Healgen® Rapid Strep A Antigen Test for Throat Infection, CLIA Waived, 25/Box

The GCSTR-501Ca is the Healgen® Rapid Strep A Antigen Test—an FDA 510(k) cleared, CE-IVDD certified, and CLIA-waived diagnostic tool designed for the qualitative detection of Group A Streptococcal antigens from throat swab specimens. Delivering reliable results in just 5 minutes, this test is ideal for point-of-care settings such as hospitals, clinics, urgent care centers, and pharmacies. Each kit contains 25 complete test units and requires no additional equipment, helping streamline diagnostics, improve patient satisfaction, and reduce unnecessary antibiotic use. Fast, accurate, and easy to use, it's a smart solution for efficient patient care.

Key Features:

• Format: Cassette
• Kit Size: 25 tests per kit
• Specimen Type: Throat swab
• Time to Results: Approximately 5 minutes
• Sensitivity: 96.5%
• Specificity: 99.5%
• Shelf Life: 24 months from the date of manufacture
• Storage Conditions: Room temperature
• Controls Included: External positive and negative controls

Kit Contents:

• 25 Test Strips
• 25 Disposables Specimen Extraction Tubes
• 25 Collection Sterile Swabs
• Extraction Reagent:
  • Reagent A (10mL): 2.0 M Sodium Nitrite Solution.
  • Reagent B (10mL): 0.2 M Acetic Acid Solution.
• Standard controls:
  • Positive Control (1mL): Non-viable Strep A; 0.05% ProClin™ 300.
  • Negative Control (1mL): Non-viable Strep C; 0.05% ProClin™ 300.
• Leaflet with instructions for use:
  • 1 Instructions For Use
  • 1 Quick Reference Instructions (QRI)
• Tube Holders

Specifications: