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RedLine Alert™

FDA cleared

TC-5123-010   


Positive (top left) and negative (lower right) results with the RedLine Alert™ test.

Intended Use: The Tetracore RedLine Alert™ Test is an immunochromatographic test intended for the rapid, in vitro qualitative presumptive identification of Bacillus anthracis from non-hemolytic Bacillus colonies cultured on sheep blood agar plates. The test is intended for use in clinical, public health, and hospital laboratories in conjunction with other markers and testing for the presumptive identification of Bacillus anthracis.

Easy to use and easy to interpret so you can accelerate the “can’t rule out” process.

On a non-hemolytic Bacillus , if the RedLine Alert™ Test is positive, then B. anthracis can’t be ruled out.  Submit the sample to the appropriate State Lab for confirmation.

RedLine Alert™ gives sentinel labs the ability to significantly shorten the time from when the plate is streaked until PCR confirmation is completed at the LRN reference lab.

Superior to gamma phage lysis when tested against 145 extremely well-characterized, independent, genetically and geographically diverse B. anthracis isolates, from 28 countries covering all major diversity groups: Ames-Sterne, Vollum, Western North America, Southern Africa, and Kruger.

  • RedLine Alert™ Test: 98.6% correct
  • Gamma Phage Lysis: 97.2% correct

The two false negative results with the RedLine Alert™ Test and the four false negative results with gamma phage lysis did not coincide, thus emphasizing that utilization of more than one detection method can aid in the identification of B. anthracis

No false positives (i.e. 100% correct negatives) test results with 49 non-hemolytic Bacillus spp, (other than B. anthracis).

 

 
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