GENETIC SYSTEMS™ HIV-1 Ag EIA

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3 - CONTENTS OF THE GENETIC SYSTEM HIV-1 ANTIGEN EIA 6 LABEL TYPE OF THE REAGENT PRESENTATION 71120 R1 Microplate 2 plates 12 strips of 8 wells coated with murine monoclonal antibodies to HIV-1 p24 Preservative : ProClin 300, Sodium azide (< 0.1%) R2 Concentrated Washing Solution (10x) 1 vial Buffer Tris NaCl pH 7.4 250 ml Preservative : 0.01 % Sodium merthiolate R3 Specimen Diluent 1 vial Preservative : 0.5% ProClin 300 20 ml Sample addition dye (green) CO Negative Control Serum (Human) 1 vial Normal human serum non reactive for HIV antigen, HBs Ag, and antibodies 10 ml and antibodies to HIV-1, HIV-2, HCV, and HTLV-1 0.005% Gentamicin sulfate Preservative : 0.5% ProClin 300 C1 Positive Control Serum 1 vial Purified, disrupled HIV-1 antigen 7 ml Preservative : 0.5 % ProClin 300 R4 Concentrated conjugate 1 (100 x) 1 vial Sheep anti-p24 conjugate 0.005 % Gentamicin sulfate 1 ml Yellow dye - Preservative : 0.5 % ProClin 300 R5 Concentrated conjugate 2 (100 x) 1 vial Avidin-HRP conjugate 0.005% Gentamicin sulfate 1 ml Green dye - Preservative : 0.5% ProClin 300 R6 Conjugate Diluent 1 vial Buffer with protein stabilisers 100 ml Preservative : 0.5% ProClin 300 R8 Substrate Buffer 1 vial Citric acid/Sodium acetate buffer pH 4.0 60 ml Hydrogen peroxide 0.015% Dimethylsulfaxide (DMSO) 4% R9 Chromogen 1 vial Tetramethylfaxide (TMB) 5 ml R10 Stopping Solution 2 vials 1N H 2 SO 4 2 x 28 ml Plate Sealers 25 sealers each 4 - MATERIAL REQUIRED BUT NOT PROVIDED • Distilled water • Household bleach (5% to 8% sodium hypochlorite) which may be diluted to a minimum concentration of 10% bleach (or 0.5% sodium hypochlorite). Alternative disinfectants include : 70% ethanol or 0.5% Wescodyne (West Chemical Products, Inc.). • Precision pipettes to deliver volumes from 10 µl to 200 µl, 1 ml, 5 ml, and 10 ml (accurate within ± 10%). A multichannel pipettor capable of delivering 100 µl or 200 µl is optional. • Graduated cylinders of 25 ml, 100 ml, 1000 ml. • Container for contaminated residues. • Water bath or dry incubator*, thermostatically set at 37±1°C or 40±1°C. • Manual, semiautomatic or automatic microplate washer (*). • Microplate reader equipped with 450 nm and 620- 700 nm filters (*). • Null strips for testing partial on automate. • EIA reagent reservoirs (optional).
• Disposable gloves • Absorbent paper • Clean plastic containers (either polystyrene or polypropylene) for preparation of Working Conjugate Solutions and TMB Solution. • Cell Culture Medium, e.g. RPMI-1640 containing 10% fetal calf serum, equivalent to that used for infected cell culture (when testing cell culture samples). (*) Consult us for detailed information about the equipment recommended by our technical department. 5 - HEALTH AND SAFETY INSTRUCTIONS All the reagents included in the kit are intended for «in vitro» diagnostic use. • Wear disposable gloves when handling reagents and samples and thoroughly wash your hands after having handled them. • Do not pipette by mouth. • Human source material used in the preparation of the negative control was tested and found non reactive for HIV- 1 antigen, anti-HIV1 and anti-HIV2 antibodies, hepatitis B antigen (HB Ag), anti-HCV antibodies, anti HTLV1/HTLV 2 antibodies and anti HIV1/HIV2. • The positive control is heat inactivated by dissociating agent. • Because no known test method can offer complete assurance that the HIV, Hepatitis B or C virus or other infectious agents are absent, consider these reagents, as well as patient samples, as potentially infectious and handle them carefully. • Any equipment directly in contact with samples and human source reagents as well as buffer solutions should be considered as contaminated products and treated accordingly. • Avoid spilling samples or solutions containing samples. • Contaminated surfaces should be cleaned 10% diluted bleach. If the contaminating fluid is an acid, the contaminated surfaces should be first neutralized with sodium bicarbonate, then cleaned with bleach, and dried with absorbent paper. The material used for cleaning should be discarded into a biohazardous waste container. • Samples, human source reagents, as well as contaminated material and products should be discarded after decontamination : - either by soaking into bleach at a final concentration of 5% sodium hypochlorite (1 volume of bleach per 10 volumes of contaminated fluid or water) for 30 minutes - or by autoclaving at 121°C for 2 hours minimum. Autoclaving is the best method to inactivate HIV and HBV. CAUTION : DO NOT PLACE SOLUTIONS CONTAINING SODIUM HYPOCHLORITE IN THE AUTOCLAVE • The Safety Data Sheet is available upon request. • Avoid any contact of the substrate buffer, the chromogen and the stopping solution with the skin and mucosa (toxicity, irritation or burn hazard). • Do not forget to neutralize and/or autoclave the wash waste solutions or any fluid containing biological samples before discarding them into the sink. • Chemicals should be handled and discarded in accordance with Good Laboratory Practices. • Some reagents contain sodium azide as a preservative. Sodium azide may form copper or lead azides in laboratory plumbing. Such azides are explosive. To prevent azide built-up, flush the pipes with a large amount of water if solutions containing azide are discarded into the sink after inactivation. • Some reagents contain 0.5% ProClin 300 ProClin 300 0.5% : Irritant R43 : May cause sensitisation by skin contact S28-37 : After contact with skin, wash immediatly with plenty of soap and water. Wear suitable gloves. Xi - Irritant 6 - PRECAUTIONS The reliability of results depends on correct observance of the following Good Laboratory Practices: • Do not use expired reagents. • Do not change the assay procedure. • Carefully reconstitute reagents avoiding any contamination. • Do not mix reagents from different lots within a given test run. 7
Page 1: GENETIC SYSTEMS HIV-1 Ag EIA 192 Te
Page 4 and 5: CONTENTS 1 - CLINICAL VALUE 2 - PRI
Page 8 and 9: Remark : For washing solution (R2,
Page 10 and 11: 10 Strictly follow the proposed pro
Page 12 and 13: 13 - PERFORMANCES Sensitivity • 1
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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
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8 - RICOSTITUZIONE DEI REAGENTI Tut
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8. Distribuire rapidamente 100 µl
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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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GENETIC SYSTEMS™ HIV-1 Ag EIA

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