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SARS-COV2 IGG NCAPSID ANTIBODY PANEL
MessageThis test is intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection. This test should not be used to diagnose acute SARS-CoV-2 infection. This test is not a measure of protective immunity and it is recommended to continue to follow public health advice regarding prevention. Negative results do not rule out infection. Test results must be interpreted in tandem with PCR and additional serologic results to determine clinical significance and the status of the current immune response. This test has not been FDA cleared or approved. This test has been authorized by FDA under an Emergency Use Authorization (EUA) for use by authorized laboratories only for the detection of IgG antibodies against SARS-CoV-2, not for any other viruses or pathogens. Note that there is no data to definitively exclude that positive results are reflective of infection with non-SARS-CoV-2 coronavirus strains, such as coronavirus HKU1, NL63, OC43, or 229E.This test is currently only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner
Test Code
SARS-COV-2 IGG NCAPSID PANEL(QL)
Alias/See Also
SARS-COV2 IGG PANEL
Preferred Specimen
gold top tube- separator
Other Acceptable Specimens
lt green top tube - lithium heparin separator tube
Transport Temperature
refrigerate
Specimen Stability
Room temperature: 2 Days
up to 7 days at 2 to 8°C
up to 7 days at 2 to 8°C
Reject Criteria (Eg, hemolysis? Lipemia? Thaw/Other?)
Specimens < 150 uL
heat-inactivated specimens
pooled specimens
grossly hemolyzed specimens
specimens with obvious microbial contamination
specimens with fungal growth
Methodology
Chemiluminesence
Setup Schedule
Batched M-F
Report Available
1-5 days
Limitations
- For use under an Emergency Use Authorization only.
- Results should be used in conjunction with other data; e.g., symptoms, results of other tests, and clinical impressions.
- 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.
- Negative results do not rule out SARS-CoV-2 infection, particularly in those who have been in contact with the virus. Testing with a molecular diagnostic should be considered to evaluate for active infection in these individuals.
- Results from antibody testing should not be used as the sole basis to diagnose or exclude SARS-CoV-2 infection or to inform infection status.
- Pedigreed specimens with direct evidence of antibodies to non-SARS-CoV-2 coronavirus (common cold) strains such as HKU1, NL63, OC43, or 229E have not been evaluated with this assay.
- Not to be used to screen units of blood for SARS-CoV-2 infection.
- Potentially interfering disease states and other cross reactants have been evaluated and are represented in the SPECIFIC PERFORMANCE CHARACTERISTICS section of this package insert.
- 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.
- Rheumatoid factor (RF) in human serum can react with reagent immunoglobulins, interfering with in vitro immunoassays.
Clinical Significance
The SARS-CoV-2 IgG assay is designed to detect immunoglobulin class G (IgG) antibodies to the nucleocapsid 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 subjects that may have been infected by SARS-CoV-2.
COVID-19 is defined as illness caused by a novel coronavirus now called severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2, formerly called 2019-nCoV), which was first identified in December 2019 during an outbreak of respiratory illness cases in China. 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 within 3 to 5 days. The most common symptoms of COVID-19 are fever, tiredness, dry cough, and difficulty breathing. A severe acute respiratory distress syndrome (ARDS) 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 may cause respiratory symptoms ranging from common cold to severe pneumonia. These viruses are common in animals worldwide and may eventually transfer to humans, as has likely happened with SARS-CoV-2.
The host immune system reacts to the infection by SARS-CoV-2 by producing specific antibodies. These antibodies have been reported to appear in serum or plasma of infected individuals after the detection of viral ribonucleic acid (RNA) in swabs in as early as a few days to 2 weeks after the onset of symptoms. Specific IgG antibodies to SARS-CoV-2 may be detectable in COVID-19 patients during the symptomatic phase of the disease after RNA is no longer detectable. The persistence of IgG antibodies allows identification of people who have been infected in the past, and likely have recovered from the illness. It is unknown if IgG antibodies to SARS-CoV-2 confer immunity to infection. IgG detection and other serological assays will likely play an important role in research and surveillance.
COVID-19 is defined as illness caused by a novel coronavirus now called severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2, formerly called 2019-nCoV), which was first identified in December 2019 during an outbreak of respiratory illness cases in China. 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 within 3 to 5 days. The most common symptoms of COVID-19 are fever, tiredness, dry cough, and difficulty breathing. A severe acute respiratory distress syndrome (ARDS) 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 may cause respiratory symptoms ranging from common cold to severe pneumonia. These viruses are common in animals worldwide and may eventually transfer to humans, as has likely happened with SARS-CoV-2.
The host immune system reacts to the infection by SARS-CoV-2 by producing specific antibodies. These antibodies have been reported to appear in serum or plasma of infected individuals after the detection of viral ribonucleic acid (RNA) in swabs in as early as a few days to 2 weeks after the onset of symptoms. Specific IgG antibodies to SARS-CoV-2 may be detectable in COVID-19 patients during the symptomatic phase of the disease after RNA is no longer detectable. The persistence of IgG antibodies allows identification of people who have been infected in the past, and likely have recovered from the illness. It is unknown if IgG antibodies to SARS-CoV-2 confer immunity to infection. IgG detection and other serological assays will likely play an important role in research and surveillance.
Performing Laboratory
Test performed in West Roxbury Chemistry Lab
Contact: Jonathan Dryjowicz-Burek, 857-203-5973
Last Updated: March 10, 2021
