Description
The Clarity Strep A Rapid Test Strips put Group A streptococcus testing in a vial format that reads from five minutes, with reagents and controls in the box. The manufacturer reports 95 percent sensitivity and 98.4 percent specificity for the waived throat swab test, made in the USA.
- Format – Strep A rapid test strips in a vial.
- Performance – 95 percent sensitivity and 98.4 percent specificity, as reported by the manufacturer.
- Read time – Read from 5 minutes and not beyond 10 minutes.
- Packaging – 25 tests per box with controls, reagents and swabs.
About These Strep A Test Strips
A sore throat visit turns on one question, whether Group A streptococcus is present and antibiotics are warranted. These strips answer from a throat swab with a read window that starts at five minutes and closes at ten, keeping the decision inside the appointment. The manufacturer reports 95 percent sensitivity and 98.4 percent specificity for the assay, which is FDA cleared and CLIA waived.
Everything the run needs is in the box, from sterile throat swabs and extraction tubes to reagents A and B and both external controls. Room temperature storage and 24 month dating with open vial stability make the kit easy to keep at the point of care.
Features and Benefits
Test Performance
- Manufacturer reported figures – Sensitivity of 95 percent and specificity of 98.4 percent are the values the manufacturer publishes for this test.
- Timed read window – Results read from five minutes and not beyond ten, which keeps interpretation consistent across staff.
Kit Completeness
- Controls in the box – Positive and negative controls ride with the strips, so waived sites can document quality runs immediately.
- Full component set – Swabs, extraction tubes, reagents, workstation, insert and procedure card are all included.
Product Specifications
Product Details
- Manufacturer: Clarity Diagnostics
- Test type: Rapid antigen test for Group A Streptococcus
- Specimen: Throat swab
- Sensitivity: 95 percent (manufacturer reported)
- Specificity: 98.4 percent (manufacturer reported)
- Read time: From 5 minutes, not to exceed 10 minutes
- Regulatory status: FDA cleared, CLIA waived
- Origin: Made in the USA
- Storage: Room temperature
- Shelf life: 24 month dating, open vial stability
Packaging
- Box contents: Test strips in a vial, disposable extraction tubes, sterile throat swabs, reagents A and B, positive and negative controls, workstation, package insert, procedure card
- Sold as: 1 box of 25 tests
Browse related categories: infectious disease tests and Clarity Diagnostics products.
Why Choose the Strep A Strips for Sore Throat Visits
The strip vial format suits offices that run strep testing all day and want a fresh strip per patient without cassette waste. Reported performance and included controls make the quality story simple to document.
- Antibiotic decisions – A five minute strep answer supports prescribing choices while the patient is still in the room.
- Vial convenience – Strips draw one at a time from the vial, which fits high volume respiratory clinics.
- Audit ready QC – Controls in every box let sites log quality runs without separate control orders.
Manuals and Troubleshooting Guides
Frequently Asked Questions
How long does the Strep A test take?
Read the strip from five minutes and do not read it beyond ten minutes. That window is printed in the manufacturer insert and keeps results consistent.
What sensitivity does the manufacturer report?
The manufacturer reports 95 percent sensitivity and 98.4 percent specificity for this test. Those are the published figures for the assay.
Are controls included?
Yes, positive and negative controls are included in the box with reagents A and B. Waived sites can run and document quality checks from the same kit.
What else comes in the box?
The box includes the strip vial, disposable extraction tubes, sterile throat swabs, a workstation, the package insert and a procedure card. It is a complete bench kit.
How is the kit stored?
Store the kit at room temperature. The strips carry 24 month dating with open vial stability as listed by the manufacturer.
