Adding Tests for COVID-19 to Your Laboratory’s Activity Menu

As your laboratory brings on testing for COVID-19, please update your laboratory’s CAP Activity Menu to reflect the testing performed.

To update your laboratory’s activity menu:

• Log into your Organization Profile by first logging into e-LAB Solutions Suite on cap.org
• Use the following activities to identify COVID-19 assays:

Molecular-based assays:

• nCOV 2019, NAA, EUA, nonwaived
• nCOV 2019, NAA, EUA, LDT
• nCOV 2019, NAA, EUA, waived
• nCOV 2019, NAA, EUA, waived, POCT

Serology assays:

• nCOV 2019 antibodies

Important information:

• The waived activities may only be used for assays that have received authorization by the FDA for use in the patient care setting. Assays that have only received authorization for CLIA-certified moderate and high complexity laboratories must use the non-waived activity, even if the test is performed in a patient care setting.
• If you are unsure how your laboratory’s test was authorized, review the EUA Letter of Authorization for your specific test on the FDA website.
• You will not be able to add the nonwaived EUA activity to an existing point-of-care section. Instead, create a new section unit and add the appropriate nonwaived activity.
• If your laboratory’s application/reapplication opened prior to 4/21/2020, you may not see the activities listed in Organization Profile. If the activities do not appear, add them as a write-in activity.

If you need assistance, contact the CAP at accred@cap.org or 800-323-4040.

Reference CAP accreditation checklist requirement: COM.01200.