Rapid Diagnostic Testing for Response to the Monkeypox Outbreak

Laboratory Response Network, United States, May 17-June 30, 2022

Tricia A. Aden; Patricia Blevins, MPH; Shannon Whitman York, PhD; Stacy Rager; Devika Balachandran, MPA, MBA; Christina L. Hutson, PhD; David Lowe, PhD; Chris N. Mangal MPH; Tyler Wolford, MS; Audrey Matheny; Whitni Davidson, MPH; Kimberly Wilkins; Rachael Cook, PharmD; Rebecca M. Roulo, MS; Michael K. White; LaShondra Berman, MSc; Janna' Murray, MPH; John Laurance; Drew Francis; Nicole M. Green, PhD; Ricardo A. Berumen III; Anthony Gonzalez, PhD; Stacy Evans; Meghan Hudziec; Diane Noel; Michael Adjei, PhD; Gregory Hovan, MBA; Phil Lee, MSc; Lisa Tate; Remedios B. Gose, MSPH; Robert Voermans; Jennifer Crew, PhD; Phillip R. Adam, PhD; Danielle Haydel; Salimatu Lukula; Nick Matluk, PhD; Sandip Shah, PhD; Joshua Featherston; Daphne Ware, PhD; Denise Pettit, PhD; Emily McCutchen, MS; Edward Acheampong, PhD; Erin Buttery, MBA; Andrew Gorzalski, PhD; Michael Perry, MS, MSEd; Randal Fowler, PhD; Robert B. Lee, PhD; Robert Nickla; Richard Huard, PhD; Amanda Moore; Katie Jones; Renee Johnson; Erin Swaney; Juan Jaramillo; Cynthia Reinoso Webb, PhD; Brandon Guin; Janine Yost; Annette Atkinson, MS; Latoya Griffin-Thomas, PhD; Jessica Chenette; Jessica Gant, MS; Alana Sterkel, PhD; Harjinder K. Ghuman, MS; James Lute, PhD; Sandra C. Smole, PhD; Vaneet Arora, MD; Courtney K. Demontigny, MS; Meilan Bielby, PhD; Evelyn Geeter; Kimberly A. M. Newman, MS; Mark Glazier; Whitney Lutkemeier, MS; Megan Nelson, MS; Raymond Martinez; Jasmine Chaitram, MPH; Margaret A. Honein, PhD; Julie M. Villanueva, PhD


Morbidity and Mortality Weekly Report. 2022;71(28):904-907. 

In This Article


CDC and LRN have collaborated with public health partners to prepare for Orthopoxvirus outbreaks, enabling rapid public health response through the development and expansion of testing capacity and medical countermeasures to prevent the spread of disease. Laboratory preparedness efforts included NVO test validation, FDA 510(k) clearance, distribution, and verification of diagnostic tests to detect NVO. This response highlights the importance of preparedness against emerging infectious diseases and the need to further strengthen and expand LRN to include other partners to enhance testing capability and increase surge testing capacity.

Because monkeypox disease has been rare in the United States, CDC's NVO assay is the only FDA 510(k)–cleared assay to detect NVO; at the onset of this outbreak, use of the assay was limited to LRN laboratories. The 510(k) clearance facilitated rapid testing and detection of a rare, high-risk, and emerging pathogen by LRN laboratories by maintaining competency and biosafety practices, results reporting, and collaborating with public health authorities, all essential to the initial national response.

CDC recommends that U.S. health care providers be alert for patients who have rash illnesses consistent with monkeypox[5] and include NVO testing as part of their clinical workup. Clinicians who suspect a case of monkeypox can contact their local or state health department** for specimen submission guidance. A rapid turnaround time for test results is critical to quickly initiate public health action to better control the spread of monkeypox disease. Treatment is the same for all NVO infections; thus, a positive test result for an Orthopoxvirus using the NVO assay is immediately actionable, leading to the use of antiorthopoxviral treatment, if warranted, and allowing public health authorities to initiate isolation, contact tracing, monitoring, investigation, and postexposure prophylaxis of exposed contacts.[5] In addition, if monkeypox is suspected based on clinical signs and symptoms, clinicians can initiate treatment, advise patients to isolate while awaiting test results, and take measures to prevent further transmission, like limiting close contact with others or avoiding the sharing of potential contaminated items. Tecovirimat (TPOXX) can also be prescribed as treatment for people with monkeypox, and two vaccines, JYNNEOS and ACAM2000[6] can be provided to close contacts as postexposure prophylaxis.

By the end of June 2022, <10% of the available nationwide LRN NVO testing capacity had been used. Despite the high capacity, some clinicians and patients reported challenges navigating public health testing procedures, including acquiring public health approvals for testing. Expansion to five commercial laboratories starting the week of July 5 should make testing more accessible, increase convenience for providers and patients by both using existing provider-laboratory relationships and eliminating the need for prior public health approval, and further augment national capacity. Expanded testing access via both LRN and commercial laboratories provides the opportunity to identify all cases of Orthopoxvirus to enhance monitoring and response to the outbreak.