Hutson Christina L, Villanueva Julie, Stenzel Timothy, Olson Victoria A, Gerald Noel, McNall Rebecca, Courtney Sean, Aden Tricia, Rager Stacy, Egan Christina, Blevins Patricia, Kuhnert Wendi, Davidson Whitni, Khan Theodora, Baird Nicolle, Kling Chantal, Van Meter Susan, Chaitram Jasmine, Salerno Reynolds M
Author Affiliations: Centers for Disease Control and Prevention , Atlanta, Georgia (Drs Hutson, Villanueva, and Olson, and McNall, Dr Courtney, Mss Aden, Rager, and Blevins, Dr Kuhnert, Mss Davidson and Khan, Dr Baird, Mss Kling, and Chaitram, and Dr Salerno), Food and Drug Administration (FDA), Silver Spring, Maryland (Drs Stenzel and Gerald); New York State Department of Health (NYS DOH) Wadsworth Center, Albany, New York (Dr Egan), and American Clinical Laboratory Association, Washington, District of Columbia (Ms Van Meter).
J Public Health Manag Pract. 2025;31(1):E1-E5. doi: 10.1097/PHH.0000000000002024. Epub 2024 Oct 25.
The first case of mpox was detected in the United States in a Laboratory Response Network (LRN) laboratory at the Massachusetts Department of Public Health on May 17, 2022. Through previous years of smallpox preparedness efforts by the United States government, testing capacity in LRN laboratories across the United States utilizing the FDA-cleared Centers for Disease Control and Prevention (CDC) Non-variola orthopoxvirus (NVO) test was approximately 6000 tests weekly across the nation prior to the mpox outbreak. By early June 2022, the LRN laboratories had capacity to perform up to 8000 tests per week. As the outbreak expanded, cases were identified in every United States state, peaking at ~3000 cases per week nationally in August 2022.
Although NVO testing capacity in LRN laboratories exceeded national mpox testing demand overall, LRN testing access in some areas was challenged and test expansion was necessary.
CDC engaged with partners and select commercial laboratories early to increase diagnostic testing access by allowing these commercial laboratories to utilize the NVO test.
The expansion of testing to commercial laboratories increased testing availability, capacity, and volume nationwide. This was the first time that CDC shared an FDA 510k-cleared molecular test with commercial laboratories to support a public health emergency.
Extensive efforts were made to ensure the CDC NVO test was used appropriately in the private sector and that the transfer process met regulatory requirements.
MAIN OUTCOME MEASURES, RESULTS, CONCLUSIONS: These novel methods to expand NVO testing to commercial laboratories increased national testing capacity to 80 000 mpox tests/week. Test volumes among these laboratories never exceeded this expanded capacity. The rapid increase in the nation's testing capacity, in conjunction and coordination with other public and private health efforts, helped to detect cases rapidly. These actions demonstrated the importance of highly functional and efficient public health and private sector partnerships for responding to public health emergencies.
2022年5月17日，美国马萨诸塞州公共卫生部的一个实验室反应网络（LRN）实验室检测到首例猴痘病例。通过美国政府前几年的天花防范工作，在猴痘疫情爆发前，美国各地LRN实验室利用美国食品药品监督管理局（FDA）批准的疾病控制与预防中心（CDC）非天花正痘病毒（NVO）检测方法，每周的检测能力约为6000次。到2022年6月初，LRN实验室每周能够进行多达8000次检测。随着疫情蔓延，美国每个州都发现了病例，2022年8月全国每周病例数峰值达到约3000例。
尽管LRN实验室的NVO检测能力总体上超过了全国猴痘检测需求，但一些地区的LRN检测渠道面临挑战，有必要扩大检测范围。
疾病预防控制中心（CDC）很早就与合作伙伴及选定的商业实验室合作，通过允许这些商业实验室使用NVO检测方法来增加诊断检测渠道。
将检测范围扩大到商业实验室提高了全国范围内检测的可及性、能力和数量。这是疾病预防控制中心首次与商业实验室共享经FDA 510k批准的分子检测方法，以支持突发公共卫生事件。
为确保疾病预防控制中心的NVO检测方法在私营部门得到合理使用，且转移过程符合监管要求，已做出了广泛努力。
主要结局指标、结果、结论：这些将NVO检测扩展到商业实验室的新方法使全国检测能力提高到每周80000次猴痘检测。这些实验室的检测量从未超过这一扩大后的能力。美国检测能力的迅速提高，以及与其他公共和私营卫生工作的协同与协调，有助于快速发现病例。这些行动表明了高效能和高效率的公共卫生与私营部门伙伴关系在应对突发公共卫生事件中的重要性。
