Instruction Manual
Table Of Contents
- Intended Use
- Summary and Explanation
- Principles of the Procedure
- Materials Required (Provided)
- DTT solution 500mM
- SARS-CoV-2 PCR Mix
- Equipment and Supplies
- Warnings and Precautions
- Specimen Collection, Handling, and Storage
- Procedure
- For viscous samples (sputum and bronchial wash): Performed inside BSC 2
- NOTE: In the event that the test system becomes inoperable, notify supervision or designee for further direction. Patient specimens must be stored in a manner that maintains the integrity of the specimen.
- Quality Control
- Limitations
- Conditions of Authorization for the Laboratory
- Performance Characteristics
- References
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• Authorized laboratories implementing pooling strategies for testing patient specimens must use the “Protocol for
Monitoring of Specimen Pooling Testing Strategies” to evaluate the appropriateness of continuing to use such
strategies based on the recommendations in the protocol.
• Authorized laboratories will keep records of specimen pooling strategies implemented including type of strategy, date
implemented, and quantities tested, and test result data generated as part of the Protocol for Monitoring of Specimen
Pooling Testing Strategies. For the first 12 months from the date of their creation, such records will be made available
to FDA within 48 business hours for inspection upon request, and will be made available within a reasonable time
after 12 months from the date of their creation.
1
Authorized Laboratories: For ease of reference, the Letter of Authorization refers to “Laboratories designated by Quest
Diagnostics that are certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. § 263a, and
meet the requirements to perform high complexity tests” as “authorized laboratories.”