Chembio receives FDA approval for rapid HIV tests

By Elaine Rigoli

Tampa, Fla., May 30 - Chembio Diagnostics, Inc. has received approval from the Food and Drug Administration for its Sure Check HIV ½ and HIV ½ Stat-Pak rapid test to market its rapid HIV tests to clinical laboratories and hospitals in the United States.

The approval is for use not only with finger-stick whole blood samples but also with venous whole blood, serum and plasma samples.

Chembio said FDA approval also allows the company to expand its international marketing efforts into countries that require regulatory approval in the manufacturer's country of domicile.

Sure Check HIV ½ and HIV ½ Stat-Pak rapid tests are highly sensitive (99.7% for HIV-1 and 100% for HIV-2) and specific (99.9%), according to a news release.

The tests, with a turnaround time of about 15 minutes, offer a 24-month shelf life from date of manufacture at 46-86 degrees Fahrenheit, the release said. This advantage may become more important if rapid HIV tests such as Chembio's are approved for the over-the-counter markets in accordance with guidelines that the FDA's Blood Products Advisory Committee recently recommended.

Located in Medford, N.Y., Chembio develops and manufactures rapid diagnostic tests for various infectious diseases.

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