and heparin interference for PT and fibrinogen were also determined. Lastly ACL9000 was compared with another coagulation analyzer, MLA Electra 1600. RESULTS: Precision of PT, aPTT and fibrinogen were acceptable, mostly. The normal reference ranges were as followings: 10.7-12.4 sec for PT, 28.7-40.8 sec for aPTT and 165-468 mg/dL for fibrinogen. The ranges of aPTT were from 49.8 sec to 84.7 sec in therapeutic heparin concentration(0.2-0.4 IU/mL) and heparin interfered determination of PT and fibrinogen in high concentrations. The comparability between ACL9000 and MLA Electra 1600 was good in determinations of PT and fibrinogen but not in determination of aPTT. CONCLUSIONS: We concluded that the performance of ACL9000 was acceptable and ACL9000 would be a useful analyzer for routine coagulation tests.