Pneumococcal Antibodies, IgG
Label Mnemonic: PNEUMO
Epic Lab Code: LAB3882
Downtime Form: A-1a Doctor/Provider Orders - Pathology Core and Specialty Care Nursery
Commercial Mail-out Laboratory
5231 RCP
356-8593
Specimen(s):
Serum
Specimen Instructions:
Mark specimen clearly as "Pre-Vaccine", "Post-Vaccine", or "Random". Referral laboratory recommends that post-immunization specimen be collected 30 days after immunization. Pre-immunization sample is stored frozen for 90 days.

If the post-immunization sample is received within 90 days, the pre and post immunization samples are submitted together for testing.

If the post-immunization sample is not received within 90 days, the pre sample is removed from storage and submitted for testing.
Collection Medium:
Red top tube 5 mL (Clot Activator)
Minimum:
Preferred Minimum: 1.5 mL serum
Rejection Criteria:
Plasma or other body fluids. Contaminated, hemolyzed, or severely lipemic specimens.
Delivery Instructions:
Deliver to laboratory within 1 hour of collection.
Turn Around Time:
1-5 days upon receipt at reference laboratory.
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.
Comments:
Note: Includes Serotypes 1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19A, 19F, 20, 22F, 23F, and 33F. (Conjugated Serotypes: 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F.)

This assay is designed to use both pre-and post-immunization specimens to assess immune responsiveness to pneumococcal vaccine. This test is not designed to determine protection to Streptococcus pneumoniaebased on a single specimen.
Methodology:
Quantitative Multiplex Bead Assay
CPT Code:
86317(x23)