Quidel QuickVue In-Line Strep A Test is a CLIA-waived, point-of-care assay that helps clinicians quickly evaluate patients with sore throat in exam rooms, urgent care, school clinics, and pharmacies. Using a patented in-line extraction design, the test streamlines the workflow, with no separate extraction tube, so a throat swab can be processed and read in about five minutes. Two-color lines make results easy to interpret, and built-in procedural controls verify that the test ran correctly. Kits store at room temperature and include positive and negative controls for routine quality checks, making the system practical for daily use and for sites with limited bench space. Clinicians often choose this assay because it is fast enough to guide “test-and-treat” decisions during the same visit, yet negative results in symptomatic patients can still be followed by a throat culture per local policy.
Common questions from users focus on setup and accuracy: the kit runs at room temperature with a typical 24-month shelf life; external controls are available and recommended with new shipments or lots, and at defined intervals; specimens should be fresh throat swabs (not transport media); read results at five minutes (not earlier or later); and remember that strep antigen may persist for several weeks after starting antibiotics, so clinical context still matters.
Features & Benefits
- Five-minute turnaround supports test-and-treat in a single visit.
- In-line extraction reduces steps and hands-on time, eliminating the need for a separate extraction tube.
- Simple, two-color readout for clear positive/negative interpretation at the bench.
- Room-temperature storage and long shelf life help inventory management.
- Quality you can check: kit includes positive and negative controls; external liquid controls also available.
- CLIA-waived lateral-flow format designed for point-of-care settings.
Specifications
- Manufacturer: QuidelOrtho
- Intended use: Qualitative detection of Group A Streptococcal antigen from throat swabs
- Complexity: CLIA-waived
- Assay format: Lateral-flow immunoassay with in-line extraction
- Result time: ~5 minutes
- Readout: Two-color line result with procedural control
- Sample type: Fresh throat swab (do not use transport media)
- Storage: Room temperature 59–86 °F (15–30 °C)
- Shelf life: Up to 24 months from manufacture
- Kit contents: Test cassettes, single-reagent solution, sterile swabs, positive & negative controls, instructions
- Performance: Overall agreement to SBA culture ≈96% (site-reported)
- Quality control: Built-in procedural control line; external control set available
- Packaging: 25 tests per kit; room-temp shipping/ storage
- Use setting: Physician offices, urgent care, retail clinics, school health, pharmacy point-of-care
Notes for Best Practice
- Run external controls with each new lot/shipment and per site policy; document per CLIA.
- Collect vigorous tonsillar/posterior pharyngeal swabs; avoid transport media.
- Read at five minutes only; negative symptomatic cases may be backed up by culture.
[1]: https://bttnusa.com/quidel-quickvue-in-line-strep-a-kit-10137_0347/ "Quidel Quickvue Strep A Kit (10137_0347)"
Additional Resources
Frequently Asked Questions (FAQ)
30-Day Returns
- 30-day return policy
- Items must be unopened
For more info view the return policy
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