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Germaine™ Laboratories Celltrion DiaTrust™ COVID-19 Ag Rapid Test, 25 Pk.

Catalog No. 23111414
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Quantity:
25 Pk.
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.
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.

Description

A rapid test based on lateral flow immunoassay intended for the qualitative detection of SARS-CoV¬2 in human nasopharyngeal swab specimens directly collected from individuals who are suspected of COVID-19 by their healthcare provider.

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)

Specifications

Buffer 0.3 mL of Extraction Buffer
CE Marker Yes
Clia Complexity Waived (FDA, EUA)
Detectable Analytes SARS-CoV-2
Sensitivity 93.33% (28/30) (95% CI: 78.7%-98.2%)
Disposable Single-use
Includes Test devices packaged individually in aluminum pouch, disposable test tube with buffer, filter cap, sterilized swabs, quick reference instruction, positive and negative control swabs
Quantity 25 Pk.
Specificity 99.03% (102/103) (95% CI: 94.7%-99.8%)
Test Time 15 min
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