https://www.statnews.com/2022/05/27/monkeypox-test-capacity-cdc-considers-expanding/
https://www.fiercebiotech.com/medtech/roche-rolls-out-trio-pcr-research-tests-monkeypox
With the United States on the lookout for more monkeypox cases, federal health officials this week said they’re considering expanding testing networks, even as they’ve stressed the current two-step process is not delaying treatment or containment of the outbreak.
For possible monkeypox cases, swabs from the patient are sent to both a local or state lab for initial testing, and to the Centers for Disease Control and Prevention for confirmatory testing. The initial tests identify whether the sample is an orthopox — the genus that monkeypox belongs to — while the CDC verifies that it is in fact monkeypox. The process explains why local communities are announcing suspected cases, followed by confirmation a few days later.
The CDC has faced questions about whether the protocol might prolong infection detection, at a time early in the outbreak when active case investigations and severing transmission chains can prevent the virus from becoming established in communities. The scrutiny is heightened by memories of the Covid-19 pandemic’s early days, when faulty tests and slow regulatory action left the country with a dearth of testing capacity — and a hindered ability to track the virus as it exploded.
Roche rolls out trio of PCR research tests for monkeypox
If there’s one positive outcome of the COVID-19 pandemic, it’s the speed at which diagnostic test makers learned to develop and begin churning out kits to test for a virus.
Roche, for one, is already applying what it learned from COVID to the next infectious disease outbreak. Only a few weeks after a spate of monkeypox cases first cropped up in Europe, the company has completed development of three separate tests for the virus.
Developed in conjunction with its subsidiary TIB Molbiol, Roche’s tests are already available to scientists for research use “in the majority of countries worldwide,” the Swiss company said Wednesday.
All three of Roche’s LightMix Modular Virus test kits analyze samples using quantitative PCR technology, requiring the tests to be run on one of the company’s PCR analyzers.
The first test looks for signs of any orthopoxvirus, a strain of viruses that includes smallpox, cowpox and horsepox as well as monkeypox. Roche’s second test looks for monkeypox specifically and is able to detect both the West African and Central African clades of the virus.
The third test combines the two. Alongside identifying the presence of orthopoxviruses, it also returns results clarifying whether either form of monkeypox is the orthopoxvirus in question.
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