Healgen Scientific
Strep A Rapid Test Kit by Healgen® – 25 Tests per Box – CLIA Waived
Rapid Strep A Antigen Test
The Rapid Strep A Antigen Test is designed for the qualitative detection of Group A Streptococcus antigen from throat swab specimens collected from symptomatic patients. This fast lateral flow test helps support the diagnosis of strep throat and other Group A Streptococcus bacterial infections in professional healthcare settings.
Built for efficient point-of-care use, this CLIA-waived test delivers dependable results in as little as 5 minutes, helping clinics, urgent care centers, and medical offices make faster treatment decisions when timely diagnosis matters.
Product Specs
| Brand | Healgen Scientific |
|---|---|
| SKU | GCSTR-501Ca |
| Target Detected | Group A Streptococcus (Strep A) antigen |
| Sample Type | Throat swab |
| Quantity in Box | 25 tests per box |
| Classification | FDA 510(k), CLIA Waived |
Test Performance
| Comparison Method | Positive Percent Agreement | Negative Percent Agreement |
|---|---|---|
| Culture Method | 97.1% | 99.4% |
Product Features
- Qualitatively detects Group A Streptococcus antigen from throat swab specimens collected from symptomatic patients.
- Delivers rapid results in as little as 5 minutes for faster clinical decision-making.
- CLIA-waived format supports convenient use in clinics, physician offices, and urgent care settings.
- Includes built-in quality control materials to help support result accuracy and consistency.
- High agreement with culture method, including 97.1% positive percent agreement and 99.4% negative percent agreement.
What's in the Box
- 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
Frequently Asked Questions
1. What does the Rapid Strep A Antigen Test detect?
This test is designed to qualitatively detect Group A Streptococcus antigen from throat swab specimens collected from symptomatic patients.
2. How fast are results available?
Results are available in as little as 5 minutes, making the test well suited for time-sensitive point-of-care screening.
3. What sample type is used for this test?
The product uses a throat swab specimen, which aligns with the product description and test sample details shown on the page.
4. Is this test CLIA waived?
Yes. The product page lists the Rapid Strep A Antigen Test as CLIA waived.
5. What is included in each kit?
Each box includes 25 test cassettes, 25 sterile throat swabs, 25 extraction tubes, Reagent A, Reagent B, positive and negative controls, tube racks, instructions, and a quick reference guide.
Shipping & Returns
Most of our products ship free within the contiguous United States on orders over $100.
Please note that free shipping is not available for deliveries to Canada, Alaska, Hawaii, or any U.S. territories.*
