• RAPID DIAGNOSTIC TESTING
• INCIDENCE TESTING
  • Aware™ BED™ EIA
  • Aware™ BED™ EIA DBS Control Pack
• SAMPLING SYSTEMS

AWARE™ BED™ EIA TEST

HIV Incidence Test

The Aware™ BED™ EIA HIV-1 Incidence EIA test (formerly the Calypte® HIV-1 BED Incidence EIA) is used to estimate the rate of new HIV infections in populations by determining what proportion of a population of HIV-infected individuals were infected within six months of sample collection. Aware™ BED™ EIA was originally developed by the U.S. Centers for Disease Control and Prevention (CDC) and Calypte now manufactures this HIV incidence test under a license from the CDC.

Click here to learn more about this innovative technology.

The Aware™ BED™ EIA HIV-1 Incidence EIA test is an in vitro quantitative enzyme immunoassay and estimates incidence by determining the proportion of HIV-1 specific IgG in a given serum, plasma or whole-blood specimen compared to total IgG. The test allows for the testing of both liquid and dried samples; a Dried Blood Spot or DBS Control Pack, available separately, is needed to test dried plasma, serum or whole blood samples. The Aware™ BED™ EIA HIV-1 Incidence EIA is a surveillance research tool designed to be used for public health purposes only, such as estimating HIV incidence in populations. Prevention programs can use data from the test in targeting resources, monitoring and evaluation, and identifying high-risk cohorts for prevention research, including vaccine trials. The test is not intended to be used for diagnosing individual patients or influencing patient treatment.

Since the Aware™ BED™ EIA HIV-1 Incidence EIA is intended only for population studies, its use is generally permitted in most countries without the need for product registration. Research institutions in the United States that intend to use the Aware™ BED™ EIA on non-USA samples must complete and submit the Certification Form for Research Use with their orders. Research institutions in the U.S. that intend to use the EIA on samples from citizens or residents of the USA must submit approval to purchase the test from Bernie Branson, M.D., of the CDC with their orders. Click here to email Dr. Branson.

Product Highlights

• The Aware™ BED™ EIA is a quantitative microwell ELISA manufactured by Calypte under license by the U.S. Centers for Disease Control. It uses conventional peroxidase/TMB chemistry and produces results in approximately four hours.
• The test is intended to be used only on samples previously determined to be positive for HIV antibody.
• The validity of each test run is confirmed using the automated Calypte® Incidence Excel Spreadsheet or by alternative analysis. Seven unique assay validity criteria ensure the integrity of the test and the results.
• The EIA allows testing of dried plasma, serum and whole-blood samples when the supplemental DBS Control Pack is used.
• The test is intended for use as an epidemiology tool to measure HIV-1 incidence (infections occurring in the prior 153 days) in populations.
• The assay principle is based on the ratio of HIV-1 specific to total IgG and not on the less relevant extreme dilution (e.g., as determined in detuned assays). Consequently, the small sample dilution of 1:101 maximizes reproducibility and can be accomplished in a single step.
• A novel branched peptide representing B, E and D HIV-1 subtypes was selected and incorporated because it provides uniform cross reactivity to all HIV-1 subtypes, including those not specifically represented in the peptide.
• Each kit contains two 96-well test plates and can test 170 specimens in the screening mode or 56 specimens in the confirmatory mode (triplicate testing).

Configurations

Product literature / downloads

• Brochure
• Aware™ BED™ EIA Material Safety Data Sheets (MSDS)
• DBS Control Pack Material Safety Data Sheets
• Aware™ Incidence Excel Spreadsheet (for calculating assay results)
• Troubleshooting guide
• Certification form for research use