Sindrome Inmunodeficiencia Adquirida

12002094001V10

HIV Ag
REF 11971611

HIV Ag - human immunodeficiency virus type 1 (groups M and O) p24 antigen 122 MODULAR ANALYTICS E170 • 100 tests • Indicates analyzers on which the kit can be used Elecsys 2010 • English cobas e 411 • cobas e 601 cobas e 602 • • Reagents - working solutions M Streptavidin-coated microparticles (transparent cap), 1 bottle, 6.5 mL: Streptavidin-coatedmicroparticles 0.72 mg/mL; preservative. R1 Anti-HIV p24-Ab~biotin (gray cap), 1 bottle, 8 mL: Biotinylated monoclonal anti-HIV p24 antibodies (mouse) > 0.5 mg/L; TRIS buffer 50 mmol/L, pH 7.4; preservative. R2 Anti-HIV p24-Ab~Ru(bpy)2+ (black cap), 1 bottle, 8 mL: 3 Monoclonal anti-HIV p24 antibodies (mouse) labeled with ruthenium complex > 0.8 mg/L; TRIS buffer 50 mmol/L, pH 7.4; preservative. Cal1Negative calibrator (white cap), 2 bottles of 1.0 mL each: Human serum; preservative. Cal2 Positive calibrator (black cap), 2 bottles of 1.0 mL each: HIV p24 antigen (E. coli, rDNA) approx. 240 pg/mL in acetate buffer, pH 4.5; preservative. Precautions and warnings For in vitro diagnostic use. Exercise the normal precautions required for handling all laboratory reagents. Disposal of all wastematerial should be in accordance with local guidelines. Safety data sheet available for professional user on request. All human material should be considered potentially infectious. The negative calibrator has been prepared exclusively from the blood of donors tested individually and shown to be free from HBsAg and antibodies to HCV and HIV. The testing methods applied were FDA-approved or cleared incompliance with the European Directive 98/79/EC, Annex II, List A. However, as no testing method can rule out the potential risk of infection with absolute certainty, the material should be treated just as carefully as a patient specimen. In the event of exposure the directives of the responsible health authorities should be followed.10,11 The reagents may not be used after the stated expirationdate. Avoid the formation of foam with all reagents and sample types (specimens, calibrators, and controls). Reagent handling The reagents in the kit are ready for use and are supplied in bottles compatible with the system. Elecsys 2010 and cobas e 411 analyzers: The calibrators Cal1 and Cal2 should only be left on the analyzers during calibration at 20-25 °C. After use, close the bottles as soon aspossible and store at 2-8 °C. Ensure that no calibration solution is trapped in the opened snap-cap. Because of possible evaporation effects, not more than 5 calibration procedures per calibrator bottle set should be performed. MODULAR ANALYTICS E170, cobas e 601 and cobas e 602 analyzers: Unless the entire volume is necessary for calibration on the analyzer, transfer aliquots of theready-for-use calibrators into empty snap-cap bottles (CalSet Vials). Attach the supplied labels to these additional bottles. Store the aliquots for later use at 2-8 °C. Perform only one calibration procedure per aliquot. All information required for correct operation is read in via the respective reagent barcodes. Storage and stability Store at 2-8 °C. Store the Elecsys HIV Ag reagent kit (M, R1, R2) uprightin order to ensure complete availability of the microparticles during automatic mixing prior to use. Stability: unopened at 2-8 °C M, R1, R2 after opening at 2-8 °C on MODULAR ANALYTICS E170, cobas e 601 and cobas e 602 on Elecsys 2010 and cobas e 411 Cal1, Cal2 after opening at 2-8 °C on Elecsys 2010 and cobas e 411 at 20-25 °C on MODULAR ANALYTICS E170, cobas e 601 and cobas e 602 1/4 up to thestated expiration date 4 weeks 4 weeks 4 weeks 4 weeks up to 5 hours use only once Elecsys and cobas e analyzers

Intended use Immunoassay for the in vitro qualitative determination of the p24 antigen of human immunodeficiency virus type 1 (HIV-1, groups M and O) in human serum and plasma and in cell culture supernates. The electrochemiluminescence immunoassay “ECLIA” is intended for use on...