印度用于登革热诊断的商用酶联免疫吸附测定法和快速诊断检测的比较评估。
Comparative assessment of commercial enzyme-linked immunosorbent assay & rapid diagnostic tests used for dengue diagnosis in India.
机构信息
Department of Communicable Diseases, Interactive Research School for Health Affairs, Bharati Vidyapeeth (Deemed to be University), Pune, Maharashtra, India.
Department of Medical Microbiology, Bharati Medical College & Research Center, Bharati Vidyapeeth (Deemed to be University), Pune, Maharashtra, India.
出版信息
Indian J Med Res. 2020 Jan;151(1):71-78. doi: 10.4103/ijmr.IJMR_613_18.
BACKGROUND & OBJECTIVES: Dengue diagnosis is routinely carried out by detection of dengue virus (DENV) antigen NS1 and/or anti-DENV IgM antibodies using enzyme-linked immunosorbent assays (ELISAs) and rapid diagnostic tests (RDTs). This study was aimed at evaluation of quality of diagnostic assays currently in use in India for the identification of DENV infection.
METHODS
During 2016 dengue season (July-November) in Pune, India, comparative assessment of a few immunoassays was undertaken using (i) WHO-approved Panbio-Dengue-Early-(NS1)-ELISA and Panbio-Dengue-IgM-Capture-ELISA as reference tests, and (ii) Bayesian latent class analysis (BLCA) which assumes that no test is perfect. The assays included J.Mitra-Dengue-NS1-Ag-MICROLISA (JME-NS1), J.Mitra-Dengue-IgM-MICROLISA (JME-IgM), and two RDTs, namely, J.Mitra-Dengue-Day-1-Test (JM-RDT) and SD-BIOLINE-Dengue-Duo (SDB-RDT). Serum samples from patients seeking dengue diagnosis (n=809) were tested using the diagnostic kits. The presence of NS1 and/or IgM was taken as evidence for dengue-positive diagnosis.
RESULTS
Panbio-NS1/IgM-ELISAs identified 38.6 per cent patients as dengue positive. With Panbio-ELISA as reference, all the tests were less sensitive for IgM detection, while for NS1, JM-RDT was less sensitive. For combined diagnosis (both markers), sensitivity of all the tests was low (55.7-76.6%). According to BLCA, Panbio-ELISA was 84 per cent sensitive for NS1, 86 per cent specific for IgM and 87 per cent specific for combined diagnosis. Accordingly, performance of the other tests was substantially improved with BLCA; however, sensitivity of both the RDTs for IgM detection remained unacceptable. The NS1 ELISAs and RDTs detected all four DENV serotypes, JME being most efficient. All IgM tests exhibited higher sensitivity in secondary infections.
INTERPRETATION & CONCLUSIONS: These results confirmed superiority of ELISAs, and testing for both NS1 and IgM markers for dengue diagnosis, and emphasized on improvement in sensitivity of RDTs.
背景与目的
登革热的诊断通常通过酶联免疫吸附试验（ELISA）和快速诊断检测（RDT）检测登革病毒（DENV）抗原 NS1 和/或抗 DENV IgM 抗体来进行。本研究旨在评估目前在印度用于识别 DENV 感染的诊断检测方法的质量。
方法
在印度浦那的 2016 年登革热季节（7 月至 11 月）期间，使用（i）世界卫生组织批准的 Panbio-Dengue-Early-（NS1）-ELISA 和 Panbio-Dengue-IgM-Capture-ELISA 作为参考检测，以及（ii）贝叶斯潜在类别分析（BLCA）对几种免疫测定法进行了比较评估，假设没有一种检测是完美的。检测方法包括 J.Mitra-Dengue-NS1-Ag-MICROLISA（JME-NS1）、J.Mitra-Dengue-IgM-MICROLISA（JME-IgM）和两种 RDT，即 J.Mitra-Dengue-Day-1-Test（JM-RDT）和 SD-BIOLINE-Dengue-Duo（SDB-RDT）。使用诊断试剂盒检测寻求登革热诊断的患者的血清样本（n=809）。存在 NS1 和/或 IgM 被视为登革热阳性诊断的证据。
结果
Panbio-NS1/IgM-ELISA 将 38.6%的患者确定为登革热阳性。以 Panbio-ELISA 为参考，所有检测方法对 IgM 检测的敏感性均较低，而对于 NS1，JM-RDT 的敏感性较低。对于联合诊断（两种标志物），所有检测方法的敏感性均较低（55.7-76.6%）。根据 BLCA，Panbio-ELISA 对 NS1 的敏感性为 84%，对 IgM 的特异性为 86%，对联合诊断的特异性为 87%。相应地，BLCA 大大提高了其他检测方法的性能；然而，两种 RDT 对 IgM 检测的敏感性仍然不可接受。NS1 ELISA 和 RDT 均能检测到所有四种 DENV 血清型，其中 JME 最为有效。所有 IgM 检测在二次感染中表现出更高的敏感性。
解释和结论
这些结果证实了 ELISA 的优势，以及用于登革热诊断的 NS1 和 IgM 标志物的检测，并强调了 RDT 敏感性的提高。
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