Celltrion DiaTrust Rapid Antigen Test

Celltrion DiaTrust COVID-19 Rapid Antigen Test (POC)

Rapid Diagnostic Test for the Detection of SARS-CoV-2 Antigen

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.

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.

  • FDA EUA: Yes. 
  • Application: POC
  • Results: 15 minutes
  • Type: Nasopharyngeal, anterior nasal
  • Lateral flow assay
  • Sensitivity: 93.3%
  • Specificity: 99.03%
  • Positive predictive value: 96.55%
  • Negative predictive value: 98.08%
  • Shelf Life: 12 months
  • Tests per Kit: 25
  • Availability: Immediate

 

Product Catalog

Quick Reference Guide

Instruction for Use

FDA EUA Letter

Fact Sheet for HealthCare Providers

Fact Sheet for Patients

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