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Syphilis Antibody Assay Combines Screening and Confirmation in One POC Test

By LabMedica International staff writers
Posted on 13 May 2022
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Image: Multiplo Complete Syphilis (TP/nTP) Antibody Test has received CE Mark (Photo courtesy of MedMira Inc.)
Image: Multiplo Complete Syphilis (TP/nTP) Antibody Test has received CE Mark (Photo courtesy of MedMira Inc.)

Syphilis is a sexually transmitted disease that has a tremendous impact on global health. In 2018 alone, the European CDC reported about 34,000 new confirmed cases of syphilis with a 70% increase in the notification rate in 2017 compared to 2010. They also concluded that for the first time since the early 2000s EU/EEA countries reported more syphilis cases than HIV. Since treatments that can prevent the progression of syphilis are available, rapid diagnosis and treatment of infected individuals along with the rapid identification of sexual contacts is a high priority. Now, the only commercially available combined screening and confirmation test for syphilis takes less than three minutes (from sample collection to easy-to-read results) for diagnosis at POC.

The Multiplo Complete Syphilis (TP/nTP) Antibody Test (Multiplo TP/nTP) from MedMira Inc. (Halifax, Canada) utilizes its unique RVF technology to combine the detection of treponemal (TP) and non-treponemal (nTP) antibodies in one test. The test targets biomarkers indicative of active as well as previous infections, thus providing a comprehensive approach that combines both the screening and confirmation stages employed in testing strategies globally.

Unlike traditional syphilis testing options, the new easy-to-use, robust diagnostic solution is MedMira’s response to the growing demand for flexible, accurate and cost-efficient testing of syphilis. Multiplo TP/nTP not only identifies exposure to TP but can determine the acute infection status through a non-treponemal screening test and a treponemal confirmation test. This enables a complete diagnosis of syphilis on one single device. MedMira has received the CE mark for its Multiplo TP/nTP test that allows the company to offer the test in all markets accepting the CE mark.

“MedMira received the CE mark in March 2022 for its Reveal TP (Syphilis) Antibody Test (Reveal TP) aimed at diagnosing potential acute syphilis infections. The product is specifically designed for hospitals and health care providers which have an existing screening setting such as VDRL or RPR but require a fast confirmation test such as our Reveal TP. MedMira’s Multiplo TP/nTP, on the other hand, will provide a complete system which combines both screening and confirmation in one test. This product is designed for clients which do not have immediate access to VDRL or RPR such as doctor’s offices, pharmacies, and home test users,” said Hermes Chan, CEO of MedMira. “Our Multiplo TP/nTP further enhances our comprehensive product offering to our distribution partners and clients by providing a clear answer within minutes at the lowest possible cost. At the same time, it increases MedMira’s brand awareness in the sexually transmitted disease market.”

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