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Streptococcus pneumoniae Antibodies, IgG, Conjugate Vaccine (12 serotypes) (INACTIVE as of 02/18/14. Refer to 0050725)
2005791
Ordering Recommendation
Mnemonic
PNEUMO 12
Methodology
Quantitative Multiplex Bead Assay
Performed
Tue
Reported
1-4 days
New York DOH Approval Status
This test is New York DOH approved.
Submit With Order
ARUP Consult®
Disease Topics
Specimen Required
Patient Preparation
 
Collect
Serum separator tube. Post-immunization specimen should be drawn 30 days after immunization and, if shipped separately, must be received within 60 days of pre-immunization specimen 
Specimen Preparation
Separate serum from cells ASAP or within 2 hours of collection. Transfer 1.5 mL serum to an ARUP Standard Transport Tube. (Min: 0.25 mL) MARK SPECIMENS CLEARLY AS "PRE" OR "POST" SO SPECIMENS WILL BE SAVED AND TESTED SIMULTANEOUSLY. 
Storage/Transport Temperature
Refrigerated. "Pre" and "post" pneumococcal vaccine specimens can be submitted separately or together for testing 
Unacceptable Conditions
Plasma or other body fluids. Contaminated, hemolyzed, or severely lipemic specimens 
Remarks
 
Stability
After separation from cells: Ambient: 48 hours; Refrigerated: 2 weeks; Frozen: 1 year (avoid repeated freeze/thaw cycles) 
Reference Interval
Interpretive Data
A post-immunization antibody concentration of 1.30 µg/mL or greater indicates adequate immune response. When comparing to pre-immunization concentrations that are 1.30 µg/mL or greater, a fourfold or greater increase in post-immunization concentration indicates adequate response; however, a high pre-immunization antibody concentration may preclude a fourfold increase.

Indication of immune system competence is demonstrated by an adequate immune response to at least 50 percent of the serotypes included in the vaccine challenge.

Compliance Statement B: This test was developed and its performance characteristics determined by ARUP Laboratories. The U.S. Food and Drug Administration has not approved or cleared this test; however, FDA clearance or approval is not currently required for clinical use. The results are not intended to be used as the sole means for clinical diagnosis or patient management decisions.

Note
Includes Serotypes 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F

This assay is designed to use both pre- and post-immunization specimens to assess immune responsiveness to vaccination. This test is not designed to determine protection to Streptococcus pneumoniae based on a single specimen
CPT Code(s)
86317 X 12
Components
Component Test Code*Component Chart NameLOINC
0050706Pneumo serotype 1 IgG (P13,PNX)27092-6
0050708Pneumo serotype 4 IgG (P7,P13,PNX)27094-2
0050709Pneumo serotype 5 IgG (P13,PNX)31183-7
0050713Pneumo serotype 6B IgG (P7,P13,PNX)27118-9
0050715Pneumo serotype 3 IgG (P13,PNX)27096-7
0050716Pneumo serotype 7F IgG (P13,PNX)25296-5
0050718Pneumo serotype 14 IgG (P7,P13,PNX)27387-0
0050722Pneumo serotype 9V IgG (P7,P13,PNX)30153-1
0050724Pneumo serotype 18C IgG (P7,P13,PNX)27395-3
0050726Pneumo serotype 19F IgG (P7,P13,PNX)27390-4
0050727Pneumo serotype 23F IgG (P7,P13,PNX)27389-6
2005785Pneumo serotype 19A IgG (P13,PNX)40974-8
2005789Pneumo Serotype Interpretation42771-6
* Component test codes cannot be used to order tests. The information provided here is not sufficient for interface builds; for a complete test mix, please click the sidebar link to access the Interface Map.
Aliases
  • Strep antibody vaccine response
  • Streptococcus pneumoniae vaccine