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Description

The LifeSign Status RSV Rapid Test Kit (#33125 / 25 per Box) includes (25x) test devices, (25x) reagent tubes prefilled with extraction buffer, (25x) anterior nasal collection swabs, a positive control swab, negative control swab, instructions for use, and a quick reference guide.

The Status RSV is a rapid immunochromatographic assay for the qualitative detection of respiratory syncytial virus (RSV) nucleoprotein antigen in anterior nasal swab specimens from patients with signs and symptoms of respiratory infections. The test is intended for in vitro diagnostic use to aid in the diagnosis of RSV infections in infants and pediatric patients aged six months to six years old, and adults over 60 years of age.

Features

LifeSign Status RSV Rapid Test Kit Features

  • CLIA waived for anterior nasal swab.
  • 15 minute results.
  • Visual read.
  • Provides a simple, rapid method for the diagnosis of RSV using anterior nasal swab (ANS) specimens.
  • User-friendly format and rapid results allow for quick diagnosis and aid in treatment and hospitalization decisions.

Frequently asked questions

How fast does this rapid test provide results?

The LifeSign Status RSV Rapid Test is designed for speed, providing clear, visual, qualitative results in just 15 minutes. This rapid turnaround time helps clinicians quickly determine the presence of the Respiratory Syncytial Virus (RSV) nucleoprotein antigen, facilitating timely diagnostic and patient management decisions.

Is this test easy to use?

Yes, this kit is designed for user-friendly operation. It features a visual read format and a straightforward test protocol, making it suitable for rapid clinical deployment.

Does this kit require anterior nasal swab specimens?

Yes, the LifeSign Status RSV Rapid Test Kit is specifically designed to utilize anterior nasal swab (ANS) specimens for the qualitative detection of the RSV nucleoprotein antigen. This method offers several benefits:

  • CLIA Waived: The test is CLIA waived specifically when using the anterior nasal swab specimen, making it easier to implement in various clinical settings.
  • Convenience: Anterior nasal swabbing is a less invasive and generally more convenient collection method.
  • Complete Kit: Each box contains 25 tests and includes 25 sterile anterior nasal collection swabs and prefilled reagent tubes, ensuring you have all necessary components for immediate use.
Who are the intended patient groups for this test?

This rapid RSV test is specifically intended for use with patients showing signs or symptoms of respiratory infection in two defined age groups:

  • Infants and pediatric patients: Those aged six months to six years old.
  • Adults: Those over 60 years of age.
Is this RSV test CLIA waived?

Yes, the LifeSign Status RSV Rapid Test Kit is CLIA waived.

This important status applies when the test is performed using anterior nasal swab (ANS) specimens, which helps simplify implementation and usage across various clinical settings.

What is included in the test kit?

The LifeSign Status RSV Rapid Test Kit contains 25 complete tests and all necessary materials required for qualitative detection. This ensures you have a comprehensive solution ready for immediate use.

Each box includes:

  • 25 Individually Pouched Test Devices/Cassettes
  • 25 Sterile Anterior Nasal Collection Swabs
  • 25 Reagent Tubes prefilled with extraction buffer and dropper tips
  • 1 Positive Control Swab (RSV)
  • 1 Negative Control Swab (RSV)
  • Instructions for Use
  • Quick Reference Instructions
Does it include controls?

Yes, the kit includes both a positive control swab and a negative control swab to ensure the validity and accuracy of your test results.

What assay method does this rapid test use?

This rapid test utilizes a rapid immunochromatographic assay for in vitro diagnostic use. It provides a visual read for quick diagnostic decisions.

Key specifications of the test method include:

  • Analyte Detected: Respiratory Syncytial Virus (RSV) nucleoprotein antigen.
  • Specimen Type: Anterior nasal swab (ANS) specimens.
  • Detection Result: Qualitative (determining the presence or absence of the antigen).
  • Result Time: Results are delivered in just 15 minutes.
  • CLIA Status: This test is CLIA Waived when used with anterior nasal swabs.
What is the intended use?

This kit is for in vitro diagnostic use to aid in the diagnosis of RSV infections, supporting rapid clinical triage and patient management.

Is this kit new?

Yes, the LifeSign Status RSV Rapid Test Kit is supplied in Factory New condition, ensuring optimal performance and reliability.