Ordering Recommendation

Use to evaluate antibody production and rule out antibody deficiency in patients vaccinated with a pure polysaccharide vaccine (eg, Pneumovax) or protein conjugated vaccine (eg, Prevnar or Vaxneuvance).

Mnemonic

PNEUMO 23

Methodology

Quantitative Multiplex Bead Assay

Performed

Tue, Fri

Reported

1-5 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. "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 pre- and postvaccination comparison is required to adequately assess the humoral immune response to the pure polysaccharide Pneumovax 23 (PNX) and/or the protein conjugated Prevnar 7 (P7), Prevnar 13 (P13), Prevnar 20 (P20), and Vaxneuvance (V15) Streptococcus pneumoniae vaccines. Prevaccination samples should be collected prior to vaccine administration. Postvaccination samples should be obtained at least 4 weeks after immunization. Testing of postvaccination 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, et al. Multilaboratory assessment of threshold versus fold-change algorithms for minimizing analytical variability in multiplexed pneumococcal IgG measurements. Clin Vaccine Immunol. 2014;21(7):982-988.
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 Category

Laboratory Developed Test (LDT)

Note

Hotline History

N/A

CPT Codes

86317 x23

Components

Component Test Code* Component Chart Name LOINC
0050706 Pn serotype 1 IgG (P13,P20,PNX,V15) 85954-6
0050708 Pn serotype 4 IgG (P7,P13,P20,PNX,V15) 86107-0
0050709 Pn serotype 5 IgG (P13,P20,PNX,V15) 86130-2
0050713 Pn serotype 6B IgG (P7,P13,P20,PNX,V15) 27118-9
0050715 Pn serotype 3 IgG (P13,P20,PNX,V15) 86080-9
0050716 Pn serotype 7F IgG (P13,P20,PNX,V15) 25296-5
0050717 Pn serotype 9N IgG (PNX) 86169-0
0050718 Pn serotype 14 IgG (P7,P13,P20,PNX,V15) 85991-8
0050719 Pn Serotype Interpretation 42771-6
0050721 Pn serotype 8 IgG (P20,PNX) 86147-6
0050722 Pn serotype 9V IgG (P7,P13,P20,PNX,V15) 30153-1
0050723 Pn serotype 12F IgG (P20,PNX) 85977-7
0050724 Pn serotype 18C IgG (P7,P13,P20,PNX,V15) 27395-3
0050726 Pn serotype 19F IgG (P7,P13,P20,PNX,V15) 86024-7
0050727 Pn serotype 23F IgG (P7,P13,P20,PNX,V15) 86064-3
2005780 Pn serotype 2 IgG (PNX) 86039-5
2005781 Pn serotype 10A IgG (P20,PNX) 86098-1
2005782 Pn serotype 11A IgG (P20,PNX) 86122-9
2005783 Pn serotype 15B IgG (P20,PNX) 40973-0
2005784 Pn serotype 17F IgG (PNX) 86009-8
2005785 Pn serotype 19A IgG (P13,P20,PNX,V15) 40974-8
2005786 Pn serotype 20 IgG (PNX) 86045-2
2005787 Pn serotype 22F IgG (P20,PNX,V15) 86052-8
2005788 Pn serotype 33F IgG (P20,PNX,V15) 40969-8
* 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

  • pneumo conjugate vaccine
  • Pneumo polysaccharide vaccine
  • S. Pneumoniae Vaccine
  • Strep Antibodies 23 serotypes
  • Strep Pneumo Antibodies
  • Strep Pneumoniae Antibody
  • Strep Vaccine
Streptococcus pneumoniae Antibodies, IgG (23 Serotypes)