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Press Release CBER(link)

Press Release CDRH (link)

FDA Letter (link)

FDA Summary (link)

Evolution Brochure

Product Insert

Evolution SDS

FDA cleared for Diagnostic testing and Blood Donor Screening

for the ASI Evolution® - fully automated RPR Syphilis analyzer.

510(k) K173376

510(k) BK170114

Automation Rules!

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

  • Fully automated walk-a-way RPR syphilis analyzer
  • 190 samples per hour
  • Accurate, consistent, objective results
  • >99.0% sensitivity
  • >99.0% specificity
  • Lowest cost per test
  • Substantial reduction in labor costs

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.


ASiManager-AT Results


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.

Image Analysis



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

  • A  2015 study by the CDC determined that nontreponemal tests can detect infection up to 14 days earlier than treponemal tests.
  • CDC recommended algorithm
  • Preserve valuable blood resources
  • Reduce confusion among clinicians

Courtesy of Centers for Disease Control and Prevention

The Arlington Scientific Advantage

  • ASI developed the first digital particle algorithm and software for the objective interpretation of nontreponemal RPR tests.
  • ASI manufactures over 20 million RPR tests annually for over 1,000 labs.
  • ASI has the only syphilis screening test FDA cleared for both living and cadaveric donors.
  • ASI is one of the very few companies  in the United States that manufactures its own carbon antigen.
  • ASI’s American-made products and technologies, deliver accurate and reproducible results, provide laboratories with measurable benefits and lower cost healthcare.
  • ASI stands behind the quality of its products with the best customer care and service.
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