Performing Lab

Chemistry - Parnassus

Performed

24 hrs per day, 7 days a week

Methodology

Chemiluminescent microparticle immunoassay(CMIA) two step  – Abbott Architect i2000

Reported

4 hours

Additional Information

Fact sheet for patients

Fact sheet for provider

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.

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

  • SARS-Cov-2
  • Cov-2
  • Coronavirus

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

COVG

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

Reference Interval

Negative

Additional Information

Fact sheet for patients

Fact sheet for provider

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.

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

Test Code

COVG

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

Stability (from collection to initiation)

Room temperature: 2 days 
Refrigerated: 7 days
Frozen: 6 months

Reported

4 hours

Additional Information

Fact sheet for patients

Fact sheet for provider

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.

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

Performing Lab

Chemistry - Parnassus

Performed

24 hrs per day, 7 days a week

Methodology

Chemiluminescent microparticle immunoassay(CMIA) two step  – Abbott Architect i2000

Reported

4 hours

Additional Information

Fact sheet for patients

Fact sheet for provider

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.

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

  • SARS-Cov-2
  • Cov-2
  • Coronavirus
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

COVG

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
Result Interpretation

Reference Interval

Negative

Additional Information

Fact sheet for patients

Fact sheet for provider

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.

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

Test Code

COVG

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

Stability (from collection to initiation)

Room temperature: 2 days 
Refrigerated: 7 days
Frozen: 6 months

Reported

4 hours

Additional Information

Fact sheet for patients

Fact sheet for provider

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.

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