Instruction Manual

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Authorization (EUA) for use in laboratories designated by Quest Diagnostics that are also certified under CLIA, and meet
the requirements to perform high complexity tests.
3. This test has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or
pathogens
4. This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of
emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal
Food, Drug and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.
5. Follow standard precautions. All patient specimens and positive controls should be considered potentially infectious
and handled accordingly.
6. Do not eat, drink, smoke, apply cosmetics or handle contact lenses in areas where reagents and human specimens are
handled.
7. Handle all specimens as if infectious using safe laboratory procedures. Refer to Interim Laboratory Biosafety Guidelines
for Handling and Processing Specimens Associated with 2019-nCoV https://www.cdc.gov/coronavirus/2019-nCoV/lab-
biosafety-guidelines.html.
8. Specimen processing should be performed in accordance with national biological safety regulations.
9. If infection with SARS-CoV-2 is suspected based on current clinical and epidemiological screening criteria
recommended by public health authorities, specimens should be collected with appropriate infection control precautions.
10. Performance characteristics have been determined with human upper respiratory specimens and lower respiratory tract
specimens from human patients submitted for respiratory infection testing (and presumed to have signs and symptoms
of disease).
Specimen Collection, Handling, and Storage
Inadequate or inappropriate specimen collection, storage, and transport are likely to yield false test results. Training in
specimen collection is highly recommended due to the importance of specimen quality. CLSI MM13-A may be referenced
as an appropriate resource.
 Collecting the Specimen
o Refer to Interim Guidelines for Collecting, Handling, and Testing Clinical Specimens from Patients Under
Investigation (PUIs) for 2019 Novel Coronavirus (2019-nCoV)
https://www.cdc.gov/coronavirus/2019-
nCoV/guidelines-clinical-specimens.html
o Follow specimen collection device manufacturer instructions for proper collection methods.
o Swab specimens should be collected using only swabs with a synthetic tip, such as nylon or Dacron®, and an
aluminum or plastic shaft. Calcium alginate swabs are unacceptable and cotton swabs with wooden shafts are
not recommended. Place swabs immediately into sterile tubes containing 1-3 ml of viral transport media (or
PBS or saline if better alternatives are not available)
 Transporting Specimens
o Specimens must be packaged, shipped, and transported according to the current edition of the International Air
Transport Association (IATA) Dangerous Goods Regulation. Follow shipping regulations for UN 3373 Biological
Substance, Category B when sending potential 2019-nCoV specimens. Store specimens at 2-8°C and ship
overnight on ice pack. If a specimen is frozen at -70°C or lower, ship overnight on dry ice
 Storing Specimens
o Specimen stability after collection: 14 days at 18°C to 25°C, 14 days at 2°C to 8°C, 14 days at -10°C to -30°C,
or at -70°C or lower.
o If a delay in extraction is expected, store specimens at -70°C or lower.
o Extracted nucleic acid should be stored at -70°C or lower.
Inspection of Returned Unobserved Self-Collection Specimens
Specimens that are received through the self-collection program are checked for the following criteria before entering the
work flow (according to the lab’s SOP):
Are the following items present?
• Swab in the collection tube
• Test requisition with patient name and a second identifier
• Tube label with patient name and a second identifier
• Collection tube that has not leaked