[Serodiagnosis of toxoplasmosis: a comparative multicenter study of a standard scale through various actual tests and expression of the results in international units. Groupe de travail toxoplasmose du Contrôle national de qualité en parasotologie. Syndicat des fabricants de réactifs de laboratoire. Groupe de travail standardisation des tests sérologiques du Réseau européen de lutte contre la toxoplasmose congénitale].
Reported are the results of a multicentre study involving 40 laboratories that was carried out in France to assess all the currently available methods used for the serodiagnosis of toxoplasmosis. For this purpose 10 batches of control sera were prepared with titres in the range 0-260 IU per ml. These sera were tested in nine laboratories using immunofluorescence methods; in three laboratories using dye tests; in forty laboratories using enzyme-linked immunosorbent assay; in four laboratories using direct agglutination and haemagglutination; in seven laboratories using the high-sensitivity IgG agglutination test; and in three laboratories using the latex agglutination test. In this way, 70 series of titrations were carried out using seven procedures and the results were compared with those obtained using the WHO reference serum in 15 cases, with the French national E6 serum in 16 other cases, and in 39 cases using 15 reference sera supplied by the reagent manufacturers. Rigorous comparison of the tests was not possible in all cases because one aim of the study was to ensure that the tests were carried out under the usual working conditions that prevailed in the participating laboratories. The results obtained indicate that the serological tests currently available for toxoplasmosis are acceptable for its serodiagnosis. Presentation of the titres in IU has advantages; however, caution is required since the definition of IU varies according to the test and reagents used. It is therefore essential that the conditions and limits for a positive reaction be carefully defined in each case, especially for commercially available kits.
Petithory
J C
JC
Service de biologie, Responsable scientifique du Contróle national de qualité en parasitologie, Centre hospitalier, Gonesse, France.
Ambroise-Thomas
P
P
De Loye
J
J
Pelloux
H
H
Goullier-Fleuret
A
A
Milgram
M
M
Buffard
C
C
Garin
J P
JP
D000372:Agglutination Tests; D004797:Enzyme-Linked Immunosorbent Assay; D005455:Fluorescent Antibody Technique; D006386:Hemagglutination Tests; D006801:Humans; D007841:Latex Fixation Tests; D012015:Reference Standards; D012698:Serologic Tests / Q000379:methods*; D014123:Toxoplasmosis / Q000175:diagnosis / Q000276:immunology*