[Screening and diagnosis of gestational diabetes. Evaluation of the methodological quality of the guidelines of the Haute Autorité de Santé, of the American Diabetes Association, and of the World Health Organisation]. / Dépistage et diagnostic du diabète gestationnel: évaluation de la qualité méthodologique des avis de la Haute autorité de santé, de l'American diabetes association et de l'Organisation mondiale de la santé

We critically appraised the methodological quality of the clinical practice guideline (CPG) published by the Haute autorité de santé (HAS) about screening and diagnosis of gestational diabetes, and we compared its quality with that of two other CPGs, i.e. that of the American diabetes association (ADA) and that of the World health organisation (WHO). According to the AGREE criteria, HAS and ADA have produced CPGs that have approximately got the same levels of quality. Both these CPGs obtain AGREE scores that are better than those of WHO. Although the CPG of the HAS suffers from a few methodological drawbacks, regarding more particularly stakeholder involvement (AGREE domain n degrees 2), applicability (AGREE domain n degrees 5) and editorial independence (AGREE domain n degrees 6), this CPG summarises, and allows to compare most, if not all, other CPGs available with each other, with their possible benefits or harms, which may be useful for professionals involved in the care of the patient.

[Principles recommended to reassure the identification of the patient, the request of analysis and the report of biological results]. / Principes recommandés pour sécuriser l'identification du patient, de la demande d'analyse et du compte rendu des résultats biologiques.

The collection of a reliable identity is required for the constitution of any medical file, and biological file in particular. The regulation concerning the rights of the patient, the organization of the Social Security, and the respect of the private life must be applied. The biologist must comply with the GBEA with a special attention when it comes to transfusion. Each individual is unique and should be identified by a single number. Maximum precautions are essential as for the data confidentiality. Adapted procedures (Charter of patient collection of the identity, procedure of bringing together of the identities) with traceability of all the operations are essential but non-sufficient preliminaries. The identitovigilance recommended by the CNIL, must be implemented as well as all other already vigilances required by the law. In this context, the biologist must be particularly active. He must ensure the correct collection of the data, the description of the anomalies and the redundant data, and take into account the corrections. By its transverse position, he plays an important part and must be part of the cells of identitovigilance. It must respect its specific requirements for the corrections of identities and must be informed for any modification taking place after the biological validation. The principal recommendations making it possible to ensure the reliability of the identification of the patient and the biological file were joined together in this article by a working group from the National College of Biochemistry of the Hospitals (CNBH).

[Practice guidelines: let us sort them]. / Guides de pratique clinique: trions-les.

A growing number of clinical practice guidelines (CPG) is published. This is understandable because CPG are the corner stone in the evaluation of professional practices (EPP). One cannot deny that EPP is necessary. However, in order for the EPP to reach their objectives, which are to use our resources better and to improve health-care, CPG at our disposal should be of good quality, both in their form and in their content. This is not always the case. What is more, health-care professionals are often not properly trained to distinguish "good" from "not so good" CPG. In this context, the Société française de biologie clinique has created a working group on "CPG and Evidence-Based Laboratory Medicine (EBLM)". One of the main objectives of our group is to publish critical appraisals of CPG on a regular basis in the Annales de Biologie Clinique (ABC). Thus, the ABC will follow the example set by other medical journals, for example in France: Prescrire. We will more particularly appraise CPGs in relation with laboratory medicine. In this first article, we describe the methods that we will use in order to distinguish "good" from "not so good" CPG. Just like Prescrire as well as like many others, our first tool will be the AGREE instrument, which is quite consensual at an international level. The AGREE tool makes it possible to appraise quite easily, and in a reproducible way, the methodological quality of CPG. We also briefly discuss the more complicated methods that can be used to make judgments about the content of CPG, bearing in mind that equity, patients' autonomy, balancing risks and benefits, are the four universal principles of medical ethics, that is of good medicine, that is of EB(L)M.

[A monoclonal immunoglobulin M not visible on the profile of serum capillary electrophoresis]. / Une immunoglobuline M monoclonale invisible sur le profil d'électrophorèse capillaire.

We report a case of an invisible monoclonal IgM on the profile of the serum electrophoresis carried out by the Paragon CZE 2000 system. This case is about a 84 years old man followed for a Waldenström disease. The level of the monoclonal IgM given at the time of the preceding visit one year before was 10 g/L. The electrophoresis is reproduced in two other laboratories using respectively the Hydrasys and Capillarys techniques which have both shown the presence of the monoclonal peak. At this occasion the frequency of these anomalies of migration and the recommendations to avoid the erroneous interpretation of the electrophoresis are discussed. The vigilance and the competence of the biologist are essential to avoid this rare pitfall, induced by the new principle of the capillary electrophoresis.

[Nephelometry or turbidimetry for the determination of albumin, ApoA, CRP, haptoglobin, IgM and transthyretin: which choice?]. / Turbidimétrie ou néphélémétrie: quel choix pour les dosages de l'albumine, l'ApoA, la CRP, l'haptoglobine, l'IgM et la transthyrétine?

Nephelometry, which is considered as the reference method for serum proteins determination requires a specific equipment. The majority of protein determinations are therefore carried out on biochemistry automats using turbidimetry. The objective of a CNBH group (Collège national de biochimie des hôpitaux) was to compare nephelometry and turbidimetry for 7 automats: 2 nephelometers, the BN Prospec (Dade-Behring) and Immage (Beckman-Coulter) and 5 biochemistry systems using turbidimetry, the Integra and Modular (Roche Diagnostics), the LX20 (Beckman-Coulter), RXL (Dade-Behring) and AU (Olympus). The study was based on the determination of sera collections (albumin, ApoA, CRP, haptoglobin, IgM, transthyretin) of 140 samples each: 110 limpid samples and 30 samples called HLI (hemolytic, lipemic or icteric). Fifteen hospitals took part to this work. An ANOVA analysis on limpid samples and quality control sera concluded to an "automat" effect for the 6 tested proteins but did not show a "method" effect, (i.e. nephelometry versus turbidimetry). On the other hand, the transferability of the results was expected to be better and an effort on the choice of the antibodies and the standardization procedures should be made.

[Propositions of interpretative comments for thyroid function tests]. / Propositions de commentaires interprétatifs pour les bilans biologiques thyroïdiens.

In the field of thyroid disease, a number of governmental organisms or professional associations have published practice guidelines containing laboratory-related recommendations, eg the Haute autorité de la santé (HAS), or the American Thyroid Association (ATA). Among the physicians who prescribe thyroid function tests, all have not read and memorized all these recommendations. In order to help them to better integrate these recommendations in their practice, we have composed a thesaurus of ready-made interpretative comments, trying to adapt our proposed comments to each possible combination of results of TSH and/or free T4 and/or free T3. The laboratorians who would prefer to use only the comments based strictly on the recommendations of HAS and/or ATA, will be able to select among our comments what is really validated by these two organizations. In addition, our work aims at enabling the patients who want it, to benefit from written information, which may be complementary to the more often spoken information provided by the clinicians.

[A proposal of ready-made interpretative comments applicable to serum protein electrophoresis]. / Proposition de commentaires interprétatifs prêts à l'emploi pour l'électrophorèse des protéines sériques.

Zone electrophoresis for separation and quantification of serum proteins is useful in numerous pathological situations to make clinical diagnostics, to follow the evolution of a disease or to evaluate the efficiency of a treatment. The biologist must apply professional recommendations according to the official nomenclature of biological analysis. He must attach a comment to each result in order to help the physician to perform the best interpretation of the results. To answer those needs, a work of standardization of these comments has been realized by a group of biologists. They are members of the national college of biologists (CNBH). All the commentaries are assembled in a thesaurus which could be a base of ready-made comments, favouring the interpretation of serum protein electrophoresis results.

Fractionation and structure of several hydroxyproline-containing urinary peptides, with special reference to some 3-hydroxyproline-containing peptides.

After a preliminary separation of the hydroxyproline-containing peptides on Biogel P 2, the largest peptides are fractionated on phosphocellulose and the smallest ones on QAE-Sephadex. The fractions obtained from QAE-Sephadex are subfractionated on a column of Dowex 50-M-82. The total number of hydroxyproline-containing peptides from human urine is not less than 78. Sixteen di, tri and pentapeptides have been purified, their N-terminal amino acids and amino acid compositions determined and a structure is proposed. 3 of these peptides contain 3-hydroxyproline and one of these 3 peptides probably originates from basement membrane collagen.

Hemoglobin Roanne [alpha 94(G1) Asp-->Glu]: a variant of the alpha 1 beta 2 interface with an unexpected high oxygen affinity.

In hemoglobin (Hb) Roanne, the aspartate residue alpha 94(G1) is replaced by a glutamic acid. This residue plays a key role in the structural changes affecting the alpha 1 beta 2 contact area during the deoxy- to oxy-state transition in the hemoglobin molecule. Aspartate alpha 94(G1) is involved in several contacts both in the deoxy- and oxy-structures. The most important of those is a hydrogen bond with asparagine beta 102 (G4), stabilizing the oxygenated structure. Alteration of this contact usually leads to a decrease in oxygen affinity. Hb Roanne is the first example in which an increased oxygen affinity was found as a result of a structural modification at this position. Functional data suggested that the mechanisms responsible for this altered property are a destabilisation of the T-structure and a modification of the allosteric equilibrium.

Rates of DNA and protein syntheses by fibroblast cultures in the presence of various glucose concentrations.

Fibroblast cells derived from human derm used between the 5th and 10th passage and submitted to an increase of over 16.5 mM in the glucose concentration of the medium, react by a decrease in the incorporation of [3H] thymidine into DNA. The intracellular proline pool is largely increased by the rise in glucose concentration while the incorporation of [U-14C] proline into total proteins and proteins digested by purified bacterial collagenase is also significantly enhanced. There is no specific effect on collagen synthesis and the apparent activation of total protein synthesis may depend on the enhancement of the free proline pool.

A case of an exceptionally high level of urinary-4-hydroxyproline containing polypeptides.

The determination of total urinary-4-hydroxyproline in an adolescent showed a very high excretion of hydroxyproline containing peptides: 26.2 mmol/24 h. Estimation of total urinary 3-hydroxyproline and peptide fractionation on Biogel P 2 demonstrated unusual features. Such cases are of great interest for structural studies of the urinary polypeptides and understanding of collagen catabolism.

Increased renal excretion of 3 hydroxyproline in patients with active glomerular nephropathies and with polycystic renal disease.

The renal excretion of 3 hydroxyproline (3 HYP) and 4 hydroxyproline (4 HYP) was investigated in control subjects and in patients with various renal diseases. In normal adult subjects urinary 3 HYP was 12.5 +/- 3.5 (SD) mumoles/24 hr, 4 HYP was 226 +/- 62 mumoles/24 hr and the percentage ratio 3 HYP/4 HYP 5.4 +/- 0.5. This ratio was reduced during growth because of a relative excess of 4 HYP. In patients with acute glomerular disease (n = 12) 3 HYP was increased to 17.1 +/- 5.8 mumoles/24 hr (P less than 0.01), and the ratio 3 HYP/4 HYP was 7.3 +/- 0.7% (P less than 0.01). Such an increase in 3 HYP was not observed in patients with chronic glomerulonephritis (n = 24) where 3 HYP was 9.6 +/- 5.0 mumoles/24 hr and 3 HYP/4 HYP 5.7 +/- 1.6% or with diabetic glomerulopathy (n = 6). In patients with chronic interstitial nephritis (n = 8) the 3 HYP/4 HYP ratio was decreased except in patients with polycystic renal disease (PKD) where it was increased (P less than 0.001). The daily urinary content of 3 HYP and 4 HYP was slightly altered by renal insufficiency. Urinary 3 HYP did not change significantly in patients with GN with the nephrotic syndrome whatever the histological lesion. These results indicate that urinary 3 HYP: 1) is increased when glomerulonephritis is clinically acute or subacute; 2) is increased in PKD whatever the level of renal insufficiency.

A column chromatography fractionation of the hydroxyproline-containing urinary peptides with continuous automatic detection.

Dialyzable and non-dialyzable urinary hydroxyproline-containing peptides are chromatographed respectively on QAE-Sephadex and on phosphocellulose. They are detected and quantitated by continuous hydrolysis in 3.3 N NaOH followed by oxidation by chloramine T and colorimetry with p-dimethylamino-benzaldehyde. The patterns of dialyzable urinary hypropeptides do not show significant qualitative differences between normal subjects and patients suffering from Paget's bone disease or cancer metastases of bone. The patterns of non-dialyzable urinary hypropeptides, show more variability in the case of normal subjects and differ more largely in the case of Paget's disease of bone.

[Biomarkers for toxicity and metabolic abnormalities of the main severe poisonings. Clinical and toxicologic symptoms. Conservative determination]. / Biomarqueurs de toxicité et anomalies métaboliques dans les principales intoxications graves. Symptomatologie clinique et toxique. Le prélèvement conservatoire.

The members of the joint group "Toxicology and Clinical Biology" of the French Society of Clinical Biology (SFBC), the French Society of Analytical Toxicology (SFTA), and the Society of Clinical Toxicology (STC), suggest guidelines to meet the requirements of clinical biologists who are not specialized in toxicology. Based on good laboratory practice they propose a number of guidelines. Three synthetic tables have been established. They are not only toxicity biomarkers and metabolic disorders associated with the main severe intoxications, but also clinical signs that are observed during these intoxications, finally biological sampling as a precautionary measure. The table also takes into account approximately fifty xenobiotics: main clinical signs emergency, identification or quantification of the suspected product, useful biological markers, therapeutic, quantitations necessary to take into consideration patient care, and poison antidotes, are described. Recommendations regarding medical and forensic techniques are also proposed by the group. It is also necessary to collect and store biological samples when the individual patients are in charge. These samples will be analyzed or not depending on the individual case history.

[Recommendations for the control of purchasing procedures]. / Recommandations pour la maîtrise des procédures d'achat.

The main relevant and useful process purchase choice of equipments and supplies as well as supplier evaluation are presented. Documents to develop to meet the accreditation standard ISO/FDIS 15189-2012 are listed. This article is intended to assist the biologist in his approach to mandatory certification.

[Supplies: inventory control and reagents]. / Recommandations pour la maîtrise des stocks et des réactifs.

The main relevant features useful for the management of reagents and consumables as well as documents to be developed to meet the requirements of the accreditation standard ISO/FDIS 15189-2012 are listed. This article is intended to help the medical laboratory to get mandatory accreditation.

[Guidelines for the formation of a multidisciplinary group for point-of-care testing supervision according to EN ISO 22870]. / Recommandations pour la constitution d'un groupe d'encadrement des examens de biologie médicale délocalisés.

EN ISO 22870 requires the medical laboratory director to form a multidisciplinary group for the management of point-of-care testing activities and to appoint a person responsible for this group. This article proposes to define the composition (representatives of the medical laboratory, care units owning point-of-care devices, administration), missions (introduction, follow-up and evaluation of point-of-care devices) and the decision circuit of this group and to describe the profile of the head and the tasks assigned.

[Guidelines for documentation management mastery according to the EN ISO 22870]. / Recommandations pour la gestion documentaire des examens de biologie médicale délocalisés.

This article proposes to organize the documentation system of point-of-care testing (POCT) to meet the requirements of EN ISO 22870. In a first part, we propose provisions to improve the control of documents circulating outside the laboratory and aimed at non-laboratory staff. Then we review POCT-related records and we propose an organization facilitating their audit. In the last part, a model of POCT quality plan is proposed : in addition to the quality manual, this document defines the specific measures taken in order to ensure the control of POCT.

[Post-examination phase: description and management control of the process]. / Description et maîtrise du processus post-analytique en biologie médicale.

This article defines the scope of the post-analytical process. This process transforms the results after quality control review into validated results, interpreted by authorized "medical biologists", reported and communicated to the clinicians and patients. This phase includes the treatment of the samples after analysis, their storage and disposal and records archiving. This phase is a key step of the examination involved often in dysfunctions that could hardly harm the patient. These errors are usually the consequence of failing in the control of organization, lack of communication with the clinicians and defect of adaptation to their needs. Examples of quality indicators are proposed, as well as a model of clinico-biological contract.

[Guidelines for advisory services and results interpretation of biological examinations]. / Recommandations concernant les prestations de conseil et l'interprétation des résultats des examens de biologie médicale.

The "medical biologist" has to play a role as a consultant for the relevant use of biological examinations and to provide comments for their interpretation, comprehensible and useful to physicians. Advisory activities of the medical laboratory may help physician in diagnosis or therapeutic algorithm, avoiding ordering incomplete or useless examinations. After presentation of regulation and requirements of the EN ISO 15189 standard, this paper gives proposals for recommendations to apply in the context of accreditation. A proven and regular continuing education program is needed and professional practices must be supported by recognized and recent guidelines. This document provides suggestions for advisory services traceability and reports a list of websites and articles to use in defining standardised comments as well.