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Test Name COVID SARS CoV2 RNA PCR (Point of Care, Inpatient)

Specimen Requirements

Preparation of Patient: 

Instruct patient that this is an uncomfortable procedure.

 

Container Type: 

Dry swab in sterile transport vial.  Acceptable swabs, sterile rayon, foam, polyester or flocked flexible-shaft nasopharyngeal swabs.

 

Specimen Type:

Nasopharyngeal

 

Specimen Collection:

  1. Tilt head back so the head is extended 70o  Place hand on the back of patient's neck if able.
  2. Pass the swab gently through the more patent nostril about 3" to 4" into the nasopharynx keeping the swab near the septum and the floor of the nose parallel to the palette.  Stop when resistance is met and do not force any further.
  3. Rub and roll the swab and leave in place for 10 - 15 seconds to absorb secretions before removing it.

 

Specimen Handling/Transport:

Place swab in empty transport vial.  Break or cut the handle end of the swab so that it fits in the vial.  Place cap on vial.  Transport to the laboratory immediately after collection.

 

Specimen Stability/Storage:

Room Temperature:  1 Hour

 

Specimen Rejection:

Swabs sent with elution in viral transport media

Bloody swab

 

Note:  Swabs sent in viral transport media or blood swabs will be performed on Cepheid platform.

Performing Laboratory

Munson Health System Laboratories

Priority, Frequency, Turnaround Time

Priority:

STAT

 

Frequency:

7 days a week, 24 hours a day

 

Turnaround Time:

60 minute from receipt in laboratory

Methodology

Isothermal nucleic acid amplification

This test is an automated assay that utilizes isothermal nucleic acid amplification technology for the qualitative detection of SARS-CoV-2 viral nucleic acids in direct nasal, nasopharyngeal or throat swabs from individuals who are suspected of COVID-19 by their healthcare provider.

Reporting

Reference Range:

Negative or Positive

 

Linearity Range:

Lower detection limit 125 GE/mL

 

Critical Decision:

None

 

Result Interpretation:

Test Result

Interpretation

Result

Code

Other Notes

Positive

COVID 19 Positive

POS

Positive results do not rule out bacterial infection or co-infection with other viruses

Negative

CoVid 19 Negative

NEG

Negative results should be treated as presumptive and, if inconsistent with clinical signs and symptoms or necessary for patient management, should be tested with an alternative molecular assay.

Invalid

Unable to determine result  Repeat testing of the sample using a different test platform (Cepheid)

N/A

If Invalid results are obtained, test should be run by another method.

Clinical Significance

An outbreak of respiratory illness of unknown etiology in Wuhan City, Hubei Province, China was initially reported to WHO on December 31, 2019.  Chinese authorities identified a novel coronavirus (2019-nCoV), which has resulted in thousands of conformed human infections in multiple provinces throughout China and in several Southeast Asian countries, Europe and more recently the United States.  Cases of severe illness and deaths have been reported.  The International Committee for Taxonomy of Viruses (ICTV) renamed the virus SARS-CoV-2. 

CPT Code(s)

87635