Test Catalog

Test Id : PNTOR

Streptococcus pneumoniae IgG Antibodies, Total, with Reflex, 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 vaccines

 

Assessing the IgG antibody response to active immunization with conjugated 13-valent and 7-valent 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

Reflex Tests
Lists tests that may or may not be performed, at an additional charge, depending on the result and interpretation of the initial tests.

Test Id Reporting Name Available Separately Always Performed
PN23 S. pneumoniae IgG Ab,23 serotypes,S Yes No

Testing Algorithm
Delineates situations when tests are added to the initial order. This includes reflex and additional tests.

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.

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, with reflex,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

Testing Algorithm
Delineates situations when tests are added to the initial order. This includes reflex and additional tests.

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.

Specimen Type
Describes the specimen type validated for testing

Serum

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 PN23 / 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

Container/Tube:

Preferred: Serum gel

Acceptable: Red top

Specimen Volume: 0.5 mL

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 vaccines

 

Assessing the IgG antibody response to active immunization with conjugated 13-valent and 7-valent 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

Testing Algorithm
Delineates situations when tests are added to the initial order. This includes reflex and additional tests.

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.

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. These include invasive disease (bacteremia and meningitis) and infections of the respiratory tract (pneumonia and otitis media). There is an annual estimated number of 5000 cases of pneumococcal bacteremia (without pneumonia) with a fatality rate of approximately 20%, reaching as high as 60% in the elderly population. It is estimated that as many as 400,000 hospitalizations from pneumococcal pneumonia occur annually in the United States, with a case-fatality rate of 5% to 7%.

 

More than 90 serotypes of S pneumoniae have been identified, based on varying polysaccharides that are 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. Vaccines containing bacterial polysaccharides can be effective in generating an immune response that results in production of IgG antibodies and generation of long-lived plasma and memory B cells, which can protect an individual against bacterial disease.

 

Active immunization is performed with a nonconjugated polysaccharide vaccine (Pneumovax) that contains a total of 23 serotypes, namely 1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19A, 19F, 20, 22F, 23F, and 33F. These 23 serotypes were included because, as a group, they account for approximately 90% of invasive pneumococcal infections. This nonconjugated vaccine is indicated for all adults 65 years of age and older, individuals between 2 and 64 years with chronic diseases (heart disease, lung disease, type I diabetes, liver disease), those who are immunocompromised (congenital or acquired immunodeficiencies, malignancy, solid-organ transplant), those with functional or anatomic asplenia, and adults 19 to 64 years who smoke. Because not all patients can generate a robust T-cell independent antibody response, conjugated vaccines such as Prevnar (7-valent) and Prevnar 13 (13-valent) were developed, in which the polysaccharide is conjugated to the CRM197 protein and therefore initiates a T-cell dependent antibody response. Immunization with the conjugated vaccine is indicated in all children under 2 years old, all adults 65 years and older, and individuals with medical conditions such as immunodeficiency, chronic obstructive pulmonary disease, and congestive heart failure.

 

Antibody responses develop in approximately 75% to 85% of nonimmunocompromised adults and older children approximately 4 to 6 weeks following immunization.

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 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.

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

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).

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

1. Parker AR, Lock E, Iftikhar A, et al: Purification and characterization of anti-pneumococcal capsular polysaccharide IgG immunoglobulins. Clin Biochem. 2017 Jan;50(1-2):80-83

2. Parker AR, Park MA, Harding S, Abraham RS: The total IgM, IgA and IgG antibody responses to pneumococcal polysaccharide vaccination (Pneumovax23) in a healthy adult population and patients diagnosed with primary immunodeficiencies. Vaccine. 2019 Feb 28;37(10):1350-1355

3. Moffitt KL, Malley R: Next generation pneumococcal vaccines. Curr Opin Immunol. 2011 June;23(3):407-413

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

5. Daly TM, Hill HR: Use and clinical interpretation of pneumococcal antibody measurements in the evaluation of humoral immune function. Clin Vaccine Immunol. 2015 Feb;22(2):148-152 

6. Reynolds MM, Murray DL, Willrich MAV, et al: Total vs antigen specific pneumococcal antibody response: A comparison of two different assay types. Clin Chem. 2015 Oct;61(10):S77

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).(Package insert: VaccZyme Anti-PCP IgG Enzyme Immunoassay Kit. The Binding Site; MK012.U, Rev. 6, 11/2015)

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.

4 to 6 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
Several factors determine the fee charged to perform a test. Contact your U.S. or International Regional Manager for information about establishing a fee schedule or to learn more about resources to optimize test selection.

  • Authorized users can sign in to Test Prices for detailed fee information.
  • Clients without access to Test Prices can contact Customer Service 24 hours a day, seven days a week.
  • Prospective clients should contact their Regional Manager. For assistance, contact Customer Service.

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. This test 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

86317 x 23 (if appropriate)

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
PNTOR S. pneumoniae IgG Ab, with reflex,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.
PNTOR S. pneumoniae IgG Ab, with reflex,S 43236-9

Test Setup Resources

Setup Files
Test setup information contains test file definition details to support order and result interfacing between Mayo Clinic Laboratories and your Laboratory Information System.

Excel | Create a PDF

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