1. Home
  2. Laboratory Improvement
  3. Proficiency Testing
  4. SARS-CoV-2 Proficiency Testing and Quality Improvement Programs

SARS-CoV-2 Proficiency Testing and Quality Improvement Programs

As laboratories expand patient testing capabilities for detection of or exposure to the novel coronavirus (SARS‑CoV‑2), we have introduced new programs to support your efforts.

Enroll in Our New SARS‑CoV‑2 PT Programs

Place your order today to ensure material availability.

Order SARS-CoV-2 Antigen (COVAG) Right Arrow Order SARS-CoV-2 Molecular (COV2Q) Right Arrow

Inspired by Your Resourcefulness and Dedication to Accuracy

As you adapt to the rapidly changing testing landscape, we are here to support you with a comprehensive offering of proficiency testing (PT) and quality improvement programs to meet your regulatory needs for COVID-19 testing.

Proficiency testing programs are available for laboratories performing nucleic acid amplification tests or antigen tests to detect the novel coronavirus and for laboratories performing serology testing to detect the presence of antibodies against the SARS-CoV-2 virus.

In addition, the Quality Cross Check—SARS-CoV-2 Molecular (COV2Q) program allows laboratories performing nucleic acid amplification testing to monitor performance across multiple instruments while maintaining compliance with the Centers for Medicare & Medicaid Services (CMS) directive and CLIA regulations prohibiting PT on multiple instruments.

SARS-CoV-2 Antigen (COVAG)

Program Benefits

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

Program Details

Program Ordering CodeCOVAG
Testing typeAntigen testing
Specimen descriptionThree 0.5-mL simulated respiratory specimens
Material contentInactivated SARS-CoV-2 virus
Challenges per shipment3
Shipments per yearOne shipment in 2020; two shipments in 2021
2020 shipment dateNovember 30
2021 shipment datesApril 12; October 4

Resources

SARS‑CoV‑2, Molecular (COV2)

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

Program Ordering CodeCOV2
Testing typeNucleic acid amplification
Specimen description1.5-mL non-infectious liquid specimens that contain the whole SARS-CoV-2 genome
Gene targetsProvides sequence targets across all assay platforms
Specimens per shipment3
Shipments per year2
2020 shipment datesMay 18; November 16
2021 shipment datesMay 24; November 22

SARS‑CoV‑2 Serology (COVS)

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

Program Ordering CodeCOVS
Antibodies detectedTotal, IgG, IgM, and IgA antibodies to SARS‑CoV‑2
Testing typeSerology testing/Antibody testing
Method compatibilityCompatible with most testing platforms
Specimen description0.5 -mL non-infectious, donor-based serum specimens
Specimens per shipment3
Shipments per year2
2020 shipment datesJune 22; November 9
2021 shipment dates June 7; December 14

Quality Cross Check—SARS-CoV-2 Molecular (COV2Q)

Program Benefits

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 Details

Program Ordering CodeCOV2Q
Testing typeNucleic acid amplification testing
Specimen description3.2-mL non-infectious liquid specimens that contain the whole SARS-CoV-2 genome
Gene targetsProvides sequence targets across all assay platforms
Challenges per shipmentThree challenges; report up to three instruments for each challenge
Shipments per yearOne shipment in 2020; there will be two shipments in 2021
2020 shipment dateOctober 26
2021 shipment datesFebruary 8; August 9