Sars-Cov-2 IGG(Spike)

Test Code

SARS-COV-2 IGG(SPIKE)

Alias/See Also

Sars-cov-2 IGG II

Preferred Specimen

serum separator tube

Minimum Volume

200 uL

Other Acceptable Specimens

lithium heparin separator tube

Instructions

Samples should only be tested from individuals that are 15 days or more post-symptom onset

Transport Temperature

Refrigerate

Specimen Stability

Room temperature: 2 Days
7 days at 2 to 8°C
7 days at -20°C

Reject Criteria (Eg, hemolysis? Lipemia? Thaw/Other?)

heat-inactivated specimens
pooled specimens
grossly hemolyzed specimens
specimens with obvious microbial contamination
specimens with fungal growth

Methodology
Chemiluminescence (CMIA)

Setup Schedule

24/7

Report Available

1-5 days

Limitations

For use under an Emergency Use Authorization only.
This assay is for in vitro diagnostic use under FDA Emergency Use Authorization only.
This test should only be used for testing samples collected 15 days after symptom onset.
This assay is for clinical laboratory use only. It is not for point of care or home use.
Immunocompromised patients who have COVID-19 may have a delayed antibody response and produce levels of antibody which may not be detected as positive by the assay.
Performance has only been established with specimen types listed in the Intended Use.
Results obtained with this assay may not be used interchangeably with results obtained with different manufacturers’ test methods.
It is unknown for how long antibodies persist following SARS-CoV-2 infection. It is not known at this time if the presence of antibodies to SARS-CoV-2 confers immunity to infection.
The clinical applicability of semi-quantitative results is currently unknown and cannot be interpreted as an indication or degree of immunity, nor protection from infection, nor compared to other SARS-CoV-2 antibody assays.

A positive result may not indicate previous SARS-CoV-2 infection. Consider other information, including clinical history and local disease prevalence, in assessing the need for a second but different serology test to confirm an immune response.
A negative result for an individual subject indicates the absence of detectable anti-SARS-CoV-2 antibodies. Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for patient management decisions. A negative result can occur if the quantity of the anti-SARS-CoV-2 antibodies in the specimen is below the detection limits of the assay, or if the antibodies are not present during the stage of disease in which a sample is collected.
This device should not be used to diagnose or exclude acute SARS-CoV-2 infection. Direct testing for SARS-CoV-2 with a molecular assay should be performed to evaluate for acute infection in symptomatic individuals.
Not to be used to determine SARS-CoV-2 infection in donated blood units. This test should not be used for blood donor screening.
Potentially interfering disease states and other cross reactants have been evaluated and are represented in the SPECIFIC PERFORMANCE CHARACTERISTICS section of this package insert.
Specimens from patients who have received preparations of mouse monoclonal antibodies for diagnosis or therapy may contain human anti-mouse antibodies (HAMA). Such specimens may show either falsely elevated or depressed values when tested with assay kits such as AdviseDx SARS-CoV-2 IgG II that employ mouse monoclonal antibodies.28, 29
Heterophilic antibodies in human serum can react with reagent immunoglobulins, interfering with in vitro immunoassays. Patients routinely exposed to animals or to animal serum products can be prone to this interference, and anomalous values may be observed.30
Rheumatoid factor (RF) in human serum can react with reagent immunoglobulins, interfering with in vitro immunoassays.30
The performance of this test has not been established in individuals that have received a COVID-19 vaccine. The clinical significance of a positive or negative antibody result following COVID-19 vaccination has not been established, and the result from this test should not be interpreted as an indication or degree of protection from infection after vaccination.
The performance of this test was established based on the evaluation of a limited number of clinical specimens collected between January 2014 and June 2020 from several hospitals in the US and one hospital in Spain. The clinical performance has not been established in all circulating variants but is anticipated to be reflective of the prevalent variants in circulation at the time and location of the clinical evaluation. Performance at the time of testing may vary depending on the variants circulating, including newly emerging strains of SARS-CoV-2 and their prevalence, which change over time.

Reference Range

NEG < 50.0 AU/mL
POS ≥ 50.0 AU/mL

Clinical Significance

The AdviseDx SARS-CoV-2 IgG II assay is designed to detect immunoglobulin class G (IgG) antibodies to the receptor binding domain (RBD) of the S1 subunit of the spike protein of SARS-CoV-2 in serum and plasma from individuals who are suspected to have had coronavirus disease (COVID-19) or in serum and plasma of individuals that may have been infected by SARS-CoV-2.
COVID-19 is defined as illness caused by a novel coronavirus now designated as severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2, formerly known as 2019-nCoV). On March 11, 2020, the World Health Organization (WHO) declared COVID-19 a global pandemic. The incubation period of COVID-19 ranges between 1 and 14 days, with the majority of cases manifesting between 3 and 10 days. The most common symptoms are fever, dry cough, and difficulty breathing. A severe acute respiratory distress syndrome may develop. Reported case fatality rates depend on geographic location, age, and comorbidities.
The causative agent of COVID-19 is a beta coronavirus and belongs to a family of viruses that are common in animals worldwide with potential to transfer to humans, as has likely happened with SARS-CoV-2.7 SARS-CoV-2 RNA encodes for four structural proteins including spike (S), membrane (M), envelope (E), and nucleocapsid (N), with the S protein comprised of two subunits S1 and S2. The receptor binding domain (RBD) is included within the S1 subunit and has a high affinity for the angiotensin converting enzyme 2 (ACE2) receptor on the cell surface membrane. Infection is mediated by interaction of the SARS-CoV-2 RBD with the ACE2 viral receptor on host cells.
Several studies have indicated that serum and plasma antibodies are typically produced to structural proteins (RBD, S, and N), with antibodies appearing as early as a few days to a few weeks after the onset of symptoms and often after the detection of viral ribonucleic acid (RNA) declines or is no longer detectable. The persistence of IgG antibodies allows for identification of subjects who have been infected in the past and recovered from the illness and is useful in serological surveys to assess the prevalence of SARS-CoV-2 infection in selected groups or broader populations.

Performing Laboratory
Testing performed at the West Roxbury Chemistry laboratory

Supervisor: Jonathan Dryjowicz-Burek 857-203-5418

Last Updated: August 4, 2021

The CPT Codes provided in this document are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payor being billed. Any Profile/panel component may be ordered separately. Reflex tests are performed at an additional charge.