Diagnostic Accuracy Assessment of Immunochromatographic Tests for the Rapid Detection of Antibodies Against Orientia tsutsugamushi Using Paired Acute and Convalescent Specimens

利用配对的急性期和恢复期标本,对免疫层析法快速检测恙虫病东方体抗体的诊断准确性进行评估

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Abstract

We assessed the diagnostic accuracy of two immunochromatographic tests (ICTs), the Access Bio CareStart Scrub Typhus test (Somerset, NJ) (IgM), and the SD BIOLINE Tsutsugamushi test (Kyonggi-do, Republic of Korea) (IgG, IgM, or IgA) compared with indirect immunofluorescence assay (IFA) and real-time PCR results as reference tests using 86 paired acute and convalescent specimens from febrile patients. The sensitivity and specificity of the CareStart test were 23.3% (95% confidence interval [CI]: 11.8-38.6) and 81.4% (95% CI: 66.6-91.6), respectively, for acute specimens and 32.6% (95% CI: 19.1-48.5) and 79.1% (95% CI: 64.0-90.0), respectively, for convalescent specimens. For the SD BIOLINE test, sensitivity and specificity were 20.9% (95% CI: 10.0-36.0) and 74.4% (95% CI: 58.8-86.5), respectively, for acute specimens and 76.7% (95% CI: 61.4-88.2) and 76.7% (95% CI: 61.4-88.2), respectively, for convalescent specimens. The poor sensitivity obtained for both ICTs during this study when performed on acute specimens highlights the difficulties in prompt diagnosis of scrub typhus.

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