Clarity Diagnostics CLA-COV19-AG25 Clarity COVID-19 Antigen
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Clarity COVID-19 Antigen Rapid Test Kit, 25 Tests

SKU: MD946011
MFG Part#: CLA-COV19-AG25
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$74.99

25 / Kit
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What's In The Box:
  • 25 test cassettes
  • 25 extraction tubes
  • 25 nasal swabs
  • Tube holder
  • Quick reference guide
  • Instructions for use
Description
When someone walks into your clinic with a cough and fever, you need a clear answer before they leave the room. This COVID-19 antigen rapid test gives you a visually read result in as little as 10 minutes from a simple anterior nasal swab. Built for professional point-of-care use, the kit is FDA-cleared and CLIA-waived, so you can run it at the front line of care without sending samples out or waiting on a lab. Each box holds 25 complete tests with cassettes, extraction tubes, and swabs, giving you a full week or more of testing capacity in one compact package.

You also get a workflow that fits real-world clinical pace. The test stores at room temperature, so there is no refrigerator space to manage and no cold-chain worry between deliveries. The collection swab reaches only three-quarters of an inch into the nostril, which keeps sample collection comfortable for adults and children alike. A built-in control line confirms each test ran properly, and a clear result window shows any positive line, even a faint one. Clinical performance data was established during the Omicron period, and analytical reactivity has been demonstrated across major variants including JN.1. An external control kit is available separately for operator training and lot verification. Whether you run an urgent care, a physician office, or an occupational health program, this kit gives you dependable rapid COVID testing you can stock in bulk and use with confidence.
Features
  • Results in 10 Minutes — Get a visually read COVID-19 antigen rapid test result within 10 to 20 minutes of adding the sample, so you can act on findings during the same visit.
  • CLIA-Waived Point-of-Care Testing — Run this FDA-cleared test on site under a Certificate of Waiver without sending specimens to an outside lab or waiting days for molecular results.
  • Comfortable Anterior Nasal Swab — Collection reaches only three-quarters of an inch into each nostril, making the process easier to tolerate for adults and children than deeper nasopharyngeal sampling.
  • Room-Temperature Storage — Store the kit anywhere between 36°F and 86°F with no refrigeration required, freeing up cold storage and simplifying inventory across multiple exam rooms or sites.
  • Built-In Procedural Control — A control line confirms proper sample flow and cassette integrity on every test, so you know each result is valid before you read it.
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Product Specifications
Test Type: Lateral flow immunoassay (visually read)
Target: SARS-CoV-2 nucleocapsid protein antigen
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: 3/4 inch
Regulatory Status: FDA 510(k) cleared
CLIA Complexity: Waived
Intended Use: Professional point-of-care use, prescription only
Patient Population: Symptomatic individuals within 5 days of symptom onset
Positive Percent Agreement (PPA): 84.38% (95% CI
Negative Percent Agreement (NPA): 99.67% (95% CI
Internal Control: Built-in procedural control line (C)
External Controls: Sold separately
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 FDA-cleared and CLIA-waived for professional point-of-care use. Your facility needs a valid CLIA Certificate of Waiver to perform it. It is labeled for prescription use only and is not intended for at-home consumer use.
It uses an anterior nasal swab collected from both nostrils with the swab provided in the kit. The swab is inserted about three-quarters of an inch, then placed in the extraction tube before four drops are added to the cassette.
Read the result between 10 and 20 minutes after adding the sample to the cassette. Results read earlier than 10 minutes or later than 20 minutes may be inaccurate. Any visible test line, even faint, is read as positive.
No. Each cassette has a built-in procedural 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.
No. Store the kit in a dry place between 36°F and 86°F (2°C – 30°C), away from sunlight and heat. Do not freeze. Bring all components to room temperature (59°F – 86°F) before testing.
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