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.
Quantitative Multiplex Bead Assay
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.
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.
Refrigerated. "Pre" and "post" pneumococcal vaccine specimens can be submitted separately or together for testing.
Plasma or other body fluids. Contaminated, hemolyzed, or severely lipemic specimens.
After separation from cells: Ambient: 48 hours; Refrigerated: 2 weeks; Frozen: 1 year (avoid repeated freeze/thaw cycles)
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.
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.
|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|