A week ago, only two laboratories in Africa could diagnose the novel
coronavirus that originated in China and is rapidly spreading around the
world. As of Sunday, the World Health Organization (WHO) expected every
nation in Africa to be able to diagnose the disease.
The rush reflects a global push for diagnostic capabilities,
particularly in developing countries, in hopes of averting a global
pandemic. But it is being slowed by a desperate need for virus samples
necessary to validate the tests.
“Without vital diagnostic capacity, countries are in the dark as to
how far and wide the virus has spread and who has coronavirus or another
disease with similar symptoms,” WHO chief Tedros Adhanom Ghebreyesus
told a news conference in Geneva on Monday.
As of early Monday, there had been 40,235 confirmed cases reported in
China and 909 deaths, as well as 319 cases in 24 other countries,
including one death.
Most of the testing is being done by public health laboratories. But
several companies including Thermo Fisher Scientific Inc, GenScript
Biotech Corp and Co-Diagnostics Inc have developed tests and are taking
steps to get them validated for clinical use.
Roche is distributing coronavirus tests developed by Tib Molbiol of
Berlin for research use on some of its instruments while developing a
test of its own. Abbott Laboratories also is working on a test.
WHO has activated a network of 15 referral laboratories that can
support national efforts in confirming new cases, and has identified 168
labs globally with the technology to diagnose the virus.
Technicians must be trained to run the tests locally to avoid delays associated with having to send them to centralized labs.
On Tuesday, WHO is convening a two-day meeting of hundreds of researchers and manufacturers to address the outbreak.
WORKLOAD ON LABS IS ‘EXTREME’
Researchers are also working to develop antibody tests that can tell
whether someone has been exposed to the virus. They could help answer
how broadly this virus has spread, and whether there are milder cases
not being detected, Dr. Mike Ryan, head of the WHO emergency program,
told reporters.
China appears to have adequate stock of the materials needed to
perform diagnostic tests, but there is a limited number of trained
technicians who can run them. “The workload on those labs is extreme,”
Ryan said.
Outside of China, manufacturers are quickly developing tests based on
the genetic code of the virus. Those tests still need to be validated
with actual virus samples, for which access has been challenging.
Live isolation of the virus allows a huge advance in diagnostics and
potential advances in therapeutics and vaccine development, Ryan said.
GenScript, which has offices in New Jersey and Nanjing, China, has
developed a test available to researchers. It cannot be used as a
diagnostic until it has been tested in hundreds of virus samples.
“In China, we couldn’t get to the samples directly because we don’t
have a lab that can handle the virus,” said Hong Li, a GenScript
scientist.
The company has sent its test kits to Chinese health officials to
assess their validity. “Because other companies in China are also doing
that, we don’t know when it will be our turn,” said Eric Wang,
GenScript’s head of marketing.
Utah-based Co-Diagnostics on Monday said it has started shipping its
test, which is available for research purposes, to clients. Chief
Scientific Officer Brent Satterfield said last week that the company has
been struggling to find clinical virus samples to validate the test for
use as a diagnostic.
Thermo Fisher developed its tests based on the genetic code of the virus, and ran computer models to validate it.
The company has been providing its test to countries and health
ministries with access to virus samples, said Thermo Fisher executive
Joshua Trotta. “They will evaluate our kits and make a determination of
what is the best test to deploy.”
Meanwhile, Thermo Fisher is scaling up production as countries
prepare for more cases. Demand is “growing every day,” Trotta said.
https://www.reuters.com/article/us-china-health-diagnostics-focus/countries-rush-to-build-diagnostic-capacity-as-coronavirus-spreads-idUSKBN2042DV