AWARE™ HIV-1/2 OMT & AWARE™ ORAL

HIV Oral Fluid Test - Aware™ HIV-1/2 OMT

The Aware™ HIV-1/2 OMT (oral fluid) test and its over-the-counter version, Aware™ Oral, is a single-use, qualitative, visually read, in vitro immunoassay for the detection of antibodies to HIV Type 1 (HIV-1) and Type 2 (HIV-2) in human oral fluid specimens (oral mucosal transudate). The test is intended for use as a point-of-care aid in the clinical diagnosis of HIV infection. It can be used as a component of a multi-test rapid algorithm in conjunction with other approved HIV-antibody assays.

We developed our Aware™ HIV-1/2 OMT (oral fluid) HIV test to address the drawbacks of current blood-based testing methods. Aware™ HIV-1/2 OMT is ideally suited for clinical or professional use in resource-constrained settings and facilitates efficient group counseling and testing. The over-the-counter version of our oral fluid HIV test addresses the issue of testing privacy and is tailored for the non-professional consumer.

The Aware™ HIV-1/2 OMT test comes in kits of 25 or 50 individual test sets, each containing everything needed to collect and test an oral fluid sample. It is intended for use in professional point-of-care settings, such as physicians’ offices and voluntary counseling and testing centers. This HIV oral fluid test is also suitable for use by clinical laboratories.

Over-The-Counter HIV Test - Aware™ Oral

The over-the-counter version of our oral fluid HIV test—“Aware™ Oral”—is sold in single-test kits containing everything needed to collect and test one sample. The Aware™ Oral (oral fluid) HIV test is intended for distribution through pharmacies and drug stores, providing optimum privacy. It includes a simplified product insert and special instructions to facilitate at-home HIV self testing.

In September 2007, the U.S. Agency for International Development placed the Aware™ HIV-1/2 OMT test on its rapid HIV test waiver list, which, under the U.S. Acquisition & Assistance Policy Directive, permits the test to be used in USAID-funded projects. The USAID decision lets countries whose governments have approved the test purchase it with funds from the President's Emergency Plan for AIDS Relief. Announced by President George W. Bush in 2003, PEPFAR was expanded in 2007 with $15 billion in Congress-approved funding through 2012. Additional funding of $30 billion over the next five years was recently proposed to Congress. PEPFAR is the largest commitment ever by any nation for an international health initiative dedicated to a single disease.

The Aware™ HIV-1/2 OMT test is approved for use in multiple countries worldwide. It is not currently available in the United States.

Product Highlights

The Aware™ HIV-1/2 OMT and Aware™ Oral tests deliver significant advantages:

Speed

Generates results in 20 minutes

Safety

Requires no handling of blood, significantly reducing risk of exposure to infectious agents
Eliminates risk of HIV infection of healthcare workers through accidental lancet/needle stick injuries
Eliminates risk of HIV infection of patients through lancet/needle reuse
Reduces disposal requirements

Ease of use

Requires practically no training
Enables easy sample collection by swabbing the tooth/gum line
Requires no phlebotomist or lab technician
Eliminates lancets, needles, Vacutainers®, tourniquets, alcohol wipes or other blood testing supplies

Encouragement of testing

Honors strong preferences for oral fluid-based over blood-based testing
Eliminates safety concerns or pain associated with blood collection
Avoids cultural taboos against handling or drawing blood
Facilitates testing of children, obese persons, individuals with collapsed veins and other patients where
drawing blood is difficult

Ease of transport and storage

Lasts 18 months at room temperature (2-30ºC)
Comes packaged in individual test packs, each containing everything needed to collect and test an oral
fluid sample

Economic benefits

Reduces costs of testing by as much as 59% (based on typical labor and supply costs in Africa)
Controls costs of infections related to blood-based testing
Facilitates early treatment when infections are easier and less expensive to treat and contain
Improves wellness and productivity
Reduces morbidity and mortality

Configurations

Product Description	Quantity	Catalog #	Product Insert
Aware™ HIV-1/2 OMT	25 tests	98142	English Arabic French Portuguese Spanish
		98150	English & Russian
		98162	English & Georgian
Aware™ HIV-1/2 OMT	50 tests	98140	English Arabic French Portuguese Spanish
		98148	English & Russian
		98160	English & Georgian
Aware™ HIV-1/2 OMT 1.0 (Available only in China)	50 tests	98185	Chinese
Aware™ Oral OTC	1 test	98134	English & Arabic
		98136	English & Russian
		98180	English & Georgian

Product literature / downloads

Calypte Biomedical Corporation develops point-of-care diagnostic HIV tests and HIV incidence testing systems. The Calypte Aware™ rapid oral fluid HIV test, blood HIV test, and urine HIV test offer unrivalled rapid HIV 1/2 testing flexibility in a non-laboratory setting.