Sale price$5,410.02

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Description

The Clarity COVIBLOCK COVID-19 IgG/IgM Rapid Test Cassette (#CD-COV19) kit includes the Covid-19 test cassettes, developer solution, disposable Pipettes, and package insert.

Warranty: Until Use or Expiration.

Note: This test is intended for use in laboratories or by healthcare workers. It is not ideal for donated blood, and results from the testing should not be used as the sole basis to diagnose infection status. Follow-up testing should be considered.

The Clarity COVIBLOCK COVID-19 Rapid Test is complete kit that provides all the tools needed for a rapid immunoassay. It can detect the differentiation of IgG and IgM antibodies of COVID-19 in human blood, plasma, or serum. It also has EUA approval through Pathway C of the FDA.

Test Results Interpretation Chart

PCR IgM Ab IgG Ab Significance
Positive Negative Negative Patients may be in the "window period" of SARS-COV-2-Infection.
Positive Positive Negative Patient may be in early stage of infection and the body's immune response first produced the antibody IgM, but not IgG was produced or the IgG content did not reach the detection limit of the test.
Positive Negative Positive Patient may be in the late or recurrent stage of infection.
Positive Positive Positive Patient is in the active phase of infection, but the human body has developed some immunity to SARS-COV-2 (the persistent antibody IgG has been produced by the body).
Negative Positive Negative Patient may be in the acute phase of SARS-COV-2 infection. At this time, nucleic acid test results need to be considered (this scenario is a good example of PCR may be false negative).
Negative Negative Positive Patient may have been infected with SARS-COV-2 in the past, but the patient has recovered or the virus in the body has been cleared.
Negative Positive Positive Patient has recently been infected with SARS-COV-2 and is in the recovery stage or the nucleic acid test result is false negative and the patient is in the active infection stage.

Features

Clarity COVIBLOCK COVID-19 IgG/IgM Rapid Test Cassette Features

  • Combined Sensitivity: 93.3%
  • Combined Specificity: 98.8%
  • Overall Accuracy: 95%
  • Uses whole blood, plasma, or serum.
  • Results in as fast as 10 minutes.

Frequently asked questions

Does the test deliver rapid results?

Yes, this rapid immunoassay test provides very fast results. The Clarity COVIBLOCK COVID-19 test delivers accurate results in as fast as 10 minutes from sample application.

Is the Clarity COVIBLOCK COVID-19 test suitable for home use?

This test is intended for use by laboratories or healthcare workers and is not designed for at-home use.

Is the Clarity COVIBLOCK COVID-19 test approved by the FDA?

Yes, the Clarity COVIBLOCK COVID-19 IgG/IgM Rapid Test Cassette has received EUA approval through Pathway C of the FDA.

What does the Clarity COVIBLOCK COVID-19 test detect?

This test is designed to detect and differentiate IgG and IgM antibodies of COVID-19 in human blood, plasma, or serum.

Is this test for professional use only?

The Clarity COVIBLOCK COVID-19 IgG/IgM Rapid Test Cassette is specifically intended for use in laboratories or by healthcare workers only. It is not designed or approved for self-testing or for screening donated blood.

What is included with each rapid test kit?

The Clarity COVIBLOCK COVID-19 Rapid Test is supplied as a complete kit intended for professional use in laboratories or by healthcare workers. The kit contains all the necessary components for testing, including:

  • Test cassette
  • Developer solution (Buffer)
  • Disposable Pipettes
  • Package insert (Instructions for use)

This test is designed to work with whole blood, plasma, or serum samples and delivers rapid results.

What is the accuracy of the Clarity COVIBLOCK COVID-19 Rapid Test Cassette?

This rapid test cassette offers a combined sensitivity of 93.3%, a specificity of 98.8%, and an overall accuracy of 95%.

What sample types does the test accept?

The Clarity COVIBLOCK COVID-19 IgG/IgM Rapid Test Cassette is designed for versatility and can utilize three different types of human blood samples:

  • Whole blood
  • Plasma
  • Serum
Does this test differentiate between antibodies?

Yes, the Clarity COVIBLOCK COVID-19 Rapid Test Cassette is designed for the rapid detection and differentiation of both IgG and IgM antibodies to COVID-19. This allows for insights into the different stages of infection.