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

Title
Validation of the world health organization enzyme-linked immunosorbent assay for the quantitation of immunoglobulin G serotype-specific anti-pneumococcal antibodies in human serum
Authors
Lee H.Lim S.Y.Kim K.-H.
Ewha Authors
김경효
SCOPUS Author ID
김경효scopus
Issue Date
2017
Journal Title
Journal of Korean Medical Science
ISSN
1011-8934JCR Link
Citation
vol. 32, no. 10, pp. 1581 - 1587
Keywords
AntibodiesEnzyme-linked immunosorbent assayStreptococcus pneumoniaeValidation studies
Publisher
Korean Academy of Medical Science
Indexed
SCI; SCIE; SCOPUS; KCI WOS scopus
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. © 2017 The Korean Academy of Medical Sciences.
DOI
10.3346/jkms.2017.32.10.1581
Appears in Collections:
의과대학 > 의학과 > Journal papers
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