Lab Test

SARS-CoV-2 (CoVID-19) by NAA, Limited Use

For asymptomatic COVID-19 screening, should not be ordered on patients exhibiting signs of a respiratory virus infection
Wuhan, PCR, RT-PCR, Coronavirus, 2019-nCoV, COVID-19, SARS, Novel coronavirus

Test Codes

EPIC: LAB7980

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. 

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 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:

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

Laboratory

Royal Oak Microbiology Laboratory
Dearborn Microbiology Laboratory

Performed

Sunday – Saturday.
Results available within 3 days.

Reference Range

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

Test Methodology

Nucleic Acid Amplification (NAA)/Polymerase Chain Reaction (PCR).

The COVID-19 by NAA, Limited Use test is performed by pooling up to 5 patient specimens. Specimen pools with a positive, inconclusive, or invalid result are tested individually prior to reporting a result. Negative results from pooled testing should be treated as presumptive and, if inconsistent with clinical signs and symptoms or

necessary for patient management, pooled samples should be tested individually. The specimen pooling procedure was developed, and its performance characteristics determined by Beaumont Laboratory Microbiology Department, Royal Oak. It has not been cleared or approved by the U.S. FDA.

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. As with non-pooled testing, negative results must also be considered in the context of an individual’s recent exposures, history and/or presence of clinical signs and symptoms consistent with COVID-19. If a negative result is inconsistent with clinical signs and symptoms or necessary for patient management, please order SARS-CoV-2 (CoVID-19) by NAA to test patient samples individually.

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

 

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

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