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Coagulometer, known as blood coagulation analyzer, is a product that can provide accurate test results for medical diagnosis and treatment analysis by detecting a series of items closely related to thrombosis and hemostasis in coagulation reaction. On the basis of previous traditional methods, and with our deep understanding about the principles of hemagglutination detection, we propose a hemagglutination detection method by using the dual-magnetic circuit beads method. Then, the corresponding hemagglutination detection module is designed. The coagulation time of plasma can be measured by detecting the movement of the magnetic beads when the magnetic field intensity is appropriate. The activated partial thromboplastin time(APTT) of plasma is tested when the most suitable magnetic field intensity is found. The results preliminarily show that this blood coagulation test method is valid and the corresponding test module has a potential value in business.
Subject(s)
Blood Coagulation , Blood Coagulation Tests , Magnetic Phenomena , Magnetics , Partial Thromboplastin TimeABSTRACT
Objective@#To investigate the consistency of plasma prothrombin time (PT) results detected by the STAGO STA-R Evolution and Mindray Precil C3510 automatic coagulation analyzers. @*Methods@#The PTs from 69 plasma samples were detected by the STA-R Evolution and Precil C3510 coagulation analyzers, respectively, and the obtained results were compared. Based on the CLSI EP9-A3 protocol, the ESD test was used to detect outliers, the scatter plot, difference plot, and frequency distribution plot were drawn, and the method comparison and bias evaluation were performed using the Passing-Bablok regression and Bland-Altman plot. @*Results@#The PTs (median \[P 25, P 75\]) detected by the STA-R Evolution and Precil C3510 analyzers were 19.00 (13.85, 25.65) s and 20.50 (13.83, 26.30) s, respectively, and there was no significant difference between them (P＞0.05). No outliers were detected by the ESD test, and the variation of PTs (CV) was constant. There were no systematic, random and proportional differences in PT results from two coagulation analyzers. The bias between two coagulation analyzers was within the acceptable range (1/2 CLIA′88 TEa). The predicted bias of PT at each medical decision point was also within the acceptable range. @*Conclusion@#The results of PT detected by the Precil C3510 and STA-R Evolution coagulation analyzers are comparable, and the bias is within the acceptable range, which can meet the needs of clinical diagnosis and treatment.
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<p><b>OBJECTIVE</b>To detect the anticoagulation and antiplatelet effects of different concentrations of puerarin, heparin sodium and tirofiban hydrochloride on the blood samples of healthy volunteers by Sonoclot coagulation and platelet function analyzer.</p><p><b>METHODS</b>Peripheral blood samples were extracted from 20 healthy volunteers, followed by adding different concentrations of puerarin, heparin sodium and tirofiban hydrochloride. Samples were detected for activated clotting time (ACT), clot rate (CR) and platelet function (PF) by Sonoclot coagulation and platelet function analyzer instrument.</p><p><b>RESULTS</b>For puerarin and heparin sodium, the values of ACT gradually increased, and the values of CR and PF gradually decreased with increasing in drug concentration. There was a linear (or log linear) relationship between ACT, CR, PF value and drug concentration (P<0.01). Corresponding to each value, a regression equation was obtained. For tirofiban hydrochloride, the values of ACT and CR had no significant changes, while PF values gradually decreased with concentration increasing. There was also a linear relationship between PF values and concentrations of tirofiban hydrochloride (P<0.01). Under the same ACT values, the puerarin corresponding CR values (CR = e, P<2.2e-16) were always higher than the corresponding values (CR = e, P-value<2.2e-16) of heparin sodium. For high concentrations of puerarin (e.g. 3.8 mg/600 μL) and tirofiban hydrochloride (e.g. 0.8 μg/600 μL), PF values had no significant difference. However, PF values for high puerarin concentration had a larger variance.</p><p><b>CONCLUSIONS</b>Puerarin has similar anticoagulant and antiplatelet effects with the heparin sodium, and may have a lower hemorrhage risk than heparin sodium when obtained the same anticoagulation effect in the concentration range of this experiment. In addition, for high concentration, puerarin had the same antiplatelet function as tirofiban hydrochloride but with a larger individual variability.</p>
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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 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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When the device is installed,it needs to be verified by some special tests to evaluate its performance and to determine whether the device is in accordance with the requirements of the relevant inspection specifications.The projects of the automated coagulation analyzer are particularity different from other tests,especially the biochemistry tests.So the clinical laboratory should establish and implement the matching performance validation protocol.This article refers to the CLSI related documents to summarize a feasible and applicable evaluation protocol,helping for evaluating automated coagulation analyzer.
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Objective To evaluate the clinical performance of AQT90 FLEX,a novel time-resolved fluorescence based point-of-care test (POCT) for quantification of D-dimer in elderly patients.Methods The method from Quantitative D-dimer assay (WS/T 477-2015) for testing equipment performance was used as a reference to evaluate the clinical performance of AQT90 FLEX.The correlation was compared between testing results of D-dimer using the AQT90 immune-assay analyzer and those using the ACL TOP coagulation analyzer.Results At high concentration of D-dimer,the within-run precision coefficient of variation (CV)was 2.619％,and at low concentration of D-dimer,the within-run precision CV was 2.767％.The pollution-carrying rate was 0.12％.The measured data from AQT90 and ACL TOP had a correlation coefficient of r =0.9491 (P ＜ 0.01).The equation of the line of best fit for D-dimer with which all AQT90 results can be adapted to the ACL TOP was:AQT90 =2.52 ACL TOP + 0.15.The number from the equation was slightly greater in female than that in male,and it was also increased in elderly.Conclusions The AQT90 FLEX had rational precision and linearity in determination of concentration.There was a high agreement between the testing results from AQT90 and those from ACL TOP.It was recommended to use a slope of 2.52 and an intercept of 0.15 to adjust the D-dimer values of the ACL TOP to the AQT90 FLEX assay systems.POCT for D-dimer by AQT90 FLEX raises feasibility for use in elderly patients.
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Objective: To investigate the detection ability of two reagents by automated coagulation analyzer ACL-TOP using immune turbidimetric method, and to determine the merits and demerits of them. Methods:Two reagents were compared in the study. We selected 532 cases of hospitalized patients in Anzhen Hospital, 388 cases of which were unstable angina, 60 cases were pulmonary thromboembolism, 70 cases were coronary atherosclerosis, 14 cases were abdominal aneurysm, and the rest were the patients with high blood pressure and coronary heart disease. The plasmas of all the patients were extracted, and D-dimer was detected on ACL-TOP by D-Dimer (referred to as reagent A) and D-DHS (referred to as reagent B). Results:The results of D-dimer increased in different degrees, and there are 88 cases of false positive cases. The case whose FDP and individual D-dimer of D-dimer simultaneous detection was elevating and clinical symptoms were disappeared was detected by the VIDAS instrument platform verification. There were significant differences between A and B. The detection result of reagent A was [1594.15±2286.18], and reagent B was [912.97±1814.06]. There were significant differences between them (t=3.654, P<0.05). In addition, the consistency of the two reagents was poor (r=0.419, P<0.05). Conclusion:Comparing two reagents to detect D-dimer quantitatively by automated coagulation analyzer ACL-TOP, D-DHS owns greater ability to exclude false-positive results, so does the ability of anti-interference with jaundice, hemolysis and chylemia.
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Objective To explore the procedures of 3Q validation for blood coagulation analyzer under the good laboratory prac‐tice(GLP) system based on the Sysmex CA7000 automatic blood coagulation analyzer .Methods Four test indicators of PT ,APTT , TT and FIB were chosen to conduct the performance verification in the within‐run precision ,between‐day precision ,accuracy ,linear‐ity ,carry‐over contamination rate of the automatic blood coagulation analyzer .They were prothrombin time(PT) ,activated partial thromboplastin time(APTT) ,thrombin time(TT) ,and fibrinogen(FIB) .Results The within‐run precision CV values of PT , APTT ,TT and FIB were 1 .33% ,1 .57% ,1 .47% and 1 .90% ,respectively ;the inter‐day precision CV values of PT ,APTT ,TT and FIB were 1 .73% ,1 .52% ,1 .55% and 2 .14% respectively ;in terms of accuracy ,the normal quality control CV values were 7 .45% ,3 .88% ,-4 .98% and 4 .36% respectively ;the abnormal quality control CV values of PT and APTT were 8 .11% and 8 .77% respectively ;the r value of FIB linear correlation coefficient was 0 .999 3 ,the a value was 1 .02 ;the highest CV value of car‐ry‐over contamination rate was 2 .15% ;the detected results all conformed to the general industry standards and requirements of in‐strument manufacturer .Conclusion The 3Q validation under the GLP system proves that the Sysmex CA7000 automatic blood co‐agulation analyzer is good in performance and is appropriate for the laboratory work of clinical laboratory department .
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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 evaluate the performance of ACL TOP coagulation analyzer system in the laboratory of children′s hospital. Methods According to the documents of CLSI, the analytic characteristics including precision, accuracy, linearity, interference and carryover rate were examined; specimens from healthy children were collected and assayed to determine the reference range of Prothrombin Time (PT), Activated Partial Thromboplastin Time (APTT), Thrombin Time (TT), Fibrinogen (FIB) and D-Dimer (D-D) from children on ACL TOP. Results The within-run and between-day coefficient of variability (CV) were within an acceptable range; The accuracy deviation of PT , APTT and FIB were less than 1/2 allowed total errors; The results of determination of FIB linearity test were correlated with the results of calculation: Y = 1.002 1X-0.122, R2 =0.998 2; The extent of influence of low to middle grade of jaundice , fat and hemolysis on each test were all less than 1/2 allowed total error; The carryover rates were lower than 1.81% and within an acceptable range; The reference range of PT, APTT, TT and FIB were PT (9.1-13.1 s), APTT (24.9-42.1 s), TT (12.6-21.1 s), FIB (1.924-4.011 g/L). Conclusion The ACL TOP coagulation analyzer has good repeatability, stability, linearity and capability of anti-interference and anti-carryover.
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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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Objective To comparatively analyze the results of the PT derivative method and the Clauss method for detecting fi-brinogen(Fib) by the automated coagulation analyzer and to explore their accuracy and clinical value .Methods Fib was detected in 156 blood samples selected from the patients in this hospital from March to May 2013 ,25 normal control samples and 13 positive samples of D-dimer (DD) by the TP derivative method and the Clauss method .Results The Clauss method and the PT derivative method by Sysmex CA-1500 coagulation analyzer had good repetitive rate in measuring Fib for 25 times ;when Fib0 .05);when Fib in the range of 4 .1 -5 .0 g/L ,the detection results had statistically significant difference (P5 .0 g/L ,the detection results had statistically significant difference (P<0 .05);in 13 DD positive samples ,the detection results of the PT derivative method were significantly higher than those of the Clauss method with statistically significant difference (t=8 .530 , P<0 .05) .Conclusion The difference exists between the PT derivative method and the Clauss method for detecting Fib ,but the ac-curacy of the Clauss method is higher than its specificity ,the Clauss method should be the first choice for the clinical determination of plasma Fib .
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Objective To adopt the method performance decision chart to evaluate the performance of the Stago R Evolution au-tomatic blood coagulation analyzer .Methods The method performance decision chart was drawn by the results of external quality assessment and internal quality control according to the requirement of the total error in the clinical laboratory improvement amend-ment (CLIA′88) .The 6 indexes of 3 items including prothrombin time(PT) ,activated partial thromboplastin time(APTT) and fi-brin (Fg) were analyzed .Results The 2 indexes of the PT normal level and APTT abnormal level in the automatic blood coagula-tion analyzer were qualified .The PT abnormal level was fine and 3 indexes of the APTT normal level ,Fg normal level and abnormal level were excellent .Conclusion Six indexes of automatic blood coagulation analyzer could be evaluated by the method evaluation decision chart and it was more directly and clearly compared with σvalue statistical table .
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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: Plasma interference is a problem for coagulation analyzers using a photo-optical detection method. Sysmex® CS-2100i is a fully-automated coagulation analyzer which has been developed to reduce this problem. Objective: To evaluate the influence of interferences on prothrombin time (PT), activated partial thromboplastin time (APTT), and fibrinogen analyzed by Sysmex® CS-2100i. The performance of this analyzer was also assessed in this study. Methods: Pooled plasma samples spiked with interfering substances including hemoglobin, bilirubin and lipid were used in the interference study. Real patients’ samples with these interferences were also tested. Control materials and pooled samples were used for precision, comparison, and carryover studies. Results: The PT, APTT, and fibrinogen could be analyzed in both plasma samples with interference added and real abnormal patients’ plasma samples. The deviation of PT, APTT, and fibrinogen levels was not obvious, except for an upward trend of fibrinogen level with increased hemoglobin. The highest %CV of PT, APTT, and fibrinogen were 1.24, 3.18, and 4.31, respectively for within-run and 2.32, 2.11, and 6.06, respectively for between-run precision analysis. The correlation coefficients of PT, APTT, and fibrinogen between Sysmex® CS-2100i and Sysmex® CA-1500 were 0.99, 0.99, and 0.98 with intra-class correlation coefficients of 0.99, 0.99, and 0.98 respectively. No significant carryover of specimen was observed. Conclusion: Sysmex® CS-2100i could analyze both samples with artificial interfering substance added and real abnormal patients’ samples. This machine also had an acceptable performance by our evaluation.
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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.