SARS-CoV-2 Total Ab Assay

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Overview

The Platelia SARS-CoV-2 Total Ab assay ensures reliable detection of anti-SARS-CoV-2 IgM, IgA and IgG in one test to determine the immune response to SARS-CoV-2.

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Description

Description

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The Platelia SARS-CoV-2 Total Ab assay ensures reliable detection of anti-SARS-CoV-2 IgM, IgA and IgG in one test to determine the immune response to SARS-CoV-2.

Accurate Performance

  • High specificity (>99%)
  • Excellent sensitivity allows for earlier identification of seroconversion and reliable screening
  • No cross-reactivity

Convenient & Fast

  • 1-step antigen capture format (only 90-minute incubation time required)
  • 96-well microplate testing with breakable strips
  • Ready to use with colored reagents
  • Visual control of sample dilution and reagent addition

In the U.S., the test has been authorized by the FDA under an EUA for use by authorized laboratories. The test has not been FDA cleared or approved. The test has been authorized only for the presence of total antibodies against SARS-CoV-2, 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.

This antibody test is for in vitro diagnostic use only by professionals in laboratories certified to perform high complexity tests.

Please contact your Bio-Rad local representative to check the availability in your country.

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12015289
Qualitative detection of antibodies IgM, IgA and IgG to
SARS-CoV-2 all in one test using EIA technology. Testing can be performed in human serum or plasma samples (96 tests).
Image
idd_12013798_Sars-CoV-2_tn.jpg
12015253
Qualitative detection of antibodies IgM, IgA and IgG to
SARS-CoV-2 all in one test using EIA technology. Testing can be performed in human serum or plasma samples (480 tests).

Documents

Documents

Number Description Options
IFU-US_0001745
IFU for Platelia SARS-CoV-2 Total Ab: 12015289, 12015253 (English, February 2022)
IFU-US_0001745-1
IFU Addendum for Platelia SARS-CoV-2 Total Ab: Fact Sheet for Healthcare Providers
IFU-US_0001745-2
IFU Addendum for Platelia SARS-CoV-2 Total Ab: Fact Sheet for Recipients