Instruction Manual

16
Conditions of Authorization for the Laboratory
The Quest SARS-CoV-2 rRT-PCR test Letter of Authorization, along with the authorized Fact Sheet for Healthcare
Providers, the authorized Fact Sheet for Patients and other authorized labeling are available on the FDA website:
https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-
devices/vitro-diagnostics-euas
To assist clinical laboratories running the test, the relevant Conditions of Authorization are listed below, and are required to
be met by laboratories performing the EUA test.
• Authorized laboratories
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using Quest SARS-CoV-2 rRT-PCR test will include with test result reports, all authorized
Fact Sheets. Under exigent circumstances, other appropriate methods for disseminating these Fact Sheets may be
used, which may include mass media.
• Authorized laboratories using Quest SARS-CoV-2 rRT-PCR test will perform the COVID-19 RT-PCR Test as
outlined in the COVID-19 RT-PCR test Instructions for Use. Deviations from the authorized procedures, including
the authorized instruments, authorized extraction methods, authorized clinical specimen types, authorized control
materials, authorized other ancillary reagents and authorized materials required to perform the COVID-19 RT-PCR
Test are not permitted.
• Authorized laboratories testing authorized specimens self-collected using the Quest Diagnostics Self-collection Kit
for COVID-19, or any other authorized home specimen collection kit with your product must follow any Specimens
Accessioning protocols provided with the authorized self-collection kit and/or outlined in Quest Diagnostics’ “Self-
Collected Sample Processing Non-Technical SOP,” when accepting specimens for testing.
• Authorized laboratories testing authorized specimens self-collected using the Quest Diagnostics Self-collection Kit
for COVID-19, or any other authorized home specimen collection kit with your product, must include in the test
report for specific patients whose specimen(s) were self-collected without observation the following limitation:
“Specimens that are self-collected were not tested with an internal control to confirm that the specimen was properly
collected. As such, unobserved self-collected specimens from SARS-CoV-2 positive individuals may yield negative
results if the specimen was not collected properly”.
• Authorized laboratories that receive Quest SARS-CoV-2 rRT-PCR test must notify the relevant public health
authorities of their intent to run the test prior to initiating testing.
• Authorized laboratories using Quest SARS-CoV-2 rRT-PCR test will have a process in place for reporting test
results to healthcare providers and relevant public health authorities, as appropriate.
• Authorized laboratories will collect information on the performance of the test and report to DMD/OHT7-
OIR/OPEQ/CDRH (via email: [e-mail]) and Quest Diagnostics (via email:
[e-mail]) any suspected occurrence of false positive or false negative results and
significant deviations from the established performance characteristics of the test of which they become aware.
• All laboratory personnel using the test must be appropriately trained in RT-PCR techniques and use appropriate
laboratory and personal protective equipment when handling this kit, and use the test in accordance with the
authorized labeling.
• Quest Diagnostics and authorized laboratories using Quest SARS-CoV-2 rRT-PCRT test will ensure that any
records associated with this EUA are maintained until otherwise notified by FDA. Such records will be made
available to FDA for inspection upon request.
• Authorized laboratories using specimen pooling strategies when testing patient specimens with your product will
include with test result reports for specific patients whose specimen(s) were the subject of pooling, a notice that
pooling was used during testing and that “In very rare cases, estimated at about 1 in 1,000 (0.1%) or less patient
specimens with low viral loads may not be detected in sample pools due to the decreased sensitivity of pooled
testing.”