[Introducing the new international vocabulary of metrology]. / Présentation du nouveau Vocabulaire international de métrologie.

The 3rd edition of the "International vocabulary of metrology - Basic and general concepts and associated terms (VIM)" is a fundamental document for the people who are concerned by metrology. This international standard is bilingual (french/english). The VIM contains definitions of metrological concepts, their hierarchy, numerous explicative notes and examples. This approach confirms that the concepts of the VIM are applicable to various disciplines including clinical laboratory sciences.

[Recommendations for metrological control of measuring equipments in the clinical laboratories]. / Recommandations pour la maîtrise métrologique des équipements de mesure au laboratoire d'analyses de biologie médicale (Document D).

The control of the measuring equipment (balances, mass standards, micropipettes, dilutors, volumetric glassware, thermometers...) is essential to obtain reliable analytical results. This control requires knowledge and use of the main standards, instructions for use, metrological verifications and confirmations as well as creation of checking and standardizing certificates ensuring metrological traceability. These items should help to control the quality of the analytical performances (fidelity and trueness in particular).

[Recommendations for expressing uncertainty of measurement of quantitative results in laboratory medicine]. / Recommandations relatives à l'expression de l'incertitude de mesure des résultats quantitatifs en biologie médicale (Document F).

In laboratory medicine, the quantitative results of examinations are interpreted with regard to reference intervals, clinical decision limits or previous results of a patient, from which it is necessary to inform the clinician about the uncertainty of measurement linked to the value of the result. This document explains the problematic of the expression of the uncertainty of measurement. It proposes recommendations concerning a simple way to evaluate uncertainty of measurement using long term internal quality control data and the value of the uncertainty linked to the method calibration. It approaches the determination of analytical goals and the choice of methods and also the comments accompanying the record of results and a help to their interpretation.

[Prescription, assay and interpretation of cardiac troponins tests: guidelines from SFBC-CNBC troponin working group]. / Recommandations sur la prescription, le dosage et l'interprétation des troponines cardiaques.

Troponin (I or T) has become the gold-standard marker in acute coronary syndromes during the last few years, as confirmed by a national survey realized within french clinical chemists, cardiologists and emergency practitioners. The importance of this marker and the heterogeneousness of circulating forms of troponin after myocardial necrosis fully justify international studies about standardization of this assay, which is a central bulk to reach a global market coherence. Checking analytical problems, although necessary, must be absolutely associated with an informed clinical interpretation. The knowledge of the crucial thresholds of each assay, the kinetic curves and the specificity limits of troponin assays allow the best use of their potential in diagnosis and prognosis together with an optimal patient care in very different clinical settings, in addition to others clinical and technical arguments. The quality improvement through successive generations of assay kits must nowadays persuade the physicians never to ignore a significant and valid troponin increase, which mainly reveals a cardiac injury, whatever its origin.

[Recommendations for the installation in the laboratory of metrological functions and corresponding documentation (Document B)]. / Recommandations pour l'installation dans le laboratoire de la fonction métrologie et de la documentation correspondante (Document B).

In order to ensure the quality of analytical results, clinical laboratories shall have a perfect control of process and equipments of measurement. Therefore is recommended individualisation of metrological function, generally entrusted the quality manager. This quality manager will draw up a metrological traceability, verifications and confirmations, control of non conformities, follow-up and evaluation of metrological function.

[Presentation for the use of a clinical laboratories of standards of metrology (Document A)]. / Présentation, à l'usage des laboratoires d'analyses de biologie médicale, des normes de métrologie (Document A).

Clinical laboratories shall have a perfect control of "in vitro diagnostic medical devices" to ensure the quality of their analytical results. This introductory presentation to a serie of documents of recommendations tackles the different standards of metrology concerning the requirements to reference materials, metrological traceability, metrological confirmation, management of measurement as well as uncertainty of measurement. The standards concerning clinical laboratories are then succinctly described.

[Prevalence of various pneumo-allergens among the positives in global in vitro diagnostic tests for allergy; possible importance of restricted mixtures]. / Prévalence des différents pneumallergènes dans la positivité des tests globaux de dépistage in vitro de l'allergie; intérêt éventuel des mélanges restreints.

With in vitro utilization of allergenic extracts' mixes, for 67 positive serums to Phadiatop or Allergy Screen, the prevalence of positivity is increased to moulds (6%), grass pollen allergens (34%), ragweed pollen allergens (13%) and tree pollens (12%). Moreover prevalence is 67% to D. pteronyssinus, 7.5% to Cockroaches and 25% to domestic mammals. At least 20% of positive serums are bisensible and 10% polysensible, which leads to do broader testing.

Rapid, specific and sensitive method for isoniazid determination in serum.

An original simple, specific and rapid high-performance liquid chromatographic assay for the determination of isoniazid (INH) in human serum is presented. The drug was extracted from the serum by protein precipitation with 30% (w/v) trichloroacetic acid, then the drug was reacted with the coupling reagent, trans-cinnamaldehyde, to form a derivative absorbing at 340 nm. A 20-microliters aliquot was injected into the chromatograph after neutralization with 1 M KOH solution. A liquid chromatograph equipped with a reversed-phase 30-microns C18 precolumn linked to a 4-microns C18 analytical column was used. The drug was eluted with a mixture of acetonitrile-water-triethylamine-acetic acid (400:600:2:1, v/v), pH value was 5 +/- 1. Flow-rate and wavelength were set at 1 ml/min and 340 nm, respectively. The extraction recoveries from human serum averaged 100% for INH at concentrations of 1, 2 and 4 mg/l. The coefficients of variation for three different concentrations for INH in serum in the within-day study varied between 1.2 and 3.5%, whereas those in the day-to-day study varied between 2.8 and 4.3%.

Automated liquid-chromatographic analyzer used for toxicology screening in a general hospital: 12 months' experience.

We evaluated the clinical utility of an automated HPLC system (Remedi, Bio-Rad) for identification of drugs and metabolites in biological fluids. Serum or urine or both from 354 consecutive cases of poisoning were analyzed by the system and by a set of fluorescence polarization immunoassay (FPIA, Abbott) and thin-layer chromatographic (TLC) procedures. Antidepressants and most phenothiazines were recognized by the new system. Comparison of Remedi results with final clinical diagnoses yielded diagnostic specificity and sensitivity of 80% and 90%, respectively. Remedi detected 26 additional compounds that were neither reactive in the immunoassay screening tests nor detected by TLC procedures. Because the Remedi expands the range of drugs covered by the immunoassays and provides a rapid, preliminary report in emergency situations, we conclude that this system can be a useful complementary technique in the clinical toxicology laboratory. Although urine toxicological screening seemed adequate for a good toxicological report, blood analysis allows extra toxicokinetic data such as blood concentrations and half-life estimations.