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.
COVID-19 Antigen Test
RAPID POC TEST
As an intended point-of-care (POC) designated test performed by medical professionals with a 10 minutes processing time, COVID-19 Antigen Test helps provide critical answers about active infections to patients and healthcare workers alike.
- Lateral flow assay
- Rapid results in 10 minutes
- Nasopharyngeal swab specimen collection
- Intended at POC setting (i.e., in patient care settings) by medical professionals operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation
- Detect SARS-CoV-2 nucleocapsid protein antigen
- Identify acute infection in symptomatic patients with 88.4% sensitivity and 100% specificity
- Designated as a CLIA waived tests
SARS-CoV-2 IgM/IgG Ab Test
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 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.