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Test Code PNTOR Streptococcus pneumoniae IgG Antibodies, Total, with Reflex, Serum

Reporting Name

S. pneumoniae IgG Ab, with reflex,S

Performing Laboratory

Mayo Clinic Laboratories in Rochester

Useful For

Assessing the IgG antibody response to active immunization with nonconjugated 23-valent pneumococcal vaccines

 

Assessing the IgG antibody response to active immunization with conjugated 13-valent, 15-valent and 20-valent pneumococcal vaccines

 

Determining the ability of an individual to produce an antibody response to polysaccharide antigens, as part of an evaluation for humoral or combined immunodeficiencies

Method Name

Enzyme-Linked Immunosorbent Assay (ELISA)


Ordering Guidance


This test is the preferred test for patients being evaluated for possible immunodeficiency or for assessment of pneumococcal vaccination response (initial evaluation).

 

The preferred test for patients previously tested for Streptococcus pneumoniae antibodies (as part of follow up testing or part of pre/post vaccine assessment) is PNTO / Streptococcus pneumoniae IgG Antibodies, Total, Serum.

 

The preferred test for patients previously tested for S pneumoniae serotypes (as part of follow up testing or part of pre/post vaccine assessment) is PN23M / Streptococcus pneumoniae IgG Antibodies, 23 Serotypes, Serum.



Specimen Required


Collection Container/Tube:

Preferred: Serum gel

Acceptable: Red top

Submission Container/Tube: Plastic vial

Specimen Volume: 0.5 mL

Collection Instructions: Centrifuge and aliquot serum into plastic vial.


Specimen Type

Serum

Specimen Minimum Volume

0.3 mL

Specimen Stability Information

Specimen Type Temperature Time Special Container
Serum Refrigerated (preferred) 21 days
  Frozen  21 days

Reject Due To

Gross hemolysis OK
Gross lipemia OK
Gross icterus OK
Heat-inactivated specimen Reject

Reference Values

≥9.7 mcg/mL

Interpretation

Low antipneumococcal antibody concentrations (<9.7 mcg/mL) indicate a poor response to the pneumococcal vaccine, while high concentrations (>270.0 mcg/mL) indicate a robust vaccine response. Results falling in the modest (9.7-40.9 mcg/mL), intermediate (41.0-180.9 mcg/mL), and moderate (181.0-270.0 mcg/mL) categories may warrant serotype-specific antibody testing, to be determined at the discretion of the physician.

 

When comparing pre- and post-vaccination samples, an increase in antibody concentrations is generally considered to be indicative of a normal vaccine response. However, the specific fold increase is influenced substantially by the antibody concentration observed in the pre-vaccination sample.

Day(s) Performed

Thursday

Report Available

2 to 8 days

Test Classification

This test was developed and its performance characteristics determined by Mayo Clinic in a manner consistent with CLIA requirements. It has not been cleared or approved by the US Food and Drug Administration.

CPT Code Information

86317

86317 x 23 (if appropriate)

LOINC Code Information

Test ID Test Order Name Order LOINC Value
PNTOR S. pneumoniae IgG Ab, with reflex,S 43236-9

 

Result ID Test Result Name Result LOINC Value
PNTOR S. pneumoniae IgG Ab, with reflex,S 43236-9

Reflex Tests

Test ID Reporting Name Available Separately Always Performed
PN23M S. pneumoniae IgG Ab,23 serotypes,S Yes No

Testing Algorithm

If the result is 41.0 mcg/mL or greater and less than 181.0 mcg/mL, then Streptococcus pneumoniae IgG antibodies for 23 serotypes will be performed at an additional charge.