Automated Test Kits
Press Release CDRH (link)
Press Release CBER(link)
The ASI Evolution® is a powerful new analyzer that standardizes the interpretation of RPR testing. The ASI Evolution is the first fully automated RPR Syphilis analyzer cleared for diagnostic and blood donor screening (FDA 510(k) K173376, FDA 510(k) BK170114, FDA 510(k) K182391). The ASI Evolution can process and analyze up to 190 samples per hour eliminating the need for manual RPR testing. The Evolution can also perform titers up to 1:2048. This new technology offers diagnostic and blood donor screening labs an instrument that will improve workflow efficiencies, reduce labor costs and provide consistent, dependable and objective results.
Ease of operation was built into the design and function of the ASI Evolution. A single operator can easily run three to four instruments at a time and perform over 4000 tests in an eight-hour day. In an internal study comparing the hands-on time required to run 900 tests on the ASI Evolution and 900 tests manually, it was found that the ASI Evolution required only 15 minutes hands-on time versus 180 minutes manually. In that study, hands-on time was reduced by 92% with the implementation of the ASI Evolution.
There are two different types of serologic assays for syphilis; nontreponemal and treponemal. A nontreponemal assay (traditional algorithm), such as the rapid plasma reagin (RPR) test, is an indicator of an active or recent syphilis infection and can be used to monitor response to therapy over time. The nontreponemal testing algorithm is recommended by the CDC, preferred by doctors and used in a majority of labs for syphilis screening.
A treponemal test (reverse algorithm) cannot differentiate between active or previously treated infection, which can create a false-positive result. The immune response to syphilis creates antibodies to fight the infection; those antibodies remain in the blood after successful treatment. Because treponemal tests cannot monitor the response to therapy, the CDC continues to recommend the traditional screening algorithm using a nontreponemal test.
A total of 5838 specimens were evaluated to determine reactivity. Of the 5838 specimens, the ASI Evolution determined that 1761 were reactive and 4077 specimens were nonreactive. A sensitivity >99.0% and a specificity >99.0% were determined.
ASI Evolution® Results
*Note: The 5 discordant results were tested with a treponemal and a nontreponemal test and found to be nonreactive. The reactive samples ranged in reactivity from minimal 1:1 titers to 1:64 titers.
The ASI Evolution's HD camera, allows the proprietary algorithm to digitally analyze particle size and densities to determine reactivity. Visual results can then be stored, archived and retrieved.
ASI Evolution® Automated Syphilis Analyzer #2800-000
ASI Automated 480 Test Kit #900480A
ASI Automated 768 Test Kit #900768A
ASI Automated 4800 Test Kit #9004800A
ASI Automated RPR Control Set 2.5ml #905002.5A
ASI Automated RPR Control Set 5ml #905005A
ASI Evolution® Waste Container #2800-018
ASI Evolution® Waste System (Stand and waste container) #2800-019 ASI Evolution® Sample Rack #2800-021
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