SARS-CoV-2 Proficiency Testing/External Quality Assessment (PT/EQA) and Quality Improvement Programs

Program Benefits

Enrolling in our COV2 program can help your laboratory:

• Add a level of quality assurance to your molecular testing ensuring you deliver accurate, reliable test results to diagnose COVID-19
• Enable your laboratory to assess your entire workflow from nucleic acid extraction through detection
• Meet requirements for assessing the quality of your assay at least twice per year

Program Details

Resources

• Listen to an interview with one of the developers of the COV2 PT Program

To overcome supply chain issues, many laboratories have implemented multiple molecular instruments to meet the demand of testing for SARS-CoV-2. Under CLIA regulations, CMS does not permit a laboratory to test PT samples on multiple instruments unless that is how the laboratory routinely tests patient specimens. Designed to complement existing proficiency testing, the Quality Cross Check—SARS‑CoV‑2 Molecular program allows the laboratory to monitor up to three instruments and maintain compliance with CMS.

Enrolling in our COV2Q program can help your laboratory:

• Evaluate performance across all your SARS-CoV-2 molecular instruments at one time—Quality Cross Check is not PT and not subject to CMS restrictions.
• Assess comparability across all SARS-CoV-2 molecular instruments to ensure you deliver accurate, reliable test results.
• Identify potential instrument problems before they impact patient testing and proficiency testing results.

Program Benefits

Enrolling in our COVS program can help your laboratory:

• Evaluate the accuracy of antibody testing—report results for qualitative and quantitative methods for total, IgG, IgM and IgA antibodies
• Detect potential issues in your antibody testing using donor-based serum PT specimens that are clinically relevant and mimic patient testing
• Meet requirements for assessing the quality of your assay at least twice per year

Program Details

Resources

• Newsroom | College of American Pathologists: CAP Statement on the Current Role of Serologic Testing for SARS-CoV-2
• Listen to an interview to learn more about the clinical use of antibody testing for SARS-CoV-2 and the new PT program COVS

Ensuring accuracy and comparability across various methods and multiple instruments can be a challenge for laboratories, particularly with the extra supply chain demands created during the COVID-19 pandemic. The Quality Cross Check—SARS-CoV-2 Serology program allows the laboratory to monitor performance of up to three serology assays to identify potential issues before they affect patient results, and maintain compliance with the CMS directive regarding performing PT on multiple assays.

Enrolling in our COVSQ program can help your laboratory:

• Evaluate performance across all your SARS-CoV-2 serology assays at one time—Quality Cross Check is not PT and not subject to CMS restrictions
• Assess comparability across all SARS-CoV-2 serology assays to ensure you deliver accurate, reliable test results 
• Compare your serology assay’s performance with other laboratories via your custom report package that includes peer group comparison

Enrolling in our COVAG program can help your institution:

• Add a level of quality assurance to your antigen testing ensuring you deliver accurate, reliable test results to diagnose COVID-19
• Benchmark your results against other testing laboratories; specimens contain inactivated SARS-CoV-2 virus to provide clinically relevant challenges that mimic patient testing
• Meet requirements for assessing the quality of your assay at least twice per year

• Listen to an interview to learn more about the use of antigen testing for SARS-CoV-2 and the about the COVAG proficiency testing program.

Many laboratories are performing SARS-CoV-2 antigen testing across multiple platforms—and, in some instances, multiple locations. The Quality Cross Check—SARS-CoV-2 Antigen (COVAQ) program enables your laboratory to monitor performance of up to three assays at once, allowing you to identify potential issues before they affect patient results. Moreover, you can ensure the accuracy of all your laboratory’s COVID-19 tests for antigen detection—while staying within CLIA regulations.

Enrolling in our COVAQ program can help your laboratory:

• Assess comparability across all SARS-CoV-2 antigen assays—Quality Cross Check is not PT and not subject to CMS restrictions
• Compare your antigen assay’s performance with other laboratories via your custom report package that includes peer group comparison
• Receive enough specimen to test up to three assays with three challenges per mailing