AccessBio CareStart Rapid Antigen Test

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: 2-3 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.

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