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.
Literature
Clarity COVIBLOCK COVID-19 IgG/IgM Rapid Test Cassette Literature
Clarity COVIBLOCK COVID-19 IgG/IgM Rapid Test Cassette - Verificaction of EUA
Clarity COVIBLOCK COVID-19 IgG/IgM Rapid Test Cassette - Clinical Diagnostic Laboratory Fee Schedule
Clarity COVIBLOCK COVID-19 IgG/IgM Rapid Test Cassette - Fact Sheet for Healthcare Providers
Clarity COVIBLOCK COVID-19 IgG/IgM Rapid Test Cassette - Fact Sheet for Patient
Clarity COVIBLOCK COVID-19 IgG/IgM Rapid Test Cassette Sheet