Americans must be able to trust accuracy of viral tests during outbreaks 

Washington, D.C. — House Energy and Commerce Committee Republican Leader Cathy McMorris Rodgers (R-WA), Subcommittee on Health Republican Leader Brett Guthrie (R-KY), and Subcommittee on Oversight and Investigations Republican Leader Morgan Griffith (R-VA) sent a letter to Centers for Disease Control and Prevention (CDC) Director Rochelle Walensky regarding faulty Monkeypox tests, which may have left Americans infected with the virus believing they were healthy and non-contagious: 

“From the CDC’s fiasco in rolling out effective COVID-19 tests in early 2020, to the recent faulty Monkeypox test information, this further highlights another example of why Americans have lost trust in our public health agencies and their ability to keep individuals safe and contain outbreaks. If the Biden administration is serious about restoring trust, public health agencies must be transparent and accountable to the American people,” said Republican Leader Rodgers, Guthrie, and Griffith. 

CLICK HERE to read more on the letter and E&C Republicans’ oversight agenda.

KEY EXCERPT: “We write to request information about the flawed CDC diagnostic testing procedures for monkeypox virus. This follows a similar CDC breakdown during the pandemic response when CDC distributed faulty and contaminated COVID-19 test kits in February 2020.” 

The members asked for specific answers to the following questions by November 17, 2022: 

1. Why were CDC’s published primers and probes specifically targeting Monkeypox unable to detect the virus in some cases? 
2. Were the CDC’s published primers and probes based on currently circulating monkeypox strains? 
3. How did the CDC become aware that its published primers and probes led to false negatives? 
4. What action has CDC taken to correct this problem? Is CDC re-designing and reworking its published primers and probes? 
5. Is CDC actively performing in silico analysis of this assay against the most current monkeypox sequence database? 
6. If yes, did CDC observe any potential limitation with the assay to give a potential false negative result? 
7. If yes, is CDC developing new signatures and assays to counter the limitations? 
8. If yes, when will these new signatures and assays be available to the public health/laboratory community? 
9. Has CDC thought about developing RT-PCR assays for multiple regions or loci to enhance sensitivity and eliminate false negative results? If not, why not? 
10. Monkeypox virus has two clades. Clade 1 or Congo Basin clade monkeypox virus has about a 10 percent fatality rate in unvaccinated persons. Clade 2 or West African clade monkeypox virus (the version currently circulating in humans) is associated with less than one percent mortality.10 Does CDC have a monkeypox specific assay that detects both clade 1 and clade 2 viruses? If not, why not? 
11. The non-variola orthopoxvirus assay cross-reacts with other viruses. Is this a concern to CDC? If not, why not? 

CLICK HERE to read the full letter to Director Walensky.