Streptococcus pneumoniae Antibodies, IgG (14 Serotypes)

0050725
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Example Reports
Non-Responder
Responder
Ordering Recommendation

Evaluate the ability of a patient to produce antibody to pure polysaccharide vaccines (Pneumovax) or protein conjugated vaccines (Prevnar) after vaccination to rule out antibody deficiency.

Mnemonic
PNEUMO AB
Methodology

Quantitative Multiplex Bead Assay

Performed

Sun-Sat

Reported

1-3 days

New York DOH Approval Status
This test is New York DOH approved.
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.

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 pre- and post-vaccination comparison is required to adequately assess the humoral immune response to Prevnar 7 (P7), Prevnar 13 (P13), and/or Pneumovax 23 (PNX) Streptococcus pneumoniae vaccines. Pre-vaccination samples should be collected prior to vaccine administration. Post-vaccination samples should be obtained at least 4 weeks after immunization. Testing of post-vaccination samples alone will provide only general immune status of the individual to various pneumococcal serotypes.

In the case of pure polysaccharide vaccine, indication of immune system competence is further delineated as an adequate response to at least 50 percent of the serotypes in the vaccine challenge for those 2-5 years of age and to at least 70 percent of the serotypes in the vaccine challenge for those 6-65 years of age. Individual immune response may vary based on age, past exposure, immunocompetence, and pneumococcal serotype.

Responder Status                           Antibody Ratio
Non-Responder . . . . . . . . . . . . . . Less than 2-fold
Weak Responder . . . . . . . . . . . . . 2-fold to 4-fold
Good Responder . . . . . . . . . . . . . Greater than 4-fold

A response to 50-70 percent or more of the serotypes in the vaccine challenge is considered a normal humoral response1. Antibody concentration greater than 1.0 - 1.3 µg/mL is generally considered long-term protection2.

References:
1.Daly TM, Pickering JW, Zhang X, Prince HE, Hill HR. Multilaboratory assessment of threshold versus fold-change algorithms for minimizing analytical variability in multiplexed pneumococcal IgG measurements. Clin Vaccine Immunol. 2014;21(7):982-8.
2.Daly TM, Hill HR. Use and Clinical Interpretation of Pneumococcal Antibody Measurements in the Evaluation of Humoral Immune Function. Clin Vaccine Immunol. 2015;22(2):148-152.

Compliance Statement B: For laboratory developed tests not using a RUO kit, and for FDA approved, cleared or 510(k) exempt assays with alterations. 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
Hotline History

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Hotline History

Date of Change
Test Name Change
Methodology
Performance/Reported Schedule
Specimen Requirements
Reference Interval
Interpretive Data
Note
CPT Code
Component Change
Other Interface Change
New Test
Inactive
11/12/2018
X
N/A
CPT Codes

86317 x14

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Components
Component Test Code* Component Chart Name LOINC
0050706 Pneumo serotype 1 IgG (P13,PNX) 85954-6
0050708 Pneumo serotype 4 IgG (P7,P13,PNX) 86107-0
0050709 Pneumo serotype 5 IgG (P13,PNX) 86130-2
0050713 Pneumo serotype 6B IgG (P7,P13,PNX) 27118-9
0050715 Pneumo serotype 3 IgG (P13,PNX) 86080-9
0050716 Pneumo serotype 7F IgG (P13,PNX) 25296-5
0050717 Pneumo serotype 9N IgG (PNX) 86169-0
0050718 Pneumo serotype 14 IgG (P7,P13,PNX) 85991-8
0050719 Pneumo Serotype Interpretation 42771-6
0050721 Pneumo serotype 8 IgG (PNX) 86147-6
0050722 Pneumo serotype 9V IgG (P7,P13,PNX) 30153-1
0050723 Pneumo serotype 12F IgG (PNX) 85977-7
0050724 Pneumo serotype 18C IgG (P7,P13,PNX) 27395-3
0050726 Pneumo serotype 19F IgG (P7,P13,PNX) 86024-7
0050727 Pneumo serotype 23F IgG (P7,P13,PNX) 86064-3
* 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
  • Immune Response
  • pneumo conjugate vaccine
  • Pneumo polysaccharide vaccine
  • Pneumococcal Antibodies
  • S. Pneumoniae Vaccine
  • Strep Antibodies 14 serotypes
  • Strep Pneumo Antibodies
  • Strep Pneumoniae Antibody
  • Strep Vaccine
  • Streptococcus pneumoniae Immune Response
  • Streptococcus pneumoniae Vaccine Response
  • Vaccine Response
Streptococcus pneumoniae Antibodies, IgG (14 Serotypes)