Abstract

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 immunochromatography 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); CFT 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. Key words: Brucellosis; Diagnostic tests, routine; Sensitivity and specificity; Systemic review

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