Tuesday, January 22, 2019

New Logistics/Supply Chain Issues -- For Ebola PCR (Viral) Diagnostics Tests...


This morning's news comes from the prestigious science journal Nature. I suspect it is published there, in no small part, to goad the rest of the life sciences community to pitch in and help -- as well as suggest that Biocartis, a molecular diagnostics company based in Mechelen, Belgium, should step up (again), and do some (more) largely pro bono, work here.

In truth, I am just a little skeptical -- that a diagnostic test, even with immediate availability on site, and speedy turnaround of the (genetically amplified) PCR result, is going to make a big difference -- in urban areas. Once a patient presents with fever and vomiting or bleeding in urban Beni or Butembo, the safest course is to monitor -- and isolate. And immediately vaccinate all contacts -- and contacts of contacts.

It seems a PCR diagnostic kit would be of most use -- if immediately available, in the field, in rural, or remote settings (where a return takes days or weeks, for MSF volunteers to find the contact anew) -- but any delay -- beyond a few hours' time, in any urban center, in isolating a feverish person. . . risks a spread of the dread, deadly virus.

Here is the story, though -- just the same:

. . . .[H]ealth workers and organizations trying to stem the current outbreak cannot obtain diagnostic tests fast enough. Even when funds from international donors are available to pay for them, it is taking staff at laboratories or health centres two to eight weeks to get hold of the tests.

There are two types of diagnostic test for Ebola. Rapid diagnostic tests detect a viral protein; those based on the polymerase chain reaction (PCR) identify the virus’s genomic material. By filling out company request forms, e-mailing manufacturers and searching their websites, we established that, of the recently approved tests provided by companies, only four are readily available to buyers. . . . All of these are PCR-based tests. OraSure Technologies in Bethlehem, Pennsylvania, has made its rapid diagnostic test OraQuick available to the WHO and the US Centers for Disease Control and Prevention (CDC), which are distributing the test to health workers in the current outbreak. But it is not available to other buyers.

Our analysis reveals that research and scaled-up production have been sustained for only a few of the company-provided tests that were developed and approved during the 2014–16 emergency. Indeed, we were co-developers of a diagnostic test for Ebola that is no longer available because the manufacturer [Biocartis] decided to focus exclusively on oncology. . . .


Consider that a dose of. . . moral suasion, from the editors of Nature. Onward to the trains -- on a gray but promising Tuesday. They do seem to slide on air, suspended all-but silently -- gliding over the white snowbanks, and swirling sugar behind them -- on days like today. Smile.

नमस्ते

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