• COVID-19 Testing Solutions, Made in America

Rapid Antigen CLIA-Waived Test Kits

Our Product

FDA, EUA Authorized Rapid Antigen CLIA-Waived Test Kits

As an intended point-of-care (POC) designated test with a 10 minute processing time, Rapid Antigen Detection allows effective screening of COVID-19 infection on a large scale.

  • For health care providers with a CLIA certificate of waiver, we offer an FDA EUA authorized rapid antigen test.
  • Lateral flow assay
  • Rapid results in 10 minutes
  • Nasopharyngeal swab specimen collection
  • Intended at POC setting (i.e., in patient care settings) by medical professionals operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation
  • Detect SARS-CoV-2 nucleocapsid protein antigen
  • Identify acute infection in symptomatic patients with 88.4% sensitivity and 100% specificity
  • Designated as a CLIA waived tests
  • Made in America
  • Not intended for home use
  • $25 per Unit (20 Units per Package)
  • Please allow 2-3 Business Days for Shipping
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Notices About This Product

  • Rapid Antigen Tests are intended for point of care application, they are not intended for home use without clinician, provider or lab oversight to interpret test results. Negative results do not rule out SARS-CoV-2 infection, particularly in those who have been in contact with the virus. Frequent testing is recommended. If acute infection is suspected, direct testing for SARS-CoV-2 is necessary.
  • Results from one rapid test should not be used as the sole basis to diagnose or exclude SARS-CoV-2 infection or to inform infection status. Those who receive negative results should still continue to follow physical safety protocol to avoid exposure. For those with positive results, isolation and follow-up testing is recommended. Consider follow up testing with molecular diagnostic to rule out infection in these individuals.
  • Additional information including clinical validation studies, fact sheets, and supplemental information available upon request. This product has not been approved by the FDA.
  • Report All Adverse events, including problems with test performance or results, by submitting the online FDA Form 3500 or by calling 1-800-FDA-1088.
  • All information, content, trademarks, service marks and logos are protected by copyright, trademark laws and various other intellectual property rights and unfair competition laws of the United States, foreign jurisdictions, and international conventions. Reproduction and distribution of this material without written authorized consent from Acumen Diagnostics Inc is strictly prohibited.