自动粪便处理分析系统临床应用性能评估

Clinical application performance evaluation of fully automatic feces analyzer

目的评价自动粪便处理分析系统的临床应用性能。方法对沃文特FA160自动粪便处理分析系统检测有形成分及隐血试剂的重复性、携带污染、隐血试剂检测范围,以及仪器与手工法对有形成分及隐血检测结果的一致性进行比较。结果 3种浓度红细胞、白细胞及虫卵标本重复检测结果与参考浓度一致。隐血试验批内、批间重复性检测结果符合要求。有形成分及隐血试验携带污染检测结果符合要求。比对试剂与待测试剂最低检测限均为0.2μg/mL,浓度达到3.2mg/mL时两种试剂均出现"后带现象"。616例标本中手工法检出白细胞阳性21例(3.41%)、红细胞阳性10例(1.62%);仪器检出白细胞阳性24例(3.89%)、红细胞阳性12例(1.95%)。隐血检测手工法检出阳性或弱阳性79例(12.82%),仪器法检出阳性或弱阳性标本83例(13.47%)。手工法检测阳性的标本仪器检测结果均为阳性,仪器检测结果阳性而手工法阴性的标本,经过手工法复检结果均为阳性或弱阳性。结论 FA160自动粪便处理分析系统与传统手工法具有较好的一致性。

Objective To evaluate the clinical application value and performance of automatic stool analyzer FA160. Methods Both the carryover and repeatability of stool routine test and fecal occult blood test （FOBT） were conducted.The FOBT detection range was evaluated and the consistency between the automatic stool analyzer and the manual microscopy examination was observed. Results The within-run precision of three concentration of red blood cell （RBC）,white blood cell （WBC）,parasitic ovum,FOBT and the between-day precision of FOBT were in accordance with reference concentration.The carryover of RBC,WBC and FOBT was not observed.The minimum detection limit of the both FOBT colloidal gold assay regent was 0.2 μg/mL and the postzone phenomenon occurred at the theoretical value greater than 3.2 mg/mL.According to the traditional manual test,21 of the samples had leukocytes （3.41%）,10 had erythrocytes （1.62%） and 79 were FOBT positive （12.82%） among the 616 samples.However,according to the examination by the FA160,24 of the samples had leukocytes （3.89%）,12 had erythrocytes （1.95%） and 83 were FOBT positive （13.47%）. Conclusion The overall performance of FA160 automatic stool analyzer is excellent and it could meet the basic requirements of clinical application.