Opinion, Berkeley Blogs

Academic labs can help U.S. ramp up coronavirus testing

By Julia Schaletzky


Grand Princess cruise ship in Oakland

Passengers of the Grand Princess cruise ship affected by COVID-19 recently disembarked at the Port of Oakland and moved into quarantine facilities for several weeks. Out of 46 passengers tested, 21 tested positive, including 19 crew members who likely had been in contact with passengers.

One can’t help but wonder why not all of the 3,000 passengers on board were tested for COVID-19 swiftly and unbureaucratically. It seems lack of testing capacity is to blame. But why? We had several weeks of warning before we detected the first case on U.S. soil and published and validated test protocols have been available since mid-January.

The United States has a long and illustrious history of leading the response for global pandemics and successfully managed previous outbreaks such as Zika and SARS. Now we are scrambling to provide a minimum number of tests (i.e. Louisiana – testing capacity 12 tests per day, i.e. six patients), while South Korea has tested more than 66,000 patients within a week after the outbreak began.

Instead we are required to cancel events and bring public life to a screeching halt, because we can’t tell who has it and who doesn’t, so everyone has to stay put to stop the spread. This has disastrous consequences for public life and the economy.

The Centers for Disease Control made an early mistake trying to centralize the response and manufacture kits to be distributed all over the United States, with testing initially only allowed in state public health laboratories.

The massive logistical and quality control challenges associated with this approach became soon evident, as several approved kits had to be recalled due to contamination and short-staffed local public health laboratories could not ramp up capacity quickly enough. While the FDA has in the meantime relaxed the rules and allowed others to develop assays and build capacity, the response is confined to existing, CLIA-certified clinical laboratories, which are few and far in-between and often at capacity already handling routine testing for the medical sector.

A solution could come from harnessing resources that already exist in universities and research settings and crowdsource a comprehensive diagnostic response to this epidemic. Academic laboratories have the technical skills to provide surge capacity for testing and could increase testing capacity exponentially.

The devices needed are present in many laboratories, assays are relatively straightforward and could be up and running in a few days. In my building alone, we have several RT-PCR machines that could be used, as well as Biosafety level 2 and 3 laboratories that would allow comprehensive study of coronavirus.

With the proper controls, we would be able to run an assay as good as what is provided in clinical laboratories. What’s stopping us? Red tape. We would first have to get CLIA clinical lab certification (4-12 weeks) and apply for FDA emergency authorization (2 weeks, testing can happen concurrently), a Biological Use Authorization and Environmental Health & Safety review to be allowed to bring coronavirus samples into the laboratory and work with them (several days to one month), as well as Institutional Review Board approval due to ethical concerns working with human samples (several days to one month).

In addition, we would have to ensure existing funding could be used for the work, no one will be prosecuted for misappropriation of funds by using resources earmarked for other projects, or some reimbursement process is implemented for providing testing. While emergency funding has been approved, access is far from immediate. Accelerated review at the National Institutes of Health for repurposing existing funding for coronavirus research can take up to 60 days. Several calls and emails to private foundations who have pledged hundreds of millions for coronavirus remain unanswered.

Despite all this, with decisive leadership and a clear directive, as well as collaboration and support around handling patient data and communicating results to patients with CDC, FDA and clinical laboratories, swift, effective action could be taken. Academic laboratories could provide testing on a broad scale, either freestanding or as a first line screening tests, with positive results being referred to a FDA-approved laboratory. Every day that passes makes it harder to stop this epidemic. The time to act is now.