DPP® HIV 1/2 Assay

20 Tests/Kit

An FDA approved, rapid point-of-care test that detects antibodies to HIV-1 and HIV-2  in oral fluid, whole blood, serum or plasma.

• Small Sample Size: 10 micro liters
• Utilizes Proprietary Dual Path Platform (DPP) technology
• Performance: Sensitivity (99%), Specificity (99.9%) across all matrices
• Patented DPP® SampleTainer® for convenient sample processing,  consistent performance
• Results in 15 minutes

NOT APPROVED FOR HOME USE - MEDICAL PROFESSIONALS ONLY.

The Chembio DPP HIV 1/2 Assay is a single-use immunochromatographic test for the detection of antibodies to Human Immunodeficiency Virus Types 1 and 2 (HIV-1/2) in oral fluid, fingerstick whole blood, venous whole blood, serum, or plasma samples.  The Chembio DPP HIV 1/2 Assay is intended for use as a point-of-care test to aid in the diagnosis of infection with HIV-1 and HIV-2. This test is suitable for use in multi-test algorithms designed for the statistical validation of rapid HIV test results. When multiple rapid HIV tests are available, this test should be used in appropriate multi-test algorithms

For Use With:

• Oral fluid sample
• Venipuncture whole blood
• Serum
• Plasma
• Fingerstick whole blood

Assay Features:

• Built-in procedural control to human IgG
• DPP®SampleTainer® bottle: a safe, closed system for handling potentially infectious blood and oral fluid samples
• Minimal sample size required, 10 µL
• Room temperature storage and procedure
• Ready-to-use reagents
• 24-month open vial stability for quality controls, 50 control runs per vial
• Long shelf life 23 months from date of manufacture
• No special laboratory equipment required

1 kit contains:

• 20 test devices
• 20 swabs
• 20 sample loops
• 20 specimen containers
• 1 running buffer
• 1 quick reference guide
• 20 subject information notices
• 1 product insert

Additional Features

• Low sample volume: only 10 μl
• Long Shelf life: 23 months
• Safe, closed system for sample handling with DPP SampleTainer®
• Patented DPP® Technology allows for higher sensitivity and specificity
  Built-in procedural control

Reimbursement Information

My Bio Tests and Chembio strongly recommends that providers contact their payors to determine appropriate coding prior to submitting claims for HIV testing.