Novel Coronavirus (2019-nCoV)
Brief Description
Novel Coronavirus (2019-nCoV) Polymerase Chain Reaction (PCR)
SARS-CoV-2 Antigen
SARS-CoV-2 TrimericS IgG semi-quantitative Serology*
* The LIAISON® SARS-CoV-2 Antigen test and TrimericS IgG are only for use under the Food and Drug Administration's Emergency Use Authorization.
Laboratory Unit
Molecular (rRT-PCR)
Virology (Chemiluminescent Immunoassay)
Methodology
Real-Time PCR
Chemiluminescent Immunoassay (CLIA)
Specimen Collection
2019-nCoV Collection Kits
SARS-CoV-2 IgG Collection Kits
SARS-CoV-2 Antigen Collection Kits
Storage/Transport
Collection and Submission of SARS-CoV-2 specimens
SARS-CoV-2 IgG Serology Kit Instructions
SARS-CoV-2 Antigen Kit Instructions
GIS map of courier drop off locations Monday-Friday
Acceptable Specimen Type(s)
Real-Time PCR
- Nasopharyngeal swab in Viral Transport Media (VTM)
Antigen
- Nasal swab in provided inactivation buffer
IgG Serology (Collected 15 days or more post symptom onset)
- Serum (preferred)
- Plasma (lithium heparin and dipotassium EDTA)
Test Request Form(s)
Possible Results
Real-Time PCR
- Detected*
- Not Detected
- Invalid (Specimen is inadequate for testing, a new specimen may need to be collected)
Antigen
- Positive
- Negative
- Invalid (Specimen is inadequate for testing, a new specimen may need to be collected)
IgG Serology
- Positive – antibody level expressed as AU/ml
- Negative
- Invalid (Specimen is inadequate for testing, a new specimen may need to be collected)
* Effective October 1, 2021, all specimens submitted for SARS-CoV-2 Real-Time PCR analysis will also receive testing for Influenza A & B by Real-Time PCR analysis.
Unacceptable Conditions
- The name on the specimen does not match the name on the requisition form.
- The specimen container is not labeled with the patient’s name.
- Improper storage/transport of specimen.
- The sample collected with improper collection device—cotton-tipped or calcium-alginate swab, wooden-shaft swab, transport media not intended for viruses.
- The specimen is not one of the listed acceptable specimens.
- Quantity Not Sufficient for testing
- Hemolyzed specimen
Interfering Substances
Cotton-tipped or calcium-alginate swab, wooden-shaft swab, transport media not intended for viruses
Result Reported
PCR - Testing is performed and results are reported the same day the specimen is received.
Fees
None
CPT Codes
N/A
LOINC/SNOMED Codes
N/A
Additional Information
- CDC Influenza SARS-CoV-2 (Flu SC2) Multiplex Assay Fact Sheet for Patients
- CDC Influenza SARS-CoV-2 (Flu SC2) Multiplex Assay Fact Sheet for Healthcare Providers
- CDC Novel Coronavirus (2019-nCoV) Website
- DiaSorin Fact sheet for Healthcare providers – Serology
- DiaSorin Fact sheet for Recipients – Serology
- DiaSorin Letter of Authorization – Serology
- DiaSorin Fact sheet for Healthcare providers – Antigen
- DiaSorin Fact sheet for Recipients – Antigen
- DiaSorin Letter of Authorization – Antigen
- CDC Influenza SARS-CoV-2 (Flu SC2) Multiplex Assay FDA Letter of Authorization