Clarity COVID-19 Antigen Rapid Test (20/Box)

Clarity COVID-19 Antigen Rapid Test
Key Features
  • SKU: CLY-CLA-COV19-AG20
  • Condition: Factory New
  • Country of Origin: USA
  • Warranty: Not Available
  • Provides accurate results in just 15 minutes
  • Utilizes a simple anterior nasal swab for comfortable testing
  • FDA safety and performance compliant
  • Authorized for certified labs and clinical settings

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Description

The Clarity COVID-19 Antigen Rapid Test (#CLA-COV19-AG20 / 20 per Box) includes:

  • (20) Individually pouched test devices.
  • (20) Sample collection swabs.
  • (20) Ampules of extraction buffer.
  • (20) Empty tubes.
  • (1) Negative control swab.
  • (1) Positive control swab.
  • (1) Package insert.
  • (1) Quick start guide.

The Clarity COVID-19 Antigen Rapid Test is a fast, reliable, and accurate nasal swab test designed to detect COVID-19 antigens in individuals suspected of infection within six days of symptom onset. Made in the USA and Pathway C EUA approved, it delivers results in just 15 minutes with a relative sensitivity of 84.78% and specificity greater than 99.69%.

510(k) cleared, POCT approved, and CLIA-waived, this test is authorized for use in certified laboratories and point-of-care settings under CLIA regulations. Not approved for over-the-counter or at-home use.

Features

Clarity COVID-19 Antigen Rapid Test Features

  • Delivers fast and accurate results in just 15 minutes.
  • Uses a simple anterior nasal swab for comfortable and efficient specimen collection.
  • Provides a relative sensitivity of 84.78% and a specificity greater than 99.69% for reliable results.
  • 510(k) cleared, meeting FDA standards for safety and performance.
  • POCT approved for convenient use in patient care settings.
  • CLIA-waived, allowing testing in certified laboratories and point-of-care environments.
  • Pathway C EUA approved for authorized use during the ongoing public health emergency.
  • Designed for professional use only and not approved for at-home or over-the-counter use.

Frequently asked questions

How quickly are test results available?

The Clarity COVID-19 Antigen Rapid Test is designed for speed, delivering actionable diagnostic results in just 15 minutes. This rapid turnaround facilitates quick decision-making in professional clinical and point-of-care (POCT) environments.

Is the test highly specific?

Absolutely. This test offers a high specificity of greater than 99.69%, providing reliable confirmation for COVID-19 antigen detection.

What is the recommended age for use?

This test is intended for individuals aged 2 and up, making it suitable for a wide range of patients in a professional setting.

Is the specimen collection method simple?

Yes, the test utilizes a simple anterior nasal swab collection method, making it easy to use for healthcare professionals.

Is this test for professional use only?

Yes, this test is strictly for professional use only and is not approved for over-the-counter or at-home use.

What professional regulatory clearances does this test hold?

This test holds several key professional regulatory clearances, confirming its suitability for certified laboratories and point-of-care environments:

  • 510(k) Cleared
  • POCT (Point-of-Care Testing) Approved
  • CLIA-Waived
  • Pathway C EUA Approved

These clearances authorize the test for Professional Use Only and it is not intended for OTC or at-home use.

How many tests are included per box?

Each box contains 20 individually pouched test devices, along with all necessary components for each test.

Does it come with control materials?

Yes, the box includes one negative control swab and one positive control swab, in addition to the individual test components, a package insert, and a quick start guide.

What is the relative sensitivity of the test?

The Clarity COVID-19 Antigen Rapid Test has a relative sensitivity of 84.78%.

What is the optimal detection window after symptoms?

The Clarity COVID-19 Antigen Rapid Test is intended for professional use in detecting COVID-19 antigens in individuals who are suspected of infection within six days of symptom onset.