A Guyard's research while affiliated with Agence National de Sécurité du medicament and other places

Publications (12)

Article
Full-text available
Background: A study performed in 2007 comparing the evaluation procedures used in European external quality assessment schemes (EQAS) for hemoglobin and leukocyte concentrations showed that acceptance criteria vary widely. For this reason, the Hematology working group from the European Organisation for External Quality Assurance Providers in Labor...
Article
Concerning the external quality assessment of medical laboratories, the National Quality Control (CNQ) organised by the French health products Safety Agency (Afssaps) is mandatory. The high number of participating laboratories is a very important tool for the medical biology despite involving difficulties of organisation. The CNQ gives a global vie...
Article
Further to a survey set up in 2006 over 2600 laboratories by the French agency for health product safety (AFSSAPS), seven ABO grouping errors and 53 negative answers to red blood cell antibody screening with a serum containing anti-RH1 antibody, have been found. A questionnaire sent to the involved laboratories revealed non-analytical errors alread...
Article
Further to a survey set up in 2006 over 2600 laboratories by the French agency for health product safety (AFSSAPS), seven ABO grouping errors and 53 negative answers to red blood cell antibody screening with a serum containing anti-RH1 antibody, have been found. A questionnaire sent to the involved laboratories revealed non-analytical errors alread...
Article
The French quality control is organized by the French Health Products Safety Agency. In 2005, the immuno-haematology testing control included the screening of an anti KEL 1 antibody. 17 out of 2639 laboratories (0,64%) answered 'negative screening'. All laboratories received a questionnaire in order to understand the failure. In this paper the auth...
Article
Lors de l'opération de 2005 du Contrôle national de qualité portant sur les RAI, 17 laboratoires sur les 2639 participants ont rendu un dépistage faussement négatif. Un questionnaire a été adressé aux laboratoires concernés afin de déterminer la cause de leur erreur. L'analyse de ce questionnaire a fait apparaître, outre la forte implication des bi...
Article
The French Health Products Safety Agency organized in 2005, for the scheme of the national external quality assessment, a survey on antibodies against thyroid constituents which included for the first time the quantitative assay. The purpose of this survey was to assess the quality of the different methods of these assays. The overall qualitative r...
Article
In 2003, for the scheme of the French national external quality assessment, Afssaps organized for the first time a survey on auto-antibodies detected on liver, kidney and stomach tissues. This survey had two purposes: first to make an inventory of the methodology applied by the medical laboratories and secondly to assess the quality of the results....
Article
Our objective was to evaluate performance of the clinical laboratories for the detection of antinuclear antibodies (ANA) by using indirect immunofluorescence method (IIF), in France. A national external quality assessment (EQA) on ANA detection was organized by the French health products safety agency once a year since 1998. Between 606 to 687 labo...
Article
In 2003, for the scheme of the French national external quality assessment, Afssaps sent to medical laboratories a sample for which two analyses could be carried out: the electrophoresis of proteins and the characterization for monoclonal immunoglobulin. The purpose of this new approach was to make it possible to the laboratories to transpose their...
Article
A national quality assessment «immunopathologyå was organized by the French health products safety agency in 2001. The serum contained an IgD monoclonal immunoglobulin and a lambda Bence-Jones protein. The sample was sent to 1 381 laboratories and 1 118 answers were analyzed. The demonstration and characterization of monoclonal immunoglobulin show...

Citations

... EQA is crucial for ensuring acceptable analytical quality in medical laboratories, and CCLM has published numerous papers dealing with this issue and with improvement in adopting valuable APS [55], the harmonization of currently available programs [56,57], the increasing importance of EQA programs in the accreditation of medical laboratories according to ISO 15189 [58], and the role of commutable materials for assuring clinical traceability of laboratory results [59]. Importantly, EQA programs consider not only clinical biochemistry measurands but all other laboratory tests, including coagulation [60], hematology [61] circulating tumor DNA (ctDNA) and other molecular tests [62]. Further contributions regard lot-to-lot variation, "a neglected issue" [63] until the recent publications of seminal papers which not only make an in-depth evaluation of challenges in, and risks to, the reliability of results, but also propose potential solutions [64], including an approach for determining acceptable between reagent lot variation. ...
... However, according to the International Council for Standardization in Haematology (ICSH) in 2002, suggesting that anticoagulants contained in blood samples will experience cell morphology changes after 30 minutes of collection, therefore ICSH recommends that the examination should be carried out for a maximum of 4 hours (Vives-Corrons et al., 2014). ...
... La maîtrise des caractéristiques de la technique est un élément primordial pour choisir la technique et interpréter les résultats de manière pertinente. Par exemple, il est important de savoir que la recherche des anticorps antinucléaires (ANA) sur human epithelial cell line type 2 (Hep2) par immunofluorescence indirecte (IFI) doit être réalisée avec une dilution du sérum à 1/80 et lue au microscope à un grossissement de × 40 [5]. L'aspect de la fluorescence oriente vers des AC particuliers. ...
... Cependant, ce contrôle quotidien ne permet pas de répondre à l'ensemble des problématiques analytiques rencontrées. En effet, l'AFSSAPS (Agence de sécurité sanitaire devenue ANSM) rapportait, lors du contrôle national de qualité en 2006, 53 dépistages négatifs sur un échantillon contenant un anti-RH1, parmi les 2 542 laboratoires participants (taux d'erreur à 2,1 %), la grande majorité des erreurs ayant été produite sur support de microfiltration [27]. La première cause d'erreur était un défaut de prélèvement de l'échantillon par l'automate, en raison de la présence de bulles à sa surface. ...
... Though some commercial IQC products are available, such as WBcorQC from Immucor, AlbaQ-Chek from Ortho, DG Gel Control from Diana, and the Pelicheck panel from Sanquin, these products do not apply to cross-matching and therefore they cannot be relied upon to ensure comprehensive IQC. At present, most studies focus on external quality assessment in transfusion laboratories; studies on the IQC of pre-transfusion compatibility testing in laboratories remains rare [20][21][22]. Uniform and standardized IQC products and methods have not yet been developed for pre-transfusion compatibility testing in China [19,23]. In this paper, we present the IQC tests that were conducted in our laboratory from 2012 to 2014, and we analyze the sensitivity, specificity, and confidence levels of these products. ...
... 3,19 In a recent audit by the Czech Myeloma Group, 20 only 38% of laboratories had correctly diagnosed IgD-l MM. A similar experience from the French national external quality assessment was reported by Albarede et al. 21 The staging of IgD MM is controversial. The most popular MM clinical staging system proposed by Salmon and Durie 14 in 1976 did not include IgD MM because of its rarity. ...
... 6,7 However, the IFA method is influenced by cell type, fixation procedure, dilution of patient serum, inspection time, day-to-day performance, the experience level of the microscopist, and the microscope itself. 8,9 To overcome these issues, enzyme immunoassays including Solid Phase Immunoassays (SPI) were developed. [10][11][12] Several ANA antigens have been identified, and quantitative SPIs have been developed using either purified extracts or recombinant antigens. ...