This assay is designed to detect IgG antibodies to the nucleocapsid protein of SARS-CoV-2 in plasma from patients with signs and symptoms of infection who are suspected of coronavirus disease (COVID-19) or in plasma of subjects that may have been previously infected by SARS-CoV-2. NOTE: This assay does not detect antibodies formed in response to vaccination intended to specifically increase production of antibodies against the spike protein of SARS-CoV-2.
Information on assay specificity:
In 997 blood specimens collected prior to September 2019 (pre-COVID-19 outbreak) and presumed to be negative for CoV-2 IgG antibodies, testing by the manufacturer with this serologic assay yielded 993 negative results (99.6% negative) and 4 positive results (0.4% positive). In 73 specimens collected in 2020 from subjects who were exhibiting signs of respiratory illness but who tested negative for SARS-CoV-2 by a PCR method, all 73 samples tested negative in this serologic assay.
Information on assay sensitivity:
The sensitivity for detecting IgG antibody to SARS-Cov-2 depends on when the blood sample is drawn in relation to the onset of infection and to the function of an individual’s immune system. According to a report by the assay manufacturer and internal studies at UCSF, this assay may detect IgG antibody in 99% of non-immunocompromised subjects who test positive for SARS-CoV-2 by PCR assay and get samples for antibody drawn 21 days or more after onset of symptoms. Immunocompromised subjects may fail to generate detectable antibody in response to SARS-CoV-2 infection.
• This test has not been reviewed by the FDA.
• Negative results do not rule out SARS-CoV-2 infection, particularly in those who have been in contact with the virus. Follow-up testing with a molecular diagnostic should be considered to rule out 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.
• Positive results may be due to past or present infection with non-SARS-CoV-2 coronavirus strains, such as coronavirus HKU1, NL63, OC43, or 229E. See data on specificity performance for details
• Not for the screening of donated blood.
• Reported by Lab to Public Health. Physician reporting also required
Synonyms
Coronavirus
Cov-2
SARS-Cov-2
Covid-19
Sample Type
Plasma
Collect
Lt Green (Li-Heparin) top preferred. Gold and Red top acceptable.
Amount to Collect
1 mL blood
Preferred Volume
0.3 mL plasma
Minimum Volume
0.15 mL plasma
Stability (from collection to initiation)
Room temperature: 2 days
Refrigerated: 7 days
Frozen: 6 months
Test Code
COVIG
Performing Lab
Chemistry - Parnassus
Preferred Volume
0.3 mL plasma
Minimum Volume
0.15 mL plasma
Stability (from collection to initiation)
Room temperature: 2 days
Refrigerated: 7 days
Frozen: 6 months
This assay is designed to detect IgG antibodies to the nucleocapsid protein of SARS-CoV-2 in plasma from patients with signs and symptoms of infection who are suspected of coronavirus disease (COVID-19) or in plasma of subjects that may have been previously infected by SARS-CoV-2. NOTE: This assay does not detect antibodies formed in response to vaccination intended to specifically increase production of antibodies against the spike protein of SARS-CoV-2.
Information on assay specificity:
In 997 blood specimens collected prior to September 2019 (pre-COVID-19 outbreak) and presumed to be negative for CoV-2 IgG antibodies, testing by the manufacturer with this serologic assay yielded 993 negative results (99.6% negative) and 4 positive results (0.4% positive). In 73 specimens collected in 2020 from subjects who were exhibiting signs of respiratory illness but who tested negative for SARS-CoV-2 by a PCR method, all 73 samples tested negative in this serologic assay.
Information on assay sensitivity:
The sensitivity for detecting IgG antibody to SARS-Cov-2 depends on when the blood sample is drawn in relation to the onset of infection and to the function of an individual’s immune system. According to a report by the assay manufacturer and internal studies at UCSF, this assay may detect IgG antibody in 99% of non-immunocompromised subjects who test positive for SARS-CoV-2 by PCR assay and get samples for antibody drawn 21 days or more after onset of symptoms. Immunocompromised subjects may fail to generate detectable antibody in response to SARS-CoV-2 infection.
• This test has not been reviewed by the FDA.
• Negative results do not rule out SARS-CoV-2 infection, particularly in those who have been in contact with the virus. Follow-up testing with a molecular diagnostic should be considered to rule out 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.
• Positive results may be due to past or present infection with non-SARS-CoV-2 coronavirus strains, such as coronavirus HKU1, NL63, OC43, or 229E. See data on specificity performance for details
• Not for the screening of donated blood.
• Reported by Lab to Public Health. Physician reporting also required
CPT Codes
86769
LOINC Codes
94507-1
Available Stat
No
Test Code
COVIG
Performing Lab
Chemistry - Parnassus
Performed
24 hrs per day, 7 days a week
Methodology
Chemiluminescent microparticle immunoassay(CMIA) two step – Abbott Architect i2000
Collect
Lt Green (Li-Heparin) top preferred. Gold and Red top acceptable.
Amount to Collect
1 mL blood
Sample Type
Plasma
Preferred Volume
0.3 mL plasma
Minimum Volume
0.15 mL plasma
Reference Interval
Negative
Synonyms
Coronavirus
Cov-2
SARS-Cov-2
Covid-19
Stability (from collection to initiation)
Room temperature: 2 days
Refrigerated: 7 days
Frozen: 6 months
This assay is designed to detect IgG antibodies to the nucleocapsid protein of SARS-CoV-2 in plasma from patients with signs and symptoms of infection who are suspected of coronavirus disease (COVID-19) or in plasma of subjects that may have been previously infected by SARS-CoV-2. NOTE: This assay does not detect antibodies formed in response to vaccination intended to specifically increase production of antibodies against the spike protein of SARS-CoV-2.
Information on assay specificity:
In 997 blood specimens collected prior to September 2019 (pre-COVID-19 outbreak) and presumed to be negative for CoV-2 IgG antibodies, testing by the manufacturer with this serologic assay yielded 993 negative results (99.6% negative) and 4 positive results (0.4% positive). In 73 specimens collected in 2020 from subjects who were exhibiting signs of respiratory illness but who tested negative for SARS-CoV-2 by a PCR method, all 73 samples tested negative in this serologic assay.
Information on assay sensitivity:
The sensitivity for detecting IgG antibody to SARS-Cov-2 depends on when the blood sample is drawn in relation to the onset of infection and to the function of an individual’s immune system. According to a report by the assay manufacturer and internal studies at UCSF, this assay may detect IgG antibody in 99% of non-immunocompromised subjects who test positive for SARS-CoV-2 by PCR assay and get samples for antibody drawn 21 days or more after onset of symptoms. Immunocompromised subjects may fail to generate detectable antibody in response to SARS-CoV-2 infection.
• This test has not been reviewed by the FDA.
• Negative results do not rule out SARS-CoV-2 infection, particularly in those who have been in contact with the virus. Follow-up testing with a molecular diagnostic should be considered to rule out 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.
• Positive results may be due to past or present infection with non-SARS-CoV-2 coronavirus strains, such as coronavirus HKU1, NL63, OC43, or 229E. See data on specificity performance for details
• Not for the screening of donated blood.
• Reported by Lab to Public Health. Physician reporting also required
CPT Codes
86769
LOINC Codes
94507-1
Ordering
Available Stat
No
Performing Lab
Chemistry - Parnassus
Performed
24 hrs per day, 7 days a week
Methodology
Chemiluminescent microparticle immunoassay(CMIA) two step – Abbott Architect i2000
This assay is designed to detect IgG antibodies to the nucleocapsid protein of SARS-CoV-2 in plasma from patients with signs and symptoms of infection who are suspected of coronavirus disease (COVID-19) or in plasma of subjects that may have been previously infected by SARS-CoV-2. NOTE: This assay does not detect antibodies formed in response to vaccination intended to specifically increase production of antibodies against the spike protein of SARS-CoV-2.
Information on assay specificity:
In 997 blood specimens collected prior to September 2019 (pre-COVID-19 outbreak) and presumed to be negative for CoV-2 IgG antibodies, testing by the manufacturer with this serologic assay yielded 993 negative results (99.6% negative) and 4 positive results (0.4% positive). In 73 specimens collected in 2020 from subjects who were exhibiting signs of respiratory illness but who tested negative for SARS-CoV-2 by a PCR method, all 73 samples tested negative in this serologic assay.
Information on assay sensitivity:
The sensitivity for detecting IgG antibody to SARS-Cov-2 depends on when the blood sample is drawn in relation to the onset of infection and to the function of an individual’s immune system. According to a report by the assay manufacturer and internal studies at UCSF, this assay may detect IgG antibody in 99% of non-immunocompromised subjects who test positive for SARS-CoV-2 by PCR assay and get samples for antibody drawn 21 days or more after onset of symptoms. Immunocompromised subjects may fail to generate detectable antibody in response to SARS-CoV-2 infection.
• This test has not been reviewed by the FDA.
• Negative results do not rule out SARS-CoV-2 infection, particularly in those who have been in contact with the virus. Follow-up testing with a molecular diagnostic should be considered to rule out 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.
• Positive results may be due to past or present infection with non-SARS-CoV-2 coronavirus strains, such as coronavirus HKU1, NL63, OC43, or 229E. See data on specificity performance for details
• Not for the screening of donated blood.
• Reported by Lab to Public Health. Physician reporting also required
Synonyms
Coronavirus
Cov-2
SARS-Cov-2
Covid-19
Collection
Sample Type
Plasma
Collect
Lt Green (Li-Heparin) top preferred. Gold and Red top acceptable.
Amount to Collect
1 mL blood
Preferred Volume
0.3 mL plasma
Minimum Volume
0.15 mL plasma
Stability (from collection to initiation)
Room temperature: 2 days
Refrigerated: 7 days
Frozen: 6 months
Processing
Test Code
COVIG
Performing Lab
Chemistry - Parnassus
Preferred Volume
0.3 mL plasma
Minimum Volume
0.15 mL plasma
Stability (from collection to initiation)
Room temperature: 2 days
Refrigerated: 7 days
Frozen: 6 months
This assay is designed to detect IgG antibodies to the nucleocapsid protein of SARS-CoV-2 in plasma from patients with signs and symptoms of infection who are suspected of coronavirus disease (COVID-19) or in plasma of subjects that may have been previously infected by SARS-CoV-2. NOTE: This assay does not detect antibodies formed in response to vaccination intended to specifically increase production of antibodies against the spike protein of SARS-CoV-2.
Information on assay specificity:
In 997 blood specimens collected prior to September 2019 (pre-COVID-19 outbreak) and presumed to be negative for CoV-2 IgG antibodies, testing by the manufacturer with this serologic assay yielded 993 negative results (99.6% negative) and 4 positive results (0.4% positive). In 73 specimens collected in 2020 from subjects who were exhibiting signs of respiratory illness but who tested negative for SARS-CoV-2 by a PCR method, all 73 samples tested negative in this serologic assay.
Information on assay sensitivity:
The sensitivity for detecting IgG antibody to SARS-Cov-2 depends on when the blood sample is drawn in relation to the onset of infection and to the function of an individual’s immune system. According to a report by the assay manufacturer and internal studies at UCSF, this assay may detect IgG antibody in 99% of non-immunocompromised subjects who test positive for SARS-CoV-2 by PCR assay and get samples for antibody drawn 21 days or more after onset of symptoms. Immunocompromised subjects may fail to generate detectable antibody in response to SARS-CoV-2 infection.
• This test has not been reviewed by the FDA.
• Negative results do not rule out SARS-CoV-2 infection, particularly in those who have been in contact with the virus. Follow-up testing with a molecular diagnostic should be considered to rule out 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.
• Positive results may be due to past or present infection with non-SARS-CoV-2 coronavirus strains, such as coronavirus HKU1, NL63, OC43, or 229E. See data on specificity performance for details
• Not for the screening of donated blood.
• Reported by Lab to Public Health. Physician reporting also required
Administrative
CPT Codes
86769
LOINC Codes
94507-1
Complete View
Available Stat
No
Test Code
COVIG
Performing Lab
Chemistry - Parnassus
Performed
24 hrs per day, 7 days a week
Methodology
Chemiluminescent microparticle immunoassay(CMIA) two step – Abbott Architect i2000
Collect
Lt Green (Li-Heparin) top preferred. Gold and Red top acceptable.
Amount to Collect
1 mL blood
Sample Type
Plasma
Preferred Volume
0.3 mL plasma
Minimum Volume
0.15 mL plasma
Reference Interval
Negative
Synonyms
Coronavirus
Cov-2
SARS-Cov-2
Covid-19
Stability (from collection to initiation)
Room temperature: 2 days
Refrigerated: 7 days
Frozen: 6 months
This assay is designed to detect IgG antibodies to the nucleocapsid protein of SARS-CoV-2 in plasma from patients with signs and symptoms of infection who are suspected of coronavirus disease (COVID-19) or in plasma of subjects that may have been previously infected by SARS-CoV-2. NOTE: This assay does not detect antibodies formed in response to vaccination intended to specifically increase production of antibodies against the spike protein of SARS-CoV-2.
Information on assay specificity:
In 997 blood specimens collected prior to September 2019 (pre-COVID-19 outbreak) and presumed to be negative for CoV-2 IgG antibodies, testing by the manufacturer with this serologic assay yielded 993 negative results (99.6% negative) and 4 positive results (0.4% positive). In 73 specimens collected in 2020 from subjects who were exhibiting signs of respiratory illness but who tested negative for SARS-CoV-2 by a PCR method, all 73 samples tested negative in this serologic assay.
Information on assay sensitivity:
The sensitivity for detecting IgG antibody to SARS-Cov-2 depends on when the blood sample is drawn in relation to the onset of infection and to the function of an individual’s immune system. According to a report by the assay manufacturer and internal studies at UCSF, this assay may detect IgG antibody in 99% of non-immunocompromised subjects who test positive for SARS-CoV-2 by PCR assay and get samples for antibody drawn 21 days or more after onset of symptoms. Immunocompromised subjects may fail to generate detectable antibody in response to SARS-CoV-2 infection.
• This test has not been reviewed by the FDA.
• Negative results do not rule out SARS-CoV-2 infection, particularly in those who have been in contact with the virus. Follow-up testing with a molecular diagnostic should be considered to rule out 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.
• Positive results may be due to past or present infection with non-SARS-CoV-2 coronavirus strains, such as coronavirus HKU1, NL63, OC43, or 229E. See data on specificity performance for details
• Not for the screening of donated blood.
• Reported by Lab to Public Health. Physician reporting also required
