Validation of the world health organization enzyme-linked immunosorbent assay for the quantitation of immunoglobulin G serotype-specific anti-pneumococcal antibodies in human serum

Hyunju Lee, Soo Young Lim, Kyung Hyo Kim

Research output: Contribution to journalArticlepeer-review

6 Scopus citations

Abstract

The World Health Organization (WHO) enzyme-linked immunosorbent assay (ELISA) guideline is currently accepted as the gold standard for the evaluation of immunoglobulin G (IgG) antibodies specific to pneumococcal capsular polysaccharide. We conducted validation of the WHO ELISA for 7 pneumococcal serotypes (4, 6B, 9V, 14, 18C, 19F, and 23F) by evaluating its specificity, precision (reproducibility and intermediate precision), accuracy, spiking recovery test, lower limit of quantification (LLOQ), and stability at the Ewha Center for Vaccine Evaluation and Study, Seoul, Korea. We found that the specificity, reproducibility, and intermediate precision were within acceptance ranges (reproducibility, coefficient of variability [CV] ≤ 15%; intermediate precision, CV ≤ 20%) for all serotypes. Comparisons between the provisional assignments of calibration sera and the results from this laboratory showed a high correlation > 94% for all 7 serotypes, supporting the accuracy of the ELISA. The spiking recovery test also fell within an acceptable range. The quantification limit, calculated using the LLOQ, for each of the serotypes was 0.05-0.093 μg/mL. The freeze-thaw stability and the short-term temperature stability were also within an acceptable range. In conclusion, we showed good performance using the standardized WHO ELISA for the evaluation of serotypespecific anti-pneumococcal IgG antibodies; the WHO ELISA can evaluate the immune response against pneumococcal vaccines with consistency and accuracy.

Original languageEnglish
Pages (from-to)1581-1587
Number of pages7
JournalJournal of Korean Medical Science
Volume32
Issue number10
DOIs
StatePublished - 1 Oct 2017

Bibliographical note

Publisher Copyright:
© 2017 The Korean Academy of Medical Sciences.

Keywords

  • Antibodies
  • Enzyme-linked immunosorbent assay
  • Streptococcus pneumoniae
  • Validation studies

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