The United States badly bungled coronavirus testing—but things may soon improve

[Ronan Kelly]

The United States badly bungled coronavirus testing—but things may soon improve
By Jon CohenFeb. 28, 2020 , 5:45 PM

Speed is critical in the response to COVID-19. So why has the United States been so slow in its attempt to develop reliable diagnostic tests and use them widely?

The World Health Organization (WHO) has shipped testing kits to 57 countries. China had five commercial tests on the market 1 month ago and can now do up to 1.6 million tests a week; South Korea has tested 65,000 people so far. The U. S. Centers for Disease Control and Prevention (CDC), in contrast, has done only 459 tests since the epidemic began. The rollout of a CDC-designed test kit to state and local labs has become a fiasco because it contained a faulty reagent. Labs around the country eager to test more suspected cases—and test them faster—have been unable to do so. No commercial or state labs have the approval to use their own tests.

In what is already an infamous snafu, CDC initially refused a request to test a patient in Northern California who turned out to be the first probable COVID19 case without known links to an infected person.
...
https://www.sciencemag.org/news/202...d-coronavirus-testing-things-may-soon-improve

 

[Dexxy]

Similar content from ProPublica, including interviews with state and federal employees here:

https://www.propublica.org/article/cdc-coronavirus-covid-19-test

 

[JJackson]

To RT PCR test you need probes which are short sections of DNA/RNA selected from conserved regions of the viral genome. There are various options and the list below shows the probes produced by various countries.
Summary table of available protocols

Country	Institute	Gene targets
China	China CDC	ORF1ab and N
Germany	Charit?	RdRP, E, N
Hong Kong	HKU	ORF1b-nsp14, N
Japan	National Institute of Infectious Diseases, Department of Virology III	Pancorona and multiple targets, Spike protein
Thailand	National Institute of Health	N
US	US CDC	Three targets in N gene

As the articles above explains the US decided to make its own using three separate sections of the N gene but it has not worked as planned and they have had to go back and start again.

 

[Dexxy]

To RT PCR test you need probes which are short sections of DNA/RNA selected from conserved regions of the viral genome. There are various options and the list below shows the probes produced by various countries.
Summary table of available protocols

Country	Institute	Gene targets
China	China CDC	ORF1ab and N
Germany	Charit?	RdRP, E, N
Hong Kong	HKU	ORF1b-nsp14, N
Japan	National Institute of Infectious Diseases, Department of Virology III	Pancorona and multiple targets, Spike protein
Thailand	National Institute of Health	N
US	US CDC	Three targets in N gene

As the articles above explains the US decided to make its own using three separate sections of the N gene but it has not worked as planned and they have had to go back and start again.

Oh excellent, I'd been looking for more detailed information on testing protocols. Do you have a source that I can reference? Haven't had much luck looking through the literature.

 

[Ronan Kelly]

Policy for Diagnostics Testing in
Laboratories Certified to Perform
High Complexity Testing under CLIA
prior to Emergency Use Authorization
for Coronavirus Disease-2019 during
the Public Health Emergency
Immediately in Effect Guidance for
Clinical Laboratories and
Food and Drug Administration Staff
Document issued on the web on February 29, 2020.
...
https://www.fda.gov/media/135659/download

 

[JJackson]

https://www.who.int/emergencies/dis...s-2019/technical-guidance/laboratory-guidance