CONTEXT: 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. OBJECTIVE: 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. PARTICIPANTS: CDC engaged with partners and select commercial laboratories early to increase diagnostic testing access by allowing these commercial laboratories to utilize the NVO test. SETTING: 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. DESIGN: 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.

As part of public health preparedness for infectious disease threats, CDC collaborates with other U.S. public health officials to ensure that the Laboratory Response Network (LRN) has diagnostic tools to detect Orthopoxviruses, the genus that includes Variola virus, the causative agent of smallpox. LRN is a network of state and local public health, federal, U.S. Department of Defense (DOD), veterinary, food, and environmental testing laboratories. CDC developed, and the Food and Drug Administration (FDA) granted 510(k) clearance* for the Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set (non-variola Orthopoxvirus [NVO] assay), a polymerase chain reaction (PCR) diagnostic test to detect NVO. On May 17, 2022, CDC was contacted by the Massachusetts Department of Public Health (DPH) regarding a suspected case of monkeypox, a disease caused by the Orthopoxvirus Monkeypox virus. Specimens were collected and tested by the Massachusetts DPH public health laboratory with LRN testing capability using the NVO assay. Nationwide, 68 LRN laboratories had capacity to test approximately 8,000 NVO tests per week during June. During May 17-June 30, LRN laboratories tested 2,009 specimens from suspected monkeypox cases. Among those, 730 (36.3%) specimens from 395 patients were positive for NVO. NVO-positive specimens from 159 persons were confirmed by CDC to be monkeypox; final characterization is pending for 236. Prompt identification of persons with infection allowed rapid response to the outbreak, including isolation and treatment of patients, administration of vaccines, and other public health action. To further facilitate access to testing and increase convenience for providers and patients by using existing provider-laboratory relationships, CDC and LRN are supporting five large commercial laboratories with a national footprint (Aegis Science, LabCorp, Mayo Clinic Laboratories, Quest Diagnostics, and Sonic Healthcare) to establish NVO testing capacity of 10,000 specimens per week per laboratory. On July 6, 2022, the first commercial laboratory began accepting specimens for NVO testing based on clinician orders.

Objective: In 2010, the United States Agency for Toxic Substances and Disease Registry (ATSDR) created the National ALS Registry (Registry) to examine the epidemiology of ALS and potential risk factors. We are currently recruiting population-based controls for an epidemiologic case-control study to examine ALS environmental risk factors using this Registry. To date, we have recruited 181 non-diseased, population-based controls for comparison to Registry cases (n = 280). Here we report our recruitment methods for controls and the associated response rates and costs. Methods: Eligible ALS cases had complete risk factor survey data, DNA analysis, and blood concentrations of persistent organic pollutants (POPs). Age, sex, and county-matched controls were identified from commercial/consumer databases using a targeted landline phone sample. Eligible controls were consented, surveyed, and mailed the POPs' blood analysis consent form. Once consented, phlebotomy was scheduled. Results: We mailed 3760 recruitment letters for 181 potential case-matches across 42 states between 9/2018 and 3/2020. After making phone contact and determining eligibility, 146 controls agreed to participate (response rate = 11.4%, cooperation rate = 22.8%). To date, 127 controls completed the survey and bloodwork. Though controls were matched to cases on age, sex, and county, unmatched characteristics (e.g. smoking) did not differ statistically. Interviewing and incentive costs are estimated at $211.85 per complete participation. Conclusions: Recruiting matched population-based controls for comparison to cases from the Registry for a study involving completion of a detailed survey and blood specimen provision is relatively feasible and cost effective. This recruitment method could be useful for case-control studies of other rare disorders.