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Qualitative detection of nucleocapsid and receptor binding domains (RBDs) from the SARS-CoV-2 in human nasopharyngeal swab specimens directly collected from individuals who are suspected of COVID-19 by their healthcare provider within the first seven 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. Emergency use of this test is limited to authorized laboratories.

Celltrion DiaTrustTM COVID-19 Ag Rapid Test is a rapid test based on lateral flow immunoassay intended for the qualitative detection of nucleocapsid and receptor binding domains (RBDs) from the SARS-CoV- 2 in human nasopharyngeal swab specimens directly collected from individuals who are suspected of COVID-19 by their healthcare provider within the first seven 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 high complexity, moderate complexity, or waived tests. This test 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.

The Celltrion DiaTrustTM COVID-19 Ag Rapid Test does not differentiate between SARS-CoV and SARS- CoV-2.

 

Results are for the identification of SARS-CoV-2 nucleocapsid and RBD protein antigen. Antigen is generally detectable in human nasopharyngeal swab specimens during the acute phase of infection. Positive results indicate the presence of viral antigens, but clinical correlation with the 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.

 

Negative results should be treated as presumptive and confirmation with a molecular assay, if necessary, for patient management may be performed. Negative results do not rule out SARS-CoV-2 infection and should not be used as the sole basis for treatment or patient management decisions, including infection control decisions. Negative results should be considered in the context of a patient’s recent exposures, history and the presence of clinical signs and symptoms consistent with COVID-19. For serial testing programs, additional confirmatory testing with a molecular test for negative results may be necessary, if there is a high likelihood of SARS-CoV-2 infection, such as in an individual with a close contact with COVID-19 or with suspected exposure to COVID-19 or in communities with high prevalence of infection. Additional confirmatory testing with a molecular test for positive results may also be necessary, if there is a low likelihood of SARS-CoV-2 infection, such as in individuals without known exposures to SARS-CoV-2 or residing in communities with low prevalence of infection.

The Celltrion DiaTrustTM COVID-19 Ag Rapid Test is intended for use by medical professionals or trained operators who are proficient in performing tests, trained clinical laboratory personnel, or individuals trained in POC settings. In the United States, the Celltrion DiaTrustTM COVID-19 Ag Rapid Test is only for use under the Food and Drug Administration’s Emergency Use Authorization.