Rapid test based on lateral flow immunoassay intended for the qualitative detection of nucleocapsid and receptor binding domains (RBDs) from the SARS-CoV2 in human nasopharyngeal swab specimens directly collected from individuals who are suspected of COVID-19.
- Authorized Settings: Point of Care Testing (H,M,W)
- Lateral Flow Immunoassay, (No additional instrument required)
- Test Time: Read results at 15 mins
- Sample Type: Nasopharyngeal Swab (NPS)
- Intended Use: Detection of Antigen from SARS-CoV-2
Celltrion DiaTrust™ 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 spike proteins in human nasopharyngeal swab specimen. Results are for the identification of SARS-CoV-2 nucleocapsid and RBD protein antigen.
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.
Clinical Sensitivity: 93.33% (28/30)
(95% CI: 78.7-98.2%)
Clinical Specificity: 99.03% (102/103)
(95% CI: 94.7-99.8%)
Certifications: This product has not been FDA cleared or approved, but has been authorized by FDA under an Emergency Use Authorization (EUA) for use by laboratories certified under the CLIA that meet the requirements to perform high or moderate complexity, or waived tests. This product 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.
Ordering information: Includes 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).
Caution: For use under Emergency Use Authorization Only. For in vitro diagnostic use only. For prescription use only.
