血清PSA检测的方法学评价

A methodological evaluation on serum PSA test

目的对时间分辨荧光免疫法(TRFIA)测定血清总前列腺特异性抗原(tPSA)和游离前列腺特异性抗原(fPSA)的方法学予以评价,评价TRFIA法测定血清总前列腺特异性抗原(tPSA)和游离前列腺特异性抗原(fPSA)灵敏度、精密度、回收试验及与化学发光免疫法(CLEIA)的相关性。方法采用重复性试验、回收试验、比较试验方法。结果tPSA和fPSA检测下限分别为0.02μg/L和0.05μg/L,批内变异系数分别为2.38%、3.16%,回收率分别为101.2%和102.4%,与CLEIA法高度相关,r值分别为0.986和0.964。结论TRFIA测定tPSA和fPSA稳定性好、灵敏度和准确度高,是当前免疫最有发展前途的超微量检测技术。

Objective To evaluate the method of time-resolved fluoroimmunoassay （TRFIA） for serum total prostate specific antigen （tPSA） with free prostate specific antigen（fPSA） and compare TRFIA with chemiluminescent enzyme immunoassay （ CLEIA） for the assay of tPSA and fPSA in the sensitivity, precision and recovery rate. Methods Repeat test,callback test and compatison test. Results The lower limits of tPSA and fPSA were 0.02μg/L and 0. 05 μg/L respectively. The CV within were 2.38% and 3. 16% respectively. The recovery rates were 101.2% and 102.4% respectively. Being in high agreement with CLEIA, the values of r was 0.986 and 0. 964. Conclusion The sensitivity of TRFIA for serum tPSA and fPSA is high. It is also highly accurate. TRFIA appears to be a useful biochemical uhrami croanalysis technique worthy of further development.