Status RSV Test (25 Tests/Kit)
$250.00
FDA 510(k) Cleared
Rx Only
25 Tests/Kit
25 tests per kit • $10.00 per test
The LifeSign STATUS RSV Test is a prescription-use rapid immunochromatographic assay for the qualitative detection of respiratory syncytial virus nucleoprotein antigen in anterior nasal swab specimens from symptomatic patients. It is intended for children ages 6 months through 6 years and adults older than 60 years.
- CLIA-waived for use with the kit-provided anterior nasal swabs
- FDA 510(k) cleared and intended for professional use
- Read results visually at 15 minutes
- Includes 25 tests, swabs, prefilled reagent tubes and dropper tips
- Positive and negative external control swabs included
| 1-5 | 6-10 | 11+ |
| $250.00 | $230.00 | $217.50 |
LifeSign STATUS RSV Test Overview
The LifeSign STATUS RSV Test is a rapid, visual immunochromatographic assay for the qualitative detection of respiratory syncytial virus nucleoprotein antigen in anterior nasal swab specimens. It is intended to aid in diagnosing RSV infection in symptomatic children ages 6 months through 6 years and symptomatic adults older than 60 years.
This prescription-use professional test is FDA 510(k) cleared and CLIA-waived when used with the anterior nasal swabs supplied in the kit. Results are read visually at 15 minutes.
FDA 510(k) Cleared
Rx Only
25 Tests per Kit
Features and Benefits
Qualitatively detects RSV nucleoprotein antigen in anterior nasal swab specimens
CLIA-waived when used with the anterior nasal swabs provided in the kit
Provides a visual result at 15 minutes
Prefilled extraction-buffer tubes and dropper tips simplify specimen preparation
Includes positive and negative external control swabs for quality-control testing
Stores at 36-86°F (2-30°C) without freezing
Product Details
33125
DTK-400140
25 Tests per Kit
Prescription / Professional In-Vitro Diagnostic Use
Technical Specifications
| Specification | Details |
|---|---|
| Test method | Rapid visual immunochromatographic assay |
| Analyte | Respiratory syncytial virus nucleoprotein antigen |
| Specimen | Direct anterior nasal swab collected with a kit-provided swab |
| Intended population | Symptomatic children ages 6 months through 6 years and symptomatic adults older than 60 |
| Result time | Read visually at 15 minutes; do not read before 15 minutes or after 20 minutes |
| Regulatory status | FDA 510(k) cleared, K240280; CLIA-waived for anterior nasal swabs; prescription use only |
| Storage | 36-86°F (2-30°C) in the original sealed pouch; do not freeze |
| Package size | 25 tests per kit |
Kit Contents
25 individually pouched test devices with desiccant
25 reagent tubes prefilled with 350 µL of extraction buffer and 25 dropper tips
25 anterior nasal sample-collection swabs
1 positive control swab containing noninfectious RSV antigen
1 negative control swab containing noninfectious nasal clinical matrix
Instructions for Use and Quick Reference Instructions
A timer, specimen tube rack and necessary personal protective equipment are required but are not included.
Anterior Nasal Sample Collection
Position: Tilt the patient’s head back approximately 70 degrees.
Insert: Insert the soft swab tip no more than 3/4 inch into one nostril, or no more than 1/2 inch when swabbing a child.
Rotate: Slowly rotate the swab against the inside of the nostril at least five times for a total of 15 seconds.
Repeat: Use the same swab tip to repeat the collection procedure in the other nostril.
Test Procedure Summary
Open the reagent tube: Peel the foil from the tube containing 350 µL of extraction buffer.
Insert the swab: Place the collected swab into the tube until the swab head touches the bottom.
Extract the specimen: Squeeze the tube around the swab head and stir the swab at least 10 times.
Remove the swab: Squeeze the tube while withdrawing the swab to recover as much liquid as possible, then discard the swab properly.
Attach the dropper: Firmly push the supplied dropper tip onto the reagent tube without touching the dropper opening.
Apply the sample: Hold the tube vertically and dispense two drops into the test device sample well.
Read the result: Read visually at 15 minutes. Do not read earlier than 15 minutes or later than 20 minutes.
This summary does not replace the package insert. Follow the current instructions supplied with the kit for collection, quality control, precautions, procedure, timing, interpretation and disposal. Use only the swabs provided in the kit.
Understanding the Results
Positive: Both the Control (C) line and Test (T) line appear. Any visible faint red or pink test line with a visible control line is interpreted as positive.
Negative: Only the Control (C) line appears. Negative results are presumptive and may require confirmation with a molecular assay for patient management.
Invalid: If the Control (C) line does not appear, the result is invalid. Repeat the test using a new swab and test device.
Clinical Performance
The manufacturer evaluated 818 prospectively collected anterior nasal specimens from symptomatic patients at six U.S. CLIA-waived sites. STATUS RSV results were compared with an FDA-cleared RT-PCR method, with the following reported agreement:
| Performance Measure | Manufacturer-Reported Result |
|---|---|
| Positive Percent Agreement | 83.8% (93/111); 95% CI: 75.8-89.5% |
| Negative Percent Agreement | 99.6% (704/707); 95% CI: 98.8-99.9% |
These agreement values describe the manufacturer’s study population and comparator method; they do not guarantee the accuracy of every individual result. Specimen quality, viral-antigen level, timing, circulating variants and adherence to the instructions may affect performance.
Storage and Specimen Handling
Store the kit at 36-86°F (2-30°C) in the original sealed packaging; do not freeze
Bring all test components to room temperature for at least 30 minutes before use
Use an opened test device within 90 minutes
Process a fresh swab within 1 hour at 59-86°F (15-30°C), or within 24 hours when stored at 36-46°F (2-8°C); do not freeze swab specimens
Process a specimen in extraction buffer within 30 minutes when held at room temperature
Do not use kit components after the expiration date printed on the outer box
Instructions and Product Documents
STATUS RSV Quick Reference Instructions
STATUS RSV Product Sell Sheet
STATUS RSV CLSI Procedure
Frequently Asked Questions
What does the LifeSign STATUS RSV Test detect?
It qualitatively detects respiratory syncytial virus nucleoprotein antigen in direct anterior nasal swab specimens from symptomatic patients within the labeled age groups.
Is the STATUS RSV Test CLIA-waived?
Yes. It is CLIA-waived when used with the anterior nasal swabs supplied in the kit and according to the manufacturer’s instructions. A Certificate of Waiver is required to perform it in a waived setting.
Is this an over-the-counter home RSV test?
No. STATUS RSV is a prescription-use professional in-vitro diagnostic test and is not labeled for at-home use.
Who can be tested with STATUS RSV?
The labeled population is symptomatic children ages 6 months through 6 years and symptomatic adults older than 60. Performance has not been established for ages 7-59 or immunocompromised patients.
Which specimen type is required?
The test requires a direct anterior nasal swab collected using only the swabs supplied with the kit. Nasopharyngeal swabs and viral transport media are not labeled specimen types for this configuration.
How quickly are results available?
Read the test visually at 15 minutes. Do not interpret it before 15 minutes or after 20 minutes.
Are quality-control materials included?
Yes. The kit contains one positive control swab and one negative control swab in addition to the internal procedural control built into each test device.
Does a negative result rule out RSV infection?
No. Negative antigen-test results are presumptive and may require confirmation with a molecular assay when necessary for patient management.
How should the kit be stored?
Store the kit at 36-86°F (2-30°C) in the original sealed packaging and do not freeze it. Bring all components to room temperature for at least 30 minutes before testing.
Looking for General RSV Information?
Review current CDC information about RSV symptoms, transmission, risk factors and prevention.
Additional information
| Weight | 1 lbs |
|---|---|
| Dimensions | 8.5 × 5 × 4 in |
