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33558 - Pneumococcal Antibody Comprehensive Panel (32 Serotype)

Test Code: 33558
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Clinical and Procedure
Clinical Utility

Eurofins Viracor’s pneumococcal antibody panel provides quantitative measurement of serotype-specific IgG antibodies to assess immune response to pneumococcal vaccination, particularly in immunocompromised patients.

About Pneumococcal Antibody Testing

Pneumococcal antibody testing designed for the Comprehensive Panel evaluates immune response for all 32 serotypes included in all approved vaccines types: (1, 2, 3, 4, 5, 6A, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15A,15B, 15C,16F, 17F, 18C, 19A, 19F, 20A, 22F, 23A, 23B, 23F, 24F, 31, 33F, 35B). This testing is clinically important for assessing protection against invasive pneumococcal disease, particularly in individuals at increased risk.21 The serotype coverage included in this testing enhances the panel's ability to evaluate protective immunity across a broader spectrum of pneumococcal strains.

Procedure

Multiplex fluorescent immunoassay using beads coupled with capsular polysaccharide antigens corresponding to the analyzed Streptococcus pneumoniae serotypes present in the available vaccines.  The assay is calibrated to international reference material to ensure accuracy. This test was developed and its performance characteristics determined by Eurofins Viracor. It has not been cleared or approved by the U.S. Food and Drug Administration.

Turnaround Time

7 business days from receipt of specimen.

Specimen Information
Specimen Type Test Code CPT Code NY Approved Volume Assay Range Special Instructions
Serum 33558 86581 No

1 mL (min. 200 uL)

>1.3 µg/mL

  • Collection container: Red top or serum separator tube (SST).
  • Blood should be allowed to clot 30-60 minutes.
  • Centrifuge tube at 1,000 xg for 15 minutes, ambient.
Causes for Rejection

Insufficient sample volume (<200 uL)

Disclaimer

Specimens are approved for testing in New York only when indicated in the Specimen Information field above. The CPT codes provided are based on Eurofins Viracor’s interpretation of the American Medical Association's Current Procedural Terminology (CPT) codes and are provided for informational purposes only. CPT coding is the sole responsibility of the billing party. Questions regarding coding should be addressed to your local Medicare carrier. Eurofins Viracor assumes no responsibility for billing errors due to reliance on the CPT codes illustrated in this material.

References

1. Orange JS, Ballow M, Stiehm ER, et al. Use and interpretation of diagnostic vaccination in primary immunodeficiency: a working group report of the Basic and Clinical Immunology Interest Section of the American Academy of Allergy, Asthma & Immunology. J Allergy Clin Immunol. 2012 Sep;130(3 Suppl):S1-24.

2. Bonilla FA, Bernstein IL, Khan DA, et al. Practice parameter for the diagnosis and management of primary immunodeficiency. Ann Allergy Asthma Immunol. 2005 May;94(5 Suppl 1):S1-63.

3. Schauer U, Stemberg F, Rieger CH, et al. Levels of antibodies specific to tetanus toxoid, Haemophilus influenzae type b, and pneumococcal capsular polysaccharide in healthy children and adults. Clin & Diagn Lab Immunol. 2003 Mar;10(2):202-7.

4. Silk HJ, Zora JA, Goldstein J, Tinkleman DG and Schiffman G. Response to pneumococcal immunization in children with and without recurrent infections. J of Asthma. 998;35(1):101-12.

5. Popa V, Kim K, Heiner DC. IgG deficiency in adults with recurrent respiratory infections. Annals Allergy. 1993 May;70(5):418-24.

6. Wheeler JG, Steiner D. Evaluation of humoral responsiveness in children. Pediatr Infect Dis J. 1992 Apr;11(4):304-10.

7. Jeurissen A, Moens L, Raes M, Wuyts G, Willebrords L, Sauer K, et al. Laboratory diagnosis of specific antibody deficiency to pneumococcal capsular polysaccharide antigens. Clinical Chemistry. 2007 Mar;53(3);505-10.

8. Kamchaisatian W, Wanwatsuntikul W, Sleasman JW, Tangsinmankong N. Validation of current joint American Academy of Allergy, Asthma & Immunology and American College of Allergy, Asthma and Immunology guidelines for antibody response to the 23-valent pneumococcal vaccine using a populationg of HIV-infected children. Basic and clinical immunology. 2006 Dec;118(6):1336-41.

9. Millar EV, O’Brian KL, Bronsdon MA, Madore D, Hackell JG, Reid R, et al. Anticapsular serum antibody concentration and protection against pneumococcal colonization among children vaccinated with 7-valent pneumococcal conjugate vaccine. Clinical Infectious Diseases. 2007 May 1;44(9);1173-79.

10. Epstein MM, Gruskay F. Selective deficiency in pneumococcal antibody response in children with recurrent infections. Annals Allergy. 1995 Aug;75(2):125-31.

11. Sorensen RU, Leiva LE, Javier FC 3rd, et al. Influence of age on the response to Streptococcus pneumoniae vaccine in patients with recurrent infections and normal immunoglobulin concentrations. J Allergy Clin Immunol. 1998 Aug;102(2):215-21

12. Hidalgo H, Moore C, Leiva LE, Sorensen RU. Preimmunization and postimmunization pneumococcal antibody titers in children with recurrent infections. Annals Allergy Asthma & Immunol. 1996 Apr;76(4):341–6.

13. Johnson HL, Deloria-Knoll M, Levine OS, et al. Systematic Evaluation of Serotypes Causing Invasive Pneumococcal Disease among Children Under Five: The Pneumococcal Global Serotype Project. PLoS Med. 2010;7:1-13.

14. Centers for Disease Control and Prevention. Manual for the surveillance of vaccine-preventable diseases. Centers for Disease Control and Prevention, Atlanta, GA, 2012.

15. Hare ND, Smith BJ, Ballas ZK. Antibody response to pneumococcal vaccination as a function of preimmunization titer. J Allergy Clin Immunol. 2009 Jan;123(1):195-200.

16. Pickering JW, Martins TB, Greer RW, Schroder MC, Astill ME, Litwin CM, et al. A multiplexed fluorescent microsphere immunoassay for antibodies to pneumococcal capsular polysaccharides. Am J Clin Pathol. 2002 April;117(4):589-96.

17. Quataert SA, Kirch CS, Wiedl LJ, Phipps DC, Strohmeyer S, Cimino CO, et al. Assignment of weigh-based antibody units to a human antipneumococcal standard reference serum, lot 89-S. Clin & Diagn Lab Immunol. 1995 Sept;2:590-7.

18. Musher DM, Luchi MJ, Watson DA, Hamilton R, Baughn RE. Pneumococcal polysaccharide vaccine in young adults and older bronchitics: determination of IgG responses by ELISA and the effect of absorption of serum with non-type-specific cell wall polysaccharide. J Infect Dis. 1990 Apr;161(4):728-35.

19. Concepcion NF, Frasch CE. Pneumococcal type 22f polysaccharide absorption improves the specificity of a pneumococcal-polysaccharide enzyme-linked immunosorbent assay. ClinDiagn Lab Immunol. 2001 March;8(2):266-72.

20. Douglas J, Davidson J, Church M, Nutt J, Morris P, Kleiboeker S. Development of a Luminex Multiplexed Bead Based Assay to Detect IgG Vaccine Response to 32 Streptococcus pneumoniae Serotypes. Poster presented at: IDWeek 2025; October 2025; United States. Eurofins Viracor, Lenexa, KS.

21. Centers for Disease Control and Prevention. (2024, September 12). Types of Pneumococcal Vaccines. U.S. Department of Health and Human Services. Retrieved January 9, 2026, from https://www.cdc.gov/pneumococcal/vaccines/types.html [cdc.gov]

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