Buy 10 Get 1 Free!
Clarity Strep A Rapid Test Strips, 25 Tests
In Stock
Usually ships in 1 - 3 Days
Promotion
Sale:
$43.12
25
/ Kit
Ask an expert
Buy with confidence.
Contact our experts today.
Buy with confidence.
Contact our experts today.
Description
When someone walks in with a sore throat and fever, you need a clear answer before they leave. These Strep A rapid test strips give you a qualitative result for group A streptococcal antigen directly from a throat swab in about five minutes, so you can decide on next steps during the same visit instead of waiting 18 to 48 hours on a culture. This CLIA waived strep test is FDA cleared and cleared for use in physician offices, urgent care, hospitals, and clinical labs, with 95% sensitivity and 98.4% specificity backed by clinical evaluation against confirmed culture.
The kit is built to remove friction from your workflow. Each box gives you 25 complete tests: strips sealed in a vial, disposable extraction tubes, sterile rayon throat swabs, Reagents A and B, and a workstation rack, so nothing has to be sourced separately. Positive and negative controls are included, letting you verify each new lot or shipment without buying controls on the side. Storage is simple, too. Keep the kit at 2–30°C in its vial, out of direct sunlight, with no refrigerator space required. Add four drops of each reagent, swirl the swab, wait one to two minutes, insert the strip, and read the result at five minutes. A built-in control line confirms the strip ran correctly every time. Made in the USA and packed 25 to a box, this throat swab antigen test kit is a dependable, cost-effective choice for any practice that runs strep testing through the fall and winter season.
Features
- Results in Five Minutes — Read a clear positive or negative for group A strep antigen directly from a throat swab in about five minutes, letting you act during the same visit instead of waiting on culture.
- CLIA Waived and FDA Cleared — This CLIA waived strep test meets the requirements for physician office labs, urgent care, hospitals, and clinical labs, so you can run it under a Certificate of Waiver.
- Proven Accuracy — With 95% sensitivity and 98.4% specificity established against confirmed culture, this strep A rapid test gives you results you can rely on for confident clinical decisions.
- Complete Kit With Controls Included — Every box includes swabs, extraction tubes, reagents, workstation, and positive and negative controls, so you can validate each new lot without purchasing separate QC materials.
- Room-Temperature Storage — Store the kit at 2–30°C in its vial with no refrigeration required, freeing up cold storage and making it easy to keep stock ready throughout strep season.
Product Specifications
| Test Type: | Rapid immunochromatographic antigen test |
|---|---|
| Target Analyte: | Group A streptococcal antigen |
| Specimen Type: | Throat swab |
| Tests per Box: | 25 |
| Test Format: | Strips packaged in a vial |
| Read Time: | 5 minutes (read no later than 10 minutes) |
| Extraction Time: | 1–2 minutes |
| Sensitivity: | 95% |
| Specificity: | 98.4% |
| Analytical Sensitivity: | 1.5 × 10⁵ CFU/mL |
| CLIA Complexity: | Waived |
|---|---|
| CDC Analyte Identifier Code: | 5810 |
| Regulatory Status: | FDA cleared, for in vitro diagnostic use |
| Storage Temperature: | 2–30°C (35–86°F), do not freeze |
| Extraction Reagent A: | 6.5 mL, 2.0 M sodium nitrite |
| Extraction Reagent B: | 6.5 mL, 0.2 M phosphoric acid |
| Positive Control: | 1 mL, extracted non-infective group A strep antigen |
| Negative Control: | 1 mL, extracted non-infective group B strep antigen |
| Swab Type: | Sterile rayon tip, plastic shaft |
| Country of Origin: | USA |
See any errors on this page? Let us know
Frequently Asked Questions (FAQs)
Yes. The test is CLIA waived and intended for use in physician offices, hospitals, and clinical laboratories. Throat swab specimens should be collected by healthcare professionals following standard clinical procedures.
Read the result at 5 minutes, once a distinct control line has formed, and no later than 10 minutes after inserting the strip. If no control line appears within 5 minutes, the test is invalid and should be repeated with a new strip and swab.
The package insert recommends confirming presumptive negative results by culture, in line with American Academy of Pediatrics guidance, especially when clinical signs still suggest group A strep infection.
Yes. Positive and negative controls are included in every box. It is recommended to run both controls before using a new lot or shipment, and at intervals set by your laboratory's QC procedures.
No. Use only the sterile rayon swabs supplied with the kit. Swabs and reagents from other products or lots should not be interchanged, as performance has not been established with other materials.