[Guidelines for the order process of medical laboratory tests].

This document presents the requirements enumerated in the ISO 15189 standard to make reliable the formulation of a medical laboratory test order. The contents and the filling conditions of the request laboratory tests form are described, to clarify the interest of the information required. The purpose is to help to construct a specific formulation allowing the adequate realization of the laboratory tests but also to collect the needed clinical information essential to allow a relevant interpretation of the results with a goal of improvement of patient care.

[Contribution of simultaneous multiple immunoassays to biology].

During the last years, research in the area of immunoanalysis has been oriented towards the marketing of more reliable, faster and low cost kits. In this field, simultaneous multiple immunoanalysis that offer long-time ignored original and specific advantages, has undergone tremendous improvements triggered by striking technological innovations and the advent of lanthanide chelate based markers. Simultaneous multiple immunoassays have turned from semi-quantitative methods restricted to pharmacology to quantitative methods for medical biology.

Results of the multicentre evaluation of an electrochemiluminescence immunoassay for HCG on Elecsys 2010.

This study evaluated the performance of the HCG STAT Elecsys assay in 8 European laboratories using the Elecsys 2010 system. Analytical sensitivity was < 0.5 mlU/mL.

Elecsys CEA, PSA and AFP. Clinical results of a multicentre evaluation.

Three tumormarker assays, Elecsys CEA, PSA and AFP, have been evaluated in an international multicentre study to characterize their clinical performance and to verify the comparability with the corresponding tests of the Enzymun-Test product line and other methods. For each of the markers results were obtained from four laboratories. On the basis of 314 and 199 specimens respectively, (preliminary) reference ranges could be established for CEA and PSA.

Elecsys TSH, FT4, T4, T-uptake, FT3 and T3. Clinical results of a multicentre study.

6 assays for the assessment of thyroid function (TSH, FT4, T4, T-uptake, FT3 and T3) were targets of the International Multicenter Study on the random access analyzer Elecsys 2010. The aim of the study was to characterize the clinical performance of the assay in method comparison and reference range studies. The assays under evaluation were compared to a broad variety of radio isotopic and non-radio isotopic assays.