72841-Platelia Toxo IgM.pdf - BIO-RAD

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• If a sample is tested too early during a recent primo-infection, anti-T. gondii IgM antibodies could be not yet present. If a suspicion exists, a second sample should be drawn about 3 weeks later on which IgM testing will be performed again. 11. QUALITY CONTROL OF THE MANUFACTURER All manufactured reagents are prepared according to our Quality System, starting from reception of raw material to commercialization of the final product. Each lot is submitted to quality control assessments and is released to the market only after conforming to pre-defined acceptance criteria. The records related to production and controls of each single lot are kept within Bio-Rad. 12. REFERENCES 1. ANDERSON S.E. and REMINGTON J.S. : The diagnosis of toxoplasmosis. Southern Med. J. 1975; 68, 1433-1443. 2. DECOSTER A., DARCY F., CARON A., VINATIER D., HOUZE DE L’AULNOIS D., VITTU G., NIEL G., HEYER F., LECOLIER B., DELCROIX M., MONNIER J.C., DUHAMEL M. and CAPRON A. : Anti-P30 IgA antibodies as prenatal markers of congenital Toxoplasma infection. 1992; 87, 310-315. 3. JENUM P.A., STRAY-PEDERSEN B., MELBY K.K., KAPPERUD G., WHITELAW A., ESKILD A. and ENG J. : Incidence of Toxoplasma gondii infection in 35 940 pregnant women in Norway and pregnancy outcome for infected women. J. Clin.Microbiol. 1998; 36, 2900-2906. 4. JENUM P.A. and STRAY-PEDERSEN B. : Development of specific immunoglobulins G, M, and A following Toxo-plasma gondii infection in pregnant women in Norway and pregnancy outcome for infected women. J. Clin. Microbiol. 1998; 36, 2907-2913. 5. JENUM P.A., STRAY-PEDERSEN B. and GUNDERSEN A.G. : Improved Diagnosis of primary Toxoplasma gondii infection in early pregnancy by determination of anti-Toxoplasma immunoglobulin G avidity. J. Clin. Microbiol. 1997 ; 35, 1972-1977. 6. LECOLIER B. and PUCHEU : Usefulness of IgG avidity analysis for the diagnosis of toxoplasmosis. Path. Biol. 1993; 42, 2 155-158. 7. REMINGTON J.S. and DESMONTS G. : Toxoplasmosis in infectious disease of the fetus and newborn infant. JS Remington and JO Klein, eds. WB Saunders Co., Philadelphia 1976; 191-332. 8. SULHANIAN A., NUGUES C., GARIN J.F., PELLOUX H., LONGUET P., SLIZEWICZ B. and DEROUIN F. : Serodiagnosis of toxoplasmosis in patients with acquired or reactivating toxoplasmosis and analysis of the specific IgA antibody response by ELISA, agglutination and immunoblotting. Immunol.Infect. Dis. 1993; 3, 63-69. 14
9. WILSON M., REMINGTON J.S., CLAVET C., VARNEY G., PRESS C., WARE D. and the FDA TOXOPLASMOSIS AD HOC WORKING group : Evaluation of six commercial kits for detection of human immunoglobulin M. antibodies to Toxoplasma gondii. J. Clin. Microbiol. 1997; 35, 3112-3115. 10. WONG S.Y. and REMINGTON J.S. : Biology of Toxoplasma gondii. AIDS 1993; 7, 299-316. 15
Page 1 and 2: PLATELIA TOXO IgM 72841 96 TESTS Q
Page 3 and 4: • Step 2 The conjugate (mixture o
Page 5 and 6: included in various Bio-Rad reagent
Page 7 and 8: 3. Samples containing 90 g/l of alb
Page 9 and 10: 1 2 3 4 5 6 7 8 9 10 11 12 A R3 S5
Page 11 and 12: 8.5 Trouble Shooting Guide Non vali
Page 13: Within-run precision (repeatability
Page 18 and 19: 1. DOMAINE D’UTILISATION Platelia
Page 20 and 21: 4. COMPOSITION DE LA TROUSSE Les r
Page 22 and 23: • Ne pas laisser la microplaque s
Page 24 and 25: • Système de lavage automatique,
Page 26 and 27: 26 1 2 3 4 5 6 7 8 9 10 11 12 A R3
Page 28 and 29: 8.5 Expertise des causes d’erreur
Page 30 and 31: Précision intra-essai (répétabil
Page 33 and 34: PLATELIA TOXO IgM 72841 96 PRUEBAS
Page 35 and 36: 3. PRINCIPIO Platelia Toxo IgM es u
Page 37 and 38: Etiquetado Naturaleza de los reacti
Page 39 and 40: CUIDADO: no introducir en el autocl
Page 41 and 42: • R3, R4, R5, R6b, R7: Después d
Page 43 and 44: 8.2 Cálculo de la Ratio de la Mues
Page 45 and 46: 9.3 Sensibilidad La sensibilidad se
Page 47: a la vez, presencia de IgM anti-T.
Page 50 and 51: 1. VERWENDUNGSZWECK Platelia Toxo I
Page 52 and 53: 4. PRODUKTINFORMATIONEN Die mitgeli
Page 54 and 55: wieder vollständig geleert werden.
Page 56 and 57: • Mikrotiterplatten-Lesegerät, m
Page 58 and 59: 1 2 3 4 5 6 7 8 9 10 11 12 A R3 S5
Page 60 and 61: 8.4 Auswertung der Ergebnisse Probe
Page 62 and 63: 62 9.4 Kreuzreaktivität Ein Panel
Page 65 and 66:
PLATELIA TOXO IgM 72841 96 TEST DE
Page 67 and 68:
3. PRINCIPIO Platelia Toxo IgM è u
Page 69 and 70:
R9 Marcatura Natura dei reagenti Pr
Page 71 and 72:
• Evitare qualsiasi contatto dei
Page 73 and 74:
• R2: Dopo la diluizione, la Solu
Page 75 and 76:
13. Bloccare la reazione enzimatica
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Popolazione analizzata / sito Sito
Page 79:
10. LIMITI DELLA PROCEDURA La diagn
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