Test Catalog

Test Id : PN23

Streptococcus pneumoniae IgG Antibodies, 23 Serotypes, 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 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

Microsphere Photometry

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,23 serotypes,S

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

Pneumococcal Antibody (IgG) 23 Serotype Panel

Strep Antibodies

Strep Pneumo Antibodies

Strep Pneumoniae Antibody

Strep Vaccine

Streptococcus Pneumoniae

Vaccine

Specimen Type
Describes the specimen type validated for testing

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

0.4 mL

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

Gross hemolysis Reject
Gross lipemia Reject
Gross icterus OK

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 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 bacteria that causes a variety of infectious diseases in children and adults, including invasive disease (bacteremia and meningitis) and infections of the respiratory tract (pneumonia and otitis media).(1,2) In 2009, it is estimated that S pneumoniae was responsible for approximately 43,500 infections and 5,000 deaths in the United States. 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 of adults and children older than 2 years is performed with nonconjugated polysaccharide vaccines (Pneumovax and Pnu-Immune 23) that contain 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.(3) These 23 serotypes were included because, as a group, they account for approximately 90% of invasive pneumococcal infections. Antibody responses develop in approximately 75% to 85% of nonimmunocompromised adults and older children approximately 4 to 6 weeks following immunization. Immunization with a 23-valent vaccine is recommended for all adults 65 years of age and older, and for adults 18 to 64 years of age with certain chronic diseases (heart disease, lung disease, type I diabetes, liver disease), those who are immunocompromised (congenital or acquired immunodeficiencies, malignancy, solid-organ transplant), and those with functional or anatomic asplenia.(3) 

 

In contrast to adults and older pediatrics, 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 multiple injections of vaccine prepared from purified polysaccharides conjugated to an immunogenic carrier (Corynebacterium diphtheria strain C7 protein), which results in a T-cell dependent antibody response. 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 conjugated vaccine available for children younger than age 2 (Prevnar) contained these 7 serotypes.(4,5) 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. In addition, it was demonstrated that after Prevnar became part of the routine vaccination schedule, only 2% of invasive disease was associated with any of the serotypes present in the 7-valent conjugate vaccine. Instead, approximately 61% of the invasive disease was caused by an additional 6 serotypes, including 1, 3, 5, 6A, 7F, and 19A. This led to development of a 13-valent S pneumoniae polysaccharide conjugate vaccine, which is marketed as Prevnar13. Prevnar13 is approved for administration to all children ages 6 weeks to 71 months, and has replaced the previous 7-valent Prevnar vaccine.(6)

 

Patients with intrinsic defects in humoral immunity, such as common variable immunodeficiency, may have impaired antibody responses to pneumococcal vaccination. Further, impaired polysaccharide responsiveness, also known as selective antibody deficiency, is a recognized clinical entity in patients older than 2 years and is characterized by recurrent bacterial respiratory infections, absent or subnormal antibody response to a majority of the polysaccharide antigens, and normal or increased immunoglobulin levels, including IgG subclasses, in the context of an intact humoral response to protein antigens. In several other primary immunodeficiencies, including Wiskott-Aldrich syndrome, autoimmune lymphoproliferative 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.

Results are reported in mcg/mL. 

Serotype

Normal Value

1 (1)

 > or =2.3

2 (2)

 > or =1.0

3 (3)

 > or =1.8

4 (4)

 > or =0.6

5 (5)

 > or =10.7

8 (8)

 > or =2.9

9N (9)

 > or =9.2

12F (12)

 > or =0.6

14 (14)

 > or =7.0

17F (17)

 > or =7.8

19F (19)

 > or =15.0

20 (20)

 > or =1.3

22F (22)

 > or =7.2

23F (23)

 > or =8.0

6B (26)

 > or =4.7

10A (34)

 > or =2.9

11A (43)

 > or =2.4

7F (51)

 > or =3.2

15B (54)

 > or =3.3

18C (56)

 > or =3.3

19A (57)

 > or =17.1

9V (68)

 > or =2.6

33F (70)

 > or =1.7

Interpretation
Provides information to assist in interpretation of the test results

As a general guideline, nonimmunocompromised adults develop IgG antibodies approximately 4 to 6 weeks following nonconjugated vaccination. A study conducted at the Mayo Clinic assessed IgG antibody concentrations prior to and following vaccination in a cohort of 100 healthy adults who met stringent exclusion criteria, including lack of previous pneumococcal vaccination or pneumonia associated with Streptococcus pneumoniae infection. Based on this data, reference ranges were established that most effectively discriminated between prevaccination and postvaccination antibody concentrations. Antibody concentrations greater than or equal to the reference value for at least 50% of serotypes in either a pre- or postvaccination specimen or a 2-fold or greater increase in antibody concentrations for at least 50% of serotypes when comparing the pre- to the postvaccination results would be consistent with a normal response to S pneumoniae vaccination.

 

Serotype-specific antibodies may persist for up to 10 years following immunization or infection.

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 Streptococcus pneumoniae is age dependent and the database of IgG antibody concentrations to different serotypes is incomplete.

 

Protective concentrations of IgG antibodies, or those required to prevent infection from S pneumoniae, have not been defined for any serotype.

 

Quantitation of the IgG antibody response to pneumococcal serotypes does not provide any information on the functional capacity of the serotype-specific antibodies generated (opsonization efficiency).

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

1. Weisberg SS: Pneumococcus. Dis Mon 2007 October;53(10):495-502

2. Braido F, Bellotti M, De Maria A, et al: The role of pneumococcal vaccine. Pulm Pharm Ther 2008 August;21(4):608-615

3. Nuorti JP, Whitney CG: Updated recommendations for prevention of invasive pneumococcal disease among adults using the 23-valent pneumococcal polysaccharide vaccine (PPSV23). Morb Mortal Wkly Rep 2010 September;59(34)1102-1106

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

5. 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

6. Nuorti JP, Whitney CG: Prevention of pneumococcal disease among infants and children-Use of 13-valent pneumococcal conjugate vaccine and 23-valent pneumococcal polysaccharide vaccine. MMWR Recomm Rep 2010 Dec;59(RR-11):1-18

7. Jacob GL, Homburger HA: Simultaneous Quantitative Measurement of IgG Antibodies to Streptococcus Pneumoniae Serotypes by Microsphere Photometry. J Allergy Clin Immunol 2004;113(2) Suppl (Abstract 1049,  S288)

8. Plikaytis BD, Holder PF, Pais LB, et al: Determination of parallelism and nonparallelism in bioassay dilution curves. J Clin Microbiology 1994 October;32:2441-2447

9. Plikaytis BD, Goldblatt D, Frasch CE, et al: An analytical model applied to a multicenter pneumococcal enzyme-linked immunosorbent assay study. J Clin Microbiol 2000 June;38(6):2043-2050

10. Park MA, Snyder MR, Smith C, et al: New guidelines for interpretation of IgG pneumococcal antibody data: results from a cohort study of healthy adults. Clin Immunol 2010 May;135(2):38

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

IgG antibodies to Streptococcus pneumoniae serotypes are measured by microsphere photometry. Purified pneumococcal polysaccharides coupled covalently to polystyrene microspheres bind IgG antibodies in patients' sera during the first incubation. After incubation, the microspheres are washed and incubated with phycoerythrin-conjugated antihuman IgG antibody. The concentration of IgG antibodies to each polysaccharide is determined by comparison to dose-response curves calculated from serial dilutions of a serum pool from immunized adults with known concentrations of antibodies to each polysaccharide (secondary standard). The secondary standard is traceable to a standard reference preparation (FDA 89-SF) that contains known concentrations of IgG antibodies to 23 different S pneumoniae serotypes. Dose-response curves prepared from serial dilutions of the secondary standard parallel the dose-response curves of the primary reference preparation for all polysaccharides.(Jacob GL, Homburger HA: Simultaneous Quantitative Measurement of IgG Antibodies to Streptococcus Pneumoniae Serotypes by Microsphere Photometry. Poster Presentation; AAAAI 60th Annual Meeting, March 19-23, 2004. San Francisco, CA. J Allergy Clin Immunol Vol 113, No 2, [Abstract 1049, pS288] 2004; Plikaytis BD, Holder PF, Pais LB, et al: Determination of parallelism and nonparallelism in bioassay dilution curves. J Clin Microbiol 1994;2441-2447; Plikaytis BD, Goldblatt D, Frasch CE, et al: An analytical model applied to a multicenter pneumococcal enzyme-linked immunosorbent assay study. J Clin Microbiol 2000;38:2043-2050)

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.

Monday through Friday

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

8 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 x 22

LOINC® Information

Test Id Test Order Name Order LOINC Value
PN23 S. pneumoniae IgG Ab,23 serotypes,S 42366-5
Result Id Test Result Name Result LOINC Value
Result LOINC Value Tooltip
23979 Serotype 1 (1) 85954-6
23949 Serotype 2(2) 86039-5
23950 Serotype 3 (3) 86080-9
23951 Serotype 4 (4) 86107-0
23952 Serotype 5 (5) 86130-2
23953 Serotype 8 (8) 86147-6
23954 Serotype 9N (9) 86169-0
23955 Serotype 12F (12) 85977-7
23956 Serotype 14 (14) 85991-8
23957 Serotype 17F (17) 86009-8
23958 Serotype 19F (19) 86024-7
23959 Serotype 20 (20) 86045-2
23960 Serotype 22F (22) 86052-8
23961 Serotype 23F (23) 86064-3
23962 Serotype 6B (26) 27118-9
23963 Serotype 10A (34) 86098-1
23964 Serotype 11A (43) 86122-9
23965 Serotype 7F (51) 25296-5
23966 Serotype 15B (54) 40973-0
23967 Serotype 18C (56) 27395-3
23968 Serotype 19A (57) 40974-8
23969 Serotype 9V (68) 30153-1
23970 Serotype 33F (70) 40969-8

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 | 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