中性粒细胞明胶酶相关脂质运载蛋白同源二聚体快速检测试剂在腹膜透析相关性腹膜炎诊断中的应用  

Utility of homodimer neutrophil gelatinase-associated lipocalin rapid test kit for the diagnosis of peritoneal dialysis-associated peritonitis

作　　者：陈岩冰[1] 张涛[2] 孔刚[3] 吕学爱[3] 王健英[4] 张坤英[4] 陈钦开[1] Chen Yanbing;Zhang Tao;Kong Gang;Lyu Xueai;Wang Jianying;Zhang Kunying;Chen Qinkai(Department of Nephrology,the First Affiliated Hospital of Nanchang University,Nanchang 330000,China;Department of Nephrology,the Third Hospital of Hebei Medical University,Shijiazhuang 050000,China;Department of Nephrology,Taian Central Hospital,Taian 271000,China;Department of Nephrology,Weifang People's Hospital,Weifang 261000,China)

机构地区：[1]南昌大学第一附属医院肾内科,南昌330000 [2]河北医科大学第三医院肾内科,石家庄050000 [3]泰安市中心医院肾内科,泰安271000 [4]潍坊市人民医院肾内科,潍坊261000

出　　处：《中华肾脏病杂志》2024年第11期868-874,共7页Chinese Journal of Nephrology

摘　　要：目的探索中性粒细胞明胶酶相关脂质运载蛋白同源二聚体(homodimer neutrophil gelatinase-associated lipocalin,H-NGAL)快速检测试剂在腹膜透析(peritoneal dialysis,PD)相关性腹膜炎(PD-associated peritonitis,PDAP)中的诊断效能。方法该研究为多中心前瞻性观察性研究。纳入2021年12月27日至2022年7月18日在南昌大学第一附属医院、河北医科大学第三医院、泰安市中心医院及潍坊市人民医院4家医院肾内科门诊就诊或住院的PD患者,根据患者入选时是否发生PDAP分为PDAP组和非PDAP组。收集患者PD透出液样本,并进行H-NGAL检测。患者或其家属分别采用检测卡、检测条及检测笔方式H-NGAL检测试剂检测样本中H-NGAL,医护人员仅使用检测卡检测H-NGAL。所有患者或其家属在检测前完成H-NGAL试剂使用说明书调查问卷,并在检测完成后汇总操作体验和评价问卷。以临床诊断为金标准,计算H-NGAL快速检测试剂诊断PDAP的灵敏度、特异度、符合率和95%置信区间(CI)。使用Kappa检验法评估H-NGAL检测结果与临床诊断的一致性。结果共221例PD患者被纳入该研究,PDAP组42例,非PDAP组179例。H-NGAL快速检测诊断PDAP的灵敏度和特异度分别为100%(95%CI 91.62%~100%)和99.44%(95%CI 96.90%~99.90%),准确度为99.55%(95%CI 97.48%~99.92%),阳性符合率为97.67%(95%CI 87.94%~99.59%),阴性符合率为100%(95%CI 97.89%~100%);一致性评估结果显示,Kappa值为0.985(95%CI 0.956~1.000)。患者或其家属使用H-NGAL快速检测试剂所得检测结果在3种方式间是一致的,非医护人员与医护人员使用H-NGAL快速检测试剂所得检测结果也是一致的。两个问卷(试剂使用说明书问卷与操作体验和评价问卷)结果显示,患者对H-NGAL快速检测试剂的整体满意度为很好。结论H-NGAL快速检测试剂在PDAP诊断中具有较高的灵敏度和特异度,可作为快速诊断PDAP的检测方法。Objective To evaluate the efficacy of homodimer neutrophil gelatinase-associated lipocalin(H⁃NGAL)rapid test kit in diagnosing peritoneal dialysis(PD)-associated peritonitis(PDAP).Methods It was a multicenter prospective observational study.The PD patients from the nephrology clinics or wards at four hospitals:the First Affiliated Hospital of Nanchang University,the Third Hospital of Hebei Medical University,Taian Central Hospital,and Weifang People's Hospital from December 27,2021,and July 18,2022 were enrolled.The patients were categorized into PDAP and non-PDAP groups based on whether PDAP occurred at the time of enrollment.PD effluent samples were collected,and H⁃NGAL test was performed.The patients or their families used cassette-type,strip-type,and pen-type H⁃NGAL test kits to detect H⁃NGAL.Healthcare professionals only used the cassette-type H⁃NGAL kit to detect H⁃NGAL.All participants completed a questionnaire regarding the instructions for use of H⁃NGAL kit before testing,and a summary of patient experience and evaluation questionnaires after testing.The sensitivity,specificity,compliance rate,and 95%confidence interval(CI)of H⁃NGAL rapid test kit for diagnosing PDAP were calculated using clinical diagnosis as the standard.Kappa test was used to assess the consistency between H⁃NGAL detection results and clinical diagnoses.Results A total of 221 PD patients were enrolled,with 42 PDAP patients and 179 non-PDAP patients.The sensitivity and specificity of H⁃NGAL rapid test kit for diagnosing PDAP were 100%(95%CI 91.62%-100%)and 99.44%(95%CI 96.90%-99.90%),respectively,with accuracy rate of 99.55%(95%CI 97.48%-99.92%).The positive agreement rate was 97.67%(95%CI 87.94%-99.59%),and the negative agreement rate was 100%(95%CI 97.89%-100%).The consistency evaluation results showed that kappa value was 0.985(95%CI 0.956-1.000).The results obtained by patients and their families using the H⁃NGAL rapid test kits were consistent across all three methods(cassette,strip,and pen-type H⁃NGAL test

关 键 词：腹膜透析 腹膜炎 早期诊断 检测试剂 中性粒细胞明胶酶相关脂质运载蛋白同源二聚体 

分 类 号：R692.5[医药卫生—泌尿科学] R572.2[医药卫生—外科学]