PDF
ePub
Citation
Print
Abstract
Background
Due to the westernization of living environments in Korea, a number of allergy patients are greatly increasing. External quality control assessments are difficult for allergy tests due to the lack of reference methods. We surveyed the current status of allergy tests performed in medical laboratories in Korea to prepare for an external quality control assessment in the near future.
Methods
We conducted a survey on internal and external quality control trials, calibrations and its intervals, medical staffs, analyzers in use, an average number of tests per months, and report formats.
Results
Among the 85 laboratories surveyed, 61 were doing allergy tests including 6 reference laboratories. There were two different types of analyzers (1) qualitative or semi-quantitative and (2) quantitative. These analyzers use either chemiluminescent or immunoblot method. Fifty-five laboratories were using ‘qualitative or semi-quantitative’ analyzers as a screening test and 31 laboratories were using quantitative analyzers. Most of the laboratories were only doing an internal quality control assessment included in the test kits. Excepting a few laboratories, calibrations were not done. About 34 laboratories reported numerical values with interpretative reports prepared by laboratory medical doctors.
Conclusions
The necessity of external quality control assessment has become an issue for improving the quality of allergy tests. But due to the lack of standardization, it is difficult to carry out external quality control assessments. By grouping the laboratories in terms of the type of analyzers, we could overcome the problem of analyzer variations and launch an external quality control assessment program in the near future.
REFERENCES
1.Lim HS., Yoon JK., Lee HH. Allergen patterns using MAST CLA test in Korean pediatric patients. Korean J Clin Pathol. 2001. 21:292–7. (시험을 이용한 한국 소아에서의알레르겐양상. 대한임상병리학회지 2001;21: 292-7.).
2.Brown CR., Higgins KW., Frazer K., Schoelz L., Dyminski JW., Marinkovich VA, et al. Simultaneous determination of total IgE and allergen-specific IgE in serum by the MAST chemiluminescent assay system. Clin Chem. 1985. 31:1500–5.
3.Taylor G., Walker J. Charles Harrison Blackley, 1820-1900. Clin Allergy. 1973. 3:103–8.
4.Reddy PM., Nagaya H., Pascual HC., Lee SK., Gupta S., Lauridsen JI, et al. Reappraisal of intracutaneous tests in the diagnosis of reaginic allergy. J Allergy Clin Immunol. 1978. 61:36–41.
5.Ishizaka K., Ishizaka T. Physicochemical properties of reaginic antibody. 1. Association of reaginic activity with an immunoglobulin other than gamma A- or gamma G-globulin. J Allergy. 1966. 37:169–85.
6.Wide L., Bennich H., Johansson SG. Diagnosis of allergy by an in-vitro test for allergen antibodies. Lancet. 1967. 2:1105–7.
7.Ali M., Nalebuff DJ., Ramanarayanan R., Fayemi AO., Mesa-Tejada R. Assay of IgE antibodies against June and Timothy grasses by an immunoperoxidase technique. Clin Allergy. 1980. 10:203–9.
8.Ali M., Nalebuff DJ., Fadai R., Fayemi AO. Correlation of the diagnostic skin test with the immunoperoxidase assay in ragweed hyper-sensitivity. Ann Allergy. 1980. 45:63–6.
9.Tsay YG., Halpern GM. IgE fluoroallergosorbent (IgE FAST™) test: Concept and clinical applications. Immunol Allergy Prac. 1984. 6:169–74.
10.Bonetti SM., Bonizzato CM., Piacentini GL., Verga A., Harris RI., Boner AL. Relationships between skin prick test, radioallergosorbent test, and chemiluminescent assays in allergic children. Ann Allergy. 1991. 66:137–41.
11.Ownby DR., Bailey J. Comparison of MAST with radioallergosorbent and skin tests for diagnosis of allergy in children. Am J Dis Child. 1986. 140:45–8.
12.Curran WS., Goldman G. The incidence of immediately reacting skin tests in a normal adult population. Ann Intern Med. 1961. 55:777–83.
13.DeVore NC., Slater JC. Quantification and standardization of allergens. Detrick B, Hamilton RG, editors. , eds.Manuals of molecular and clinical immunology. 7th ed.Washington DC: ASM Press;2006. p. 937–8.
14.Hamilton RG. Immunological methods in the diagnostic allergy clinical and research laboraotry. Detrick B, Hamilton RG, editors. Manuals of molecular and clinical immunology. 7th ed.Washington DC: ASM Press;2006. p. 960.
15.Diagnostic immunology resource committee. Diagnostic allergy survey SE-A 2007 participant summary. Northfield, IL: College of American Pathologists;2007.
Table 1.
Analyzers used for allergy specific tests according to the size of hospitals in Korea
| Name of analyzer | Size of hospital (N. beds) | Reference laboratories | ||
|---|---|---|---|---|
| <500 | 500-1,000 | >1,000 | ||
| MAST-CLA | 5 | 18 | 4 | 3 |
| AllergyScreen | 2 | 19 | 1 | 3 |
| UniCap | 5 | 18 | 3 | 3 |
| Immulite | - | - | - | 1 |
| Stallergy | - | - | - | - |
| ADVIA Centaur | - | - | - | - |
| RAST∗ | - | - | - | 4 |
Table 2.
Number of laboratories using multiple allergen analyzers in Korea
Table 3.
Number of laboratories according to the frequency of quality control materials used in Korea
Table 4.
Number of laboratories according to the calibration intervals of allergen analyzers in Korea
| Calibration intervals | Hospital laboratories | Reference laboratories | Total |
|---|---|---|---|
| No calibration | 10 | 1 | 11 |
| >10 times/yr | 18 | 5 | 23 |
| 3-4 times/yr | 5 | 0 | 5 |
| 1-2 times/yr | 6 | 0 | 6 |
| Only when a problem was detected | 10 | 0 | 10 |
Table 5.
Number of laboratories participating in external quality control programs in Korea
| Kinds of external quality control programs participating | Hospital laboratories (n=55) | Reference laboratories (n=6) |
|---|---|---|
| Inter-laboratory comparison | 15 | 1 |
| CAP | 4 | 1 |
| Not participating | 37 | 4 |
Table 6.
Quantitative measurements of allergens items in Korean laboratories
Table 7.
Characteristics of qualitative or semi-quantitative analyzers available in Korea
Table 8.
Characteristics of quantitative analyzers available in Korea
XML Download