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Test Code COV19 SARS Coronavirus 2 RNA Detection

Performing Laboratory

Hunterdon Medical Center Laboratory

Useful For

The detection of RNA from SARS-CoV-2 coronavirus. Positive results are indicative of the presence of SARS-CoV-2 RNA. Clinical correlation with patient history and other diagnostic information is necessary to determine patient infection status.

Specimen Required

 

Collection Requirements Specimen Container
Acceptable  Nasopharyngeal Swab (NP) Viral Transport Media
Acceptable Oropharyngeal Swab (OP) Viral Transport Media/Saline
Acceptable Nasal Swab Viral Transport Media/Saline
Minimum Volume 3mL 3mL
  • Collection Instructions NP Specimen:
  • Collection Instructions Nasal Swab:
    • Insert swab approximately 2cm into the nare.
    • Rotate the swab against all sides of the nasal mucosa, using a circular motion.
    • Repeat the process with the other nare.
    • Place swab in transport media

 

Specimen Type

NP (Nasopharyngeal), OP (Oropharyngeal), nasal midturbinate, nasal specimens.

Specimen Stability Information

  1. Temperature
 Time Frame
Refrigerated 2-8°C 4 days

Specimen Transport Temperature

Refrigerated 2-8°C

Reject Due To

  • Media should not contain Guanidium thiocyanate or any guanidine containing material.
  • Wooden-shafted, foam or cotton swab.
  • Broken, leaking containers.

Day(s) Test Setup

Monday through Sunday

Turn around time 24-36 hours.

Reference Values

Negative

Negative results do not preclude SARS-CoV-2 infeciton and should not be used as the sole basis for patient management decisions. Negative results must be combined with clinical observations, patient history and epidemiological information.

Methodology

Nucleic Acid Amplification (NAA)

Test Classification

The Aptima SARS-CoV-2 assay is for use only under Emergency Use Authorization (EUA) in US Laboratories certified under the Clinical Laboratory Improvement Ammendments of 1988 (CLIA), 42 U.S.C.§263a, that meet requirements to perform high complexity tests.

 

CPT Code Information

U0003

LOINC Code Information

94559-2