Streptococcus pneumoniae IgG Antibodies, 7 Serotypes, Serum
NY State Approved Indicates the status of NY State approval and if the test is orderable for NY State clients.
Assessing the response to active immunization with Prevnar pneumococcal 7-valent conjugate vaccine
Reporting Name A shorter/abbreviated version of the Published Name for a test; an abbreviated test name
S. pneumoniae IgG Ab, 7 Serotypes,S
Pneumococcal Antibody (IgG) 7 Serotype Panel
Strep Pneumo Antibodies
Strep Pneumoniae Antibody
Strep Pneumo Antibodies
Strep Pneumoniae Antibody
Specimen Type Describes the specimen type needed for testing
Specimen Required Defines the optimal specimen. This field describes the type of specimen required to perform the test and the preferred volume to complete testing. The volume allows automated processing, fastest throughput and, when indicated, repeat or reflex testing.
Preferred: Red top
Acceptable: Serum gel
Specimen Volume: 0.5 mL
Specimen Minimum Volume Defines the amount of specimen required to perform an assay once, including instrument and container dead space. Submitting the minimum specimen volume makes it impossible to repeat the test or perform confirmatory or perform reflex testing. In some situations, a minimum specimen volume may result in a QNS (quantity not sufficient) result, requiring a second specimen to be collected.
Mild OK; Gross reject
Mild OK; Gross reject
Mild OK; Gross OK
Specimen Stability Information Provides a description of the temperatures required to transport a specimen to the laboratory. Alternate acceptable temperature(s) are also included.
|Serum||Refrigerated (preferred)||14 days|
Clinical Information Discusses physiology, pathophysiology, and general clinical aspects, as they relate to a laboratory test
Streptococcus pneumoniae causes infectious diseases in children and adults, including invasive infections (eg, bacteremia and meningitis) and infections of the respiratory tract (eg, pneumonia and otitis media).(1,2) Streptococcus pneumoniae is responsible for approximately 40,000 deaths and 500,000 cases of pneumonia annually in the United States.
There are more than 90 serotypes of Streptococcus pneumoniae. The serotypes responsible for disease vary with age and geographic location. In children younger than 6 years, 7 serotypes (4, 6B, 9V, 14, 18C, 19F, and 23F) account for 80% of invasive disease and up to 100% of all isolates that are highly resistant to treatment with penicillin.(3,4)
The greatest risk of invasive infection with Streptococcus pneumoniae occurs in children <2 years of age; and active immunization with conjugate vaccine is recommended to prevent invasive infections caused by Streptococcus pneumoniae.(5) Bacterial polysaccharides elicit antibodies in children by a T-cell-independent mechanism, and immune responses to polysaccharide antigens such as Streptococcus pneumoniae are generally poor in children <2 years, requiring multiple injections of vaccine prepared from purified polysaccharides conjugated to an immunogenic carrier (Corynebacterium diphtheria strain C7 protein). The recommended vaccine for children <2 years (Prevnar) contains the 7 serotypes mentioned above and is administered in 4 doses. The vaccine is highly effective in preventing invasive disease in children with reported efficacy of 88% to 100%.
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 results within the normal value range are consistent with a normal humoral immune response to 7-valent conjugate vaccine.
Published data are available from efficacy studies that define the geometric mean concentrations and the 95% confidence intervals for children after 3 and 4 doses of the vaccine.(6)
Concentrations of IgG antibodies to Streptococcus pneumoniae serotypes greater than the lower limits of the 95% confidence intervals are consistent with a normal humoral immune response to 7-valent conjugate vaccine.
The minimum concentration of IgG antibody necessary to insure protection against invasive disease has not been determined for any serotype of Streptococcus pneumoniae.
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.
Clinical Reference Provides recommendations for further in-depth reading of a clinical nature
1. Schuchat A, Robinson K, Wenger JD, et al: Bacterial meningitis in the United States in 1995. N Engl J Med 1997;337:970-976
2. Zangwill KM, Vadheim CM, Vannier AM, et al: Epidemiology of invasive pneumococcal disease in Southern California: implications for the design and conduct of a pneumococcal conjugate vaccine efficacy trial. J Infect Dis 1996;174:752-759
3. Butler JC, Breiman RF, Lipman HB, et al: Serotype distribution of Streptococcus pneumoniae infections among preschool children in the United States, 1978-1994: implications for development of a conjugate vaccine. J Infect Dis 1995;171:885-889
4. Butler JC, Hoffman J, Cetron MS, et al: The continued emergence of drug-resistant Streptococcus pneumoniae in the United States. An update from the Centers for Disease Control and Prevention's Pneumococcal Sentinel Surveillance System. J Infect Dis 1996;174:986-993
5. 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, pS288)
6.Table 2: Geometric mean concentrations (ug/mL) of pneumococcal antibodies following the third and fourth doses of Prevnar or control when administered concurrently with DTP-HbOC in the efficacy study. In Physician's Desk Reference 2003. 57th edition. Montvale, NJ, Thompson PDR, p 3455
7. 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
8. Plikaytis BD, Goldblatt D, Frasch CE, et al: An analytical model applied to a multicenter pneumococcal enzyme-linked immunosorbent assay study. J Clin Microbiology 2000 June;38(6):2043-2050
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 Streptococcus 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)
Day(s) and Time(s) Test Performed Outlines the days and times the test is performed. This field reflects the day and time the sample must be in the testing laboratory to begin the testing process and includes any specimen preparation and processing time required before the test is performed. Some tests are listed as continuously performed, which means assays are performed several times during the day.
Monday through Friday; 8 a.m.
Analytic Time Defines the amount of time it takes the laboratory to setup and perform the test. This is defined in number of days. The shortest interval of time expressed is "same day/1 day," which means the results may be available the same day that the sample is received in the testing laboratory. One day means results are available 1 day after the sample is received in the laboratory.
Maximum Laboratory Time Defines the maximum time from specimen receipt at Mayo Medical Laboratories until the release of the test result
Specimen Retention Time Outlines the length of time after testing that a specimen is kept in the laboratory before it is discarded
Performing Laboratory Location The location of the laboratory that performs the test
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's instructions, or as products that do not undergo full FDA review and approval, and are then labeled as an Analyte Specific Reagent (ASR), Investigation Use Only (IUO) product, or a Research Use Only (RUO) 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 U.S. 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 Medical Laboratories interpretation of CPT coding requirements. It is the responsibility of each laboratory to determine correct CPT codes to use for billing.
86317 x 7
LOINC® Code Information Provides guidance in determining the Logical Observation Identifiers Names and Codes (LOINC) values for the result codes returned for this test or profile.
|Result ID||Reporting Name||LOINC Code|
|23980||Serotype 4 (4)||27094-2|
|23943||Serotype 14 (14)||27387-0|
|23944||Serotype 19F (19)||27390-4|
|23945||Serotype 23F (23)||27389-6|
|23946||Serotype 6B (26)||27118-9|
|23947||Serotype 18C (56)||27395-3|
|23948||Serotype 9V (68)||30153-1|