对2004—2014年人间布鲁杆菌病实验室检测方法的系统评价

Systematic literature review of diagnostic test methods for human brucellosis used in China from 2004 to 2014

目的分析近10年我国人间布鲁杆菌病（简称布病）实验室检测方法的使用现状，并对其敏感度和特异度进行评价。方法检索2004—2014年《中国人兽共患病学报》、《中华流行病学杂志》、《中华地方病学杂志》、《中国地方病防治杂志》、《疾病监测》杂志中有关布病实验室检测的文献，统计各省份各检测方法的检测样本量和各检测方法的灵敏度、特异度及符合率。结果筛选出157篇文献，共由24个省份报告，实际样本检测时间为1954—2012年，共使用14种方法检查了716280份次的样本。检测方法中，检测样本量由大到小分别为试管凝集试验（SAT，256050份），虎红平板凝集试验（RBPT，224699份），皮内变态反应试验（CET，184787份）．平板凝集试验（PAT，33018份）。24个省份使用SAT，20个省份使用RBPT，10个省份使用CET，7个省份分离布鲁杆菌；各省份检测样本量由大到小分别为河南（114031份）、内蒙古（104287份）、浙江（93484份）；使用的检测方法由多到少分别为浙江（9种）、内蒙古（7种）、山东（5种）和黑龙江（5种）。各检测方法与SAT的符合率最高的是胶体金方法，为99．77％（9811／9834）；其次为PAT，为97．73％（86／88）；双抗原夹心酶联免疫吸附试验（BAgS—ELISA），为96．49％（110／114）；RBPT为94．55％（2465／2607）；人免疫球蛋白G酶联免疫吸附试验（IgGELISA）为86-38％（2068／2394）；IgMELISA为76．23％（1825／2394）；补体结合试验（CFT）为69．17％（83／120）；CET为56.36％（31／55）。结论大多数省份都采用了SAT和RBPT方法，且检测样本量大，灵敏度、特异度均高。使用其他方法的检测单位和检测量都相对较少。胶体金操作简便，可现场使用；ELISA的灵敏度、特异度均不是很高，但是可以分别检测IgG及IgM．对慢性布病诊断有一定参考价值。

Objective To analyze the application and accuracy of the diagnostic test methods used in China from 2004 to 2014. Methods A search was conducted in Chinese Journal of Zoonoses, Chinese Journal of Epidemiology, Chinese Journal of Endemiology, Chinese Journal of Control of Endemic Diseases and Disease Surveillance for papers on diagnostic test methods for human brucellosis in China published from 2004 - 2014. Application data and the validity of the test methods were extracted from the included papers, merged and analyzed. Results One hundred and fifty-seven papers, published by 25 provinces, were included, containing up to 716 280 cases of samples, tested from 1954 - 2012 with 14 kinds of different diagnostic test methods. Standard tube agglutination test （SAT）was used in 256 050 cases, in 24 provinces; rose bengal plate agglutination test （RBPT）, 224 699 cases, in 20 provinces; intradermic allergy test （CET）, 184 787 cases, in 10 provinces; plate agglutination test （PAT）, 33 018 cases; and Brucella strain was isolated in 7 provinces. The samples in each province were 114 031 in Henan, then, 104 287 in Inner Mongolia, and 93 484 in Zhejiang. The number of test methods used in each province was 9 in Zhejiang, 7 in Inner Mongolia, and 5 in Shandong and Heilongjiang, respectively. The agreement rate of gold immunoehromatography assay （GICA） was 99.77% （9 811/9 834） controlled with SAT; PAT was 97.73% （86/88）; double antigens sandwich enzyme linked immunosorbent assay （DAgS-ELISA） was 96.49% （110/114）; RBPT was 94.55% （2 465/2 607）; IgG ELISA was 86.38% （2 068/2 394）; IgM ELISA was 76.23% （1 825/2 394）; CFF was 69.17% （83/120）; and CET was 56.36% （31/55）. Conclusions SAT and RBPT are the most widely used test methods in China. Other tests are relatively less applied. GICA has good sensitivity and specificity, and easy to operate and can be applied in the field. The sensitivity and specificity of ELISA are not very high, but it can determine IgG and IgM levels, which has a certain reference value in diagnosis of chronic brucellosis.