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 9
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 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 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
N/A
CPT Codes

86317 x9

Components
Component Test Code* Component Chart Name LOINC
0050719 Pneumo Serotype Interpretation 42771-6
2005780 Pneumo serotype 2 IgG (PNX) 86039-5
2005781 Pneumo serotype 10A IgG (PNX) 86098-1
2005782 Pneumo serotype 11A IgG (PNX) 86122-9
2005783 Pneumo serotype 15B IgG (PNX) 40973-0
2005784 Pneumo serotype 17F IgG (PNX) 86009-8
2005785 Pneumo serotype 19A IgG (P13,PNX) 40974-8
2005786 Pneumo serotype 20 IgG (PNX) 86045-2
2005787 Pneumo serotype 22F IgG (PNX) 86052-8
2005788 Pneumo serotype 33F IgG (PNX) 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
Streptococcus pneumoniae Antibodies, IgG (9 Serotypes)