COVID - 19, Qualitative

Last Modified: 5/15/2020 10:56:46 AM


Medical Necessity Documentation:  
Client Notes:  
Patient Preparation:  
Specimen Requirements: Nasopharyngeal Specimen: One (1) nasopharyngeal (NP) swab collected in a multi microbe media (M4, M4RT, M5, M6), VCM (UTM) medium (green-top) tube, Amies liquid elution swab (ESwab), or equivalent Viral Transport Media (VTM) 

OR

Nasal specimen:
One (1) nasal swab for collected in an acceptable viral transport medium (including saline and PBS)
Collection Instructions: Nasopharyngeal Collection

or 

Nasal Collection: Collect specimens from both nares of a symptomatic patient. Insert swab into 1 nostril straight back (not upwards). Once the swab is in place, rotate it in a circular motion 2 times and keep it in place for 15 seconds. Repeat this step for the second nostril using the same swab. Remove swab and insert the swab into an acceptable viral transport medium (including saline and PBS).
Transport & Storage: Temperature/Stability: 5 days Ambient
5 days Refigerated 
Acceptable: at  Frozen -20° C or Frozen -70° C 

Must be frozen before sent to Quest
Rejection Criteria: Calcium alginate swabs • Cotton swabs with wooden shaft • Amies liquid or gel transport used for bacterial cultures
Reference Range: Not Detected
Critical Ranges:  
Test Comments:  
Methodology: Nucleic Acid Amplification Test (NAAT) includes PCR or TMA
Clinical Significance:
The SARS-CoV-2 RNA (COVID-19), Real-Time RT-PCR test is a qualitative multi-target molecular diagnostics test that aids in the detection of COVID-19. This test is intended to be performed on respiratory specimens collected from individuals who meet the Centers for Disease Control and Prevention (CDC) clinical and/or epidemiological criteria for COVID-19 testing. For details visit: https://www.cdc.gov/coronavirus/2019-ncov/hcp/index.html.

Result interpretation:
• A Detected result is considered a positive test result for COVID-19. This indicates that RNA from SARS-CoV-2 was detected and that the patient is considered infected with the virus and presumed to be contagious. If requested by public health authorities, specimens will be send for additional testing.
• A Not Detected (negative) test result for this test means that SARS-CoV-2 RNA was not present in the specimen above the limit of detection. However, it does not rule out the possibility of COVID-19 and should not be used as the sole basis for patient management decisions.
• An Inconclusive result means not all of the testing targets were detected. This could be due to a sample with viral concentrations near the limit of detection of the test or other factors. An additional sample collection may be considered.

Laboratory test results should always be considered in the context of clinical observations and epidemiological data in making a final diagnosis and patient management decisions.

Test results are typically available 3-4 days from the time of specimen pickup and may be impacted by high demand.
Documentation:  
Custom Panel: No

PRODUCTION SCHEDULE

Turn Around Time: 1 to 2 days
Days Performed: Sunday, Monday, Tuesday, Wednesday, Thursday, Friday, Saturday
Sites Performed: Quest - Chantilly
PHL Test Code: QCOV
EPIC Test Code: LAB14197
Send Out Test Code: 39448
Alternate Test Names: Coronavirus; COVID19; COVID-19; nCOV; Novel Coronavirus; SARS COV2 RNA (COVID-19); SARS-CoV-2 RNA (COVID-19), Qualitative NAAT; Wuhan
Included Tests:
 
CPT Coding: 87635

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