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If you would like to place an order or contact us, please fill out the information below or call us at 949-561-0664

      Covid Test

      GenBody America

      GenBody COVID-19 Rapid Ag Test

      Product Model: COVAG025-NU

      Point-of-care Use | 949-561-0664

      Catalog Number
      Price (USD)

      Unit Size

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      25 Tests / Kit

      Product Overview


      Intended Use

      The GenBody COVID-19 Ag is an immunochromatographic rapid diagnostic test (RDT) intended for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 in direct nasopharyngeal (NP) or anterior nasal (AN) swab specimens from individuals who are suspected of COVID-19 by their healthcare provider within the first six days of symptom onset, or from individuals without symptoms or other epidemiological reasons to suspect COVID-19 when tested twice over two or three days with at least 24 hours and no more than 48 hours between tests. Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet the requirements to perform moderate, high or waived complexity tests. This product is authorized for use at the Point of Care (POC), i.e., in patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance or Certificate of Accreditation.

      Results are for the identification of SARS-CoV-2 nucleocapsid antigen. Antigen is generally detectable in nasopharyngeal (NP) or anterior nasal (AN) swab specimens during the acute phase of infection. Positive results indicate the presence of viral antigens, but clinical correlation with patient history and other diagnostic information is necessary to determine infection status. Positive results do not rule out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease. Laboratories within the United States and its territories are required to report all results to the appropriate public health authorities.

      FDA Emergency Use
      Authorized (EUA)
      Control Sets Positive, Negative
      CLIA Complexity Waiver
      Detectable Analysis SARS-CoV-2
      Format Test Cassette Kit
      Sample Type Nasal Swab
      Type In Vitro Diagnostic
      Sensitivity 92.31%
      Specificity 99.04%
      Organism Group Virus
      Quantity 25 Tests
      Shelf Life 21 Months
      Test Time 15-20 Minutes

      Content and Storage

      • 25 single-use test devices with individual foil pouches.
      • 25 single-use individually sleeved sterilized anterior nasal swabs
      • 1 positive and negative external control swabs
      • 25 single-use extraction tubes and dropper tips
      • 2 bottles of extraction solution
      • GenBody COVID-19 Ag kit should be stored between 2 to 30°C (35.6 to 86°F)
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      Contact Us

      If you would like to place an order, please fill out the information below or call us at 949-561-0664