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Specimen Collection Manual and Test Catalog

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SARS-COV-2 (COVID-19), NAAT

Geisinger Epic Procedure Code:  LAB3777    Geisinger Epic ID:  137323

SPECIMEN COLLECTION
Specimen type: 

See table below:


Preferred collection container: 
Specimen required: 
Inpatient Outpatient
SourceCollection deviceSourceCollection device
Nasopharyngeal (NP)Universal Transport Medium (UTM) Flocked swabNasopharyngeal (NP)Universal Transport Medium (UTM) Flocked swab (only for symptomatic patients )
Nasal TurbinateUniversal Transport Medium (UTM) Flocked swabNasal TurbinateUniversal Transport Medium (UTM) Flocked swab (only for symptomatic patients
SputumSterile Specimen Container  
Tracheal AspirateSterile Specimen Container  
Bronchoalveolar lavage (BAL)Sterile Specimen Container  

Special notes: 

Check expiration date on collection/transport device before use. Specimens in sterile containers (sputum, tracheal aspirate, BAL): Must be transferred into UTM within one hour of collection.



SPECIMEN PROCESSING
Transport temperature: 

Specimens in UTM or sterile container: Refrigerated (2-8°C).


Specimen stability: 

UTM: Stable at 4°C for up to 5 days after collection. Stable for 24 hours at room temperature (15-25°C). Specimens in sterile containers (sputum, tracheal aspirate, BAL): Must be transferred into UTM within one hour of collection.


Rejection criteria: 

Specimens stored or transported at incorrect temperature. Swab specimens not in transport medium. Improperly labeled/identified specimens. Expired transport medium. Specimens which exceed stability limits. Insufficient specimen volume. Inappropriate specimen type. Swab specimens should be collected only on swabs with a synthetic tip (such as polyester or Dacron®) with aluminum or plastic shafts. Swabs with calcium alginate or cotton tips with wooden shafts are not acceptable.



TEST DETAILS
Reference interval: 

Negative. 2019 Novel Coronavirus not detected.


Critical values/courtesy alerts: 
Positive. 2019 Novel Coronavirus detected.
Additional information: 

A false negative result may occur if inadequate numbers of organisms are present in the specimen due to improper collection, transport, or handling.

This test is also performed at Geisinger's Pottsville (technical lead Sharon Shikora), Grays Woods (technical lead Kristin Carr) and Tunkhannock (technical lead Karen Rencavage) clinics.

Respiratory Testing Algorithm


CPT code(s):  87635 or U0002 (depending on method used)
Note: The billing party has sole responsibility for CPT coding.  Any questions regarding coding should be directed to the payer being billed.
The CPT codes provided by GML are based on AMA guidelines and are for informational purposes only.

Test includes: 

Molecular detection of RNA from approved respiratory specimens. This assay uses real-time polymerase chain reaction (RT-PCR) for in vitro qualitative detection of SARS-CoV-2.


Methodology: 
Real-time Polymerase Chain Reaction (PCR)
Synonyms: 

Comprehensive viral studies, PCR, respiratory pathogen (PCR), coronavirus, COVID-19, COVID, nCoV, SARS-CoV-2, SARS-CoV-2, MOLECULAR DETECTION, RESPIRATORY– (2019- nCoV) , CORONAVIRUS NCOV19


Clinical significance: 

Respiratory pathogens cause acute local and systemic disease of varying severity, with the most severe cases occurring in children, the elderly, and immunocompromised individuals. Due to the similarity of diseases caused by many viruses and bacteria, diagnosis based on clinical symptoms alone is difficult. Identification of potential causative agents provides data to aid the physician to determine appropriate patient treatment and public health response for disease containment.


Doctoral Director(s): 
Donna Wolk PhD, D(ABMM)
Julie Hirschhorn, PhD, HCLD(ABB)
Review Date:  12/31/2024

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