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.