Ordering Recommendation

Aid in diagnosis or monitoring of immune deficiency disorders.

New York DOH Approval Status

This test is New York state approved.

Specimen Required

Patient Preparation
Collect

Serum separator tube.

Specimen Preparation

Separate serum from cells ASAP or within 2 hours of collection. Transfer 5.5 mL serum to ARUP standard transport tubes. (Min: 2.5 mL total)

Storage/Transport Temperature

Refrigerated.

Unacceptable Conditions

Plasma.

Remarks
Stability

After separation from cells: Ambient: Unacceptable; Refrigerated: 14 days; Frozen: 60 days (avoid repeated freeze/thaw cycles). (Refer to individual components for further information.)

Methodology

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

Performed

Mon-Sat

Reported

1-4 days

Reference Interval

Test Number
Components
Reference Interval
  Immunoglobulin A
Age Reference Interval (mg/dL)
0-2 years 2-126
3-4 years 14-212
5-9 years 52-226
10-14 years 42-345
15-18 years 60-349
19 years and older 68-408

  Immunoglobulin G
Age Reference Interval (mg/dL)
0-2 years 242-1108
3-4 years 485-1160
5-9 years 514-1672
10-14 years 581-1652
15-18 years 479-1433
19 years and older 768-1632

  Immunoglobulin M
Age Reference Interval (mg/dL)
0-2 years 21-215
3-4 years 26-155
5-9 years 26-188
10-14 years 47-252
15-18 years 26-232
19 years and older 35-263

  Immunoglobulin G Subclass 1
Age Reference Interval (mg/dL)
0-2 years 167-900
3-4 years 313-941
5-9 years 363-1276
10-14 years 316-1076
15-18 years 325-894
19 years and older 240-1118

  Immunoglobulin G Subclass 2
Age
Reference Interval (mg/dL)
0-2 years 55-359
3-4 years 72-287
5-9 years 27-398
10-14 years 86-509
15-18 years 156-625
19 years and older 124-549

  Immunoglobulin G Subclass 3
Age Reference Interval (mg/dL)
0-2 years 34-85
3-4 years 25-117
5-9 years 17-169
10-14 years 14-201
15-18 years 34-246
19 years and older 21-134

  Immunoglobulin G Subclass 4
Age
Reference Interval (mg/dL)
0-2 years 1-34
3-4 years 1-65
5-9 years 0-168
10-14 years 1-103
15-18 years 2-170
19 years and older 1-123

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)

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.


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)

Note

Hotline History

N/A

CPT Codes

86317 x16; 82787 x4; 82784 x3

Components

Component Test Code* Component Chart Name LOINC
0050210 Diphtheria Antibody, IgG 13227-4
0050340 Immunoglobulin A 2458-8
0050350 Immunoglobulin G 2465-3
0050355 Immunoglobulin M 2472-9
0050535 Tetanus Antibody, IgG 53935-3
0050571 Immunoglobulin G Subclass 1 2466-1
0050572 Immunoglobulin G Subclass 2 2467-9
0050573 Immunoglobulin G Subclass 3 2468-7
0050576 Immunoglobulin G Subclass 4 2469-5
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.

Aliases

  • Diphtheria Antitoxoid
  • Diphtheria IgG
  • Immunoglob subclasses
  • Strep Pneumoniae
  • Tetanus Antitoxoid
  • Tetanus IgG
Humoral Immunity Panel I