Evaluation of point-of-care testing for D-dimer in elderly patients / 中华急诊医学杂志

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.

Establishment of normal reference interval for four items of blood coagulation on ACL-TOP Automatic coagulation analyzer / 国际检验医学杂志

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 .

Evaluation of an Automated Coagulation Analyzer Coapresta 2000

BACKGROUND: The Coapresta 2000 (Sekisui Medical CO., LTD, Japan) is a fully automated random-access multiparameter hemostasis coagulation analyzer, which is equipped with a photo-optical clot detection unit and a cap-piercing system. It is able to perform clotting time assays as well as colorimetric assays (synthetic substrate method and latex turbidimetric method). In this study, we evaluated the analytical performance of the Coapresta 2000 for coagulation test items and compared with that of the ACL-TOP (Instrumentation Laboratory, Lexingtion, MA, USA) analyzer, which is currently used for routine coagulation test items in our hospital. METHODS: The Coapresta 2000 was evaluated with respect to its technical characteristics in the determination of 8 routine coagulation test items: prothrombin time, activated partial thromboplastin time, fibrinogen, fibrin-degradation product (FDP) antithrombin III, D-dimer, factors VIII and IX. Analyse-it (Analyse-it Software Ltd, UK) and SigmaStat (Systat Software, Inc., USA) were used for statistical analysis between items on the Coapresta 2000 and the ACL-TOP analyzer. RESULTS: The intra-assay and inter-assay coefficients of variation (CV) were below 5% for both groups of samples having values within the reference interval and outside the reference interval. Significant interference was observed with hemolytic and icteric samples. Carryover was not detected. The results obtained by Coapresta 2000 were well correlated with those obtained by the ACL-TOP analyzer (r2 in the range from 0.781 to 0.969). CONCLUSIONS: We concluded that Coapresta 2000 analyzer was well correlated with ACL-TOP analyzer for the routine coagulation test items tested.

An Evaluation of the ACL TOP Automated Coagulometer for Determination of D-Dimer / 임상검사와정도관리

BACKGROUND: D-dimer is a specific marker of secondary fibrinolysis. D-dimer assay is widely used in the diagnosis of disseminated intravascular coagulation, deep vein thrombosis, pulmonary embolism, and arterial thromboembolism. Enzyme linked immunosorbent assays have been validated as the reference method for plasma D-dimer measurement, but it took long time. We evaluated the analytical performance of new automated coagulation system, ACL TOP, for quantification of D-dimer. METHODS: The total plasma D-dimer concentrations were measured by Nycocard and ACL TOP. To test the linearity, a serial dilution samples were prepared and measured. Between run precision of the ACL TOP D-dimer assay was evaluated with HemosIL D-Dimer controls for 20days. The correlation was evaluated using 75 plasma samples from patients. ACL TOP was evaluated according to CLSI guidelines. RESULTS: ACL TOP showed good linearity (r=0.9996) and between run coefficient of variation was within 4.0%. Coefficient of correlation between Nycocard and ACL TOP was 0.798. Positive concordance rate of ACL TOP was 67%, and negative concordance rate of ACL TOP was 80%. CONCLUSIONS: Since the ACL TOP showed a satisfactory precision, linearity, and comparative high correlation with Nycocard, and is more convenient and automatic than the Nycocard, it should be potentially beneficial in the clinical laboratories.