Description
The Clarity RSV Antigen Test detects respiratory syncytial virus from an anterior nasal swab with results in fifteen minutes. External control swabs ride in the box, so pediatric and senior care sites can document quality runs without a separate control order.
- Format – Rapid RSV antigen cassette test.
- Specimen – Anterior nasal swab.
- Read time – Results in fifteen minutes.
- Packaging – 25 tests per box with control swabs included.
About This RSV Rapid Antigen Test
RSV drives hard decisions in two very different populations, infants and young children on one side and older adults on the other. The manufacturer clears this test for children from 6 months to 6 years and for adults 60 and older, the groups where an RSV answer changes management most. The anterior nasal swab collection is shallow and quick, which matters when the patient is a toddler.
Each box includes positive and negative control swabs alongside the test devices, reagent tubes and collection swabs. The kit is CLIA waived, FDA 510(k) cleared and made in the USA, with a 24 month shelf life for season ahead stocking.
Features and Benefits
Patient Fit
- Cleared age groups – The test covers children 6 months to 6 years and adults 60 and older, matching the highest risk RSV populations.
- Gentle collection – An anterior nasal swab avoids the deep nasopharyngeal collection young children resist.
Kit Completeness
- Controls in the box – Positive and negative control swabs are included, so quality runs do not wait on a separate shipment.
- Prefilled reagent tubes – Extraction buffer tubes arrive prefilled at 350 microliters with dropper tips, cutting preparation steps.
Product Specifications
Product Details
- Manufacturer: Clarity Diagnostics
- Test type: Rapid antigen test for respiratory syncytial virus (RSV)
- Specimen: Anterior nasal swab
- Read time: 15 minutes
- Patient groups: Children 6 months to 6 years, adults 60 years and older
- Regulatory status: FDA 510(k) cleared, CLIA waived
- Origin: Made in the USA
- Shelf life: 24 months
Packaging
- Box contents: 25 test devices in sealed pouches, 25 prefilled reagent tubes with dropper tips, 25 anterior nasal swabs, 1 positive control swab, 1 negative control swab, instructions for use, quick reference instruction
- Sold as: 1 box of 25 tests
Browse related categories: infectious disease tests and Clarity Diagnostics products.
Why Choose the RSV Test for High Risk Age Groups
The value of an RSV result concentrates in the youngest and oldest patients, and this kit is cleared exactly for those groups. Controls and prefilled tubes in the box keep the test runnable the day it arrives.
- Right populations – Clearance for ages 6 months to 6 years and 60 plus matches where RSV decisions carry the most weight.
- Quality runs included – Control swabs in every box mean documented QC without a second purchase order.
- Season ready dating – A 24 month shelf life lets clinics buy ahead of the winter RSV peak.
Manuals and Troubleshooting Guides
Frequently Asked Questions
Who can this RSV test be used for?
The manufacturer clears the test for children from 6 months to 6 years and for adults 60 and older. Those are the age groups where RSV most often changes care decisions.
What sample does the test need?
Collection uses an anterior nasal swab, the shallow nasal swab included in the box. The swab is processed in the prefilled reagent tube before the cassette step.
Are control materials included?
Yes, each box includes one positive control swab and one negative control swab. Sites can run documented quality checks from the same box as patient tests.
How long until results?
Results read in fifteen minutes. The quick reference instruction in the box walks staff through timing and reading.
Is the test CLIA waived?
Yes, the manufacturer lists the test as FDA 510(k) cleared and CLIA waived. Your facility still operates it under its own CLIA certificate of waiver.
