ACCESS TO LIFE,

BIO FOR HOPE.

COVID-19

CARESTART

Antigen

COVID-19 RAPID DETECTION SARA-Cov-2 Antigen
Antigen_EUA-1-site image.png

ACCESS BIO'S CARETECH COVID-19 Antigen

RAPID POC TEST

Due to the highly contagious nature and global health crisis, SARS-CoV-2 has been designated as a pandemic by the World Health Organization (WHO) and continues to have devastating impacts on healthcare systems and the world economy including the U.S. To effectively end the SARS-CoV-2 pandemic, systematic screening and detection of both clinical and asymptomatic COVID-19 cases is critical.

As an intended point-of-care (POC) designated test with a 10 minute processing time, CareStart™ COVID-19 Antigen Test allows effective screening of COVID-19 infection on a large scale.

  • Lateral flow assay

  • Rapid results in 10 minutes

  • Minimally invasive specimen collection (nasopharyngeal)

  • Intended at POC setting (i.e., in patient care settings) by medical professionals

  • Detect SARS-CoV-2 nucleocapsid protein antigen

  • Identify acute infection with high sensitivity and 100% specificity

COVID-19

CARESTART

IgM/IgG

COVID-19 RAPID Diagnostic Test for the Detection of SARA-CoV-2 IgM/IgG Ab
IgM:IgG Access Bio.png

ACCESS BIO'S CARETECH COVID-19 IgM/IgG

RAPID COVID-19 TESTING TOOL

NOW FDA EMERGENCY USE AUTHORIZED

SARS-CoV-2, A highly contagious novel virus, had severely impacted the U.S. and global healthcare system and economy. A rapid in vitro testing is a key component to identify and mitigate the spread. The CareStart™ Covid 19 IgM/IgG Rapid Diagnostic Test for the Detection of SARS-CoV-2 IgM/IgG Ab provides a fast and easy diagnostic tool for COVID-19 in the limited testing environment.

  • Fast and easy to use in a qualified CLIA setting

  • Detect and differentiate IgM/IgG antibody specific to SARS-CoV-2.

  • Requires small sample volume (10 uL of venous whole blood, serum, or plasma).

  • Results available in 10 minutes.

  • No equipment or training required.

  • Identify and monitor individual’s previous infection history and immune response to COVID-19.

  • Clinical performance (NIH/NCI) of 100% sensitivity and 97.5% specificity.

  • CE certified.