Test Catalog

Test Id : PNTO

Streptococcus pneumoniae IgG Antibodies, Total, Serum

Useful For
Suggests clinical disorders or settings where the test may be helpful

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
A short description of the method used to perform the test

Enzyme-Linked Immunosorbent Assay (ELISA)

NY State Available
Indicates the status of NY State approval and if the test is orderable for NY State clients.

Yes

Reporting Name
Lists a shorter or abbreviated version of the Published Name for a test

S. pneumoniae IgG Ab, Total, S

Aliases
Lists additional common names for a test, as an aid in searching

Total Pneumococcal Antibodies

Strep Antibodies

Strep Pneumo Antibodies

Strep Pneumoniae Antibody

Strep Vaccine

Streptococcus Pneumoniae

Vaccine

Specimen Type
Describes the specimen type validated for testing

Serum

Ordering Guidance

This test is the preferred test for patients previously tested for Streptococcus pneumoniae antibodies (as part of follow up testing or part of pre/post vaccine assessment).

 

The preferred test for patients being evaluated for possible immunodeficiency or for assessment of pneumococcal vaccination response (initial evaluation) is PNTOR / Streptococcus pneumoniae IgG Antibodies, Total, with Reflex, 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
Defines the optimal specimen required to perform the test and the preferred volume to complete testing

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 a plastic vial.

Specimen Minimum Volume
Defines the amount of sample necessary to provide a clinically relevant result as determined by the Testing Laboratory

0.3 mL

Reject Due To
Identifies specimen types and conditions that may cause the specimen to be rejected

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

Specimen Stability Information
Provides a description of the temperatures required to transport a specimen to the performing laboratory, alternate acceptable temperatures are also included

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

Useful For
Suggests clinical disorders or settings where the test may be helpful

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

Clinical Information
Discusses physiology, pathophysiology, and general clinical aspects, as they relate to a laboratory test

Streptococcus pneumoniae is a gram-positive bacterium that causes a variety of infectious diseases in children and adults, including invasive disease (bacteriemia and meningitis) and infections of the respiratory tract (pneumonia and otitis media).(1) More than 90 serotypes of S. pneumoniae have been identified, based on varying polysaccharides found in the bacterial cell wall. The serotypes responsible for disease vary with age and geographic location. Bacterial polysaccharides induce a T-cell independent type II humoral immune response. In adults and older children, bacterial polysaccharides are effective in generating an immune response that results in production of IgG antibodies and generation of long-lived plasma cells and memory B cells.(2) S. pneumoniae purified polysaccharide vaccines (PPSV) that contain a total of 23 serotypes (1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19A, 19F, 20, 22F, 23F, and 33F) are available; these are referred to as PPSV23.(3) These 23 serotypes were included because, as a group, they account for approximately 90% of invasive pneumococcal infections. Antibody responses develop in 75% to 85% of nonimmunocompromised adults and older children approximately 4 to 6 weeks following immunization with purified polysaccharide vaccines. A meta-analysis estimated an efficacy of 74% for prevention of invasive pneumococcal disease in adults vaccinated with pneumococcal polysaccharide vaccine (PPSV23).(4) In contrast, immune responses to polysaccharide antigens in children younger than 2 years of age are generally weak.

 

Active immunization of children younger than 2 years requires vaccines prepared of polysaccharides conjugated to an immunogenic carrier protein (Corynebacterium diphtheria strain C7), which results in a T-cell dependent antibody response.(3) In children younger than age 6, prior to the availability of routine S. pneumoniae vaccination, 7 serotypes (4, 6B, 9V, 18C, 19F, and 23F) accounted for 80% of invasive disease and up to 100% of all isolates that were found to be highly resistant to treatment with penicillin. The first pneumococcal conjugated vaccine (PCV) available for children younger than age 2 contained these 7 serotypes (PCV7). The vaccine was highly effective, with invasive disease in children younger than age 5 reduced from 99 to 21 cases per 100,000 population from 1998 to 2008.(5) In addition, it was demonstrated that after PCV7 became part of the routine vaccination schedule, only 2% of invasive disease was associated with any of the serotypes present in the vaccine. Instead, approximately 61% of the invasive disease was caused by an additional 6 serotypes (1, 3, 5, 6A, 7F, and 19A). This led to development of a 13-valent conjugated vaccine, known as pneumococcal conjugate vaccine (PCV13). More recently, additional pneumococcal conjugate vaccines have been approved, specifically 15-valent (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, 33F) and 20-valent (1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, and 33F) vaccines, known as PCV15 and PCV20, respectively.

 

Conjugated pneumococcal vaccination is included in the routine childhood schedule, with 4 doses of PCV13 or PCV15 administered at 2, 4, 6, and 12 to 15 months.(6) For adults younger than 65 years, a single dose of PCV20 or a single dose of PCV15 followed 1 year later with a single dose of PPSV23 is recommended.(7) This same pneumococcal vaccination strategy is recommended for adults 19 to 64 years of age with immunocompromising conditions, cochlear implants, cerebrospinal fluid leaks, or other chronic health conditions.

 

Patients with intrinsic defects in humoral immunity, such as common variable immunodeficiency, may have impaired antibody responses to pneumococcal vaccination.(8,9) Selective antibody deficiency is a recognized clinical entity in patients older than 2 years of age and is characterized by recurrent bacterial respiratory infections, absent or subnormal antibody response to a majority of polysaccharide antigens, and normal or increased immunoglobulin concentrations, including IgG subclasses, in the context of intact humoral response to protein antigens. In several other primary immunodeficiencies, including Wiskott-Aldrich syndrome, autoimmune lymphoproliferate syndrome, and DiGeorge syndrome, IgG subclass deficiencies may also result in impaired antibody responses to polysaccharide antigens.

Reference Values
Describes reference intervals and additional information for interpretation of test results. May include intervals based on age and sex when appropriate. Intervals are Mayo-derived, unless otherwise designated. If an interpretive report is provided, the reference value field will state this.

> or =9.7 mcg/mL

Interpretation
Provides information to assist in interpretation of the test results

Low anti-pneumococcal 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.

Cautions
Discusses conditions that may cause diagnostic confusion, including improper specimen collection and handling, inappropriate test selection, and interfering substances

The humoral immune response to Streptococcal pneumoniae vaccination is affected by multiple factors, including age, immune status, vaccination history, prior infections, and carrier status.

Protective concentrations of IgG antibodies, or those required to prevent infection from Streptococcus pneumoniae, have not been defined.

 

Quantitation of the IgG antibody response to pneumococcal serotypes does not provide any information on their functional capacity (opsonization efficiency).

Supportive Data

The utility of measuring the total IgG response to Streptococcus pneumoniae vaccination was assess in a study published by Parker et al. In a cohort of healthy individuals (n=77), a median 9-fold increase in IgG reactivity was observed 4 to 6 weeks after vaccination, with median IgG concentrations of 41 mcg/mL and 375 mcg/mL in pre- and post-vaccination samples, respectively. Based upon data in the healthy control group, a concentration of 77 mcg/mL was established as the threshold for defining a normal vaccination response. Using this cut-off, in a cohort of individuals with humoral primary immunodeficiencies, 62.7% (64/102) had results below this cut-off following vaccination, compared to 3.9% (3/77) in the healthy control group (10). While measurement of antibodies against Streptococcus pneumoniae is not diagnostic for any specific disease, it can be used to understand the nature and magnitude of immunoglobulin deficiencies in patients with suspected humoral immune disorders.

Clinical Reference
Recommendations for in-depth reading of a clinical nature

1. Weisberg SS. Pneumococcus. Dis Mon. 2007;53(10):495-502. doi:10.1016/j.disamonth.2007.09.013

2. Grabenstein JD, Manoff SB. Pneumococcal polysaccharide 23-valent vaccine: long-term persistence of circulating antibody and immunogenicity and safety after revaccination in adults. Vaccine. 2012;30(30):4435-4444

3. Musher DM, Anderson R, Feldman C. The remarkable history of pneumococcal vaccination: an ongoing challenge. Pneumonia (Nathan). 2022;14(1):5. Published 2022 Sep 25. doi:10.1186/s41479-022-00097-y

4. Moberley S, Holden J, Tatham DP, Andrews RM. Vaccines for preventing pneumococcal infection in adults. Cochrane Database Syst Rev. 2013;2013(1):CD000422

5. Paradiso PR. Advances in pneumococcal disease prevention: 13-valent pneumococcal conjugate vaccine for infants and children. Clin Infect Dis. 2011;52(10):1241-1247

6. Kobayashi M, Farrar JL, Gierke R, et al. Use of 15-Valent Pneumococcal Conjugate Vaccine and 20-Valent Pneumococcal Conjugate Vaccine Among U.S. Adults: Updated Recommendations of the Advisory Committee on Immunization Practices - United States, 2022. MMWR Morb Mortal Wkly Rep. 2022;71(4):109-117

7. Kobayashi M, Farrar JL, Gierke R, et al. Use of 15-Valent Pneumococcal Conjugate Vaccine Among U.S. Children: Updated Recommendations of the Advisory Committee on Immunization Practices - United States, 2022. MMWR Morb Mortal Wkly Rep. 2022;71(37):1174-1181

8. Bonilla FA, Khan DA, Ballas ZK, et al. Practice parameter for the diagnosis and management of primary immunodeficiency. J Allergy Clin Immunol. 2015;136(5):1186-205.e2078

9. Orange JS, Ballow M, Stiehm ER, et al. Use and interpretation of diagnostic vaccination in primary immunodeficiency: a working group report of the Basic and Clinical Immunology Interest Section of the American Academy of Allergy, Asthma & Immunology. J Allergy Clin Immunol. 2012;130(3 Suppl):S1-S24

10. Parker AR, Park MA, Harding S, Abraham RS. The total IgM, IgA and IgG antibody responses to pneumococcal polysaccharide vaccination (Pneumovax 23) in a healthy adult population and patients diagnosed with primary immunodeficiencies. Vaccine. 2019;37(10):1350-1355

Method Description
Describes how the test is performed and provides a method-specific reference

Pneumococcal capsular polysaccharide (PCP) antibodies bind to the wells of a microwell plate pre-coated with PCP antigen (1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19F, 19A, 21, 22F, 23F, 33F). Calibrators and controls are pre-adsorbed with C-polysaccharide (CPS) and samples are diluted in a diluent containing CPS. The calibrators, controls, and patient samples are added to the wells and antibodies recognizing the PCP antigen bind during the first incubation. After washing the wells to remove all unbound proteins, purified peroxidase labelled rabbit anti-human IgG (gamma-chain specific) conjugate is added. The conjugate binds to the captured human antibody and the excess unbound conjugate is removed by another wash step. The bound conjugate is incubated with 3,3',5,5'-tetramethylbenzidine (TMB) substrate, which gives a blue reaction product. The enzyme reaction is stopped by adding phosphoric acid, which produces a yellow end point color and is read at 450nm. The optical density (OD) of the solution at 450 nm is directly proportional to the concentration of antibody in the sample. The standard curve is established by plotting the antibody concentrations of the calibrators (x-axis) and their corresponding measured OD values (y-axis).(Unpublished Mayo method)

PDF Report
Indicates whether the report includes an additional document with charts, images or other enriched information

No

Day(s) Performed
Outlines the days the test is performed. This field reflects the day that the sample must be in the testing laboratory to begin the testing process and includes any specimen preparation and processing time before the test is performed. Some tests are listed as continuously performed, which means that assays are performed multiple times during the day.

Tuesday, Thursday

Report Available
The interval of time (receipt of sample at Mayo Clinic Laboratories to results available) taking into account standard setup days and weekends. The first day is the time that it typically takes for a result to be available. The last day is the time it might take, accounting for any necessary repeated testing.

2 to 8 days

Specimen Retention Time
Outlines the length of time after testing that a specimen is kept in the laboratory before it is discarded

12 weeks

Performing Laboratory Location
Indicates the location of the laboratory that performs the test

Rochester

Fees
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Test Classification
Provides information regarding the medical device classification for laboratory test kits and reagents. Tests may be classified as cleared or approved by the US Food and Drug Administration (FDA) and used per manufacturer instructions, or as products that do not undergo full FDA review and approval, and are then labeled as an Analyte Specific Reagent (ASR) product.

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
Provides guidance in determining the appropriate Current Procedural Terminology (CPT) code(s) information for each test or profile. The listed CPT codes reflect Mayo Clinic Laboratories interpretation of CPT coding requirements. It is the responsibility of each laboratory to determine correct CPT codes to use for billing.

CPT codes are provided by the performing laboratory.

86317

LOINC® Information
Provides guidance in determining the Logical Observation Identifiers Names and Codes (LOINC) values for the order and results codes of this test. LOINC values are provided by the performing laboratory.

Test Id Test Order Name Order LOINC Value
PNTO S. pneumoniae IgG Ab, Total, S 43236-9
Result Id Test Result Name Result LOINC Value
Applies only to results expressed in units of measure originally reported by the performing laboratory. These values do not apply to results that are converted to other units of measure.
PNTO S. pneumoniae IgG Ab, Total, S 43236-9

Test Setup Resources

Setup Files
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Sample Reports
Normal and Abnormal sample reports are provided as references for report appearance.

Normal Reports | Abnormal Reports

SI Sample Reports
International System (SI) of Unit reports are provided for a limited number of tests. These reports are intended for international account use and are only available through MayoLINK accounts that have been defined to receive them.

SI Normal Reports | SI Abnormal Reports