전립선암 진단에 있어서 Architect 총 PSA 화학발광면역검사법의 유용성 평가
Evaluation of Architect Total PSA Chemiluminescence Immunoassay for Diagnosing Prostate Cancer
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배경 : 혈청 prostate specific antigen (PSA) 검사는 전립선암 조기 진단, 치료 추적 및 재발의 판정에 절대적으로 중요하다.한국에서는 15종 이상의 PSA 측정기가 사용되고 있다. 이에최근에 많이 사용하고 있는 화학발광면역분석법인 Architect totalPSA (Abbott Lab., Abbott Park, IL., USA)의 분석력 및 전립선암 진단의 유용성을 평가하고자 한다. 재료 및 방법 : 검사내 및 검사간 정밀도 평가, 최저검출한계는세 단계(0,5, 4.0, 23.0 ng/mL)의정도관리 물질을 사용하였다.직선성검토는 PSA 100 ng/mL의 환자 검체로, 기 상관성 검토는 환자검체 42개로 시행하였다. 임상적 검토는 2003년 10월부터 2004년 3월까지 이대동대문병원 진단검사의학과에 PSA 검사를 의뢰한 230명으로 전립선암 17명, 양성 질환 213명 환자를 대상으로 하였다. 전립선암 여부는 의무기록지의 경직장전립선 초음파소견 및 전립선 조직검사 보고서로 확인하였다.결과 : PSA의 정밀도는 5% 정도를 보였고, 100 ng/mL까지직선성을 유지하였다. 최저검출한계는 기능적 예민도는 0.025 ng/mL, 분석예민도는 0.001 g/mL이었다. 기간 비교는 Y (Archi-tect)=1.0575X (AxSYM)+0.1895, r=0.9960이었다. 전립선암진단에 있어서 PSA 결정치는 8.35 ng/mL으로 예민도 88.2%,특이도 80.3%이었다. 결론 : Architect 총 PSA를 이용한 검사는 전립선암의 조기진단과 치료 후 최저치 및 재발 판정 추적검사에 적절한 검사로 판단된다.
Abstract
Background : Serum prostate specific antigen (PSA) is used as a marker for early diagnosis, monitoring of therapy, and detection of recurrence of the prostatic tumor or benign prostatic hyperplasia (BPH). In Korea, over 15 instruments have been used for measuring PSA. In this study, chemiluminescence microparticle immunoassay Architect total PSA (Abbott Lab., Abbott Park, IL, USA) was evaluated for analytical performance and diagnostic usefulness as a marker for prostate cancer. Methods : The within-run and between-run precision, lower detection limits, correlation with AxSYM total PSA (Abbott Lab., Abbott Park, IL, USA) and clinical investigation were evaluated. Three level control serums (0.5, 4.0, and 23.0 ng/mL) were used for a precision test. The linearity was evaluated using a patient serum sample with a PSA concentration of 100 ng/mL. Functional and analytical sensitivities were tested using a patient serum sample with a PSA concentration of less than 0.1 ng/ mL and saline. A correlation study with AxSYM total PSA was done with 42 serum samples. Clinical evaluation was done with 230 patients of whom 17 had prostate cancer. Results : The total PSA showed a good precision result with less than 5 % of CV and showed linearity to 100 ng/mL. The functional sensitivity was 0.025 ng/mL and analytical sensitivity 0.001 ng/mL. The correlation evaluation showed Y (Architect)=1.0575X(AxSYM)+0.1895, r=0.9960. A Cut-off value of 8.35 ng/mL showed 88.2% sensitivity, 80.3% specificity as a diagnostic marker for prostate cancer. Conclusions : Architect total PSA showed an acceptable analytical performance with its high sensitivity and could be a useful marker for early detection and recurrence of prostate cancer.
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