November 3, 2020
In an effort to ensure the safety of our faculty and staff, while maintaining service excellence for our clients and mutual patients, Michigan Medicine Laboratories (MLabs) has updated our tissue submission requirements. Complete evaluation of skeletal muscle requires submission of fresh, frozen tissue, which will be handled without fixation and remain frozen. Fresh, frozen tissue represents an infectious risk (SARS-CoV-2) to laboratory personnel who perform aerosolizing procedures in order to prepare the fresh, frozen tissue.
To submit patient skeletal muscle biopsy tissue to Michigan Medicine Laboratories, this policy requires:
- Patients undergoing skeletal muscle biopsy that will be referred to MLabs must have a pre-procedure test for SARS-CoV-2 (COVID19).
- As with all other COVID tests, the patient must be instructed to isolate as much as possible following the specimen collection, after the test result and prior to their procedure.
- The specimen collection must occur within 96 hours prior to the procedure.
- The pre-procedure test must be a high sensitivity PCR assay to detect viral nucleic acids.
- SARS-CoV-2 antigen tests are not acceptable for pre-procedure tests as they are insufficiently sensitive to detect virus in asymptomatic patients.
- SARS-CoV-2 antibody testing (IgM/IgG) are also not acceptable for pre-procedure tests as they measure immune response to SARS-CoV-2 and not the presence/absence of virus.
- The patient test result must be NEGATIVE (NO VIRAL RNA DETECTED).
- A copy of the COVID test result must accompany the specimen requisition.
- Michigan Medicine Laboratories cannot accept fresh, frozen tissue that will remain unfixed (not placed in formalin or glutaraldehyde) from COVID19 POSITIVE, COVID19 EQUIVOCAL, or UNTESTED patients.
- If the pre-procedure COVID test is positive or equivocal, the biopsy procedure should be rescheduled and the patient re-tested within 96 hours prior to the procedure.