SAR-CoV-2 Rapid Test Kits
CareStart™ COVID-19 Antigen
FDA Authorized Under EUA
The CareStartTM COVID-19 Antigen Test is a lateral flow immunochromatographic assay for the detection of extracted
nucleocapsid protein antigens specific to SARS-CoV-2 in swab specimens directly collected from individuals who are suspected of COVID-19 by their healthcare providers.
​
-
Lateral flow assay
-
Results interpreted in10 minutes
-
Nasopharyngeal swab specimen collection
-
Intended at POC setting 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
Access Bio CareStart™ Tests
FDA Authorized Under EUA
IgM/IgG Rapid Test
The CareStart™ Covid 19 IgM/IgG Rapid Diagnostic Test for the Detection of SARS-CoV-2 IgM/IgG Ab is a lateral flow immunochromatographic assay which can differentiate SARS-CoV-2 Immunoglobin IgM and IgG antibodies
​
Results interpreted after 10 minutes
​
20 µl micropipette and Centrifuge (plasma only) not provided.
Mdx RT-PCR
The CareStart™ COVID-19 MDx RT-PCR is intended for qualitative detection of SARS-CoV-2 RNA in upper respiratory specimens (such as and nasopharyngeal wash/aspirate or nasal aspirate) and bronchoalveolar lavage from individuals suspected of COVID-19 by their healthcare provider. At this time, testing is limited to CLIA-certified laboratories.
​
Processing time less than 83 minutes
​
Available for use with the following lab systems:
-
CFX96™ system (Bio-Rad Laboratories, Inc.)
-
Applied Biosystems 7500/7500 Fast Real-Time PCR System
(Thermofisher Scientific)