Lab Test

SARS-CoV-2 (CoVID-19) by NAA, Routine

Wuhan, Coronavirus, 2019-nCoV, COVID-19, SARS, Novel coronavirus

Test Codes

EPIC: LAB7913

Instructions

COVID-19 testing will be performed in-house as testing reagents permit. All positive results will be reported to MDHHS. 

Specimen Collection Criteria

Collect: ONE of the following specimen types:

  • Nasopharyngeal (NP) Swab: Place in approved collection device and make sure the cap is tightly sealed. Approved Nasopharyngeal and Oropharyngeal Collection Kits for COVID-19 Testing. 
    • During collection, please remember to leave the NP swab in the patient's nasopharynx for 30 seconds and to gently rotate the swab to obtain an adequate specimen. For more information, please refer to the Specimen Collection Manual for NP Swab Collection.
  • Oropharyngeal (OP) Swab: Place in approved collection device and make sure the cap is tightly sealed. Approved Nasopharyngeal and Oropharyngeal Collection Kits for COVID-19 Testing. 
    • For collection, gently insert the oropharyngeal swab into the posterior pharynx and tonsillar areas. Rub the swab over both tonsillar pillars and posterior oropharynx while avoiding contact with the tongue, teeth and gums.
  • Bronchoalveolar Lavage (BAL): Place in a sterile collection container.
  • Sputum (Expectorated, Tracheal, Trans-Tracheal, Nasotracheal, Endotracheal): Place in a sterile collection container. 

Physician Office/Draw Specimen Preparation

    

Room Temperature (20-26°C or 68-78.8°F): Transport to laboratory immediately.

Maintain all specimens refrigerated (2-8°C or 36-46°F) prior to transport.

Preparation for Courier Transport

Transport: Nasopharyngeal swab in viral transport medium, refrigerated (2-8°C or 36-46°F).

Rejection Criteria

  • Dry swabs.
  • Specimens in non-sterile or leaking containers.
  • Specimens subjected to repeated freeze/thaw cycles.

In-Lab Processing

Specimens are stable for eight (8) hours at room temperature (20-26°C or 68-78.8°F).

Specimens may also be refrigerated (2-8°C or 36-46°F) prior to testing.

Storage

Specimen Stability for Testing:

Room Temperature: Unacceptable
Refrigerated (2-8°C or 36-46°F): 72 hours
Frozen (-20°C/-4°F or below): 7 days

Specimen Storage in Department Prior to Disposal:

Refrigerated (2-8°C or 36-46°F): 7 days (negative samples only).

Laboratory

Royal Oak Clinical Molecular Pathology Laboratory

Performed

Sunday – Saturday.
Results available within 24-48 hours.

The limited availability of reagents or consumables during this outbreak may impact the labs ability to meet expected turn-around-times for this test.

Reference Range

Not Detected: No SARS-CoV-2 RNA detected.

Test Methodology

Nucleic Acid Amplification. This test was developed, and its performance characteristics determined by Beaumont Laboratory Clinical Molecular Pathology Department, Royal Oak. It has not been cleared or approved by the U.S. FDA. Emergency Use Authorization (EUA) has been submitted to the FDA for approval. 

Interpretation

By report.

Clinical Utility

This assay aids in the detection of the SARS-CoV-2 (CoVID-19) novel Coronavirus. This assay detects the pathogen's RNA and does not rely upon the presence of infectious virus or seroconversion.

Clinical Disease

Symptoms of SARS-CoV-2 (CoVID-19) infection are similar to those of other respiratory viruses that occur seasonally in the winter and include:

  •  Fever
  • Dry cough
  • Fatigue
  • Shortness of breath
  • Sore throat
  • Chills
  • Pneumonia


Epidemiology

The 2019 novel Coronavirus SARS-CoV-2 was identified as the cause of an outbreak of respiratory illness first detected in December, 2019 near Wuhan City, Hubei Province, China. As this is an emerging pathogen, the incidence and distribution of the virus in the US and world-wide is constantly evolving. Currently, SARS-CoV-2 cases in the US include those that are associated with travel, cases among close contacts of known cases and community-acquired cases where the source of the infection is unknown.

Incubation Period

According to estimates from the World Health Organization (WHO), the incubation period for SARS-CoV-2 ranges from 2 – 14 days with a median incubation period of 5 days.

Transmission

The virus is thought to spread mainly from person-to-person.

  • Between people who are in close contact with one another (within about 6 feet).
  • Through respiratory droplets produced when an infected person coughs or sneezes.

It may be possible that a person can get COVID-19 by touching a surface or object that has been recently contaminated by the virus and then touching their own mouth, nose, or possibly their eyes, but this is not thought to be the main way the virus spreads.

CPT Codes

U0003

Contacts

Last Updated

5/4/2021

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