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STREPTOCOCCUS PNEUMONIAE IgG ANTIBODIES, 23 SEROTYPE (PNEUM AB 23)

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TEST NAME: STREPTOCOCCUS PNEUMONIAE IgG ANTIBODIES, 23 SEROTYPE
Ordering Guidance:
 This test is the preferred test for patients previously tested for Streptococcus pneumoniae serotypes (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 Streptococcuspneumoniae IgG Antibodies, Total, with Reflex, Serum.
 The preferred test for patients previously tested for total Streptococcus pneumoniae antibodies (as part of follow up testing or part of pre/post vaccine assessment) is Streptococcus pneumoniae IgG Antibodies, Total, Serum
LAB DEPT: Core Lab Sendouts
 
SPECIMEN REQUIREMENTS
Specimen Type:
Blood, serum
Container/Tube
 
Preferred:
Gold/Red SST Vacutainer®.
 
Acceptable:
Plain, red-top Vacutainer®.
 
Collection Volume:
1.0 mL (minimum 0.8 mL)
 
Patient Preparation:
None
 
Sample Rejection:
Grossly hemolyzed and/or grossly lipemic specimens.
Mislabeled or unlabeled specimens.
 
Special Instructions:
None
 
LOGISTICS
Test Availability:
Daily
Turnaround Time:
4-7 days
Test set-up:
Monday-Friday
Lab Testing Section:
Send-outs
Referred to:
Mayo Medical Laboratories (MMLI) / Test ID: PN23M
 
INTERPRETIVE
Reference Range:
Results are reported in mcg/mL
Serotype
Normal Value
 
Serotype
Normal Value
1 (1)
>or= 1.0
 
22F (22)
>or= 1.0
2 (2)
>or= 1.0
 
23F (23)
>or= 1.0
3 (3)
>or= 1.0
 
6B (26)
>or= 1.0
4 (4)
>or= 1.0
 
10A (34)
>or= 1.0
5 (5)
>or= 1.0
 
11A (43)
>or= 1.0
8 (8)
>or= 1.0
 
7F (51)
>or= 1.0
9N (9)
>or= 1.0
 
15B (54)
>or= 1.0
12F (12)
>or= 1.0
 
18C (56)
>or= 1.0
14 (14)
>or= 1.0
 
19A (57)
>or= 1.0
17F (17)
>or= 1.0
 
9V (68)
>or= 1.0
19F (19)
>or= 1.0
 
33F (70)
>or= 1.0
20 (20)
>or= 1.0
 
 
 
Critical Values:
None established
Limitations:
The humoral immune response to Streptococcus pneumoniae 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 for any serotype.
Methodology:
Bead-Based Multiplex Immunoassay
Test Classification:
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.
 
ADDITIONAL INFORMATION
For SLCH Laboratory use only
Lab Processing instructions:
Centrifuge to separate. Aliquot sample into a 5-mL screw-cap plastic vial for transport.
 
Processed Volume:
minimum 0.4 mL serum
 
Transport Temperature:
Refrigerated
 
Analyte Stability:
Ambient (unprocessed): NA
PROCESSED
Ambient: NA
Refrigerated: 21 days
Frozen: 21 days
 
Notes:
1.
Reject due to gross hemolysis and/or gross lipemia (mild okay)
2.
DO NOT freeze/thaw
 
GENERAL INFORMATION
EPIC order name:
Strep pneumonia Antibody  (EPIC Test# LAB778)
Cerner order name:
Pneum Ab 23
CPT Codes:
86317x23
LOINC Value:
42366-5
Synonyms:
Pneumococcal Antibody (IgG) 23 Serotype Panel
Last Updated: 10/23
Last Reviewed: 09/24