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Test Menu Details

SARS-CoV-2 & Influenza A/B Multiplex Real-Time RT-PCR

Updated

10/19/2023

Search TermsCOVID-19; 2019 nCoV; Influenza A; Influenza B; Flu SC2
How to Order On the Virology/Immunology Test Request Form (OHA0042), in the “Molecular” section, check the box for “SARS-CoV-2, RT-PCR or NAAT.” Complete all required fields.

If the specimen is associated with an identified outbreak, include the outbreak umber in the Outbreak Number box on the test request form.
Availability With State Acute and Communicable Disease Prevention Program (ACDP) approval only. Please review the for Criteria for COVID-19 Testing at OSPHL (pdf).
PerformedOnce per week or more, depending on demand
Time to ReportingWithin 5 working days after receipt of specimen
CPT Code87636


Specimen Collection Details

CollectionCollect specimen(s) using Dacron polyester tips or flocked swabs on a plastic shaft (wooden shaft swabs are not acceptable). Insert swabs into viral transport media (preferred). Universal transport media and sterile saline are acceptable. Do not submit a dry swab for testing.

DO NOT SUBMIT Molecular Transport Media (MTM) for this test. Media containing guanidine thiocyanate or similar chemicals are not acceptable for testing.

Acceptable specimen sources include:
  • Upper Respiratory: Nasopharyngeal swabs (preferred), nasal swabs, throat swabs, combination swabs (2 swabs from accepted specimen sources in one vial)
  • Lower respiratory: nasal aspirates, nasal washes, bronchoalveolar lavages, bronchial washes, tracheal aspirates, sputum, lung tissue, or cell culture isolates.
Instructions for collecting respiratory specimens are available at: https://www.cdc.gov/flu/pdf/freeresources/healthcare/flu-specimen-collection-guide.pdf.
Optimal Volume3.0 mL
Minimum Volume1.0 mL
Handling

Store specimens at refrigerated temperatures (2-8°C) pending transport.

Specimens that will not be tested within 72 hours of collection should be frozen at -70° C pending transport. Minimize the potential for multiple freeze/thaw cycles during handling, storage, and testing to prevent viral degradation.
Transport Package specimens with fully frozen ice packs to maintain refrigerated temperatures during transport.

Transport for receipt at the OSPHL within 3 days of specimen collection.

If specimen is frozen, transport using dry ice to maintain frozen temperatures during transport.
Rejection CriteriaDry swabs; swabs containing calcium alginate, cotton tips, or wooden shafts; and specimens submitted in the incorrect transport media.

Specimens are subject to the requirements of the OSPHL Specimen Submission Policy and Criteria, available at: http://bit.ly/SpecimenCriteria.
Comments Qualifying specimens may be reflexed to additional testing. Discrepant results between test platforms may occur for specimens containing low quantity of virus. For additional details about OSPHL's testing process, please review the COVID-19 and Influenza Testing Algorithm (pdf).

COVID-19 Positive Specimens:
Qualifying specimens may be selected for next generation sequencing for SARS-CoV-2 surveillance. For more detail, please review the SARS-CoV-2 Next Generation Sequencing Test Menu page.

Influenza Positive Specimens:
Specimens that test positive for influenza A or influenza B will be reflexed to subtyping or genotyping assays, respectively, for further characterization. For more details refer to the Influenza A and B Real-Time RT-PCR with Reflex Subtyping and Lineage Test Menu page.

State epidemiologists may request additional respiratory pathogen testing or SARS-CoV-2 sequencing from OSPHL if needed for outbreak identification and management.

Original material submitted for testing is retained for 7 calendar days after receipt at the laboratory.

Method Details

Methodology

Influenza SARS-CoV-2 (Flu SC2) Multiplex Assay - Real-time reverse transcriptase polymerase chain reaction (rRT-PCR) (Entity: Centers for Disease Control and Prevention)

Performance Specifications This assay is performed as a modification of the procedure under FDA Emergency Use Authorization. Performance Specifications are available on the FDA Emergency Use Authorization webpage.

Change Log

10/19/2023
Updated Collection section
5/23/2023
Reviewed; no changes
11/9/2022Updated COVID-19 and Influenza Testing Algorithm
11/4/2022

New Test Menu Page