간편형 전립선특이항원검사 키트®의 유용성

Abstract

Purpose: The incidence rate of prostate cancer has increased remarkably in Korea. The serum prostate specific antigen (PSA) value has been used for screening, although its clinical significance in prostate cancer screening is still inconclusive. However, if the measurement time was short and the cost was low, such an assay kit should be sufficient for prostate cancer screening. Materials and Methods: We developed pared monoclonal antibodies against PSA which could be used in assay kits for PSA. The Rapid PSA Kit used an immunochromatographic method to qualitatively judge a positive or negative result. Serum specimens from 78 men with benign prostate hyperplasia or prostate cancer were tested using the kit. Results: The sensitivity of the kit was determined to be 4ng/ml. 33 samples had a value of greater than 5ng/ml, so were considered positive. 5 samples had values between 4ng/ml and 5ng/ml, of which 3 were positive. The other 40 samples had values less than 4ng/ml, and 11 of these were judged positive. These results indicated that the sensitivity and specificity of the Rapid PSA Kit were 94.7 and 72.5%, respectively. Conclusions: Tests using the Rapid PSA Kit can be easily performed at outpatient clinics or elsewhere. This kit is useful in the initial screening of prostate cancer as the results can be obtained within 15 minutes and the cost is lower than with ordinary serum PSA tests.