Clarity Diagnostics CLA-COVFLUAB25 Clarity 3 in 1 COVID-19 F
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Clarity 3 in 1 COVID-19 Flu A and B Antigen Rapid Test Kit, 25 Tests

SKU: MD946010
MFG Part#: CLA-COVFLUAB25
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$149.98

25 / Kit
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What's In The Box:
  • 25 sealed test cassettes
  • 25 buffer tubes
  • 25 nasal swabs
  • Tube holder
  • Quick reference guide
  • Instructions for use
Description
Fever, cough, body aches — every fall and winter you see the same symptoms, and telling COVID from flu on presentation alone is guesswork. This COVID-19 Flu A and B antigen rapid test gives you all three answers from a single anterior nasal swab in as little as 10 minutes. The cassette carries separate test lines for SARS-CoV-2, Influenza A, and Influenza B, so one specimen tells you which virus is present, including co-infections, without running three separate kits. It is 510(k)-cleared and CLIA-waived for professional point-of-care use, letting you test at the front desk or exam room under a Certificate of Waiver and act on the result during the same visit.

The workflow is built for busy respiratory season. Each box holds 25 complete tests with sealed cassettes, prefilled buffer tubes, swabs, and a tube holder. The kit stores at room temperature, so you can keep it stocked in every room without tying up refrigerator space. The swab reaches only three-quarters of an inch into each nostril, which keeps collection quick and comfortable for adults and children two years and older. A built-in control line confirms every run, and clinical performance against PCR shows negative agreement above 99% for all three targets. An external control kit is available separately for operator training and new-lot verification. For urgent cares, physician offices, pediatric practices, and occupational health programs, this multiplex COVID flu test kit lets you cut testing time and consumables while giving each person a clear, differentiated result.
Features
  • 3-in-1 Differentiated Results — One anterior nasal swab detects and separately identifies COVID-19, Influenza A, and Influenza B, so you can distinguish between viruses and spot co-infections without running multiple tests.
  • Results in 10 Minutes — Read this COVID-19 Flu A and B antigen rapid test between 10 and 20 minutes after adding the sample, giving you answers while the person is still in the room.
  • CLIA-Waived Point-of-Care Testing — 510(k)-cleared and waived for professional use, so you can perform testing on site under a Certificate of Waiver instead of sending samples to a reference lab.
  • Room-Temperature Storage — Store between 36°F and 86°F with no refrigeration required, making it easy to keep this multiplex COVID flu test kit stocked across exam rooms and satellite sites.
  • Built-In Procedural Control — A control line confirms proper reagent flow and cassette integrity on every test, so you know each result is valid before you read the target lines.
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Product Specifications
Test Type: Lateral flow immunochromatographic assay (visually read)
Targets: SARS-CoV-2 nucleocapsid antigen, Influenza A nucleoprotein, Influenza B nucleoprotein
Result Format: Separate test lines for COVID-19 (CoV), Flu A (F-A), and Flu B (F-B) plus control (C)
Sample Type: Anterior nasal swab
Time to Result: 10 minutes
Read Window: 10 to 20 minutes after sample is added
Sample Volume: 4 drops of extracted sample
Swab Insertion Depth: Up to 3/4 inch (1.5 cm)
Regulatory Status: FDA 510(k) cleared
CLIA Complexity: Waived
Intended Use: Professional point-of-care use
Patient Population: Symptomatic individuals within 4 days of symptom onset; ages 14+ self-collected, ages 2+ adult-collected
SARS-CoV-2 PPA / NPA: 87.8% / 99.8%
Influenza A PPA / NPA: 87.2% / 99.7%
Influenza B PPA / NPA: 87.9% / 99.7%
Internal Control: Built-in procedural control line (C)
External Controls: Sold separately
Opened Cassette Stability: Use within 1 hour
Storage Temperature: 36°F – 86°F (2°C – 30°C)
Operating Temperature: 59°F – 86°F (15°C – 30°C)
Shelf Life: Stable until printed expiration date
Tests per Box: 25
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Frequently Asked Questions (FAQs)
Yes. The test is 510(k)-cleared and CLIA-waived for professional point-of-care use. Your facility needs a valid CLIA Certificate of Waiver. It is intended for symptomatic individuals within four days of symptom onset and is not sold as an at-home consumer test.
Yes. The cassette has three distinct test lines, labeled CoV, F-A, and F-B, plus a control line. Any line that appears alongside the control is read as positive for that virus, so a single swab can show COVID-19, Flu A, Flu B, or a combination.
Yes. The test is intended for self-collection by individuals 14 and older, or adult-collected samples for children two years and older. With children, the swab may not need to go as far into the nostril, and a second adult may be needed to steady the head.
Yes. Do not use within two weeks of a live intranasal flu vaccine, or with nasal corticosteroids or zinc-based throat sprays, as these can cause false results. Hand soap and sanitizer residue may also interfere. Negative results are presumptive and may need molecular confirmation.
No. Each cassette has a built-in control line, but positive and negative external controls are sold separately. Running external controls is recommended for each new operator and each new shipment or lot, per your facility's QC procedures.
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