Lab Test

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

Rapid COVID-19 PCR tsting, available to EC Providers ONLY
Wuhan, PCR, RT-PCR, Coronavirus, 2019-nCoV, COVID-19, SARS, Novel coronavirus

Test Codes

EPIC: LAB7912

Specimen Collection Criteria

Collection instructions For Nasopharyngeal specimens:

  • Collect: 1 NP swab only. 
  • Specimen Collections Manual: Nasopharyngeal (NP) Specimens
  • Place the swab into the approved transport medium tube and make sure that the cap is tightly sealed.
  • Specimens must be double-bagged prior to sending to the laboratory. BOTH BAGS MUST BE SEALED. 

Collection instructions for Oropharyngeal specimens: 

  • Collect: 1 OP swab only. 
  • 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.
  • Place the swab into the approved transport medium tube and make sure that the cap tightly sealed. 
  • Specimens must be double-bagged prior to sending to the laboratory. BOTH BAGS MUST BE SEALED.

Approved collection kits:  Approved Nasopharyngeal and Oropharyngeal Collection Kits for COVID-19 Testing

Physician Office/Draw Specimen Preparation

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

Preparation for Courier Transport

Transport: Nasopharyngeal or Oropharyngeal swab in approved 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: 8 hours
Refrigerated (2-8°C or 36-46°F): 7 days
Frozen (-20°C/-4°F or below): 7 days

Specimen Storage in Department Prior to Disposal:

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

Laboratory

Royal Oak Microbiology Laboratory
Dearborn Microbiology Laboratory
Farmington Hills Microbiology Laboratory
Grosse Pointe Microbiology Laboratory
Troy Microbiology Laboratory
Wayne Microbiology Laboratory
Taylor Microbiology Laboratory
Trenton Microbiology Laboratory

Performed

Sunday – Saturday.
Results available within 1-2 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. When the laboratory has used all allocated tests for the day, orders will be converted to a routine test (24 hour TAT) until a new allocation begins.

Reference Range

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

Test Methodology

Nucleic Acid Amplification (NAA) / Polymerase Chain Reaction (PCR). The SARS-CoV-2 (COVID-19) test is for in vitro diagnostic use under the FDA Emergency Use Authorization (EUA) for US laboratories certified under CLIA to perform high complexity testing. This test has not been FDA cleared or approved.

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
LOINC: 94306-8, 94500-6, 95209-3, 94309-2, 94500-6

Contacts

Last Updated

7/20/2021

Microtainer® and Vacutainer® are registered trademarks of Becton, Dickinson and Company.
UroVysion® is a registered trademark of Abbott Laboratories. ThinPrep® is a registered trademark of Hologic, Incorporated.