CAJ | 학술논문

目的：对日本积水（SEKISUI）医疗株式会社生产的胶乳免疫比浊法FDP试剂(Nanopia P-FDP)在法国Stago公司生产的STA-R全自动凝血仪上使用的性能评估。方法试剂评估主要包括精密度、线性范围和前带现象。结果使用FDP试剂测定2个不同水平质控品及混合血浆，CV批内为2.8％~7.3％，符合参考资料中CV≤10％的要求。在136 ug/mL以内线性良好。用浓度约为936.83 ug/mL的标本进行测试，未出现前带现象。当浓度大于467.80 ug/mL时仪器出现报警，结果显示V＞Vmax。结论在法国Stago公司生产的STA-R全自动凝血仪使用日本积水生产的胶乳免疫比浊法FDP试剂符合临床的使用要求。
목적：대일본적수（SEKISUI）의료주식회사생산적효유면역비탁법FDP시제(Nanopia P-FDP)재법국Stago공사생산적STA-R전자동응혈의상사용적성능평고。방법시제평고주요포괄정밀도、선성범위화전대현상。결과사용FDP시제측정2개불동수평질공품급혼합혈장，CV비내위2.8％~7.3％，부합삼고자료중CV≤10％적요구。재136 ug/mL이내선성량호。용농도약위936.83 ug/mL적표본진행측시，미출현전대현상。당농도대우467.80 ug/mL시의기출현보경，결과현시V＞Vmax。결론재법국Stago공사생산적STA-R전자동응혈의사용일본적수생산적효유면역비탁법FDP시제부합림상적사용요구。
Objective To evaluate the analytical performance of the reagent for the FDP (Nanopia P-FDP produced by SEKISUI MEDICAL CO., LTD) on STA-R. Methods The precision, the linearity and the frontal zone phenomenon were evaluated. Results The imprecision of intra-assay was 2.8%~7.3%, two dif erent control items and pooled plasma checked. The linearity range of the reagent was 0.00~136ug/mL. There is no failed results in the test of frontal zone phenomenon, when carry on the over-range material (936.83ug/mL). When the sample is high at FDP (>467.80ug/mL), STA-R makes a Alarm (V>Vmax). Conclusions The comparison test shows the method for detecting FDP was excellent, Nanopia P-FDP on STA-R is suitable for FDP measurement. The method can be used in clinical diagnosis.