BioCheck SARS-CoV-2 IgM and IgG Antibody Test Kits

BioCheck SARS-CoV-2 IgM and IgG Antibody Test Kits

Detect COVID-19 antibodies in about 30 minutes

The BioCheck SARS-CoV-2 Antibody Test Kits contain chemiluminescent immunoassays that qualitatively detect the content of SARS-CoV-2 IgM and IgG antibodies in human serum samples performed on the Sophonix MS-Fast Automated Chemiluminescent Immunoassay Analyzing System.

The Sophonix MS-Fast analyzer and SARS-CoV-2 Antibody Test Kits are for in vitro diagnostic use in the United States under FDA Emergency Use Authorization.
 

COMBO TEST KIT

  • For use in the US under the
    FDA Emergency Use Authorization
  • BioCheck SARS-CoV-2
    Combo kit includes:
  • 10 IgM tests and 10 IgG tests
    (BCM-1005)

SARS-CoV-2 IgM

  • For use in the US under the
    FDA Emergency Use Authorization
  • BioCheck SARS-CoV-2
    IgM kit includes:
  • 10 SARS-COV-2 IgM tests
    (BCM-1003)

SARS-CoV-2 IgG

  • For use in the US under the
    FDA Emergency Use Authorization
  • BioCheck SARS-CoV-2
    IgG kit includes:
  • 10 SARS-COV-2 IgG tests
    (BCM-1001)
SARS-COV-2 IgG and IgM

Results from Early Validation

Results of an early validation study conducted in Wuhan, China on 153 specimens.

Download a review by R. Humphries

Get Answers Have questions about our COVID-19 products?

For detection of COVID-19 antibodies

The BioCheck SARS-CoV-2 Antibody Test Kits are intended for the qualitative detection of antibodies (IgM and IgG) to the 2019 novel coronavirus (SARS-CoV-2) in serum specimens from individuals meeting CDC 2019-nCoV clinical and epidemiological criteria.

The assays run on the MS-Fast Automated Chemiluminescent Immunoassay Analyzing System. Results are for the detection of SARS-CoV-2 IgM and IgG antibodies, which are generally detectable in blood several days after the acute phase of infection.

 

Specifications

The BioCheck SARS-CoV-2 Combo Test kit (BCM-1005) consists of ten SARS-CoV-2 IgM test kits and ten SARS-CoV-2 IgG test kits. Each kit contains test cartridges, positive control, negative control and QR code labels. The BioCheck SARS-CoV-2 IgM Antibody Test Kit (BCM-1003) and BioCheck SARS-CoV-2 IgG Antibody Test Kit (BCM-1001) contents are shown in Tables 1 and 2, respectively

Table 1: SARS-CoV-2 IgM Kit Components

Kit Components
Quantity
Description

Cartridge
10 Tests
All reagents necessary for antibody results

Positive control
200μLx1
Human SARS-CoV-2 S1 IgM Antibody. Batch Specific

Negative control
200μLx1
BSA-containing buffer. Batch Specific

QR code label
1 label
Contains positive controls and negative control reference values

All SARS-CoV-2 kits must be stored at 2-8° Celsius.

Table 2: SARS-CoV-2 IgG Kit Components

Kit Components
Quantity
Description

Cartridge
10 Tests
All reagents necessary for antibody results

Positive control
200μLx1
Human SARS-CoV-2 S1 IgG Antibody. Batch Specific

Negative control
200μLx1
BSA-containing buffer. Batch Specific

QR code label
1 label
Contains positive controls and negative control reference values

IMPORTANT INFORMATION:

  • This test has not been FDA cleared or approved;
  • This test has been authorized by FDA under an Emergency Use Authorization for use by authorized laboratories;
  • This test has been authorized only for the presence of IgG and IgM antibodies against SARS-CoV-2, not for any other viruses or pathogens; and
  • This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests 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.

Order SARS-CoV-2 test kits

Accelerate Diagnostics distributes the BioCheck SARS-CoV-2 Antibody Test Kits and Sophonix MS-Fast system.

The Sophonix MS-Fast Analyzer and BioCheck SARS-CoV-2 IgM and IgG Antibody Test Kits are for in vitro diagnostic use in the United States under FDA Emergency Use Authorization.

US Product Numbers:
BioCheck SARS-CoV-2 IgM and IgG Combo Test Kit: BCM-1005
BioCheck SARS-CoV-2 IgM Antibody Test Kit: BCM-1003
BioCheck SARS-CoV-2 IgG Antibody Test Kit: BCM-1001

Customers outside the US: contact us for more information.
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