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EUA Status for SARS-COV-2 LDT’s

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

EUA Status for SARS-COV-2 LDT’s

The FDA released a memo based on the totality of scientific evidence available, that laboratories that have developed qualitative nucleic acid LDT’s (laboratory developed tests) for SARS-COV-2 are eligible for EUA status. This authorization is restricted to the single CLIA compliant high complexity lab where the test was developed and validated.

Some of the requirements are:

  1. IPC: – internal process control must be included in the extraction of RNA from patient specimen such as RNase P control or exogenous RNA like MS2 phage used for spiking patient samples
  2. EC: – extraction control that can serve both as a negative control (this is not the no template control) to monitory carry over or cross contamination and successful extraction yields such as known negative patient sample
  3. PTC: – positive control to show that the testing system (reagents, instruments, protocols) is functioning properly such as a known positive patient sample.
  4. NTC: – no template control to monitor non-specific amplification such as nuclease free water or buffer

Like labs running EUA kits, the limit of detection must be established to meet the same performance criteria. Labs must be able to provide traceability of any FDA recommended reference materials for analytic sensitivity and specificity. All adverse events must be tracked and reported. Testing performance and quality, specifically any suspected false negatives or positives or significant deviations from your validated performance metrics must be reported upon each event to the DMD/OHT7-OIR/OPEQ/CDRH by email to: CDRH-EUA-Reporting@fda.hhs.gov.

Labeling must include:

  1. This test has not been FDA cleared or approved.
  2. This test has been authorized by the FDA under an EUA for use by ‘Authorized Laboratory”.
  3. This test has been authorized only for the detection of nucleic acid from SARS-COV-2, not for other viruses or pathogens.

This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for detection and/or  diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner. The FDA has authorized the state agencies in:

  1. CT
  2. MD
  3. MS
  4. NV
  5. NY
  6. WA

to review LDT submissions for EUA status. Records and testing documentation must be maintained for a possible onsite inspection by the FDA.

To continue to offer your LDT SARS-COV-2 test regardless of any EUA status after the end of the emergency period, the lab must perform additional validation studies to meet the remaining criteria required by CLIA and/or their accrediting agency such as CAP, COLA or Joint Commission.

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

EUA Status for SARS-COV-2 LDT’s

The FDA released a memo based on the totality of scientific evidence available, that laboratories that have developed qualitative nucleic acid LDT’s (laboratory developed tests) for SARS-COV-2 are eligible for EUA status. This authorization is restricted to the single CLIA compliant high complexity lab where the test was developed and validated.

Some of the requirements are:

  1. IPC: – internal process control must be included in the extraction of RNA from patient specimen such as RNase P control or exogenous RNA like MS2 phage used for spiking patient samples
  2. EC: – extraction control that can serve both as a negative control (this is not the no template control) to monitory carry over or cross contamination and successful extraction yields such as known negative patient sample
  3. PTC: – positive control to show that the testing system (reagents, instruments, protocols) is functioning properly such as a known positive patient sample.
  4. NTC: – no template control to monitor non-specific amplification such as nuclease free water or buffer

Like labs running EUA kits, the limit of detection must be established to meet the same performance criteria. Labs must be able to provide traceability of any FDA recommended reference materials for analytic sensitivity and specificity. All adverse events must be tracked and reported. Testing performance and quality, specifically any suspected false negatives or positives or significant deviations from your validated performance metrics must be reported upon each event to the DMD/OHT7-OIR/OPEQ/CDRH by email to: CDRH-EUA-Reporting@fda.hhs.gov.

Labeling must include:

  1. This test has not been FDA cleared or approved.
  2. This test has been authorized by the FDA under an EUA for use by ‘Authorized Laboratory”.
  3. This test has been authorized only for the detection of nucleic acid from SARS-COV-2, not for other viruses or pathogens.

This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for detection and/or  diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner. The FDA has authorized the state agencies in:

  1. CT
  2. MD
  3. MS
  4. NV
  5. NY
  6. WA

to review LDT submissions for EUA status. Records and testing documentation must be maintained for a possible onsite inspection by the FDA.

To continue to offer your LDT SARS-COV-2 test regardless of any EUA status after the end of the emergency period, the lab must perform additional validation studies to meet the remaining criteria required by CLIA and/or their accrediting agency such as CAP, COLA or Joint Commission.