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CMS Guidance for Laboratory Developed Tests for Nucleic Acid Detection

Written by Dr. Pauline Gee, Ovation’s Head of Clinical Affairs

If you have a shortage of testing supplies, call 1-888-INFO-FDA (1-888-463-6332) and press * or Email deviceshortages@fda.hhs.gov

CMS Guidance for Laboratory Developed Tests for Nucleic Acid Detection

A reminder…

  1. All diagnostic testing performed including those that use EUA instrumentation /reagent kit(s) must be performed in a laboratory that has been certified by CMS to be CLIA compliant for high complexity. Moderate complexity CLIA compliant labs are permitted to perform serology testing that are not diagnostic on their own.
  2. Only those tests that identify the presence or absence of the SARS-COV2 virus specifically detected directly by a nucleic acid test are deemed to be diagnostic for COVID-19. Serology test results alone are not diagnostic.
  3. If any modifications of, or deviation from, a test that has EUA status that consists of a specific instrument/reagent kit/specimen type/protocols combination must be validated with bridging studies before testing patient samples.
    • It is suggested that each modification be tested with 30 positive (can be contrived) and 30 negative samples to show equivalent performance metrics
    • These bridging studies are required to maintain CLIA compliance and do not need to be submitted to your CMS/CLIA agency before you begin testing unless requested by your oversight agency whether it is CLIA or an accreditation body. Such validation studies must be approved by your lab director and maintained for your next CLIA survey.
    • Bridging studies do not have to be submitted to the FDA.
    • However, the FDA will accept voluntary submission of the results of any bridging study that you may need to perform so that another lab who needs to perform the same specific study will not have to duplicate your study
    • If submitted, the specific modifications and deviations will be deemed validated with performance metrics from your bridging studies would be posted by the FDA in their FAQ’s.

CMS has released a guidance dated March 26, 2020 to expedite the review of applications (Form CMS-116) from those laboratories who wish to start testing for the SARS COV-2 virus as a diagnosis for COVID-19 disease (high complexity) and/or testing for patient antibodies (moderate complexity) to the SARS COV-2 virus which cannot be used to diagnose the COVID-19 disease. Classification of such testing into a given specialty or subspecialty is at the discretion of the laboratory.

The guidance also provides for contingencies during this pandemic to facilitate the urgency of testing. The CLIA onsite surveys and the expiration of CLIA certificates may be extended as onsite surveys have been suspended for the duration of this Emergency period. If your external provider of proficiency testing is not available, internal alternate accuracy testing can substitute to ensure quality testing of patient specimens. Contact your specific oversight agency for specific instructions if needed.

Ultimately it is the Laboratory Director who is the final arbiter of sufficient validation of any LDT using RUO reagents and instrumentation before patient samples are tested.

Written by Dr. Pauline Gee, Ovation’s Head of Clinical Affairs

If you have a shortage of testing supplies, call 1-888-INFO-FDA (1-888-463-6332) and press * or Email deviceshortages@fda.hhs.gov

CMS Guidance for Laboratory Developed Tests for Nucleic Acid Detection

A reminder…

  1. All diagnostic testing performed including those that use EUA instrumentation /reagent kit(s) must be performed in a laboratory that has been certified by CMS to be CLIA compliant for high complexity. Moderate complexity CLIA compliant labs are permitted to perform serology testing that are not diagnostic on their own.
  2. Only those tests that identify the presence or absence of the SARS-COV2 virus specifically detected directly by a nucleic acid test are deemed to be diagnostic for COVID-19. Serology test results alone are not diagnostic.
  3. If any modifications of, or deviation from, a test that has EUA status that consists of a specific instrument/reagent kit/specimen type/protocols combination must be validated with bridging studies before testing patient samples.
    • It is suggested that each modification be tested with 30 positive (can be contrived) and 30 negative samples to show equivalent performance metrics
    • These bridging studies are required to maintain CLIA compliance and do not need to be submitted to your CMS/CLIA agency before you begin testing unless requested by your oversight agency whether it is CLIA or an accreditation body. Such validation studies must be approved by your lab director and maintained for your next CLIA survey.
    • Bridging studies do not have to be submitted to the FDA.
    • However, the FDA will accept voluntary submission of the results of any bridging study that you may need to perform so that another lab who needs to perform the same specific study will not have to duplicate your study
    • If submitted, the specific modifications and deviations will be deemed validated with performance metrics from your bridging studies would be posted by the FDA in their FAQ’s.

CMS has released a guidance dated March 26, 2020 to expedite the review of applications (Form CMS-116) from those laboratories who wish to start testing for the SARS COV-2 virus as a diagnosis for COVID-19 disease (high complexity) and/or testing for patient antibodies (moderate complexity) to the SARS COV-2 virus which cannot be used to diagnose the COVID-19 disease. Classification of such testing into a given specialty or subspecialty is at the discretion of the laboratory.

The guidance also provides for contingencies during this pandemic to facilitate the urgency of testing. The CLIA onsite surveys and the expiration of CLIA certificates may be extended as onsite surveys have been suspended for the duration of this Emergency period. If your external provider of proficiency testing is not available, internal alternate accuracy testing can substitute to ensure quality testing of patient specimens. Contact your specific oversight agency for specific instructions if needed.

Ultimately it is the Laboratory Director who is the final arbiter of sufficient validation of any LDT using RUO reagents and instrumentation before patient samples are tested.