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Chembio Publishes Positive Data on Dual Path Platform Test for Syphilis

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Chembio Diagnostics has published a study demonstrating the utility of its antibody-based Dual Path Platform point-of-care test for syphilis.

Published last month in the online edition of Clinical Infectious Diseases, the study used the Dual Path test to detect antibodies linked to syphilis in whole blood, fingerprick blood, and blood plasma samples. It found that the test could detect these antibodies with sensitivities of 96.7 percent for whole blood, 96.4 percent for fingerprick blood, and 94.6 percent for blood plasma and specificities of 99.3 percent, 99.1 percent, and 99.6 percent, respectively.

The study was supported by the Rapid Syphilis Test Introduction Project through a grant from the Bill & Melinda Gates Foundation and examined 3,134 specimens from a total of 1,323 individuals at six sites across China.

The Dual Path Platform detects levels of both non-treponemal antibodies, to screen for infection, and treponemal antibodies, to confirm that the infection is active, which allows clinicians to distinguish between active and past, or previously treated, cases.

According to Lawrence Siebert, CEO of Chembio, the company plans to use the data from the study to support a 510(k) submission for the test to the US Food & Drug Administration. It hopes to make that submission by the middle of 2013, he said in a statement.

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