Geisinger Medical Laboratories/Geisinger Proven Diagnostics Test Catalog

Order Display Name: Geisinger Epic Procedure Code Or ID CPT Code:  

SARS-COV-2 ANTIGEN

ORDERING INFORMATION:
Geisinger Epic Procedure Code: LAB3951         Geisinger Epic ID: 151550

SPECIMEN COLLECTION
Specimen type:

Sources

Collection Device

Nasopharyngeal

Universal Transport Media (UTM) Flocked swab (only for screening ASYMPTOMATIC outpatients)

Nasal turbinate

Universal Transport Media (UTM) Flocked swab (only for screening ASYMPTOMATIC outpatients)

Preferred collection container:
Specimen required:
Swab in 1.0 mL in UTM.
Special notes:
Before processing, samples are stable for 12 hours in UTM refrigerated. Samples must arrive at the GMC laboratory within 12 hours of collection to be processed. Samples must arrive to the GMC lab by 12:30 pm M – F, excluding holidays. Any specimens arriving outside of these hours, or more than 12 hours after collection, will be canceled. Samples cannot be processed or run on weekends or holidays.

This test is being piloted by General Pediatrics at Woodbine only.

SPECIMEN PROCESSING
Transport temperature:
Refrigerated at 2-8°C.
Specimen stability:
Stable at 4°C for up to 12 hours after collection
Rejection criteria:
Specimens that exceed stability limits. Specimens stored or transported at incorrect temperature. Swab specimens not transported in medium. Incorrect swabs.

TEST DETAILS
Interpretation guide:
If Detected: Indicates the detection of SARS-CoV-2 antigen and COVID-19 infection. Please isolate per guidelines and seek medical treatment as appropriate. Results should be interpreted with the clinical presentation and exposure history. Results reported to PADOH.

If Not Detected: SARS-CoV-2 antigen was not detected. A negative test does not rule out COVID-19 infection. If you have had exposure to someone with known or possible COVID-19, please continue to quarantine from others despite negative test. Please continue to mask and consider re-testing by PCR if symptoms develop.
Additional information:
False negatives may occur due to improper collection. Antigen testing is less sensitive than PCR testing for the detection of SARS-CoV-2. Internal concordance studies demonstrate a 60% positive concordance between PCR and antigen testing in symptomatic patients. Currently at Geisinger, this test is intended for screening of asymptomatic outpatients, in accordance with CDC guidelines (updated 12/5/2020).
CPT code(s):
87426
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:
Chemiluminescence immunoassay for the qualitative detection of SARS-CoV-2 antigen (nucleocapsid protein). This assay was developed and its performance characteristics determined by Geisinger Medical Laboratories. It has not been cleared or approved by the U.S. Food and Drug Administration (FDA). The FDA has determined that such clearance or approval is not necessary.
Methodology:
Chemiluminescence Immunoassay
Synonyms:
Covid Ag, Covid antigen
Clinical significance:
SARS-CoV-2 causes COVID-19. The incubation period for COVID-19 is from 2 – 14 days following exposure. The nucleocapsid protein antigen is generally detectable in upper respiratory specimens during the acute phase of infection. Antigen tests are generally less sensitive than PCR tests for the detection of SARS-CoV-2, so false negatives are possible. Internal concordance studies demonstrate a 60% positive concordance between PCR and antigen testing in symptomatic patients. Currently at Geisinger, this test is intended for screening of asymptomatic outpatients, in concordance with CDC guidelines (updated 12/5/2020). Symptomatic patients should be tested by PCR.
Doctoral Director(s:)
Hoi-Ying Elsie Yu, PhD, DABCC
Stacy Kenyon, PhD, DABCC
   
Review Date: 12/28/2020

Performing Locations

Geisinger Medical Center

Performing laboratory: Immunology
Technical Lead: Kathy Hurst
Frequency: Monday-Friday, 1st shift
Performed stat? No
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