Evaluation of Allergen Specific IgE assay on ADVIA Centaur Immunoassay System.
10.3343/kjlm.2006.26.5.362
- Author:
Hyun Soo KIM
1
;
Sook Kyung CHOI
;
Yong Sang KO
;
Dukhee CHUNG
;
Jun Mo KIM
;
Young Jin KIM
;
Jeonghee CHOI
;
Dohoon KIM
;
Jung Wha SUH
;
Yeon Hwa AHN
Author Information
1. Department of Laboratory Medicine, Bundang Jesaeng General Hospital, Sungnam, Korea. hskim@dmc.or.kr
- Publication Type:Case Report
- Keywords:
Allergy;
specific IgE;
ADVIA Centaur;
evaluation
- MeSH:
Allergens;
Diagnosis;
Humans;
Hypersensitivity;
Immunoassay*;
Immunoglobulin E*;
Indicators and Reagents;
Korea;
Luminescence;
Quality Control;
Skin
- From:The Korean Journal of Laboratory Medicine
2006;26(5):362-368
- CountryRepublic of Korea
- Language:Korean
-
Abstract:
BACKGROUND: Allergen specific IgE (sIgE) assay is an important aid in the diagnosis and treatment of allergy. We evaluated the analytical performance of a quantitative chemiluminescence immunoassay for sIgE using the continuous random access ADVIA Centaur. METHODS: Six ADVIA Centaur sIgE reagents for common inhalant allergens in Korea, d1, d2, e1, e5, t3, and t7, were evaluated for precision, dilution recovery (parallelism), comparison with Pharmacia UniCAP sIgE assay and skin prick test, sample volume, and analytical speed according to the NCCLS guidelines (I/LA20-A, EP5-A2). Commercialized positive and negative quality control materials were used for a precision study, and samples from a total of 110 patients were used for dilution recovery and comparison studies. RESULTS: Within-run coefficients of variation (CV) of the 6 items were 3.45-6.14% and within-device CVs (total CVs) of all items were below 10%. Interdilutional CVs of all items were 2.84-11.95%, which showed a good linearity and parallelism over its measuring range. Positive/negative concordance rates of the 6 items with UniCAP sIgE assay were 76.3-96.1% (d1, 88.2%; d2, 96.1%; e1, 91.0%; e5, 77.0%; t3, 90.5%; and t7, 76.3%). Concordance rates of the six items with skin prick test were all above 80%. The quantity of sample volume (25 micro L/test) needed was relatively small, and a high throughput (120 tests/hr) and rapid turnaround time (47 min) could be achieved. CONCLUSIONS: The ADVIA Centaur sIgE assay was thought to be a convenient and efficient method to be used in medium- to large-sized laboratories.
