GENETIC SYSTEMS™ HIV-1 Ag EIA

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CONTENTS 1 - CLINICAL VALUE 2 - PRINCIPLE OF THE GENETIC SYSTEM HIV-1 ANTIGEN EIA 3 - CONTENTS OF THE GENETIC SYSTEM HIV-1 ANTIGEN EIA 4 - MATERIAL REQUIRED BUT NOT PROVIDED 5 - HEALTH AND SAFETY INSTRUCTIONS 6 - PRECAUTIONS 7 - COLLECTION AND HANDLING OF SPECIMENS 8 - RECONSTITUTION OF THE REAGENTS 9 - STORAGE CONDITIONS - SHELF LIFE 10 - ASSAY PROCEDURE 11 - CALCULATION AND INTERPRETATION OF THE RESULTS 12 - SPECTROPHOTOMETRIC VERIFICATION OF SAMPLE AND REAGENT PIPETTING 13 - PERFORMANCES 14 - LIMITS OF THE TEST 15 - REFERENCES 4
1 - CLINICAL VALUE The etiologic agent of Acquired Immunodeficiency Syndrome (AIDS) is a retrovirus which has been named Human Immunodeficiency Virus (HIV). HIV has been isolated from patients with AIDS and from healthy persons at high risk for AIDS 1,2 . Transmission is known to occur by intimate sexual contact, through the use of contaminated needles, by transfusions of contaminated blood products, and perinatally from infected mother to fetus or child. 1-8 Evidence of previous exposure to HIV is usually demonstrated by the presence of virus-specific antibody in an individual's serum or plasma after exposure to the virus. Prior to the appearance of detectable antibodies, there is an early period of time when free viral antigens circulate in the blood. One of these viral antigens is the major viral core protein, p24. HIV antigen assays can be used to detect the presence of viral antigens, and thus HIV infection, prior to seroconversion. The antigenemic period preceding the appearance of HIV antibodies is variable and can last for days or weeks in infected individuals. As an individual seroconverts, virus specific antibodies complex with the circulating antigens such that the levels of free antigens in the blood drop or disappear entirely. 9-11 Antigenemia may develop again later as the disease progresses. 12 The GENETIC SYSTEMS HIV-1 Antigen EIA is intended to be used as a screen for donated blood and plasma and as an aid in the diagnosis and prognosis of HIV-1 infection. 2 - PRINCIPLE OF THE GENETIC SYSTEM HIV-1 ANTIGEN EIA The Genetic Systems HIV-1 Antigen EIA is an enzyme immunoassay for the detection of HIV-1 core antigen (p24) in human serum and plasma specimens. The «GENETIC SYSTEMS HIV-1 Antigen Confirmatory» Test (code 71121) is a supplemental assay used with the HIV-1 Antigen EIA to confirm the presence of HIV p24 antigen in repeatedly reactive samples. The GENETIC SYSTEMS HIV-1 Antigen EIA is based upon the use of a solid phase prepared with mouse monoclonal antibody to HIV-1 Antigen, of a first conjugate prepared with biotinylated sheep anti-p24 antibody and a second conjugate prepared with avidin coupled to peroxidase of Raifort. The performance of the test includes the following reaction steps : 1. Specimen Diluent is added to each well. The samples to be tested and the control sera are added to their respective wells. If HIV-1 Ag is present in the specimen, it will bind to the antibodies coated on the well. Any HIV-1 Ag bound to the well will remain during the subsequent washing. The color of the Specimen Diluent changes from green to blue to confirm that a sample (or control) has been added to the well. 2. Conjugate 1 is then added to each well and the wells are incubated. This allows the biotinylated sheep anti-p24 antibody in Conjugate 1 to bind to any HIV-1 Ag that is bound to the well. The antigen-antibody complexes remain bound during the subsequent wash step. 3. Conjugate 2 is then added to the wells and allowed to incubate. The avidin in Conjugate 2 binds specifically to the antibody-HIV-1 Ag complexes that are bound to the well. Any unbound conjugate is removed by washing. 4. Working TMB Solution is added to the plate and allowed to incubate. A blue or blue-green color develops in proportion to the amount of HIV-1 Ag present in the sample. Color development is stopped by the addition of acid, which changes the blue-green color to yellow. The optical absorbance of specimens and controls is determined spectrophotometrically at a wavelength of 450/620-700 nm. 5
Page 1: GENETIC SYSTEMS HIV-1 Ag EIA 192 Te
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 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
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• 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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