Pneumococcal Antibodies, IgG

Label Mnemonic:	PNEUMO
Epic code:	LAB3882
Downtime form:	Doctor/Provider Orders - Pathology Core and Specialty Care Nursery

Commercial Mailout Laboratory
6240-8 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 45 days.

If the post-immunization sample is received within 45 days, the pre and post immunization samples are submitted together for testing.

If the post-immunization sample is not received within 45 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)