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Catalog ID COVID-19 PCR SARS-CoV-2 (COVID-19) PCR

Infectious

Specimen Requirements

Nasopharyngeal swab in sterile saline or viral transport media

BAL

CPOE Test Name

Microbiology Lab:  COVID-19

GEM Lab:  REF COVID-19

Causes for Rejection

Specimen leakage out of container; Mislabeled specimen; Wrong specimen type; Unlabeled specimen; Wrong transportation temperature

Reference Range

Negative

Interpretative Information

Specimen results are interpreted as follows:

Detected or Positive = SARS-CoV-2 (COVID-19) RNA is detected. This POSITIVE result is indicative of COVID-19 infection. Positive results do not rule out bacterial infection or co-infection with other viruses.

Not Detected or Negative = SARS-CoV-2 RNA is not detected. This negative result does not preclude SARS-CoV-2 infection and should not be used as the sole basis for treatment and or other patient management. Negative results must be combined with clinical observations, patient history and epidemiological information.

Invalid = No result was obtained with testing due to an issue with the patient’s specimen or test processing. This is typically due to excessive blood or mucus in the sample. Patients will need to have the specimen recollected for re-testing to determine infection status. This result does not indicate a negative result.

Performing Laboratory

Microbiology Lab: 706-721-2807; Testing is performed using an automated in vitro diagnostic test (Cepheid Xpert Xpress SARS-CoV-2 assay and/or Diasorin Simplexa COVID-19 assay) for the qualitative detection of nucleic acid from SARS-CoV-2. These assays have received Emergency Use Authorization from the FDA and performance has been verified by the Clinical Microbiology Laboratory at AU Medical Center, Inc.

GEM Lab: 706-721-5116; The PerkinElmer New Coronavirus Nucleic Acid Detection Kit is a real-time RT-PCR in vitro diagnostic test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 virus in human respiratory specimens collected from individuals suspected of COVID-19. The Perkin Elmer New Coronavirus Nucleic Acid Detection Kit is only for use under the Food and Drug Administration’s Emergency Use Authorization. Performance characteristics for this assay have been verified by the Georgia Esoteric and Molecular Labs, LLC.

Turn-Around-Time

Microbiology Lab: <24 hours from specimen receipt

GEM Lab: 48-72 hours from specimen receipt

***Which laboratory a specimen is performed in is determined by the Microbiology Laboratory based on the current amount of available reagent. Performing laboratory is not dictated by ordering physicians.***

CPT Code

Microbiology Lab: U0003

Gem Lab: U0004