USA Manufacturer & Market Leader

The Only Fully Automated RPR Syphilis Analyzer

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FDA Cleared for Diagnostic Testing and Blood Donor Screening

Automation Rules!

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). The ASI Evolution can process and analyze up to 190 samples per hour eliminating the need for manual RPR testing. 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.

By automating nontreponemal testing, labs will:

  • Reduce labor expenses
  • Lower costs
  • Efficiently use skilled laboratorians.

The ASI Evolution® 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

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.

Why Nontreponemal

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.

ASiManager-AT Results

Reactive

ASI Evolution® Results

Reactive

Nonreactive

Nonreactive

1760

1

*5

4072

*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.

Evaluation of the ASI Evolution® Automated Syphilis Analyzer
Image Analysis

Nonreactive

Reactive

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.

The ASI Evolution® Part Numbers

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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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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Rev. 06_2018

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