Arlington Scientific Inc (ASI), Springville, Utah, has received FDA premarket notification (510(k)) clearance for its ASI Evolution, a fully automated system for nontreponemal syphilis diagnostic testing and blood donor screening.

Release of the ASI Evolution as a low-cost analyzer for automating syphilis testing will increase efficiency and output, and effectively reduce work hours in the lab. The instrument interprets the results of 190 samples per hour while delivering consistent, dependable, and objective results. One study found that the ASI Evolution reduced hands-on time by 92% compared to a manual rapid plasma reagin (RPR) test. With intuitive software, a single operator can run multiple analyzers simultaneously, freeing up time for other laboratory tasks.

“We have always been focused on enhancing the quality and speed of diagnosing infectious diseases,” says Ben Card, president and CEO of ASI. “In 2010, we created the technology for a semiautomated analyzer designed for the objective interpretation of ASI’s RPR card test. We further developed a fully automated nontreponemal analyzer, taking the knowledge learned and applying it to an automated platform.”

The ASI Evolution enables laboratories to use a fully automated assay for performing the nontreponemal screening algorithm traditionally recommended by the Centers for Disease Control and Prevention (CDC), removing the need for a high-cost and complicated reverse screening algorithm. Screening with a treponemal test was previously introduced only because nontreponemal testing was not yet automated. Treponemal screening costs more, creates extra steps, and complicates the testing process.

“The industry has needed a fully automated nontreponemal analyzer to efficiently use the traditional screening algorithm,” says David Binks, COO of ASI. “The ASI Evolution delivers this standardization to the interpretation of syphilis testing by removing the subjective visual reading and manual steps of RPR card tests.”

To learn more, visit Arlington Scientific.