Clarity Diagnostics CLA-FLUAB25 Clarity Influenza A&B Rapid
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Clarity Influenza A&B Rapid Antigen Test Kit, 25 Tests

SKU: MD946009
MFG Part#: CLA-FLUAB25
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Buy 10 Get 1 Kit Free! 

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$124.98

25 / Kit
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What's In The Box:
  • 25 Sealed Test Cassettes
  • 25 Buffer Tubes
  • 25 Swabs
  • 1 Tube Holder
  • 1 Quick Reference Instructions (QRI)
  • 1 Instructions for Use (IFU)
Description
When someone walks in with fever, cough, and body aches, you need to know quickly whether you are dealing with influenza A, influenza B, or something else. This rapid influenza A and B antigen test gives you a clear, differentiated answer in 10 minutes from one anterior nasal swab. There is no instrument to calibrate, no reader to maintain, and no deep nasopharyngeal collection — you brush each nostril, swirl the swab in the buffer tube, add four drops to the cassette, and read the result window. Separate test lines for Flu A and Flu B let you tell the two apart at a glance, which helps you decide on next steps while the person is still in front of you.

The kit is built for busy clinics, urgent care, pharmacies, and occupational health settings where throughput matters. Each box holds 25 individually sealed cassettes with matching buffer tubes and swabs, so you always have a complete test on hand. Store the kit at room temperature between 36 and 86°F — no refrigerator space required. A built-in control line confirms every test ran correctly, and an external control kit is available separately for your quality assurance program. In a prospective clinical study of 680 evaluable subjects, the test showed 92.4% positive agreement for Flu A and 91.4% for Flu B against a molecular comparator, with 100% negative agreement for both. Negative results are presumptive and may need molecular confirmation, so this test fits best as a fast first-line screen during flu season.
Features
  • Detects and Differentiates Flu A and Flu B — Separate test lines for influenza A and influenza B give you a differentiated result from a single rapid influenza test, so you know which virus you are dealing with.
  • Results in 10 Minutes — Read the cassette between 10 and 20 minutes after applying the sample. No instrument, reader, or calibration is required, keeping the workflow simple at the point of care.
  • Comfortable Anterior Nasal Swab Collection — The swab goes no more than three-quarters of an inch into each nostril, which is easier to tolerate than nasopharyngeal collection and simpler for staff to perform on children and adults.
  • Room-Temperature Storage — Store the entire kit between 36 and 86°F with no refrigeration, so you can keep this rapid flu test kit stocked in exam rooms, pharmacies, and mobile settings.
  • Validated Clinical Performance — A 680-subject prospective study showed 92.4% positive agreement for Flu A and 91.4% for Flu B, with 100% negative agreement for both, against an FDA-cleared molecular comparator.
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Product Specifications
Test Type: Lateral flow immunochromatographic antigen assay
Analytes Detected: Influenza A and Influenza B (differentiated on separate test lines)
Specimen Type: Anterior nasal swab (both nostrils, single swab)
Time to Result: 10 minutes
Read Window: 10 to 20 minutes after sample application
Sample Volume: 4 drops of extracted sample
Symptom Window: Use within 4 days of symptom onset
Flu A Clinical Performance: PPA 92.4%, NPA 100%
Flu B Clinical Performance: PPA 91.4%, NPA 100%
Internal Control: Built-in procedural control line
External Controls: Control kit sold separately
Storage Temperature: 36–86°F (2–30°C), out of direct sunlight
Operating Temperature: 59–86°F (15–30°C)
Regulatory Status: FDA 510(k) cleared, in vitro diagnostic
Intended Use: Professional use
Tests per Box: 25
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Frequently Asked Questions (FAQs)
The test is FDA 510(k)-cleared and labeled for professional use, making it suitable for clinical and point-of-care settings. Confirm your facility's CLIA certificate level matches the test's complexity classification before use.
Run the test within 4 days of symptom onset. The test is not intended for people without symptoms, and sensitivity drops as viral load declines later in the illness.
Each cassette has a built-in control line. External positive and negative controls, sold separately, are recommended for each new operator and each new lot or shipment, and as your QC program or regulations require.
No. Negative results are presumptive. If symptoms continue or worsen, follow-up testing with a molecular assay may be appropriate. Positive results do not rule out co-infection with other respiratory pathogens.
Yes. Recent FluMist live intranasal vaccine, nasal corticosteroids, and zinc-based throat sprays can interfere. Reading before 10 minutes or after 20 minutes can also produce invalid results.
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