Healgen® Strep A Rapid Antigen Test Kit – CLIA Waived, 25 Tests per Box

The Healgen® Strep A Rapid Antigen Test is a point-of-care diagnostic tool for the qualitative detection of Group A Streptococcus from throat swab specimens. Designed for medical professionals operating under a CLIA waiver, this test provides results in approximately 5 minutes—allowing for quick decision-making and timely treatment of streptococcal infections.

Approved by the FDA (510(k) cleared) and CE-IVDD certified, this kit is ready to use out of the box with no additional instruments required.

Important: For professional use only. This test is not intended for home or over-the-counter use. A CLIA Certificate of Waiver, Compliance, or Accreditation is required.

Key Features:

• Rapid Turnaround: Delivers results in around 5 minutes

• Clinical Performance: 96.5% sensitivity and 99.5% specificity

• CLIA Waived: Suitable for use in non-laboratory environments

• User-Friendly: No specialized equipment or extensive training required

• Shelf Life: Up to 24 months from manufacturing date

• Quality Controls Included: Positive and negative controls provided for reliability

Kit Contents:

• 25 Individually Wrapped Test Cassettes

• 25 Sterile Throat Swabs

• 25 Disposable Extraction Tubes

• Reagent A (10 mL, Sodium Nitrite 2.0 M)

• Reagent B (10 mL, Acetic Acid 0.2 M)

• 1 mL Positive Control (non-viable Strep A with 0.05% ProClin™ 300)

• 1 mL Negative Control (non-viable Strep C with 0.05% ProClin™ 300)

• Tube Racks, Instructions, and Quick Reference Guide

Specifications:

• Format: Lateral Flow Cassette

• Specimen Type: Throat Swab

• Time to Result: ~5 minutes

• Storage Conditions: Room temperature (no refrigeration required)

Whether used in a clinical setting or urgent care environment, the Healgen® Rapid Strep A Test provides a fast and reliable method for detecting strep throat infections—helping providers minimize unnecessary antibiotic use and enhance patient care.