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.
Allergens/*immunology ; Chemiluminescent Measurements/standards ; Humans ; Immunoassay/instrumentation/*standards ; Immunoblotting/standards ; Immunoglobulin E/*blood/immunology ; Korea ; Quality Control

Many allergists are currently focusing on the development of new diagnostic tools, and are attempting to improve both the sensitivity and specificity. A multiple allergen simultaneous test-chemiluminescent assay (MAST-CLA) is one of the most popular diagnostic tools used in the Republic of Korea. However, there remains controversy among allergists with regard to the cut-off point for a positive result. The present study was conducted in order to determine the validity of MAST-CLA as compared with that of the skin prick test, with particular emphasis on arthropod allergens, on the basis of percentage agreement rates and k-values, and also to suggest the optimal positive cutoff points using receiver operating characteristic (ROC) curves. The study was conducted with 97 subjects (54 men, 43 women). Optimal individual cut-off points were calculated as follows; class II for Dermatophagoides farinae, class I for Dermatophagoides pteronyssinus, and trace for a cockroach mix. These findings suggest that attempting to apply optimal individual cut-off points will be a good way of improving diagnostic tests, particularly MAST-CLA.
Adult ; Allergens/*immunology ; Animals ; Antigens, Dermatophagoides/*immunology ; Chemiluminescent Measurements/*methods/standards ; Cockroaches/chemistry ; Dermatophagoides farinae/chemistry ; Dermatophagoides pteronyssinus/chemistry ; Female ; Humans ; Hypersensitivity/*diagnosis/immunology ; Insect Proteins/*immunology ; Male ; *ROC Curve ; Skin Tests/methods