Validation of enzyme immunoassay for the quantitative measurement of human IgG antibodies specific for Haemophilus influenzae Type b capsular polysaccharide / 소아과
Korean Journal of Pediatrics
;
: 143-150, 2007.
Article
in Korean
| WPRIM
| ID: wpr-71855
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 < or =15%, intermediate precision CV < or =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+/-20%). 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 < or =25%, accuracy +/-25%). Freeze-thaw stability and short term temperature stability were within +/-20% 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.
Full text:
Available
Index:
WPRIM (Western Pacific)
Main subject:
Immunoglobulin G
/
Haemophilus
/
Haemophilus influenzae
/
Immunoenzyme Techniques
/
Sensitivity and Specificity
/
Haemophilus influenzae type b
/
Academies and Institutes
/
Antibodies
Type of study:
Diagnostic study
Limits:
Humans
Language:
Korean
Journal:
Korean Journal of Pediatrics
Year:
2007
Type:
Article
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