Home Access on the facts about FDA approval of HIV at-home screen product
HOFFMAN ESTATES, Ill., July 5, 2012 /PRNewswire/ -- The Food and Drug Administration (FDA) Tuesday (July 3) approved an over-the-counter screening test for HIV. The name of the product is the OraQuick In-Home HIV test, manufactured by OraSure Technologies. The FDA has moved forward despite concerns raised by experts about the accuracy of the product and other issues.
Home Access Health Corporation, based in Hoffman Estates, IL, would like the nation's medical writers to be armed with the facts about this new product and the important distinctions between it and the Home Access Express HIV-1 Test, an over-the-counter HIV test approved by the FDA in 1996. Home Access does not wish to challenge the FDA's approval of the OraSure product but only to make known the important distinctions between its successful Home Access Express HIV-1 Test and the OraQuick product for purposes of reference and accuracy in news coverage. For more information, please refer to the FDA website Vital Facts About HIV Home Test Kits.
Key issues and distinctions:
FDA approval: The Home Access Express HIV-1 Test was approved for over-the-counter sale by the FDA in 1996; FDA approval of OraQuick was approved Tuesday (July 3).
Nature of self-collected test specimen: Home Access Express HIV-1 uses the more reliable fingerstick blood sample; OraQuick relies on oral fluid.
Speed of confirmed testing results: Home Access Express HIV-1, confirmed results next business day; OraQuick, 20 minutes for screening results, not confirmed results. Confirmation of preliminary positive results requires a separate test not available to consumers through OraSure.
Accuracy of results: In consumer trials, the Home Access® Express HIV-1 demonstrated 100 percent accuracy for both sensitivity and specificity (the measures of whether a person is truly infected or negative). OraQuick achieved 92.98 percent in sensitivity (% of detected, truly infected individuals) and 99.98 percent in specificity (% of confirmed, non-infected individuals).
Whether accuracy standards achieve benchmarks set by FDA Blood Products Advisory Committee (BPAC): Yes, for the Home Access® Express HIV-1 test; for OraQuick, no. In consumer trials, the OraQuick test identified 12 out of 13 infected individuals, but this is an estimate of product performance. However, the data presented by OraSure suggests that in the field, the OraQuick test may identify only 86.64% of infected individuals, or 1 out 7 infected individuals can be missed. BPAC's acceptable standard for the low end of sensitivity estimate is 1 out of 20.
How results are tested: All Home Access Express HIV-1 testing occurs in a lab accredited by College of American Pathologists and done by certified medical technologists responsible for sample testing, results and results interpretation. The OraQuick product relies on the lay person who uses the product to collect, test and interpret results.
Are positive results confirmed? Home Access confirms preliminary positive samples using a second, different FDA-approved test before results are released. The second test provides confirmation of results. OraQuick provides no confirmation of test results. It is a screening product that can only provide the user with indications of results. Further confirmation is then required.
Is pre- or post-testing confirmation provided? Yes for Home Access product; no for OraQuick.
Results delivered by trained HIV counselors? Yes for Home Access product; no for OraQuick.
Counselors responding to results? Home Access Express HIV-1 offers trained HIV counselors who are available for further counseling or referrals immediately upon the delivery of results to the test user. They are available for call-backs at the discretion of the test user. OraSure offers no professional counseling. As expressed to the FDA Blood Products Advisory Committee, the OraSure call center is staffed with customer service representatives who will transfer "positive" individuals to HIV hotlines or other HIV services.
About Home Access Health Corporation
Home Access Health Corporation (HAHC) was founded in 1993 to provide anonymous, direct-to-consumer laboratory test services using self-collected fingerstick blood. Individuals collect, package and send a small fingerstick blood specimen to the Company's CAP-accredited laboratory, using components provided in the Home Access test kits. HAHC received FDA approval for its HIV-1 Test System in 1996 and immediately launched a national consumer awareness campaign.
In 1998, responding to the U.S. Surgeon General's order for public health departments (and other healthcare entities) to combat Hepatitis C (HCV), the company adapted its HIV platform and fast-tracked clinical trials and regulatory filings, resulting in an FDA approval for Home Access® Hepatitis C Check test service in 1999. HAHC markets its HCV test primarily through public health departments.
In 2007, the Company received FDA clearance for its complete Cholesterol Panel, a comprehensive laboratory test system that uses self-collected fingerstick blood to measure total cholesterol, HDL-cholesterol, Triglycerides and LDL-cholesterol. The accuracy levels of the Cholesterol Panel achieve the standards established by the National Cholesterol Education Program and the test method has been certified by the CDC-sponsored National Cholesterol Reference Method Laboratory Network.
The Home Access FDA-approved test system for HIV-1 and Hepatitis C is sold directly to consumers without the need for physician intervention. These tests are anonymous, include confirmatory testing, and access to the HAHC counseling center for results delivery, counseling, and referrals.
SOURCE Home Access Health Corporation
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