Rapid Antigen Tests (POC)

RAPID ANTIGEN TESTS (POC)

The rapid antigen test is a perfect solution for testing large groups of individuals quickly, affordably, and is easy to use. Ideal for testing employees, fans, students, faculty, athletes, and more.

DEFINITION: Antigen tests detect an active Coronavirus infection by identifying pieces of proteins that make up the SARS-CoV-2 virus to determine if the person has an active infection. May also be referred to as a Rapid Diagnostic Test, because the results are given in 10 minutes.

 

BENEFITS:

  • Rapid testing for SARS-CoV-2 antigen in 10 minutes
  • Facilitates treatment decisions quickly
  • Simple, time-saving process
  • Cost-effective and affordable
  • No equipment needed
  • High sensitivity and specificity

Sienna by Salofa Oy: COVID -19 Rapid Antigen Test

This is a 10 Minute Point of Care (POC) 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. This test is an affordable, cost-effective solution, perfect for screening large groups of individuals.

  • FDA EUA: Yes
  • Application: Yes
  • Results: 10 minutes
  • Type: Nasopharyngeal, anterior (lower) nasal
  • Sensitivity: 93.80%
  • Specificity: 99.20%
  • LOD: 4.0x103TCID50/ml
  • Shelf-Life: 18 months
  • Tests per Kit: 25
  • Availability: Immediate – 2 weeks

Indicaid COVID -19 Rapid Antigen Test

The INDICAID® COVID-19 20 minute Rapid Antigen Test (FDA EUA and CE-IVD) is a lateral flow immunoassay designed for the qualitative detection of SARS-CoV-2 antigens in direct nasal swab samples.

  • FDA EUA: Yes
  • Application: POC
  • Results: 20 minutes
  • Type: anterior nasal
  • Lateral flow assay
  • Sensitivity: 84.4%
  • Specificity: 96.3%
  • Shelf Life: 12 months
  • Tests per Kit: 25
  • Availability: Immediate

 

Instruction for Use

FDA EUA Letter

AccessBio CareStart™ COVID-19 Rapid Antigen Test (POC)

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

This is an FDA EUA 10 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 CareStart™ COVID-19 Antigen Test is a lateral flow immunochromatographic assay intended for the qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 in nasopharyngeal or anterior nasal swab specimens directly collected from individuals who are either suspected of COVID-19 by their healthcare provider within the first five days of symptom onset or from individuals without symptoms or other epidemiological reasons to suspect COVID-19 when tested twice over two or three days with at least 24 hours and no more than 48 hours between tests.

  • FDA EUA: Yes. 
  • Application: POC
  • Results: 10 minutes
  • Type: Nasopharyngeal, anterior nasal
  • Lateral flow assay
  • Detect SARS-CoV-2 nucleocapsid protein antigen
  • For in vitro diagnostic use only
  • For prescription use only
  • LOD: 8x102TCID50/ml
  • Tests per Kit: 20
  • Availability: Immediate – 2 weeks

 

Instruction for Use

FDA EUA Letter

Fact Sheet for HealthCare Providers

Fact Sheet for Patients

  • 93.75% PPAa and 99.32% NPAb when used with nasopharyngeal swab
  • 87.18% PPAa and 100% NPAb when used with anterior nasal swab
aPPA: Positive Percent Agreement, bNPA: Negative Percent Agreement.

Tests are only authorized for Point-of-Care use by qualified healthcare professionals.

This product has not been FDA cleared or approved but has been authorized by FDA under an EUA for use by authorized laboratories.

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 the detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 360bbb3(b)(1), unless the declaration is terminated or authorization is revoked sooner.

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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