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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

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Product

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)

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