GENETIC SYSTEMS™ HIV-1 Ag EIA

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13 - PERFORMANCES Sensitivity • 138 patients infected by HIV at different stages (AIDS, ARC, others) have been tested and found positives with the test GENETIC SYSTEMS HIV-1 Antigen EIA. • 20 well documented seroconversions panels were studied. The results obtained are comparable to those observed with other HIV Ag assay. • 55 cell culture supernatants of HIV 1 (53 group M and 2 group O) and the dilution panel «Ag VIH SFTS 96» have been found positives with the GENETIC SYSTEMS HIV-1 Antigen EIA test except 2 dilutions of group O cell culture supernatants. - The 53 cell culture supernatants of the HIV-1 group M are composed of the following genotypes : 10 genotypes of A, 10 of B, 9 of C, 5 of D, 11 of E, 2 of F, 2 of G, 1 of H, 2 of J, and 1 of N. - The dilution panel «Ag VIH SFTS 96» includes the following genotypes : A, B, C, D, E, F, G, H genotypes from the Group M and 1 from the group O. Analytical Sensitivity The sensitivity limit of the test has been evaluated on a range of dilutions prepared from the french national standard (purified viral lysate of genotype B diluted in negative citrated plasma) and the BBI panel (PRA 801). The sensitivity limit has been estimated at 8 pg/ml Ag HIV whatever protocol is. The calibration curve obtained with HIV-1 Ag Standard (code 72217) calibrated sample is linear between 0 and 100 pg/ml Diagnostic Specificity The diagnostic specificity evaluated on : • 4038 blood donors has been estimated at 99.95%. • 209 clinical patients has been estimated at 100%. A panel of 105 patient samples has been tested. It is composed of samples : • containing antibodies to HAV, HCV, HTLV, HSV, EBV, Rubella, Toxoplasma Gondii, Treponema Pallidum, CMV • containing auto-Ab, IgG, IgM rhumatoid factor • from pregnant women, cirrhosis population, multiply transfused and patients reached of Systemic lupus erythematosus Only one sample came from and patient reached of Systemic lupus erythematosus has been found reactive with the Genetic Systems HIV-1 Ag EIA test but not confirmed with the confirmatory test. Accuracy The intra-assay reproductibility has been evaluated by testing 3 positive samples and one negative sample 30 times in the same run. The inter-assay reproductibility has been evaluated by testing testing 3 positive samples and one negative sample during 5 days with 2 different technicians. The coefficient of variation for positive samples was less than 10%. 14 - LIMITS OF THE TEST • The GENETIC SYSTEMS HIV-1 Antigen EIA Procedure and the Interpretation of Results must be followed when testing serum, plasma, or cell culture specimens for the presence of HIV-1 antigen. The user of this kit is advised to read the package insert carefully prior to conducting the test. In particular, the test procedure must be carefully followed for sample and reagent pipetting, plate washing, and timing of the incubation steps. • A designation of reactive for HIV-1 antigen must not be based on a single reactive test result. Additional testing, such as confirmatory testing, is required to establish the specificity of any specimen reactive by the screening procedure. • All highly sensitive immunoassays have a potential for non-specific reactions which can lead to false positive results. The proportion of reactives that are false will depend on the sensitivity and specificity of the test kit. • Negative results can occur if the quantity of marker present in the sample is too low for the detection limits of the assay, or if the marker which is detected is not present during the stage of disease in which a sample is collected. • The varaibility of HIV virus doesn’t allow to exclude the possibility of false negative results. No known test method can offer complete assurance that the HIV virus is absent. • Failure to add specimen or reagent as instructed in the procedure could result in a falsely negative test. Repeat testing should be considered where there is clinical suspicion of infection or procedural error. • An absorbance value of less than 0.000 AU indicates a procedural or instrument error and must be repeated. • Factors that can affect the validity of results include failure to add the specimen to the well, inadequate washing of microplate wells, failure to follow stated incubation times and temperatures, addition of wrong reagents to 12
wells, the presence of metals, or splashing of bleach into wells. • Performances of the test have not been evaluated on post mortem samples or on biological fluid other than serum, plasma or cell culture specimens. • The sample diluent coloration may not change in presence of cell culture samples according to the cell culture medium. • Even the analytical sensitivity estimated at 8 pg/ml during the evaluations of this test, it may vary according to the operating conditions and due to the variability inter-batch. Consequently, BIO-RAD guarantees only the analytical sensibility below 15 pg/ml. • The colorimetric method for the samples, conjugate and development solution deposition verification does not allow to verify the accuracy of the dispensed volumes. This method only shows the presence of sample, conjugate and development solution into wells. The rate of wrong answers with this method is closely linked to the accuracy of the utilized system (cumulated coefficient of variation of dispensing and reading over 10% significantly decrease the quality of the verification). • In case of very poor washing efficiency after the conjugate incubation, the automatic verification of the development solution pipetting (by reading OD of wells at 490 nm) may provide wrong results with OD above 0.100 in the absence of development solution. However this phenomena has not been observed during evaluation on 939 tested samples. 15 - REFERENCES See French version. 13
Page 1: GENETIC SYSTEMS HIV-1 Ag EIA 192 Te
Page 4 and 5: CONTENTS 1 - CLINICAL VALUE 2 - PRI
Page 6 and 7: 3 - CONTENTS OF THE GENETIC SYSTEM
Page 8 and 9: Remark : For washing solution (R2,
Page 10 and 11: 10 Strictly follow the proposed pro
Page 15 and 16: GENETIC SYSTEMS HIV-1 Ag EIA 192 Te
Page 17 and 18: 1 - INTÉRÊT CLINIQUE L’agent é
Page 19 and 20: • Dispositif de lavage manuel, se
Page 21 and 22: 1) Réactifs prêts à l’emploi R
Page 23 and 24: 8. Distribuer rapidement 100 µl de
Page 25 and 26: dilution "Ag VIH SFTS 96" ont tous
Page 29 and 30: 1 - INTERÉS CLÍNICO El agente eti
Page 31 and 32: • Aparato de lectura para micropl
Page 33 and 34: 8 - RECONSTITUCIÓN DE LOS REACTIVO
Page 35 and 36: ha de agitar antes de su empleo. N.
Page 37 and 38: Sensibilidad analítica El umbral d
Page 41 and 42: 1 - KLINISCHE BEDEUTUNG Erreger des
Page 43 and 44: • Wasserbad oder Trockeninkubator
Page 45 and 46: 8 - REKONSTITUTION DER REAGENZIEN A
Page 47 and 48: 8. 100 µl der Konjugat-Arbeitslös
Page 49 and 50: Diagnostische Spezifität Die diagn
Page 53 and 54: 1 - INTERESSE CLINICO L'agente ezio
Page 55 and 56: • Strip non sensibilizzate qualor
Page 57 and 58: 8 - RICOSTITUZIONE DEI REAGENTI Tut
Page 59 and 60: 8. Distribuire rapidamente 100 µl
Page 61 and 62: Sensibilità analitica La soglia di
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GENETIC SYSTEMS HIV-1 Ag EIA 192 Te
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1 - INTERESSE CLÍNICO O agente eti
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• Tiras não sensibilizadas para
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8 - RECONSTITUIÇÃO DOS REAGENTES
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8. Distribuir rapidamente 100 µl d
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- O painel de diluição "Ag VIH SF
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1 - KLINISK BETYDELSE Etiologisk ag
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• Engångshandskar. • Absorbera
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förbrukning (24 timmar efter bered
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2) Beräkning av absorbansmedelvär
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1 - KLINISK VÆRDI Det ætiologisk
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• Rene plastikbeholdere (af enten
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• Reagenser til rekonstituering S
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11 - BEREGNING OG FORTOLKNING AF RE
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• Ved cellekulturprøver må prø
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