Rapid Diagnostic Test Kit Promotion
Alere Determine HIV-1/2 Ag/Ab Combo
Antibody Test HIV Detection
Whole Blood / Serum / Plasma Sample CLIA Waived
for Fingerstick Whole Blood / CLIA Moderate
Complexity for Venous Whole Blood,
Serum and Plasma 25 Tests / Kit
Alere 7D264P

Rapid Diagnostic Test Kit Promotion
Alere Determine HIV-1/2 Ag/Ab Combo
Antibody Test HIV Detection
Whole Blood / Serum / Plasma Sample CLIA Waived
for Fingerstick Whole Blood / CLIA Moderate
Complexity for Venous Whole Blood,
Serum and Plasma 25 Tests / Kit
Alere 7D264P

Manufacturer # 7D264P Brand Alere Determine™ HIV-1/2 Ag/Ab Combo Manufacturer Alere Application Rapid Diagnostic Test Kit Promotion CLIA Classification CLIA Waived for Fingerstick Whole Blood / CLIA Moderate Complexity for Venous Whole Blood, Serum and Plasma Kit Contents Test Cards, Chase Buffer, Package Insert, Quick Reference Guide, Capillary Tubes, Disposable Workstations Number of Tests 25 Tests / Kit Reading Type Visual Read Sample Type Whole Blood / Serum / Plasma Sample Test Format Test Card Test Method Lateral Flow Method Test Name HIV Detection Time to Results 20 Minute Results Type Antibody Test UNSPSC Code 41116144 Features Alere Determine™ HIV–1/2 Ag/Ab Combo is an in vitro, visually read, qualitative immunoassay for the simultaneous detection of Human Immunodeficiency Virus Type 1 (HIV-1) p24 antigen (Ag) and antibodies (Ab) to HIV Type 1 and Type 2 (HIV-1 and HIV-2) in human serum, plasma, capillary (fingerstick) whole blood or venipuncture (venous) whole blood It is intended for use as a point-of-care test to aid in the diagnosis of infection with HIV-1 and HIV-2, including an acute HIV-1 infection, and may distinguish acute HIV-1 infection from established HIV-1 infection when the specimen is positive for HIV-1 p24 antigen and negative for anti-HIV-1 and anti-HIV-2 antibodies