Damhorst Gregory L, McLendon Kaleb, Morales Evelyn, Solis Zianya M, Fitts Eric, Bowers Heather B, Sabino Courtney, Sullivan Julie, Greenleaf Morgan, Roback John D, Colasanti Jonathan A, Sheth Anandi N, Titanji Boghuma K, Martin Greg S, Bassit Leda, Lam Wilbur A, Rao Anuradha
Division of Infectious Diseases, Department of Medicine, Emory University, Atlanta, GA, USA; The Atlanta Center for Microsystems-Engineered Point-of-Care Technologies, Atlanta, Georgia, USA; Ponce de Leon Center, Grady Health System, Atlanta, Georgia, USA.
Department of Pathology and Laboratory Medicine, Emory University, Atlanta, GA, USA.
J Clin Virol. 2024 Apr;171:105659. doi: 10.1016/j.jcv.2024.105659. Epub 2024 Feb 23.
Anorectal and oropharyngeal exposures are implicated in sexual transmission of mpox, but authorized assays in the United States are only validated with cutaneous lesion swabs. Diagnostic assays for anorectal and oropharyngeal swabs are needed to address potential future outbreaks. The Cepheid Xpert® Mpox is the first point-of-care assay to receive FDA emergency use authorization in the United States and would be a valuable tool for evaluating these sample types. Our exploratory study demonstrates 100 % positive agreement with our in-house PCR assay for natural positive anorectal and oropharyngeal specimens and 92 % sensitivity with low-positive spiked specimens. The Xpert® assay detected viral DNA in specimens not detected by our reference PCR assay from four participants with mpox DNA at other sites, suggesting it may be more sensitive at low viral loads. In conclusion, the validation of the Xpert® for oropharyngeal and anorectal sample types can be rapidly achieved if clinical need returns and prospective samples become available.
肛门直肠和口咽暴露与猴痘的性传播有关，但美国的授权检测仅通过皮肤病变拭子进行了验证。需要针对肛门直肠和口咽拭子的诊断检测来应对未来可能的疫情爆发。赛沛Xpert®猴痘检测是美国首个获得FDA紧急使用授权的即时检测方法，将是评估这些样本类型的宝贵工具。我们的探索性研究表明，对于天然阳性的肛门直肠和口咽标本，与我们的内部PCR检测的阳性一致性为100%，对于低阳性加标标本的敏感性为92%。赛沛检测在其他部位有猴痘DNA的四名参与者的标本中检测到了我们的参考PCR检测未检测到的病毒DNA，这表明它在低病毒载量时可能更敏感。总之，如果临床需求恢复且有前瞻性样本可用，赛沛检测针对口咽和肛门直肠样本类型的验证可以迅速完成。
