使用实验室培养的正痘病毒和皮疹疾病临床标本评估 Tetracore Orthopox BioThreat® 抗原检测试剂盒。
Evaluation of the Tetracore Orthopox BioThreat® antigen detection assay using laboratory grown orthopoxviruses and rash illness clinical specimens.
机构信息
Centers for Disease Control and Prevention, Division of High-Consequence Pathogens and Pathology, Poxvirus and Rabies Branch, 1600 Clifton Road NE, Atlanta, GA 30333, United States.
出版信息
J Virol Methods. 2013 Jan;187(1):37-42. doi: 10.1016/j.jviromet.2012.08.023. Epub 2012 Sep 5.
The commercially available Orthopox BioThreat® Alert assay for orthopoxvirus (OPV) detection is piloted. This antibody-based lateral-flow assay labels and captures OPV viral agents to detect their presence. Serial dilutions of cultured Vaccinia virus (VACV) and Monkeypox virus (MPXV) were used to evaluate the sensitivity of the Tetracore assay by visual and quantitative determinations; specificity was assessed using a small but diverse set of diagnostically relevant blinded samples from viral lesions submitted for routine OPV diagnostic testing. The BioThreat® Alert assay reproducibly detected samples at concentrations of 10(7)pfu/ml for VACV and MPXV and positively identified samples containing 10(6)pfu/ml in 4 of 7 independent experiments. The assay correctly identified 9 of 11 OPV clinical samples and had only one false positive when testing 11 non-OPV samples. Results suggest applicability for use of the BioThreat® Alert assay as a rapid screening assay and point of care diagnosis for suspect human monkeypox cases.
市售的正痘病毒（OPV）检测商业试剂盒 Orthopox BioThreat® Alert 已投入试用。该基于抗体的横向流动检测法标记和捕获 OPV 病毒制剂，以检测其存在。通过目视和定量测定，使用培养的牛痘病毒（VACV）和猴痘病毒（MPXV）的连续稀释液来评估 Tetracore 检测法的灵敏度；使用一小部分但具有诊断相关性的、来自用于常规 OPV 诊断检测的病毒病变的盲样评估特异性。BioThreat® Alert 检测法可重复性地检测到浓度为 10(7)pfu/ml 的 VACV 和 MPXV 样本，并且在 7 次独立实验中的 4 次中，正确识别出含有 10(6)pfu/ml 的样本。该检测法正确识别出 11 个 OPV 临床样本中的 9 个，在测试 11 个非 OPV 样本时仅出现 1 个假阳性。结果表明，该 BioThreat® Alert 检测法可作为快速筛选检测法和疑似人类猴痘病例的即时护理诊断方法使用。
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