Description
Healgen® Rapid Strep A Antigen Swab Test Kit – CLIA Waived – 25 Tests/Box
The Healgen® Rapid Strep A Antigen Test is a CLIA-waived diagnostic kit designed for the fast, accurate detection of Group A Streptococcus (Strep A) antigens from human throat swab specimens. Ideal for use in doctor’s offices, urgent care clinics, pharmacies, and other point-of-care settings, this rapid test delivers clear results in just 5 minutes—helping clinicians diagnose and treat strep throat efficiently.
FDA 510(k) cleared and CE-IVDD certified, this strep throat test kit meets U.S. regulatory standards and includes everything needed to perform 25 individual tests. No additional equipment or instruments are required.
Note: This product is intended for use by healthcare professionals or facilities operating under a CLIA Certificate of Waiver, Compliance, or Accreditation. Not for at-home or over-the-counter use.
Why Choose the Healgen Rapid Strep A Test?
- Fast Results: Results in approximately 5 minutes
- High Accuracy: Sensitivity of 96.5%, Specificity of 99.5%
- CLIA Waived: Approved for use in non-laboratory settings
- Easy to Use: No special instruments or training required
- Long Shelf Life: 24 months from date of manufacture
- Reliable: Includes external positive and negative controls
Complete Kit Includes:
- 25 Rapid Test Cassettes
- 25 Sterile Throat Swabs
- 25 Disposable Extraction Tubes
- Reagent A (10 mL): 2.0 M Sodium Nitrite
- Reagent B (10 mL): 0.2 M Acetic Acid
- 1 mL Positive Control: Non-viable Strep A, 0.05% ProClin™ 300
- 1 mL Negative Control: Non-viable Strep C, 0.05% ProClin™ 300
- Tube Holders, Instructions for Use, and Quick Reference Guide
Specifications:
- Test Format: Lateral flow cassette
- Sample Type: Human throat swab
- Result Time: ~5 minutes
- Storage: Room temperature (no refrigeration needed)
Whether you're screening for sore throat symptoms or confirming a bacterial infection, the Healgen® Rapid Strep A Test offers a dependable solution that supports antibiotic stewardship and enhances patient satisfaction.
Buy online today from UScreenTests.com—your trusted source for CLIA-waived rapid diagnostic test kits.