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FDA Letter (link)
FDA Summary (link)
FDA cleared for Diagnostic testing and Blood Donor Screening
for the ASI Evolution® - fully automated RPR Syphilis analyzer.
ASI Evolution™ Automated Syphilis Analyzer #2800-000
ASI Automated 480 Test Kit #900480A
ASI Automated 4800 Test Kit #9004800A
ASI Automated RPR Control Set #905005A
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The ASI Evolution® Automated Syphilis Analyzer
Introducing the next evolution in syphilis testing which complies with the CDC recommended traditional algorithm.1 Laboratories can now automate nontreponemal testing and drive significant operational efficiencies while minimizing false-positive results.
The ASI Automated RPR (rapid plasma reagin) Test for syphilis is a qualitative nontreponemal flocculation test for the detection of reagin antibodies in human serum and plasma as a screening test for serological evidence of syphilis for use on the ASI Evolution analyzer.
1. MMWR, Vol. 60, #5, Feb. 11, 2011
Evaluation of the ASI Evolution® Automated Syphilis Analyzer
A total of 2861 specimens were evaluated to determine reactivity. Of the 2861 specimens, the ASI Evolution® determined that 829 were reactive and 2032 specimens were nonreactive. Of those 2032 specimens, 4 discordant results were tested with a treponemal and a nontreponemal test and found to be nonreactive. A sensitivity >99.0% and a specificity >99.0% were determined.
ASI Evolution Results
*Note: The 4 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 Evolutions 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.
The Nontreponemal Advantage
Courtesy of Centers for Disease Control and Prevention
The Arlington Scientific Advantage