The Celltrion DiaTrust™ COVID-19 Ag Rapid Test is a lateral flow immunoassay test designed to detect antigen from the SARS-CoV-2 in human nasopharyngeal swab specimens from patients who are suspected of COVID-19 by their healthcare provider within the first seven days of symptom onset, or from individuals without symptoms when tested twice over two or three days with at least 24 hours and no more than 48 hours between tests.

The Celltrion DiaTrust™ COVID-19 Ag Rapid Test is validated for use from direct specimens testing without transport media, and does not differentiate between SARS-CoV and SARS-CoV-2. This 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. Variants are anticipated to be reflective of the prevalent variants in circulation at the time and location of the clinical evaluation.

In the United States, the Celltrion DiaTrust™ COVID-19 Ag Rapid Test is only for use under the Food and Drug Administration’s Emergency Use Authorization.

• No Additional Instrument Required
• Read Results In 15 min
• Nasopharyngeal Swab (NPS)
• Detection of Antigen from SARS-CoV-2
• Prospective Study Clinical Sensitivity: 93.33% (28/30) (95% CI: 78.7-98.2%)
• Clinical Specificity: 99.03% (102/103) (95% CI: 94.7-99.8%)
• 12 Month Shelf Life
• Manufactured in Republic of Korea (South Korea)