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Description

The Clarity RSV Antigen Test (#CLA-RSVNS25 / 25 per Box) includes

  • (25) Test devices in sealed aluminum foil pouches with dessicant.
  • (25) Reagent tubes prefilled with extraction buffer and dropper tips.
  • (25) Sample collection swabs.
  • (1) Negative control swab.
  • (1) Positive control swab.
  • (1) Instructions for Use.
  • (1) Quick reference instructions.

The Clarity RSV Antigen Test is a rapid immunochromatographic assay for the qualitative detection of respiratory syncytial virus (RSV) nucleoprotein antigen in anterior nasal swab specimens from patients showing signs of respiratory infection. It is intended for in vitro diagnostic use to aid in diagnosing RSV in infants and children aged 6 months to 6 years, and adults aged 60 years and older. Negative results are presumptive and should be confirmed by viral culture or an FDA-cleared molecular assay.

The test detects RSV nucleoprotein antigen by binding viral antigens in the specimen to gold-conjugated antibodies. These antigen–antibody complexes migrate along the test strip and are captured on the test line, producing a visible signal that indicates the presence of RSV antigen.

Features

Clarity RSV Antigen Test Features

  • Provides qualitative detection of RSV antigen within minutes.
  • Simple immunochromatographic assay requiring minimal training.
  • Uses anterior nasal swab specimens for patient comfort and convenience.
  • Designed for infants and children aged 6 months to 6 years, and adults aged 60 years and older.

Frequently asked questions

Does the rapid RSV test offer easy usability?

Yes, the Clarity RSV Antigen Test is designed for operational simplicity and ease of administration in point-of-care settings. It minimizes the training required for effective use.

Key features that make this test easy to use include:

  • Simple Methodology: It is a rapid, one-step immunochromatographic assay, which is a straightforward testing format.
  • Convenient Specimen Type: The test utilizes anterior nasal swab specimens, offering greater comfort for patients, especially young children, compared to more invasive methods.
  • Complete Kit Contents: Each box contains 25 individual test kits, including prefilled reagent tubes and all necessary components (swabs, controls, instructions), streamlining the testing workflow.
What age groups is this test for?

This test is specifically designed for use in infants and children aged 6 months to 6 years, and adults aged 60 years and older.

What type of sample is needed?

The test utilizes anterior nasal swab specimens, which are known for offering patient comfort and convenience during collection.

How many tests come in the box?

Each box of the Clarity RSV Antigen Test contains 25 complete test kits.

This comprehensive kit includes all components necessary for 25 rapid, point-of-care tests, such as:

  • 25 individually sealed Test Devices
  • 25 Reagent Tubes prefilled with extraction buffer and dropper tips
  • 25 Sample Collection Swabs
  • 1 Positive Control Swab and 1 Negative Control Swab
  • Instructions for Use and Quick Reference Instructions
Is this a rapid RSV test?

Yes, this is a rapid immunochromatographic assay designed for quick results. It provides qualitative detection of the RSV nucleoprotein antigen within minutes, supporting timely diagnosis.

Is the Clarity RSV Antigen Test CLIA Waived?

Yes, the Clarity RSV Antigen Test is designated as CLIA Waived.

This designation is a significant benefit because it indicates the assay is simple to perform and has minimal regulatory requirements, allowing for use in a wide variety of clinical environments, including point-of-care settings.

Does the kit include all necessary components?

Yes, the Clarity RSV Antigen Test is a complete kit providing all necessary materials for 25 individual tests. The box includes:

  • 25 Test devices (individually sealed)
  • 25 Reagent tubes prefilled with extraction buffer and attached dropper tips
  • 25 Sample collection swabs
  • 1 Positive control swab (for quality assurance)
  • 1 Negative control swab (for quality assurance)
  • Instructions for Use
  • Quick reference instructions
What is the required storage temperature range?

The Clarity RSV Antigen Test kits must be stored sealed within a temperature range of 36°F–86°F (2°C–30°C). It is essential to keep the components sealed until use, as the test devices are packaged in aluminum foil pouches with a desiccant.

Is this test for prescription use?

Yes, the Clarity RSV Antigen Test is designated for Prescription Use Only.

Are negative results definitive?

Negative results are considered presumptive and require confirmation via viral culture or an FDA-cleared molecular assay for a definitive diagnosis.