Ordering Recommendation

Secondary testing for the evaluation of patients with recurrent and chronic infections, for whom immunoglobulin testing has already been performed.

New York DOH Approval Status

This test is New York state approved.

Specimen Required

Patient Preparation

Serum separator tube.

Specimen Preparation

Transfer two 1 mL aliquots of serum to individual ARUP standard transport tubes. (Min: 0.1 mL/aliquot)

Storage/Transport Temperature


Unacceptable Conditions



After separation from cells: Ambient: 48 hours; Refrigerated: 2 weeks; Frozen: 60 days (avoid repeated freeze/thaw cycles).


Semi-Quantitative Multiplex Chemiluminescent Immunoassay/Semi-Quantitative Multiplex Bead Assay




1-4 days

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

Nonresponder . . . . . . . . . . .  Less than twofold increase and postvaccination concentration less than 1.3 ug/mL

Good responder . . . . . . . . . . .At least a twofold increase and/or a postvaccination concentration greater than or equal to 1.3 ug/mL

A response to 50-70 percent or more of the serotypes in the vaccine challenge is considered a normal humoral response. (Daly, 2014) Antibody concentration greater than 1.0-1.3 ug/mL is generally considered long-term protection. (Daly, 2015)


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.

Diphtheria Antibody, IgG Antibody concentration of  >0.1 IU/mL is usually considered protective.
Tetanus Antibody, IgG Antibody concentration of  >0.1 IU/mL is usually considered protective.

Compliance Category

Laboratory Developed Test (LDT)


Hotline History


CPT Codes

86317 x16


Component Test Code* Component Chart Name LOINC
0050210 Diphtheria Antibody, IgG 13227-4
0050535 Tetanus Antibody, IgG 53935-3
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
* 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.


  • Diphtheria Antitoxoid
  • Diphtheria IgG
  • Strep Pneumoniae
  • Tetanus Antitoxoid
  • Tetanus IgG
Humoral Immunity Panel II