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ASI Evolution® Automated Syphilis Analyzer

FDA Cleared for Diagnostic Testing and Blood Donor Screening

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Automated RPR

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.

The ASI Evolution® Advatage

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.

Certifications

  • CPT Code 86592 (Screening)
  • CPT Code 85693 (Titers)
  • FDA 510(k) K173376
  • FDA 510(k) BK170114
  • FDA 510(k) K182391
  • FDA 510(k) BK200488
  • FDA 510(k) K201438
Part Numbers
  • 480 Test Kit #900480A
  • 4800 Test Kit #9004800A
  • RPR Control Set 2.5ml #905002.5A
  • RPR Control Set 5ml #905005A
  • Waste Container #2800-018
  • Waste System #2800-019
  • Sample Rack #2800-021

Why Nontreponemal?

By automating nontreponemal testing,
labs will:
  • Reduce labor expenses
  • Lower costs
  • Efficiently use skilled laboratorians.

 

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.