Celltrion DiaTrustTM COVID-19 Ag Rapid Test
For use under the Emergency Use Authorization (EUA) only
For in vitro diagnostic Use / For Prescription Use only
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.
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.
– Test devices packaged individually in aluminum pouch (25 test/box)
– Disposable test tube with 0.3 mL of extraction buffer (25 ea/box)
– Filter cap (25 ea/box)
– Sterilized swabs for specimen collection (25 ea/box)
– Quick reference instruction (1 ea)
– Positive control swab (1 ea/box)
– Negative control swab (1 ea/box)