LOS ANGELES—BasisDx, a federally approved laboratory specializing in home-collect clinical tests, announces that its new STI-testing kit has received certification from PASS (Performer Availability Screening Services), making it the first self-testing STI kit to be certified by the adult industry testing oversight organization.
The PASS Certification board put BasisDx’s new home-collect Pro-13 testing kit through a meticulous evaluation and testing process. This certification has long been used to protect adult industry workers, and requires a stringent standard of accuracy, reliability and, most importantly, safety.
BasisDx’s Pro13 Kit includes all tests required for regular PASS clearance. The kit carries out 13 assays for HIV 1/2 Ag/Ab, HIV PCR, Hepatitis B, Hepatitis C, Syphilis, Trichomoniasis, MGen, pharyngeal, rectal and genital Chlamydia, and pharyngeal, rectal and genital Gonorrhea.
Retailing for $199, the kit comes with a guaranteed 48-hour turnaround from sample receipt in the lab, however typically delivers results in closer to 24 hours. In some areas, results will come with physician-guided, individual treatment plans.
“At-home collection and testing has long been a goal of ours, and we are elated to finally have found a partnership that can meet the industry’s specific testing and security requirements,” PASS executive director Ian O’Brien said. “With BasisDx coming on board, PASS-certified testing is now available across the USA.”
The new Pro13 kit offers enhanced security features, including a prerequisite televisit for first-time users, tamper-proof seals for the prepaid return kit, and an option to use the BDx Molecular Profile to scientifically validate that samples come from the specified user.
“This is a monumental step forward for public sexual health. We are thrilled to be the first company to offer PASS-certified home collection and testing kits,” said Dr. Andreas Kogelnik, laboratory director and founder of BasisDx. "Getting approved for PASS certification hinged on a lot of hard work and novel innovation. We developed and adapted collection methods suitable to a home-collection setting and worked alongside FDA-approved instrument makers to shrink and automate processes wherever possible without sacrificing the quality of each test.
"Together with a leading IT and customer service team, we are disrupting the way STI testing has been done, enabling more people to be tested at a higher quality and lower cost while keeping everyone safe and healthy," Dr. Kogelnik added.
The new Pro13 Kit is available to purchase from BasisDx.org. For sales inquiries, contact [email protected].
