Last Modified:
11/11/2023 8:36:30 AM
Medical Necessity Documentation:
Client Notes:
Patient Preparation:
Specimen Requirements:
Nasal Swab supplied in the Sofia Kit
Collection Instructions:
Nasal Swab Collection
Transport & Storage: Temperature/Stability:
48 hours Ambient
48 hours Refrigerated
Rejection Criteria:
specimen in M4RT, UTH, or Saline; Oropharyngeal collection (Rubbing the swab up and down against the back of the throat, avoiding the tongue and cheeks.) ;
Reference Range:
Negative
Critical Ranges:
Test Comments:
Testing performed by lateral flow immunofluorescent sandwich assay (FIA) using the Quidel Sofia 2. This test has not been FDA cleared or approved. This test has been autorized by the FDA under an Emergency Use Authorization (EUA) for use by authorized laboratories. This test has been authorized only for the detection of SARS-CoV-2 antigen, not for any other viruses or pathogens. This EUA will be effective until the declaration that circumstances exist justifying the authorization of ht eemergency use of in vitro diagnostic for detection and/or diagnosis of COVID-19 is terminated or the EUA is revoked.
Methodology:
FIA
Clinical Significance:
Documentation:
Custom Panel:
No
PRODUCTION SCHEDULE
Stat Eligible:
Yes
Days Performed:
Sunday, Monday, Tuesday, Wednesday, Thursday, Friday, Saturday
Sites Performed:
Parkview Dekalb Hospital, Parkview Huntington Hospital, Parkview LaGrange Hospital, Parkview Noble Hospital, Parkview Randallia Hospital, Parkview Regional Medical Center, Parkview Wabash Hospital, Parkview Warsaw , Parkview Whitley Hospital
PHL Test Code:
COVB
EPIC Test Code:
Lab14447
Alternate Test Names:
COVID19; COVID-19; Rapid Ag; Rapid Antigen; Rapid Covid; SARS COVID AG FIA; Sofia
Included Tests:
CPT Coding:
87426
Go back to the top of the page.