Zika Virus and Related Arbovirus Infections in Deferred Blood Donors

延迟献血者中的寨卡病毒和相关虫媒病毒感染

• 批准号: 10007376
• 负责人: Valeria de Giorgi
• 金额: --
• 依托单位: CLINICAL CENTER
• 依托单位国家: 美国
• 资助国家: 美国
• 起止时间: 至
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10007376
• 关键词: Adult; Aedes; Age; Alphavirus; Arbovirus Infections; Area; Argentina; Authorization documentation; Back; Bahamas; Biological Assay; Blood; Blood Banks; Blood Platelets; Blood Transfusion; Blood donor; Blood donor screening; Brazil; Caribbean region; Caucasians; Central America; Chikungunya virus; Clinical; Colombia; Costa Rica; Country; Culicidae; Dengue; Dengue Virus; Detection; Development; Diagnostic; Dominican Republic; Ecuador; El Salvador; Emergency Situation; Enrollment; Epidemic; Exposure to; Female; Flavivirus; India; Indonesia; Jamaica; Laboratories; Martinique; Mexico; Natural History; Nigeria; North America; Outcome; Panama; Patients; Peru; Plasma; Prevalence; Puerto Rico; RNA; Recording of previous events; Reporting; Reverse Transcriptase Polymerase Chain Reaction; Risk; Risk Factors; Sampling; Senegal; Singapore; South America; Symptoms; Tanzania; Testing; Transfusion; Travel; United States National Institutes of Health; United States Virgin Islands; Urine; Validation; Vietnam; Virus Diseases; Visit; Work; Yellow fever virus; ZIKV infection; Zika Virus; base; chikungunya; man; mosquito-borne; multiplex detection; pathogen; transfusion medicine; transmission process; viral RNA; volunteer

Zika virus (ZIKV) is an Aedes species, mosquito-transmitted Flavivirus responsible for an ongoing epidemic in over twenty countries and territories in the Caribbean, and in North, Central and South America. In addition to mosquito-borne transmission, ZIKV can likely be transmitted via blood transfusion and by sexual contact with a ZIKV-infected man. Other Flaviviruses, including yellow fever virus and dengue virus (DENV) are known to be transfusion-transmitted and have resulted in severe outcomes. Chikungunya virus (CHIKV), an alphavirus, has a high theoretical risk of transfusion-related transmission. The ZIKV, DENV and CHIKV infection rates are unknown among U.S. blood donors deferred either for travel to an endemic area or for sexual contact with a partner who travelled to an endemic area. Further, the natural history of ZIKV, DENV and CHIKV among deferred blood donors is not well-defined. Enrollment for this study began in mid June 2016 at the NIH Blood Bank, in the NIH Clinical Center Department of Transfusion Medicine. To date, 34 travel-deferred or potential blood donors who traveled to Zika virus endemic areas have been enrolled and tested using highly sensitive and specific RT-PCR-based assays for ZIKV, DENV1-4 and CHIKV (Altona Diagnostics; under FDA emergency use authorization). Enrollees have mean age of 40, 56% are female, 72% are white or Caucasian and 32% had been blood donors >10 years. Donors and potential donors traveled to 23 different countries or territories with endemic Zika virus, including: Argentina, Brazil, Colombia, Costa Rica, Ecuador, El Salvador, Mexico, Panama and Peru; in the Caribbean: the Bahamas, Dominican Republic, Jamaica, Martinique, Puerto Rico and the US Virgin Islands; elsewhere: India, Indonesia, Nigeria, Senegal, Singapore, Tanzania, UAE and Vietnam. We performed internal validation of the ZIKV RT-PCR kit using clinical samples and determined a limit of detection of approximately 100 copies per mL. Thus far, 32 of 34 deferred or potential blood donors were negative for ZIKV, DENV and CHIKV in plasma and urine. One potential donor was positive for Chikungunya RNA in urine (negative in blood) >2 weeks after mild, CHIKV-related symptoms began during a visit to Ecuador. The patient attributed the mild CHIKV symptoms to strenuous volunteer work she was doing for an aid agency in Ecuador, and would not have been reported as an illness during blood donor screening. One was a Zika virus RNA false-positive. She had no significant travel history or other risk factors and subsequent confirmatory testing was negative. The study has been closed on March 2019.

Zika病毒（Zikv）是一种迪亚斯物种，是蚊子经过的黄病毒，负责在加勒比海以及北部，中部和南美的20多个国家和领土上持续的流行病。 除了蚊子传播外，ZIKV还可以通过输血和与ZIKV感染的男子发生性接触来传播ZIKV。已知其他黄热病病毒，包括黄热病病毒和登革热病毒（DENV），是输血传播的，并导致了严重的结果。 Alphavirus Chikungunya病毒（Chikv）具有与输血相关的传播的高理论风险。 ZIKV，DENV和CHIKV感染率是未知的，在前往地方性地区旅行或与前往地方性地区的伴侣进行性接触的美国献血者中，尚不清楚。 此外，在递延献血者中，Zikv，Denv和Chikv的自然历史没有明确的定义。 这项研究的入学率始于2016年6月中旬在NIH临床中心输血医学部的NIH血库。 迄今为止，使用高度敏感和特定的基于RT-PCR的基于ZIKV，DENV1-4和CHIKV（Altona Diagnostics; Altona Diagnostics; FDA紧急使用授权）使用了高度敏感和特定的基于RT-PCR的测定法进行了34个旅行剥离或潜在的献血者。 参与者的平均年龄为40岁，女性为56％，72％是白人或高加索人，而32％的献血者> 10岁。 捐助者和潜在的捐助者前往具有地方性寨卡病毒的23个不同国家或领土，包括：阿根廷，巴西，哥伦比亚，哥斯达黎加，厄瓜多尔，埃尔萨尔瓦多，墨西哥，墨西哥，巴拿马，巴拿马和秘鲁；在加勒比海：巴哈马，多米尼加共和国，牙买加，马提尼克岛，波多黎各和美国维尔京群岛；在其他地方：印度，印度尼西亚，尼日利亚，塞内加尔，新加坡，坦桑尼亚，阿联酋和越南。 我们使用临床样品对ZIKV RT-PCR试剂盒进行了内部验证，并确定了大约100份副本的限制。 到目前为止，在血浆和尿液中，34个递延或潜在的献血者中有32个对ZIKV，DENV和CHIKV为阴性。 一个潜在的供体对尿液中的chikungunya RNA呈阳性（血液阴性）在访问厄瓜多尔期间开始轻度，与Chikv相关的症状后2周开始。患者将轻度的CHIKV症状归因于她在厄瓜多尔为援助机构所做的艰苦志愿工作，并且在献血者筛查期间不会被报道为疾病。一个是寨卡病毒RNA假阳性。 她没有明显的旅行病史或其他危险因素，随后的确认性测试为阴性。 该研究已于2019年3月关闭。