LifeSign™ Status® Strep A Flip Cassette – CLIA‑Waived Rapid Test (25 tests/box)

LifeSign™ Status® Strep A Flip Cassette – CLIA‑Waived Rapid Test (25 tests/box)

Quickly detect Group A Streptococcus (Strep A) directly from throat swab samples with the Status® Strep A Flip Cassette—a trusted, CLIA-waived rapid test ideal for use in physician offices, clinics, urgent care, and school nursing stations.

Test Performance

• Sensitivity: 96.2%
• Specificity: 98.7–99%
• Time to Results: 5 minutes (no pipetting required)
• Format: Immunochromatographic cassette with patented single-use reagent capsules and a simplified "flip" operation
  
• Regulatory: CLIA-waived for point-of-care testing settings
• Requirements: Valid CLIA certification 
• Storage: 2–30°C (35–86°F) in its original sealed pouch, out of direct sunlight. Do not freeze. 
• CPT Code: 87880QW (Rapid Group A Strep antigen detection by immunoassay, CLIA-waived)

Who It’s For

• Physicians, nurse practitioners, and care staff diagnosing streptococcal pharyngitis in CLIA certified facility
• Ideal for quick throat infection screening in clinical, educational, and workplace health settings

Test Procedure:

1. Place test device on flat surface.
2. Twist the tab off the Extraction Reagent Capsule and squeeze the entire contents of the capsule into the Extraction Well of the test device.
3. Place the specimen swab on the swab stand in the extraction well of the device. Hold the device with one hand and hold the swab with the other hand. While pressing down on the swab, spin the swab in one direction about 5 times to mix the specimen.
4. Incubate 1-2 minutes with swab in well
5. Hold device with one hand and hold the swab with the other hand. While pressing down on swab, spin the swab again 5 times in one direction. Remove and discard the swab.
6. Raise device until upright.
7. Let stand 1-2 seconds. Tap device on flat surface to ensure liquid flows into hole.
8. Immediately after tapping, lower device to original position. Read results in 5 10 minutes.

Status® Strep A Flip Cassette Kit Contents (25‑Test Box)

• 25 Status® Strep A Flip cassettes
• 25 dual‑reagent extraction capsules
• 25 throat swabs
• 1 external positive control
• 1 external negative control
• Package insert with instructions and procedure card