Chen Chuizhe, Fang Junde, Li Xuemiao, Rajaofera Mamy Jayne Nelly, Zhang Nan, Zhang Yuanyuan, Xia Qianfeng
NHC Key Laboratory of Tropical Disease Control, School of Tropical Medicine, Hainan Medical University, Haikou, 571199, Hainan, China.
Department of Cardiology, The First Affiliated Hospital, Hainan Medical University, Haikou, 570102, China.
BMC Infect Dis. 2025 Jul 1;25(1):851. doi: 10.1186/s12879-025-11214-9.
The accuracy of laboratory diagnostic tests for the rapid diagnosis of melioidosis and their potential to replace culture tests as the gold standard remain controversial. This study aims to comprehensively evaluate the accuracy of all rapid diagnostic tests.
A systematic search of PubMed, Embase, SCIE, the Cochrane Library, and Scopus databases was conducted up to July 12, 2024, to include diagnostic tests for melioidosis with culture as the gold standard. The diagnostic accuracy of all testing methods was evaluated using a bivariate mixed-effects model and an ANOVA model.
A total of 36 studies, comprising 21,289 tests, were included in this systematic review and meta-analysis. Using the bivariate mixed-effects model, the pooled sensitivity of indirect ELISA was 0.86 [95% CI (0.80-0.90)] and the pooled specificity was 0.85 [95% CI (0.80-0.89)]. For IHA with a positive threshold of 1:160, the pooled sensitivity was 0.60 [95% CI (0.46-0.72)] and the pooled specificity was 0.70 [95% CI (0.58-0.79)]. The pooled sensitivity of LFI targeting CPS was 0.52 [95% CI (0.33-0.70)] and the pooled specificity was 0.96 [95% CI (0.93-0.98)]. For IFA targeting polyclonal antibody, the pooled sensitivity was 0.60 [95% CI (0.44-0.75)] and the pooled specificity was 0.99 [95% CI (0.97-1.00)]. The pooled sensitivity of RT-PCR targeting T3SS was 0.72 [95% CI (0.41-0.91)] and the pooled specificity was 1.00 [95% CI (0.97-0.99)]. Other testing methods could not be meta-analyzed due to insufficient study numbers. The ANOVA model for network meta-analysis of the five most common testing methods showed that IFA targeting polyclonal antibody had the best advantage with a Superiority index of 6.86. In contrast, IHA with a positive threshold of 1:160 had the poorest advantage with a Superiority index of 0.19.
While rapid diagnostic methods for B. pseudomallei infection exist, bacterial culture remains the gold standard. In resource-limited settings, we recommend antigen-targeted sandwich ELISA for acute/early-stage melioidosis and IgG-based indirect ELISA for late acute or chronic cases. In high-resource settings, RT-PCR targeting the T3SS is recommended as an adjunct diagnostic modality. Strengthening training for clinicians and laboratory personnel is essential to ensure accurate application and interpretation.
CRD42024569385.
用于类鼻疽快速诊断的实验室诊断测试的准确性以及它们取代培养测试作为金标准的潜力仍存在争议。本研究旨在全面评估所有快速诊断测试的准确性。
截至2024年7月12日，对PubMed、Embase、SCIE、Cochrane图书馆和Scopus数据库进行了系统检索，纳入以培养作为金标准的类鼻疽诊断测试。使用双变量混合效应模型和方差分析模型评估所有测试方法的诊断准确性。
本系统评价和荟萃分析共纳入36项研究，包括21289次测试。使用双变量混合效应模型，间接ELISA的合并敏感性为0.86 [95%可信区间(0.80 - 0.90)]，合并特异性为0.85 [95%可信区间(0.80 - 0.89)]。对于阳性阈值为1:160的间接血凝试验（IHA），合并敏感性为0.60 [95%可信区间(0.46 - 0.72)]，合并特异性为0.70 [95%可信区间(0.58 - 0.79)]。靶向荚膜多糖的侧向流动免疫分析（LFI）的合并敏感性为0.52 [95%可信区间(0.33 - 0.70)]，合并特异性为0.96 [95%可信区间(0.93 - 0.98)]。对于靶向多克隆抗体的间接荧光抗体试验（IFA），合并敏感性为0.60 [95%可信区间(0.44 - 0.75)]，合并特异性为0.99 [95%可信区间(0.97 - 1.00)]。靶向三型分泌系统（T3SS）的逆转录聚合酶链反应（RT-PCR）的合并敏感性为0.72 [95%可信区间(0.41 - 0.91)]，合并特异性为1.00 [95%可信区间(0.97 - 0.99)]。由于研究数量不足，其他测试方法无法进行荟萃分析。对五种最常用测试方法进行网络荟萃分析的方差分析模型显示，靶向多克隆抗体的IFA优势最佳，优势指数为6.86。相比之下，阳性阈值为1:160的IHA优势最差，优势指数为0.19。
虽然存在针对假鼻疽伯克霍尔德菌感染的快速诊断方法，但细菌培养仍是金标准。在资源有限的环境中，我们建议针对急性/早期类鼻疽使用抗原靶向夹心ELISA，针对晚期急性或慢性病例使用基于IgG的间接ELISA。在资源丰富的环境中，建议将靶向T3SS的RT-PCR作为辅助诊断方法。加强对临床医生和实验室人员的培训对于确保准确应用和解释至关重要。
CRD42024569385。
