Patient Preparation

No special patient preparations are necessary.
 

Collect

Gold 6 ml tube or 6 ml SST
Green 6 ml tube or 6 ml PST - lithium heparin


Volume Requirement:
0.5 mL plasma or serum  , 0.3 mL minimum
 

Specimen Preparation

Serum:             The red or gold stopper tube should be allowed to clot before centrifuging.  Specimens should be centrifuged at a minimum of 2500 RPM for minimun 5 minutes.  Serum should be separated from the cells promptly to an appropriately labeled tube, unless using SST tube.

Plasma:            Mix anticoagulant with specimen adequately.  Centrifuge at a minimum of 2500 RPM for minimum 5 minutes.  Remove plasma promptly from cells to an appropriately labeled tube, unless using PST tube.
 

Unacceptable Conditions

Avoid assaying grossly lipemic or hemolyzed samples.
 

Stability (from collection to initiation)

Handle samples in stoppered containers to avoid contamination and evaporation.
Centrifuge specimens and remove serum or plasma from the cells within 2 hours of collection.
Store samples at room temperature up to 8 hours, or refrigerate at 2-8oC up to 48 hours.
If assays are not completed within 48 hours, or the separated sample is to be stored beyond 48 hours, samples may be frozen at -20°C or colder for up to 30 days.
Thaw only once.
 

Performed

24/7 Core Laboratory

Notes

The Access SARS-CoV-2 IgG assay is a paramagnetic particle, chemiluminescent immunoassay intended for the qualitative detection of IgG antibodies to SARS-CoV-2 in serum, serum separator tubes and plasma from individuals with current or prior COVID-19 infection. The Access SARS-CoV-2 IgG assay is intended for use as an aid in identifying patients with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection. At this time, it is unknown for how long antibodies persist following infection and if the presence of antibodies confers protective immunity. The Access SARS-CoV-2 IgG assay should not be used to diagnose or exclude acute SARS-CoV-2 infection.
The assay is specific for the detection of SARS-CoV-2 antibodies directed against the spike protein receptor binding domain antigen.  The assay does not detect antibodies directed against the COVID-19 nucleocapsid and matrix protein antigens.  IgG antibodies are generally detectable in blood several days after initial infection, although the duration of time antibodies are present post-infection is not well characterized. Patients may have detectable virus present for several weeks following seroconversion.
The sensitivity of the Access SARS-CoV-2 IgG assay early after infection is unknown. Negative results do not preclude acute SARS-CoV-2 infection. If acute infection is suspected, direct testing for SARS-CoV-2 is necessary.
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.
This assay is not used for the screening of donated blood.
Coronavirus disease-2019 (COVID-19) is caused by a novel coronavirus known as severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) which has spread worldwide in 2020 causing a global pandemic. COVID-19 is characterized by fatigue, fever, cough, shortness of breath and other respiratory symptoms. The virus uses the transmembrane receptor angiotensin-converting enzyme 2 (ACE-2) to infect epithelial cells in the airways and lungs. Some individuals infected with SARS-CoV-2 have no, or mild symptoms while others develop severe respiratory distress requiring mechanical ventilation. Infected individuals develop an immune response to the virus in the form of anti-SARS-CoV-2 IgM and IgG antibodies over the course of days to weeks. Testing for the presence of IgM/IgG antibodies to SARS-CoV-2 can help to inform clinical management of patients with current, or recent COVID-19.
The Access SARS-CoV-2 IgG assay is a two-step enzyme immunoassay. A sample is added to a reaction vessel with buffer, and the vessel and light generated by the reaction is measured with a luminometer. The light production is compared to the cut-off value defined during calibration of the instrument.paramagnetic particles coated with recombinant SARS-CoV-2 protein specific for the receptor binding domain (RBD) of the S1 protein. After incubation in a reaction vessel, materials bound to the solid phase are held in a magnetic field while unbound materials are washed away. A monoclonal anti-human IgG alkaline phosphatase conjugate is added and the conjugate binds to the IgG antibodies captured on the particles. A second separation and wash step remove unbound conjugate. A chemiluminescent substrate is added to the vessel and light generated by the reaction is measured with a luminometer. The light production is compared to the cut-off value defined during calibration of the instrument.
 

Ordering Recommendations

SAR2G (RPS only)
SAR2GB (battery)

Performed

24/7 Core Laboratory

Methodology

Beckman Coulter DxI Chemistry System

Reference Interval

  1. "Positive"  Comments: "False positive results may occur due to current or previous infections with non- SARS-CoV-2 coronavirus strains, due to cross-reactivity with pre-existent antibodies. Results should be correlated with PCR results for COVID-19 antigen."
  2. "Negative"  Comments: "Negative SARS-CoV-2 IgG antibodies results may occur in patients infected with SARS-CoV-2, but tested before the patients develop antibodies to COVID-19. Negative results cannot rule out COVID-19 infections, especially for individuals exposed to the virus who are still in the estimated incubation period. Repeat tests in 1-2 weeks if necessary".
  3. "Equivocal"  Comment: "Repeat testing in 1-2 weeks".

CPT Codes

86769
Collection

Patient Preparation

No special patient preparations are necessary.
 

Collect

Gold 6 ml tube or 6 ml SST
Green 6 ml tube or 6 ml PST - lithium heparin


Volume Requirement:
0.5 mL plasma or serum  , 0.3 mL minimum
 

Specimen Preparation

Serum:             The red or gold stopper tube should be allowed to clot before centrifuging.  Specimens should be centrifuged at a minimum of 2500 RPM for minimun 5 minutes.  Serum should be separated from the cells promptly to an appropriately labeled tube, unless using SST tube.

Plasma:            Mix anticoagulant with specimen adequately.  Centrifuge at a minimum of 2500 RPM for minimum 5 minutes.  Remove plasma promptly from cells to an appropriately labeled tube, unless using PST tube.
 

Unacceptable Conditions

Avoid assaying grossly lipemic or hemolyzed samples.
 

Stability (from collection to initiation)

Handle samples in stoppered containers to avoid contamination and evaporation.
Centrifuge specimens and remove serum or plasma from the cells within 2 hours of collection.
Store samples at room temperature up to 8 hours, or refrigerate at 2-8oC up to 48 hours.
If assays are not completed within 48 hours, or the separated sample is to be stored beyond 48 hours, samples may be frozen at -20°C or colder for up to 30 days.
Thaw only once.
 

Performed

24/7 Core Laboratory

Notes

The Access SARS-CoV-2 IgG assay is a paramagnetic particle, chemiluminescent immunoassay intended for the qualitative detection of IgG antibodies to SARS-CoV-2 in serum, serum separator tubes and plasma from individuals with current or prior COVID-19 infection. The Access SARS-CoV-2 IgG assay is intended for use as an aid in identifying patients with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection. At this time, it is unknown for how long antibodies persist following infection and if the presence of antibodies confers protective immunity. The Access SARS-CoV-2 IgG assay should not be used to diagnose or exclude acute SARS-CoV-2 infection.
The assay is specific for the detection of SARS-CoV-2 antibodies directed against the spike protein receptor binding domain antigen.  The assay does not detect antibodies directed against the COVID-19 nucleocapsid and matrix protein antigens.  IgG antibodies are generally detectable in blood several days after initial infection, although the duration of time antibodies are present post-infection is not well characterized. Patients may have detectable virus present for several weeks following seroconversion.
The sensitivity of the Access SARS-CoV-2 IgG assay early after infection is unknown. Negative results do not preclude acute SARS-CoV-2 infection. If acute infection is suspected, direct testing for SARS-CoV-2 is necessary.
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.
This assay is not used for the screening of donated blood.
Coronavirus disease-2019 (COVID-19) is caused by a novel coronavirus known as severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) which has spread worldwide in 2020 causing a global pandemic. COVID-19 is characterized by fatigue, fever, cough, shortness of breath and other respiratory symptoms. The virus uses the transmembrane receptor angiotensin-converting enzyme 2 (ACE-2) to infect epithelial cells in the airways and lungs. Some individuals infected with SARS-CoV-2 have no, or mild symptoms while others develop severe respiratory distress requiring mechanical ventilation. Infected individuals develop an immune response to the virus in the form of anti-SARS-CoV-2 IgM and IgG antibodies over the course of days to weeks. Testing for the presence of IgM/IgG antibodies to SARS-CoV-2 can help to inform clinical management of patients with current, or recent COVID-19.
The Access SARS-CoV-2 IgG assay is a two-step enzyme immunoassay. A sample is added to a reaction vessel with buffer, and the vessel and light generated by the reaction is measured with a luminometer. The light production is compared to the cut-off value defined during calibration of the instrument.paramagnetic particles coated with recombinant SARS-CoV-2 protein specific for the receptor binding domain (RBD) of the S1 protein. After incubation in a reaction vessel, materials bound to the solid phase are held in a magnetic field while unbound materials are washed away. A monoclonal anti-human IgG alkaline phosphatase conjugate is added and the conjugate binds to the IgG antibodies captured on the particles. A second separation and wash step remove unbound conjugate. A chemiluminescent substrate is added to the vessel and light generated by the reaction is measured with a luminometer. The light production is compared to the cut-off value defined during calibration of the instrument.
 
Ordering

Ordering Recommendations

SAR2G (RPS only)
SAR2GB (battery)

Performed

24/7 Core Laboratory

Methodology

Beckman Coulter DxI Chemistry System
Result Interpretation

Reference Interval

  1. "Positive"  Comments: "False positive results may occur due to current or previous infections with non- SARS-CoV-2 coronavirus strains, due to cross-reactivity with pre-existent antibodies. Results should be correlated with PCR results for COVID-19 antigen."
  2. "Negative"  Comments: "Negative SARS-CoV-2 IgG antibodies results may occur in patients infected with SARS-CoV-2, but tested before the patients develop antibodies to COVID-19. Negative results cannot rule out COVID-19 infections, especially for individuals exposed to the virus who are still in the estimated incubation period. Repeat tests in 1-2 weeks if necessary".
  3. "Equivocal"  Comment: "Repeat testing in 1-2 weeks".
Administrative

CPT Codes

86769