Status Rapid Flu A & B Test (25 Tests/Kit)
$265.00
FDA-Cleared
Professional Use
25 Tests/Kit
25 tests per kit • $10.60 per test
The LifeSign STATUS Flu A & B Test is a rapid qualitative immunoassay that detects and differentiates influenza A and influenza B nucleoprotein antigens from nasal swab, nasopharyngeal swab and nasopharyngeal aspirate/wash specimens collected from patients with signs and symptoms of respiratory infection. This is an Rx-only professional test.
- CLIA-waived when used with nasal or nasopharyngeal swab specimens
- Read results at 10-15 minutes; confirm negative results at 15 minutes
- Innovative flip-format test device with premeasured extraction-reagent capsules
- Includes 25 test devices, 25 sterile swabs and positive and negative control swabs
- Detects and differentiates influenza A and B antigens in one test
| 1-5 | 6-10 | 11+ |
| $265.00 | $243.80 | $230.55 |
LifeSign STATUS Flu A & B Test Overview
The LifeSign STATUS Flu A & B Test is an in-vitro rapid qualitative immunoassay for the direct detection and differential identification of influenza type A and type B nucleoprotein antigens. It is intended to aid healthcare professionals in the rapid differential diagnosis of influenza A and B viral infections in patients with signs and symptoms of respiratory infection.
The test accepts nasal swab, nasopharyngeal swab and nasopharyngeal aspirate/wash specimens. Its CLIA classification depends on the specimen: testing with nasal and nasopharyngeal swabs is waived, while testing with nasopharyngeal wash/aspirate specimens is moderate complexity.
FDA-Cleared
Professional Use
25 Tests per Kit
Features and Benefits
Detects and differentiates influenza A and influenza B nucleoprotein antigens
Provides results in 10-15 minutes, with negative results confirmed at 15 minutes
CLIA-waived for nasal and nasopharyngeal swab specimens
Innovative flip-format device with an easy-to-read result window
Premeasured extraction-reagent capsules simplify swab-sample preparation
Flocked sterile swabs and external positive and negative control swabs are included
Product Details
36025
DTK-357000
25 Tests per Kit
Rx Only / Professional In-Vitro Diagnostic Use
Technical Specifications
| Specification | Details |
|---|---|
| Test method | Rapid immunoassay for qualitative antigen detection and differentiation |
| Analytes | Influenza A and influenza B nucleoprotein antigens |
| Specimens | Nasal swab, nasopharyngeal swab and nasopharyngeal aspirate/wash |
| Result time | Read at 10-15 minutes; confirm negative results at 15 minutes |
| CLIA complexity | Waived for nasal and nasopharyngeal swabs; moderate complexity for nasopharyngeal wash/aspirate |
| Regulatory status | FDA-cleared; Rx only |
| Storage | 35-86°F (2-30°C) in the original sealed pouch, away from direct sunlight |
| Package size | 25 tests per kit |
Kit Contents
25 individually pouched STATUS Flu A & B test devices
25 extraction-reagent capsules for swab samples
25 sterile swabs for specimen collection
1 positive control swab containing noninfective recombinant influenza A and B nucleoprotein antigens
1 negative control swab
Package insert and procedure card
A timer and disposable gloves are required but are not included. Testing nasopharyngeal wash/aspirate specimens also requires separately available materials identified in the package insert.
Swab Test Procedure Summary
Add reagent: Tear the tab from one extraction-reagent capsule and dispense all solution into the device’s Extraction Well.
Insert and mix the swab: Place the collected specimen swab in the Extraction Well and rotate it three times.
Extract the specimen: Incubate the swab in the Extraction Well for 1 minute, rotate it three more times, then remove and discard it.
Activate the test: Raise the device upright, let it stand for 1-2 seconds, gently tap it to start liquid flow and lay it back on a level surface.
Read the result: Read the test at 10-15 minutes and confirm negative results at 15 minutes.
This summary covers only the direct swab procedure and does not replace the package insert. Follow the current instructions supplied with the kit for specimen collection, wash/aspirate testing, quality control, precautions, timing, interpretation and disposal.
Understanding the Results
Influenza A positive: A Control line and an Influenza A Test line appear. Any visible Test line should be interpreted as positive, even when faint.
Influenza B positive: A Control line and an Influenza B Test line appear. Both Test lines may appear when influenza A and B antigens are detected.
Negative: Only the Control line appears. Negative results are presumptive and do not rule out influenza infection.
Invalid: If the Control line does not appear within the designated incubation time, the result is invalid and the test must be repeated.
Negative results should not be used as the sole basis for treatment or other patient-management decisions. The package insert recommends confirming negative results by viral culture or an FDA-cleared influenza A and B molecular assay.
Clinical Performance at CLIA-Waived Sites
The manufacturer evaluated nasal and nasopharyngeal swab specimens at seven CLIA-waived sites and compared STATUS Flu A & B results with an FDA-cleared nucleic acid amplification test. The package insert reports the following combined performance:
| Analyte | Positive Percent Agreement | Negative Percent Agreement |
|---|---|---|
| Influenza A | 89.2% (124/139; 95% CI: 83.0-93.4%) | 99.4% (314/316; 95% CI: 97.7-99.8%) |
| Influenza B | 86.4% (133/154; 95% CI: 80.1-90.9%) | 99.0% (298/301; 95% CI: 97.1-99.7%) |
These values describe the manufacturer’s study population and comparator method; they do not guarantee the accuracy of every individual result. Specimen quality, circulating strains, disease prevalence and proper adherence to the package insert may affect performance.
Storage and Handling
Store at 35-86°F (2-30°C) in the original sealed pouch and away from direct sunlight
Keep the test device sealed until immediately before use
Use kit components only through the expiration date printed on the pouch or box
Bring reagents, specimens and devices to 64-86°F (18-30°C) before testing
Instructions and Product Documents
STATUS Flu A & B Procedure Card
STATUS Flu A & B Product Brochure
STATUS Flu A & B Safety Data Sheet
STATUS Flu A & B Control Set Insert
STATUS Flu A & B CLSI Procedure
STATUS Flu A & B Annual Reactivity Report
Frequently Asked Questions
What does the STATUS Flu A & B test detect?
It qualitatively detects and differentiates influenza A and influenza B nucleoprotein antigens as an aid in diagnosing influenza infection in symptomatic patients.
Is the STATUS Flu A & B test CLIA-waived?
It is CLIA-waived when used with nasal or nasopharyngeal swab specimens. Testing nasopharyngeal wash/aspirate specimens is classified as moderate complexity.
Is this an over-the-counter home test?
No. The package insert labels the test for prescription use only and professional in-vitro diagnostic use.
How quickly are results available?
Read results at 10-15 minutes. Negative results must be confirmed at 15 minutes.
Which specimen types can be used?
The test accepts nasal swab, nasopharyngeal swab and nasopharyngeal aspirate/wash specimens. Follow the specimen-specific procedure and CLIA classification in the package insert.
Are quality-control materials included?
Yes. The 25-test kit contains one positive control swab and one negative control swab.
Does a negative result rule out influenza?
No. Negative results are presumptive and do not preclude influenza infection. The package insert recommends confirmation with viral culture or an FDA-cleared influenza A and B molecular assay.
How should the kit be stored?
Store the kit at 35-86°F (2-30°C) in its original sealed packaging, away from direct sunlight. Use the components only through the expiration date printed on the pouch or box.
Need Current Influenza Testing Guidance?
Review CDC guidance on rapid influenza diagnostic tests, result interpretation and the limitations of negative rapid-test results.
Additional information
| Weight | 6 lbs |
|---|---|
| Dimensions | 10 × 10 × 5 in |
| Quantity | 1 to 5, 6 to 10, 11+ |
