Institute Of Biologie Clinique

Sotteville-lès-Rouen, France

Institute Of Biologie Clinique

Sotteville-lès-Rouen, France
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Zarski J.-P.,Grenoble University Hospital Center | Zarski J.-P.,French Institute of Health and Medical Research | Sturm N.,French Institute of Health and Medical Research | Sturm N.,Grenoble University Hospital Center | And 23 more authors.
Journal of Hepatology | Year: 2012

Background & Aims: Blood tests and transient elastography (Fibroscan™) have been developed as alternatives to liver biopsy. This ANRS HCEP-23 study compared the diagnostic accuracy of nine blood tests and transient elastography (Fibroscan™) to assess liver fibrosis, vs. liver biopsy, in untreated patients with chronic hepatitis C (CHC). Methods: This was a multicentre prospective independent study in 19 French University hospitals of consecutive adult patients having simultaneous liver biopsy, biochemical blood tests (performed in a centralized laboratory) and Fibroscan™. Two experienced pathologists independently reviewed the liver biopsies (mean length = 25 ± 8.4 mm). Performance was assessed using ROC curves corrected by Obuchowski's method. Results: Fibroscan™ was not interpretable in 113 (22%) patients. In the 382 patients having both blood tests and interpretable Fibroscan™, Fibroscan™ performed similarly to the best blood tests for the diagnosis of significant fibrosis and cirrhosis. Obuchowski's measure showed Fibrometer® (0.86), Fibrotest® (0.84), Hepascore® (0.84), and interpretable Fibroscan™ (0.84) to be the most accurate tests. The combination of Fibrotest®, Fibrometer®, or Hepascore® with Fibroscan™ or Apri increases the percentage of well classified patients from 70-73% to 80-83% for significant fibrosis, but for cirrhosis a combination offers no improvement. For the 436 patients having all the blood tests, AUROC's ranged from 0.82 (Fibrometer®) to 0.75 (Hyaluronate) for significant fibrosis, and from 0.89 (Fibrometer® and Hepascore®) to 0.83 (FIB-4) for cirrhosis. Conclusions: Contrarily to blood tests, performance of Fibroscan™ was reduced due to uninterpretable results. Fibrotest®, interpretable Fibroscan™, Fibrometer®, and Hepascore® perform best and similarly for diagnosis of significant fibrosis and cirrhosis. © 2011 European Association for the Study of the Liver. Published by Elsevier B.V. All rights reserved.


Jordan J.A.,George Washington University | Plantier J.C.,Institute Of Biologie Clinique | Templeton K.,Royal Infirmary | Wu A.H.B.,San Francisco General Hospital
Journal of Clinical Virology | Year: 2016

Background: The most important reason for measuring HIV-1 viral load (VL) is to monitor the effectiveness of antiretroviral therapy (ART), both for the initial therapeutic response and sustained responses. Maintaining low or undetectable HIV-1 VL levels can reduce both the risks of progression to AIDS and transmission of infection to others. Objectives: To evaluate the diagnostic accuracy of Xpert® HIV-1 Viral Load (VL) assay compared to the Abbott RealTime HIV-1 assay, including assessing specificity by testing plasma specimens from confirmed HIV-1 negative blood donors. Study design: Subjects were enrolled from 4 participating sites, 2 in Europe and 2 in the USA. Fresh plasma samples were tested prospectively, while frozen plasma samples were collected prospectively, and tested retrospectively after selection of specimens to cover the assay's quantification range (40 cp/mL-10,000,000 cp/mL). Eligibility criteria included a clinician ordered HIV-1 VL test from a confirmed HIV-1 positive adult (≥18 years) with a known antiviral treatment status. Exclusion criteria included previous enrollment in this study or improper specimen collection. Human blood donor specimens determined to be HIV-1 negative by standard blood bank antibody and nucleic acid amplification methods were used to assess specificity. Results: Of the 764 specimens collected, 752 were eligible for inclusion but 5 were not tested by the Xpert, leaving 747 specimens tested (28.2% from females and 71.8% from males). Valid results were obtained for 724/747 (96.9%) specimens tested using the Xpert HIV-1 VL assay. The Xpert HIV-1 VL assay detected or quantified 568/724 (78.5%) specimens, while the RealTime HIV-1 assay detected or quantified 559/724 (77.2%). Of the 724 specimens tested by both assays, 390 were quantified by both assays and showed strong correlation: r = 0.9847, with an R2 = 0.9696. Bland-Altman analysis showed good agreement between the two assays (381/390; 97.7%) with a distribution within 0.5 log10 cp/mL centered around zero. Xpert yielded VLs for 393 (80%) of the 494 quantifiable samples by Abbott. VLs of those specimens quantified by one of the assays, and either detected but not quantified or not detected by the other assay were all <170 cp/mL. Specificity of the Xpert assay was found to be 100% (109/109), 95% CI: 96.7-100.0. Conclusion: Very good correlation was seen between the Xpert HIV-1 VL and Abbott RealTime HIV-1 assays, with added benefits for Xpert HIV-1 VL of: (1) lot-to-lot consistency traceable to WHO International Standard, (2) requiring both high and low level internal controls to be in range to have a valid result, (3) use of a single HIV-1 target for PCR and (4) faster turn-around-time for results, no need to wait to do batch testing of specimens. In summary, Xpert HIV-1 VL generated accurate VL results that if implemented could allow for actionable and timely treatment decisions during the same clinic visit. This scenario could reduce the loss to follow up often seen when these test results take days to weeks to become available to the clinician and patient. © 2016.


Leoz M.,CNR Institute of Neuroscience | Leoz M.,University of Rouen | Chaix M.-L.,University of Paris Descartes | Delaugerre C.,Laboratoire Of Virologie | And 7 more authors.
AIDS | Year: 2011

Background: HIV-1 group M is characterized by substantial genetic diversity, and includes nine subtypes, more than 45 circulating recombinant forms (CRFs), and numerous unique recombinant forms (URFs). In France, the epidemic is characterized by predominance of subtype B strains, increasing prevalence of non-B subtypes (CRF02-AG being the most prevalent) and increasing at-risk behaviour in the MSM population. The high prevalence and co-circulation of B and CRF02-AG strains in this population raise the possibility that recombinant forms might emerge and spread. Methods: Samples from seven patients (five being MSM) were selected on the basis of subtyping discordances in different regions. The pattern of each near full-length genome of the viruses was characterized. The relationships between the newly and previously described B/CRF02-AG URFs were analysed using phylogenetic networks. Single genome amplification was used to search for the parental strains and confirmation of the breakpoints. Results: Seven unique recombination patterns were identified, breakpoints being found throughout the genomes, with hotspots in pol and accessory genes. No link was observed with the previous forms, but the CRF02 regions of two new viruses indicated that they are phylogenetically associated, suggesting a common ancestral strain. No evidence of circulating parental strains was found. Conclusion: This description of seven URFs involving subtype B and CRF02-AG highlights the growing complexity of HIV molecular epidemiology in France. These multiple patterns, found mostly in MSM, and the hypothesis of a better fitness of some recombinant strains, argue for a context that could lead to the genesis of CRFB/02-AG strains in France. © 2011 Wolters Kluwer Health | Lippincott Williams & Wilkins.


PubMed | San Francisco General Hospital, George Washington University, Royal Infirmary and Institute Of Biologie Clinique
Type: | Journal: Journal of clinical virology : the official publication of the Pan American Society for Clinical Virology | Year: 2016

The most important reason for measuring HIV-1 viral load (VL) is to monitor the effectiveness of antiretroviral therapy (ART), both for the initial therapeutic response and sustained responses. Maintaining low or undetectable HIV-1 VL levels can reduce both the risks of progression to AIDS and transmission of infection to others.To evaluate the diagnostic accuracy of Xpert() HIV-1 Viral Load (VL) assay compared to the Abbott RealTime HIV-1 assay, including assessing specificity by testing plasma specimens from confirmed HIV-1 negative blood donors.Subjects were enrolled from 4 participating sites, 2 in Europe and 2 in the USA. Fresh plasma samples were tested prospectively, while frozen plasma samples were collected prospectively, and tested retrospectively after selection of specimens to cover the assays quantification range (40cp/mL-10,000,000 cp/mL). Eligibility criteria included a clinician ordered HIV-1 VL test from a confirmed HIV-1 positive adult (18 years) with a known antiviral treatment status. Exclusion criteria included previous enrollment in this study or improper specimen collection. Human blood donor specimens determined to be HIV-1 negative by standard blood bank antibody and nucleic acid amplification methods were used to assess specificity.Of the 764 specimens collected, 752 were eligible for inclusion but 5 were not tested by the Xpert, leaving 747 specimens tested (28.2% from females and 71.8% from males). Valid results were obtained for 724/747 (96.9%) specimens tested using the Xpert HIV-1 VL assay. The Xpert HIV-1 VL assay detected or quantified 568/724 (78.5%) specimens, while the RealTime HIV-1 assay detected or quantified 559/724 (77.2%). Of the 724 specimens tested by both assays, 390 were quantified by both assays and showed strong correlation: r=0.9847, with an R(2)=0.9696. Bland-Altman analysis showed good agreement between the two assays (381/390; 97.7%) with a distribution within 0.5 log10 cp/mL centered around zero. Xpert yielded VLs for 393 (80%) of the 494 quantifiable samples by Abbott. VLs of those specimens quantified by one of the assays, and either detected but not quantified or not detected by the other assay were all <170cp/mL. Specificity of the Xpert assay was found to be 100% (109/109), 95% CI: 96.7-100.0.Very good correlation was seen between the Xpert HIV-1 VL and Abbott RealTime HIV-1 assays, with added benefits for Xpert HIV-1 VL of: (1) lot-to-lot consistency traceable to WHO International Standard, (2) requiring both high and low level internal controls to be in range to have a valid result, (3) use of a single HIV-1 target for PCR and (4) faster turn-around-time for results, no need to wait to do batch testing of specimens. In summary, Xpert HIV-1 VL generated accurate VL results that if implemented could allow for actionable and timely treatment decisions during the same clinic visit. This scenario could reduce the loss to follow up often seen when these test results take days to weeks to become available to the clinician and patient.


Damond F.,Laboratoire Of Virologie | Avettand-Fenoel V.,Laboratoire Of Virologie | Avettand-Fenoel V.,University of Paris Descartes | Collin G.,Laboratoire Of Virologie | And 15 more authors.
Journal of Clinical Microbiology | Year: 2010

We evaluated the performance of the prototype Cobas AmpliPrep/Cobas TaqMan HIV-1 test, version 2.0, using prospective and archived clinical samples initially underquantitated by the Cobas AmpliPrep/Cobas TaqMan HIV-1 test. The performance of the new test was significantly improved, and the majority of the underquantitation observed with the first-version test was eliminated. Copyright © 2010, American Society for Microbiology. All Rights Reserved.


Schneider P.,University of Rouen | Van Dreden P.,Hoffmann-La Roche | Rousseau A.,Hoffmann-La Roche | Marie-Cardine A.,University of Rouen | And 4 more authors.
Thrombosis Research | Year: 2011

Background: Complications of bone marrow transplantation (BMT) are usually considered to be related to the secretion of inflammatory cytokines, which generate membrane microparticles rich in procoagulant phospholipids (PPL) from different cellular origins and release of endothelial proteins such as thrombomodulin (TM). The use of soluble TM quantified by ELISA (TM:Ag) as a marker of endothelial injury is complex in children since it is age-dependent. Materials and methods: Using a functional assay which quantifies the activity of sTM activity (TMa), we performed a pilot study to analyze the ratio TMa/TM:Ag in a control group of 25 healthy children, 8 children with autologous and 16 children with allogeneic BMT. In this last group, 8 experienced BMT complications. In addition, we used a functional assay which quantifies PPL. Results: In healthy children the ratio TMa/TM:Ag was independent of age and stable in children with a favorable outcome but significantly (p < 0.05) reduced by the use of antithymocyte globulin during the conditioning regimen, and regularly decreased in children with BMT complications. Surprisingly, low plasma PPL levels were associated with a poor outcome. Conclusion: The ratio TMa/TM:Ag could constitute a marker of endothelium injury, and its follow-up could be of interest for an early discrimination of children with high risk of complications during allogeneic BMT. The decrease of PPL could be also another marker of a poor evolution and deserves further investigations. © 2011 Elsevier Ltd.


Gueudin M.,Institute Of Biologie Clinique | Gueudin M.,University of Rouen | Baron A.,Institute Of Biologie Clinique | Alessandri-Gradt E.,Institute Of Biologie Clinique | And 7 more authors.
Journal of Acquired Immune Deficiency Syndromes | Year: 2016

Objective: To evaluate the quantification performance of the new Cepheid GeneXpert HIV-1 viral load assay, on a wide panel of HIV-1 variants. Methods: Clinical performance was evaluated relative to the Abbott RealTime HIV-1 assay on 285 HIV-1 seropositive samples selected to cover the assays quantification range (40 copies/mL-10,000,000 copies/mL), and included RNA undetectable or detected seropositive samples. The panel comprised 120 subtype B, 150 non-B, and 15 nontypable clinical samples; serial dilutions of 18 viral supernatants representative of the divergent viruses of HIV-1 groups N, O, and P were also tested. Results: Based on samples selected according to the Abbott assay viral loads (VL), the Cepheid assay detected or quantified 222/285 (78%) samples and the Abbott assay 240/285 (84%). Xpert yielded VLs for 162 (76%) of the 213 quantifiable samples with Abbott. This difference corresponded to 51 samples with VL >40 copies/mL by the Abbott assay (all below 200 copies/mL) but detected (n 40) or undetectable (n 11) by the Cepheid assay. VL of samples quantifiable by both assays (n 162) showed very strong correlation, with a Spearman correlation coefficient of 0.985 and a Bland-Altman's mean of differences of -0.01. Performance for quantification of the non-M samples showed very good correlation, with significantly higher values with Cepheid for the group N and 2 group O samples. Conclusions: Our study showed that the Xpert HIV-1 VL assay offered very good performance for detection and quantification of the current HIV-1 genetic diversity; differences reported at the threshold could be an issue and requires further evaluations. The practicability of this new assay makes it suitable for low-income countries, where it could facilitate and improve follow-up of patients, as well as for high-income regions. © 2016 Wolters Kluwer Health, Inc.


Caffeine, the main alkaloid in coffee, corresponds to the 1-3-7 trimethylxanthine. Its concentration is lower in tea and chocolate, where it is associated with theophylline, 1-3 dimethylxanthine, in tea and with theobromine, 3-7 dimethylxanthine, in chocolate. Paraxanthine, 1-7dimethylxanthine, for its part, is produced by the hepatic metabolism of caffeine operated by a cytochrome of 1A2 type. The effects of these methylxanthines on awaking, anxiety, neuroprotection in Alzheimer's and Parkinson's diseases, mood, schizophrenia and nociception are briefly considered. This review is concluded by indicating that these effects of methylxanthines may be modified by various associated substances, such as polyphenols displaying antioxydant properties. © 2010 Springer Verlag France.


Wils J.,Laboratoire Of Biologie Medicale | Wils J.,Institute Of Biologie Clinique | Lavoinne A.,Institute Of Biologie Clinique | Vaillant C.,Laboratoire Of Biologie Medicale
Annales de Biologie Clinique | Year: 2013

Capillary zone electrophoresis for analysis of serum proteins, is a technic more and more used in laboratory medicine. We report the case of an interference of iomeprol, radioopaque agent, in a context of acute renal failure and aregenerative anemia in a 53 year-old patient. Copyright © 2007 John Libbey Eurotext.


Patout M.,Clinique Pneumologique | Salaun M.,Clinique Pneumologique | Brunel V.,Institute Of Biologie Clinique | Bota S.,Clinique Pneumologique | And 2 more authors.
Clinical Biochemistry | Year: 2014

Objectives: Procalcitonin (PCT) is widely used for the diagnosis of bacterial infections. The aim of this study was to evaluate PCT as a tumor and as a prognostic marker in patients with primary lung cancer. Design and methods: We retrospectively performed a PCT dosage in the frozen serum samples of 147 patients with pulmonary neoplasia for whom a test of neuron-specific enolase (NSE) had been conducted at the time of diagnosis. Results: We show that a PCT serum level above 0.15. ng/mL was independently linked to the presence of a neuroendocrine component in the tumor (HR. = 5.809 95% CI [1.695-19.908] p: 0005). Thus, median PCT serum levels were significantly more elevated in small-cell lung cancers than in pulmonary adenocarcinomas: 0.33. ng/mL versus 0.07. ng/mL ( p<. 0.001). However, the diagnostic value of serum PCT levels for diagnosing carcinoma with a neuroendocrine component remains low (sensitivity 63.8%; specificity 71.9%). In this series, serum PCT levels were significantly more elevated in the presence of liver metastases: 0.37. ng/mL versus 0.09. ng/mL in the absence of liver metastasis ( p<. 0.001). In uni- and multivariate analyses, a serum PCT level above 0.15. ng/mL and the presence of metastases and of sepsis at the time of diagnosis were independent factors of unfavorable prognosis. Conclusions: Serum PCT is elevated in patients with lung cancer with neuroendocrine component or with liver metastases. As a consequence, in this population, PCT has a poor specificity for bacterial infection. At diagnosis, an elevated serum PCT is an independent predictive factor of bad prognosis. © 2014 The Canadian Society of Clinical Chemists.

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