Successful Collaborations that Resulted in Increased U.S. Diagnostic Testing During the 2022 Mpox Outbreak

Area of Science:

• Public Health
• Infectious Disease Epidemiology
• Diagnostic Testing

Background:

• The first U.S. mpox case was detected in May 2022, with initial testing capacity managed by Laboratory Response Network (LRN) laboratories.
• Prior to the outbreak, LRN laboratories had a capacity of approximately 6,000 tests weekly, which increased to 8,000 by early June 2022.
• Mpox cases spread nationwide, peaking at around 3,000 cases per week in August 2022.

Purpose of the Study:

• To address challenges in mpox testing access despite overall capacity exceeding demand.
• To expand diagnostic testing availability and accessibility across the United States during the mpox outbreak.

Main Methods:

• The CDC collaborated with commercial laboratories to enable them to perform the FDA-cleared Centers for Disease Control and Prevention (CDC) Non-variola orthopoxvirus (NVO) test.
• This marked the first instance of the CDC sharing an FDA 510k-cleared molecular test with commercial partners during a public health emergency.
• Regulatory requirements and appropriate test utilization were ensured through extensive efforts during the transfer process.

Main Results:

• National mpox testing capacity was rapidly increased to 80,000 tests per week through the expansion to commercial laboratories.
• Test volumes within these expanded commercial laboratories did not exceed the new capacity.
• The swift enhancement of testing capacity facilitated rapid case detection.

Conclusions:

• Public and private sector partnerships are crucial for effective responses to public health emergencies.
• The strategic expansion of diagnostic testing capabilities is vital for managing infectious disease outbreaks.
• Collaboration between public health agencies and commercial laboratories can significantly enhance national health security.