AccessBio CareStart™ COVID-19 Rapid Antigen Test

Carestart AccessBio Rapid Antigen test

The Access Bio, Inc. CareStart™ COVID-19 Antigen Test is a lateral flow immunochromatographic assay for the detection of extracted nucleocapsid protein antigens specific to SARS-CoV-2 in nasopharyngeal swab specimens directly collected from symptomatic individuals who are suspected of COVID-19 by their healthcare provider.

As an intended point-of-care (POC) designated test performed by medical professionals with a 10 minutes processing time, CareStart™ COVID-19 Antigen Test helps provide critical answers about active infections to patients and healthcare workers alike.

COVID-19

AccessBio CareStart™ COVID-19 Rapid Antigen Test

The CareStartTM COVID-19 Antigen test has not been FDA cleared or approved. This test has been authorized by FDA under an EUA for use by authorized laboratories and at the Point of Care by medical professionals operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation. This test has been authorized only to detect the presence of the SARS-CoV-2 nucleocapsid protein antigen, not for any other viruses or pathogens; this test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b) (1), unless the authorization is terminated or revoked sooner.

A Rapid Point of Care Test

  • Rapid results within 10 minutes
  • No lab equipment or additional instrument required
  • Nasopharyngeal swab specimen collection
  • Detects SARS-CoV-2 nucleocapsid protein antigen via a lateral flow assay.
  • Designated as a CLIA waived tests
 

Clinical Evaluation

Sensitivity
97%
Specificity
100%

Kit Components

  • 20 Test devices
  • 20 Assay buffer
  • 20 Extraction vials and caps
  • 20 Specimen collection swabs
  • 1 Positive and 1 negative control swabs
  • 1 Instructions for Use
 

AccessBio Test Kit Demonstration Video

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E. Randy Eckert, MD
Medical Director

Need Bio

Brenda Thompson,
Vice President of Human Resources

With over 20 years of Human Resource and Operations experience, Brenda brings her expertise and specialized skill set to Dental Health Management Solutions, AnyPlace MD and AnyPlace Audiology.  Her successful career includes working as an Executive Director in senior living communities and advancing her Human Resources career to Vice President of Human Resources. Brenda has a specific style and approach to balance risk-management and employee satisfaction.

Shane Stevens
CEO/Owner

Throughout my career, I have served and volunteered with several organizations including serving as an advisory board member for Concordia University Texas, an annual participant and supporter of Hounds for Heroes, the Special Olympics, and many others. I have also served as a deacon at the Austin Baptist Church since 2009. Shane earned a BS in Long-Term Health Care Administration from Texas State University in San Marcos.