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California Issues New COVID-19 Testing Guidelines as Supply Chains Struggle

Long lines of cars waiting to get through the COVID-19 testing process are particularly hard on people, especially during the hot summer months. – Photo by Terry Miller / Beacon Media News

Lack of essential reagents, other supplies disrupt testing; slower processing times frustrate Californians

By Terry Miller

The COVID-19 outbreak has been a confusing and deeply troubling time for Americans, but one thing has been glaringly clear: The U.S. is behind when it comes to testing people for the coronavirus.

Readily accessible testing, rigorous contact tracing, enhanced laboratory capacity, and data sharing are critical parts of preventing and containing the spread of COVID-19.

In California and Nebraska, some coronavirus testing sites were recently required to close down due to a shortage in testing kits, chemical reagents, and other necessary supplies. The simultaneous scaling up of testing capacity at some labs around the world in response to the pandemic has put pressures on supply chains that handle reagents and other materials used, according to Medtechdive.

Early on in the pandemic, during a “photo op” trip to the CDC, President Trump insisted that tests for detecting the virus were widely available. “Anyone who wants a test can get a test,” Trump falsely proclaimed.

State, local and hospital officials at 13 states said they are experiencing some sort of issue with testing, according to an ABC News report July 10. “In all instances, the shortages and delays contribute to effectively limiting the number of Americans with access to coronavirus testing, which experts have long said is a first key step to stemming the spread of the virus.”

According to a recent survey by the Association for Molecular Pathology, more than 70% of U.S. clinical laboratories have suffered significant delays to COVID-19 testing programs as a result of ongoing supply chain disruptions. The organization said that the expansion of COVD-19 testing capacity at laboratories around the country has put pressure on supply chains that handle reagents and other materials used to learn whether a patient is infected.

California Health and Human Services Secretary Dr. Mark Ghaly has acknowledged the state is facing a testing supply shortage.

“As more states begin to scale their testing capabilities, new constraints are materializing within the supply chain,” Ghaly said. “Simultaneously, laboratories are becoming overwhelmed with high numbers of specimens, slowing down processing timelines.” He urged laboratories to “prioritize testing turnaround for individuals who are most at risk of spreading the virus to others.”

In an effort to answer the numerous testing questions, Ghaly held a video conference to increase awareness of the difficulties but also the positive side of working with academic institutions and private labs to speed up COVID-19 testing and results.

By moving testing to private entities and academic labs, Secretary of the Business, Consumer Services and Housing Agency Lourdes Castro Ramirez says the testing will increase significantly and hopefully results will not see the delays we’ve seen in recent weeks and months.

Testing is critical also in the rush to get students back to school. Ghaly said the state is averaging about 100,000 tests a day. The overall cost for testing is “enormous,” Ghaly admitted.  Dr. Ghaly and his staff assured Californians that reimbursements for any testing will be covered.

Health officials are also implementing tiered guidelines for who should be tested first to reduce backlogs. The California Department of Public Health now recommends first prioritizing testing of hospitalized individuals with signs or symptoms of COVID-19. The next priority for testing includes symptomatic individuals and higher risk asymptomatic individuals who live or work in congregate care facilities, correctional facilities or homeless shelters, or who work in other high-risk sectors such as health care. The third tier includes other asymptomatic individuals when certain conditions exist — such as working in retail, manufacturing, food services, agriculture, public transportation or education. The fourth tier, which includes those who are asymptomatic but believe they have a risk for being actively infected as well as routine testing by employers, will be implemented when the state’s testing turnaround time, as monitored by CDPH, is less than 48 hours.

Hopefully with the new guidelines and leadership of the testing taskforce, California can see some light at the end of the coronavirus-testing tunnel.

What about at-home tests? At this time, the FDA has not authorized any COVID-19 test to be completely used and processed at home. However, the FDA has issued emergency use authorizations (EUAs)  for certain COVID-19 molecular diagnostic tests to be used with samples collected by a person using a home collection kit that is sent to a laboratory for processing and test reporting. In general, a healthcare provider determines whether a person can use a home collection kit as explained in each test’s EUA. 

As for a vaccine, Operation Warp Speed (the U.S. government’s moniker) aims to “deliver 300 million doses of a safe, effective vaccine for COVID-19 by January 2021, as part of a broader strategy to accelerate the development, manufacturing, and distribution of COVID-19 vaccines, therapeutics, and diagnostics (collectively known as countermeasures).”

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