Chembio applies for CLIA waiver for its Sure Check HIV 1/ 2 rapid diagnostic test

By Lisa Kerner

Charlotte, N.C., July 27 - Chembio Diagnostics, Inc. said it submitted a second Clinical Laboratory Improvement Amendment (CLIA) waiver application to the Food and Drug Administration for its Sure Check HIV 1/ 2 rapid diagnostic test.

"Having two tests that are CLIA-waived would provide flexibility for pricing and user preferences in public health clinics, laboratories, hospitals and physicians' offices," chief executive officer Larry Siebert said in a company news release.

"Sure Check HIV 1/ 2 is a device format that may be preferred by some users due to its simple procedure on finger-stick whole blood samples, while the flexibility of our HIV 1/ 2 Stat Pak which uses the same procedure across all blood sample types (serum, plasma, finger-stick whole blood and venous whole blood) will be preferred by certain other users."

Tests waved under the CLIA law include those that are so simple and accurate that erroneous results are unlikely, or those that pose no reasonable risk of harm to the patient if the test is performed incorrectly.

Chembio, based in Medford, N.Y., develops rapid diagnostic tests for infectious diseases.

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