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Validation of enzyme immunoassay for the quantitative measurement of human IgG antibodies specific for Haemophilus influenzae Type b capsular polysaccharide

Korean Journal of Pediatrics 2007;50(2):143-150.
Published online February 15, 2007.
Validation of enzyme immunoassay for the quantitative measurement of human IgG antibodies specific for Haemophilus influenzae Type b capsular polysaccharide
Kyung Hyo Kim1, Soo Young Lim2
1Department of Pediatrics, College of Medicine, Ewha Womans University
2Department of Microbiology, College of Medicine, Ewha Womans University
Haemophilus influenzae type b 피막 다당질 특이 인간 IgG 항체의 정량적 측정을 위한 enzyme immunoassay의 타당성 연구
김경효1, 임수영2
1이화여자대학교 의과대학 소아과학교실
2이화여자대학교 의과대학 미생물학교실
Correspondence: 
Kyung Hyo Kim, Email: kaykim@ewha.ac.kr
Abstract
Purpose
: This study was conducted to validate enzyme immunoassay (EIA) for the quantitative measurement of human IgG antibodies specific for Haemophilus influenzae type b (Hib) capsular polysaccharide. Method : We evaluated specificity, repeatability, intermediate precision, accuracy, lower limit of quantification (LLOQ), and stability to validate standardized EIA for the quantitative measurement of human anti-polyribosylribitol phosphate (PRP) IgG antibodies.
Results
: The results indicated that this EIA showed specificity to HbO-HA antigen and repeatability and intermediate precision were within acceptance criteria (repeatability: CV 15%, intermediate precision: CV 20%). The EIA-derived results from this laboratory were equivalent to those obtained by the standard radioactive antigen binding assay (RABA) for quantitation of anti-PRP antibodies in the 28 sera. Spiking recovery result was within acceptance criteria (100?0%). The precision and accuracy of samples in LLOQ were from -14.7 to -4.7% in nominal values, which were within acceptance criteria (precision: CV 25%, accuracy: ?5%). Freeze-thaw stability and short term temperature stability were within ?0% of acceptance criteria.
Conclusions
: The EIA which is performed at the Center for Vaccine Evaluation and Study Ewha Medical Research Institute, is an appropriate serologic assay which can be used for quantitation of anti-PRP IgG antibodies in human sera.
Key Words: Haemophilus influenzae type b , Antibodies , Enzyme immunoassay , Validation studies


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