Celltrion DiaTrust™ COVID-19 Ag Rapid Test, POC
This is an FDA EUA 15 Minute Rapid Antigen Test created for the qualitative detection of COVID-19 antigen. It is intended to aid in the rapid diagnosis of COVID-19 infections.
- The Celltrion DiaTrust™ COVID-19 Ag Rapid Test is authorized for use in laboratories in the United States, certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, to perform high, moderate or waived complexity tests.
- This test is also 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.
- Detect SARS-CoV-2 nucleocapsid protein antigen
- Clinical Sensitivity: 86.1% (31/36) (95% Cl: 71.3% – 93.9%))
- Clinical Specificity: 99.4% (174/175) (95% Cl: 96.8%-99.9%)
- Positive predictive value: 96.55% (28/29) (95% CI: 82.8%-99.4%)
- Negative predictive value: 98.08% (102/104) (95% CI: 93.3%-99.5%)
- For prescription use only.
- Please refer to the Celltrion DiaTrust™ COVID-19 Ag Rapid Test instructions for use for additional information.
The Celltrion DiaTrust™ COVID-19 Ag Rapid Test is for use under Emergency Use Authorization (EUA) only. This product has not been FDA cleared or approved but has been authorized by FDA under an EUA. This product has been authorized only for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens. The emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. & 360bbb-3(b)(1), unless the declaration is terminated, or authorization is revoked sooner.
DiaTrust COVID-19 Ag Rapid Test IFU
DiaTrust COVID-19 Ag Rapid FS HCP
DiaTrust COVID-19 Ag Rapid FS Patient