Testosterone RIA 검사 kit 별 유효성 비교평가

The Validation of a Commercial Testosterone RIA Test Kits

Testosterone에 대한 방사면역측정법(radioimmunoassay, RIA) 검사는 남성의 사춘기 지연 및 androgen 결핍 시, 여성과 어린이의 경우 androgen 과잉(다모증) 및 내분비 치료 모니터링 시 시행된다. 현재 본원 핵의학 검체검사실에서는 testosterone RIA 검사를 A사 kit로 사용하고 있지만, 최근 RIA kit의 생산이 중단되거나 공급에 어려움이 발생하여, 다른 회사에서 판매되고 있는 testosterone RIA kit에 대한 유효성 평가 실험을 실시하여 비교하였다. 2021년 10월 서울대학교병원 본원에 의뢰된 검체를 대상으로 실시하였으며, 정밀도, 민감도, 회수율, 직선성, 상관성을 분석하여 비교 평가하였다. 실험 방법은 각 회사에서 제공하는 testosterone RIA kit의 매뉴얼을 준수하였으며, 검체의 양, incubation, 세척(washing) 방법에서 차이가 있었다. 실험 결과 민감도, 직선성, 상관성 실험의 경우 모두 우수한 결과를 나타내었지만, 정밀도와 회수율의 경우 허용범위를 벗어났는데, 이는 낮은 농도의 검체로 실험을 진행하여 벗어난 것으로 사료된다. 이 실험을 바탕으로 각 병원에서 사용 중인 kit가 생산이 중단되거나 공급에 문제가 생길 경우 상호 호환이 가능할 것으로 생각되나, 본 실험에서 고농도의 검체로 실험을 진행하지 못했다는 아쉬움이 있다. 따라서 추후 검사실별로 다양한 농도와 고농도의 검체를 획득하여 추가적으로 실험을 진행해야 할 것으로 사료된다.

Purpose Testosterone is a steroid hormone synthesized by the Leydig cells of the testes in men, and by the adrenal cortex and ovaries in women. Testosterone production is regulated by luteinzing hormone secreted by the anterior pituitary gland. In this experiment, the effectiveness of testosterone radioimmunoassay (RIA) kits produced by three companies was evaluated and compared in case the production of testosterone kits was stopped or supply problems occurred. Materials and Methods In October 2021, samples were collected from the patients (n=49) who requested the testosterone RIA test. The experiment was conducted by dividing the patient's sample into low concentration (1.0 ng/mL or less), medium concentration (2.0-4.0 ng/mL) and high concentration (6.0 ng/mL or more). The Testosterone RIA test compared and evaluated the validity of Company A kits used in this hospital and those of Company B and C used in other hospitals. The precision, sensitivity, recovery, linearity and correlation were evaluated for each kit. The testosterone RIA test was carried out in accordance with the insert kit manual for each manufacturer. Results As a result of measuring the precision of the intra assay, the Coefficient of Variation (CV) value of the company A kit was high at 11.4% only in the low concentration sample, and in the case of the company B and C kits, the CV value was less than 10% at low, medium, and high concentrations. In the inter-assay precision measurement, the CV value was less than 15% in both A and C kits, but in the case of the B kit, the CV value exceeded 15% at low and medium concentrations. Sensitivity was 0.13 ng/mL for company A, 0.01 ng/mL for company B, and 0.01 ng/mL for company C, and the linearity of all three kits showed excellent linearity. In the case of recovery rate, all of the A, B, and C company kits showed results that were out of 90-110%. In the case of correlation test, when compared with the company A kit currently use in here, the correlation coefficient (R²) value for the company B kit was 0.9508, and for the company C kit was 0.9352 Conclusion As a result, there was a slight difference in precision at the low concentration sample. The correlation test showed an excellent correlation coefficient. However, it was difficult to secure samples of various concentrations because there were not many tests of testosterone requested at this hospital. So, additional experiments should be carried out by acquiring samples of various concentrations on each laboratory later.