AVE-562全自动粪便分析仪性能验证及应用

Performance verification and application of AVE-562 automatic feces analyzer

目的 以《中华人民共和国医药行业标准》(YY/T 1745-2021)为依据对AVE-562全自动粪便分析仪进行性能验证并评价。方法 收集2020年11月17日至12月17日该院门诊及住院患者粪便常规标本517例,以及2022年4月6-13日该院收治的胃癌、结直肠癌患者手工法粪便隐血阳性标本各100例,以人工法为“金标准”,对仪器的粪便理学指标、检出限、检出率、重复性、携带污染、检出符合率、运行速度、配套粪便管的运输,以及胃癌、结直肠癌患者的临床适用性进行全面评价。结果 AVE-562全自动粪便分析仪的粪便理学指标、检出限、检出率、重复性、携带污染均符合评价标准。红细胞、白细胞、真菌、隐血试验检出符合率分别为96.1%、90.5%、99.0%、94.0%,Kappa值分别为0.90、0.73、0.80、0.66,对胃癌及结直肠癌患者,AVE-562与人工法粪便隐血结果阳性符合率分别为96%、97%,差异均有统计学意义(P<0.05),镜检结果与人工镜检基本一致,细胞识别灵敏度和准确度均较高。结论 AVE-562全自动粪便分析仪自动化程度高、操作简便、有形成分检出率较高,可有效减轻人力负担,带来更高的检测效率,适合临床应用。

Objective To validate and evaluate the performance of AVE-562 automatic feces analyzer according to Pharmaceutical Industry Standard of the People’s Republic of China(YY/T 1745-2021).Methods A total of 517 routine feces specimens from outpatients and inpatients at the hospital from November 17 to December 17,2020,and 100 fecal occult blood positive specimens by manual method from patients with gastric cancer and 100 with colorectal cancer admitted to the hospital from April 6 to 13,2022 were collected.The results of manual method were regarded as the gold standard.The test performance analysis,including feces physical index,detection limit,detection rate,repeatability,carrying pollution test,coincidence rate,operation speed and the transportation of supplementary feces collector,clinical applicability in patients with gastric cancer and colorectal cancer,were comprehensively evaluated.Results The verification results of feces physical index,detection limit,detection rate,repeatability and carrying pollution test of the AVE-562 automatic feces analyzer were all in line with the evaluation criteria.The coincidence rates of red blood cell(RBC),white blood cell(WBC),fungus and occult blood test were 96.1%,90.5%,99.0% and 94.0%,respectively.The Kappa values of RBC,WBC,fungus and occult blood test were 0.90,0.73,0.80,0.66,respectively.For patients with gastric and colorectal cancer,the positive coincidence rates of AVE-562 and artificial fecal occult blood results were 96% and 97%,the differences were statistically significant(P<0.05) concordance rates in fecal occult blood test were observed between AVE-562 and manual methods.The analyzer had good performance in cell recognition and its test indicators were consistent with the manual method.Conclusion The AVE-562 automatic feces analyzer can effectively reduce human resources and improve the efficiency of detection with its characters of high degree of automation,simple operation and high detection rate.It is suitable for clinical application.