A B S T R A C T S   N U M E R O   1 / 1999

Evaluation of the Sysmex CA-6000® coagulation analyzer

M. Barbarini*, A. Pacioni, P. Tramacere
*Servizio Universitario di Medicina di Laboratorio, Ospedale di Desio (Milano)

Biochimica Clinica 1999; 23(1):8-15 [Article in italian]

ABSTRACT. We have evaluated the new Sysmex CA-6000 coagulation system according to the European Committee for Clinical Laboratory Standards (ECCLS) protocol issued in 1986.The evaluation has been performed on the following tests: Prothrombin Time (PT), Activated Partial Prothrombin Time (aPTT), Thrombin Time (TT), Fibrinogen (FIB) and Antithrombin III (ATIII).For all the tests we have evaluated the within and between run imprecision, the calibration stability, the sample and reagent carry-over, and the correlation of results obtained from samples routinely analyzed on ACL 3000. The linearity of Fibrinogen has been properly investigated too.Our study has demonstrated good results in terms of within imprecision (maximum CV: 2,8% for clot based tests, and 4,4% for ATIII) and between imprecision (maximum CV: 4,7% for clot based tests, and 6% for ATIII), absence of any form of carry-over, and stability of the calibration for the tests which require it (PT, FIB and ATIII).The correlation has always shown good accordance except in the case of FIB and TT owing to, respectively, the different methodologies that were used (Clauss vs. derived FIB) and the different sensibility which thrombin reagents show in regards of pathological samples containingrelatively high concentration of heparin.In general, the instrument has evidenced good analytical and mechanical performance associated to a remarkable easiness of use which make it suitable for its introduction in the Clinical Laboratory.

Errors and inadequacies in laboratory data reporting evaluated by means of External Quality Assessment schemes

L. Sciacovelli*, S. Secchiero, L. Zardo, P. Bonvicini, M. Plebani
*Centro di Ricerca Biomedica, Castelfranco Veneto (TV)

Biochimica Clinica 1999; 23(1):16-19 [Article in italian]

ABSTRACT. The External Quality Assessment Programs (EQA) have primarily considered till now the achievement of between-laboratory consensus, focusing the attention on the alone analytical phase of the process that, really, includes three phases: pre-analytical, analytical and post-analytical. At the present, the EQA Programs should be considered as a part of total quality management activities and must be used as a tool for the improvement of quality. The EQA Programs managed from Center of Biomedical Research, that has been renewed in their contents, have the purpose to induce an improvement of the performances by providing education and help to the laboratories with inadequate performances. In order, to investigate errors imputable to the post-analytical phase, starting from 1996 the participants have been asked to submit their results in the form of a medical report, as used for patient's results in each laboratory. About 1000 reports from 142 laboratories participating in the scheme of Clinical Chemistry, and from 69 participating in the scheme of Immunoassay have been taken in examination. The type of error most frequently found concerns the units.

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