Studies Commence to Ensure Reliability of HIV 1/2 Assay

An HIV 1/2 assay detects antibodies to HIV 1 and 2 in oral fluid, finger-stick whole blood (fingerstick), venous whole blood, serum, or plasma samples.

Chembio Diagnostics' (Medford, NY, USA) DPP HIV 1/2 assay provides a simple "reactive/nonreactive" result. In a clinical evaluation of over 3,000 patients across three countries, the diagnostic sensitivity of the DPP HIV 1/2 assay to detect HIV infection ranged from 99.9%–100% for fingerstick specimens and 98.9%–100% for oral fluid specimens. The diagnostic specificity of the DPP HIV 1/2 assay was 100% for fingerstick specimens and 99.9%–100% for oral fluid specimens. The test is intended to be used in the preliminary diagnosis of patients with HIV in point-of-care (POC) settings such as public health and other clinics, hospital emergency rooms and physician offices.

The assay does not use lateral flow or other older flow-through technologies. DPP HIV 1/2 delivers visual results within approximately 15 minutes, is simple to use, requires minimal sample size, has a shelf life of 24 months, and does not require refrigeration. Providing results at the POC eliminates the chance that patients at risk would not return or call back for results, thereby improving prevention efforts of forward transmission.

A convenient swab for collection of oral fluid samples is a feature of DPP HIV 1/2. Sharp distinct test lines are obtained due to the DPP technology. The sample collection system enables each sample to be contained in a convenient, closed collection vial, or Sampletainer, which provides additional sample for repeat testing.

Although the US Food and Drug Administration (FDA; Silver Spring, MD, USA) approved Chembio's new DPP HIV 1/2 Assay multisite assay in December 2012, it requires Clinical Laboratory Improvement Amendments (CLIA) waiver studies to establish the quality standards for laboratory testing. These must ensure the accuracy, reliability, and timeliness of patient tests results regardless of where the tests are performed.

The CLIA clinical study will test samples prospectively collected from approximately 1,000 subjects who are HIV positive and of unknown HIV status. The study is expected to be completed within three to four months. The company anticipates that the FDA's review of the CLIA Waiver Application will be completed during the fourth quarter of 2013.

"We are very pleased to commence the CLIA clinical testing for our DPP HIV 1/2 Assay. It is a key component for Chembio as we finalize our commercial strategy to launch the DPP assay in the US," noted Lawrence Siebert, Chembio's CEO.

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