Stratégies du diagnostic biologique de l infection due au VIH chez les sujets âgés de plus de 18 mois (à l exclusion du dépistage sur les dons de sang et chez les donneurs d organes ou de tissus) - Laboratory diagnosis of HIV Infection 2000 - Guidelines
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Stratégies du diagnostic biologique de l'infection due au VIH chez les sujets âgés de plus de 18 mois (à l'exclusion du dépistage sur les dons de sang et chez les donneurs d'organes ou de tissus) - Laboratory diagnosis of HIV Infection 2000 - Guidelines

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Posted on Jan 01 2000 Laboratory markers of HIV infection Laboratory diagnosis strategies in relation to clinical situations Guidelines concerning prescription of laboratory tests and communication of the results Posted on Jan 01 2000

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Professor François DENIS, virologist, Hôpital Dupuytren, Limoges I.3. Level of evidence of the guidelines A further screening test is performed on the second sample ; it is not necessary to perform a Testing for p24 Ag or HIV-RNA is the second choice, if a conclusion cannot be drawn from
Dr. Jean-Michel DESCAMPS, specialist in internal medicine, Centre Hospitalier Général, Niort confirmation test routinely. interpretation of serology tests (see algorithm below).
Unless indicated otherwise, the guidelines are based on professional agreement.Dr. Patrice DOSQUET, project manager for ANAES, Paris
This guideline for a diagnostic strategy is based on professional agreement and requires aProfessor François FREYMUTH, virologist, Centre Hospitalier Universitaire, Caen Viral culture combined with testing for proviral DNA cannot be used in routine practice and is
Dr. Syria LAPERCHE, laboratory analyst, French National Blood Transfusion Service, Paris - Project Manager modification of the current wording of the nomenclature for laboratory testing procedures. reserved for specific clinical situations (suspected variant, persistent atypical serological profile) and
II. LABORATORY MARKERS OF HIV INFECTIONMme Rose-Marie LEBLANC, pharmacist and pathologist, Bordeaux for laboratories equipped to perform such tests.
Dr. Pascale MAISONNEUVE, laboratory analyst, Agence Française de Sécurité Sanitaire des Produits de Santé, II.5. Two methods should be used for the screening test
Saint-Denis II.1. Laboratory markers tested for in routine practice
III.2.2. General algorithmFor a screening test for HIV antibodies, the current wording of the nomenclature for laboratory testProfessor Patrice MASSIP, specialist in infectious disease, Hôpital Purpan, Toulouse
The laboratory markers tested for in a blood sample in routine practice are: procedures requires that two methods should routinely be used on the same sample, at least one ofDr. François PREVOTEAU DU CLARY, general practitioner, Paris The algorithm below is designed for laboratory diagnosis of infection when the presumed exposure• HIV antibodies (HIV Ab), using serological screening and confirmation methods;Dr. Christian RABAUD, specialist in infectious disease, Centre Hospitalier Universitaire, Vandœuvre-lès-Nancy them being a mixed ELISA method. The present guidelines do not call this into question. Even if the to HIV occurred more than three months previously. It is based on professional agreement.• p24 antigen (p24 Ag), tested for by enzyme immunoassay (ELISA);Professor Christine ROUZIOUX, virologist, Hôpital Necker-Enfants Malades, Paris performances of HIV infection screening methods have been improved, particularly for screening for
Dr. Catherine TAMALET, virologist, Hôpital de la Timone, Marseilles • HIV RNA (HIV-RNA), tested for by molecular biology methods. early infection, it is recommended that two methods still be used on the same sample when carrying III.3. Strategy for laboratory diagnosis if there are clinical signs suggesting primary infectionDr. Chantal VERNAY-VAÏSSE, dermatologist, Anonymous Free Screening Centre, Bouches du Rhône
Testing for proviral DNA and isolating the virus by viral culture are not commonly performed and are out a screening test. with HIVDr. Alain WAJSBROT, general practitioner, Avignon
only carried out in laboratories equipped to perform such tests. The requirement to use two methods in a screening test has been retained out of a concern to minimise
III.3.1. Laboratory markers which can be used
the number of false negatives obtained during screening, particularly if the prevalence of seropositive
II.2. Marker kinetics during the early phase of HIV-1 infectionREADING GROUP During primary infection with HIV, the HIV antibodies, indirect markers of infection, are absentsubjects exceeds 0.1% in the population studied. This recommendation may be reviewed once a national
A diagrammatic representation of the kinetics of the viral markers tested for in routine practice during during the very early phase which follows contamination (see Fig. 1). It is therefore recommendedprospective study designed to evaluate the relevance of using two methods for screening testing compared
Dr. Patrick ALVIN, paediatrician, Hôpital de Bicêtre, Le Kremlin-Bicêtre
the early phase of HIV-1 infection is shown in Fig 1. Times to appearance of the various markers are that screening for HIV antibodies, which must be carried out in all cases, be combined with testingwith just one has been completed. The working group hopes to see this study begun in the near future.Dr. Jean-Pierre AUBERT, general practitioner, Paris
given as mean guideline data, obtained using the best available techniques to detect each marker. for a direct marker of viral replication, either p24 Ag or plasma HIV-RNA.Professor Alain BERGERET, company medical officer, Lyon The combination recommended is to perform two mixed screening methods, one of which must be an
These times are subject to variation depending on the performance of the methods used and theDr. François BONNAL, specialist in internal medicine, Centre Hospitalier de la Côte Basque, Bayonne ELISA method. ELISA testing for p24 Ag is performed more easily and more commonly than testing for plasma HIV-
Dr. Vincent CALVEZ, virologist, Hôpital Pitié-Salpêtrière, Paris immune response of the infected subject.
RNA, which requires a molecular biology method. Although p24 Ag is detected later than HIV-RNA,
Dr. Hélène CHAPOULART, obstetrician and gynaecologist, Bordeaux II.6. Applicability of combined screening methods and only transitorily during the very early phase of infection (see Fig. 1), testing for p24 Ag is stillDr. Bernard COADOU, general practitioner, Bordeaux
HIV Ab Like, simple screening methods the current combined screening methods should be employed indicated for diagnosing early infection when testing for HIV-RNA is not available locally. TheDr. Joël COGNEAU, general practitioner, member of ANAES ‘ Scientific Council, Chambray-lès-Tours
Dr. Christophe COMPAGNON, dermatologist, Marseilles exclusively in the context of screening for infection. They should not be used for testing for just p24 laboratory analyst should routinely perform a neutralisation test on each screened sample which is
Dr. Anne-Marie COUROUCÉ, laboratory analyst, French National Blood Transfusion Service, Paris Ag. Specific methods should be used to test for p24 Ag. positive for p24 Ag, in order to confirm the specificity of the reaction observed.
Professor Elisabeth DUSSAIX, virologist, Hôpital Paul-Brousse, Villejuif
In comparative studies, it appears that the combined screening tests currently available are often ableDr. Joseph FAGOUR, general practitioner, Fort-de-France Algorithm (Part 1) Presumed exposure occurred more than three months previouslyHIV-1-RNA to detect infection earlier than the simple screening methods (a mean of 2 to 4.8 days earlier); but thisDr. Sylvie FERRARA, general practitioner, Ajaccio
Dr. Jean-Marc FRANCO, general practitioner, Saint-Pierre observation has been inconsistent. It is therefore premature to recommend the routine inclusion of
Dr. Gilles GRATEAU, specialist in internal medicine, Hôtel-Dieu, Paris combined screening methods in the two methods which are used for the screening test.
Dr. Anne GRUSON, laboratory analyst, member of ANAES’ Scientific Council, Arras
Dr. Philippe HOFLIGER, general practitioner, Nice II.7. Confirmation testMarker detection
Dr. Michel JANOWSKI, specialist in internal medicine, Centre Hospitalier Intercommunal, Montreuil threshold p24 Ag The confirmation test for HIV infection remains WB or IB. The criteria for interpreting HIV-1-WBProfessor Michel KAZATCHKINE, immunologist, Hôpital Broussais, Paris
D1 Time (days) are summarised in the annex.Dr. Alain LAFEUILLADE, specialist in internal medicine, Hôpital Chalucet, Toulon INFECTION 8-17 20-4512-26
Dr. Anne LAPORTE, epidemiologist, Health Monitoring Service, Saint-Maurice
II.8. Distinction between infection with HIV-1 and HIV-2Dr. Michèle MANIEZ-MONTREUIL, laboratory analyst, Nord-Pas-de-Calais Blood Transfusion Centre, Lille Figure 1. Relative of kinetics of viral markers during the early phase of infection with HIV-1.
Dr. Sophie MATHERON, specialist in infectious disease, Hôpital Bichat-Claude-Bernard, Paris It is necessary to distinguish between HIV-1 infection and HIV-2 infection in the confirmation test
Dr. Christophe MICHON, specialist in infectious disease, Centre Hospitalier de la Région Annecienne, Annecy
because of the differences in pathogenicity of the two viruses, in particular because of the slowII.3. Terminology for tests to detect HIV antibodiesProfessor Jean-Michel MOLINA, specialist in infectious disease, Hôpital Saint-Louis, Paris
progress of infection with HIV-2, and also the natural resistance of HIV-2 to certain antiretroviralDr. Anne MYARA, laboratory analyst, Hôpital Saint-Joseph, Paris Screening test: test intended to detect HIV antibodies, without determination of specificity. The
agents and the current unavailability of tests to quantify plasma RNA for HIV-2.Professor Dominique PEYRAMOND, specialist in infectious disease, Hôpital de la Croix-Rousse, Lyon
methods used in screening for HIV antibodies are
Josiane PILLONEL, epidemiologist, Health Monitoring Institute, Saint-Maurice
• ELISA; II.9. Diagnosis of infection with a variant of HIV-1Dr. Bernard POLITUR, general practitioner, Cayenne
• agglutination;Dr. Nerina PROFIZI, laboratory analyst, Centre Hospitalier Intercommunal, Toulon The pathologist may suspect

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