Celltrion DiaTrust™ COVID-19 IgG/IgM Rapid Test is an in vitro diagnostic test based on an immunochromatographic assay. It is designed for qualitative detection of Immunoglobulin G and Immunoglobulin M antibodies of the novel Coronavirus (COVID-19) in human whole blood, plasma or serum. Celltrion DiaTrust™ COVID-19 IgG/IgM Rapid Test is intended as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection. At this time, it is unknown for how long antibodies persist following infection and if the presence of antibodies confers protective immunity. Celltrion DiaTrust™ COVID-19 IgG/IgM Rapid Test should not be used to diagnose acute SARS-CoV-2 infection.
Product Specifications
Precautions
  • For in vitro diagnostic use only
  • Store the test device packaged in a sealed foil pouch at 2 to 30°C (36 to 86°F).
  • Do not use the test device beyond the expiration date.
  • Keep sealed until usage, and use immediately once opened.
  • Do not use the test device if the pouch is damaged or the device is seriously broken.
  • Do not re-use the device.
  • Handle all specimens safely as it may be potentially infectious.
Limitations
  • Failure to follow the procedures may give inaccurate results.
  • The test should not be used to diagnose or exclude acute SARS-CoV-2 infection.
  • Results are not intended to be used as the sole basis for treatment or patient management decisions. Consider other information, including clinical history and local disease prevalence, in assessing the need for a second but different serology test to confirm an immune response.
  • A negative result for an individual subject indicates absence of detectable anti-SARS-CoV-2 antibodies. Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for patient management decisions. A negative result can occur if the quantity of the anti-SARS-CoV-2 antibodies present in the specimen is below the detection limits of the assay, or the antibodies that are detected are not present during the stage of disease in which a sample is collected. If acute infection is suspected, direct testing for SARS-CoV-2 is necessary.
  • False positive results due to cross-reactivity with antibodies to other coronaviruses can occur. Positive results may be due to past or present infection of non-SARS-CoV-2 coronavirus strains, such as coronavirus HKU1, NL63, OC43, or 229E.
  • The recommended sample collection period is dating from 7 to 21 days after the onset of symptoms.
  • This test is not for at home testing.
  • This test is not for screening of donated blood.
  • This test has not been reviewed by the FDA.
  • This test has not been FDA cleared or approved. This webpage is intended for U.S. audiences only. This webpage may contain information on products that are targeted to U.S. audiences, and could contain product details or information not approved in countries or regions outside U.S.