By By Steve Baragona/*

Federal regulators are allowing hospitals and other laboratories to develop their own tests for the coronavirus in an effort to relieve what critics say is a shortage of testing for the virus.  

The urgency for testing is growing as health officials report several new coronavirus cases in the United States and the country’s first death — a man in his 50s from Washington state.

The new policy unveiled on Saturday by the U.S. Food and Drug Administration (FDA), follows criticism that a lack of testing has allowed the virus to spread undetected.

“It’s going to be really useful for greatly expanding the number of places that can do the tests,” said Jennifer Nuzzo, a senior scholar at the Johns Hopkins Center for Health Security.

Hospitals have been sending samples to the U.S. Centers for Disease Control and Prevention (CDC) in Atlanta for testing. Getting results takes 48 hours.

Problems with CDC test

The CDC had produced a test for health departments across the country to use. But many reported problems with the tests giving inconclusive results. The problem was traced to an improperly manufactured ingredient. The CDC said the test could be used with the other components. In addition, it plans to send out new test kits to public health labs.  

In the meantime, however, the problems limited the ability of health care workers to test patients for coronavirus.  

“If we had the ability to test earlier, I’m sure we would have identified patients earlier,” said Jeff Duchin, an official of Seattle & King County Public Health, during a conference call with reporters.  

Washington state identified two new cases on Friday, including one with no known connection to other cases, which raises concerns that the virus is spreading undetected.  

The New York State health department, some hospital labs and others had developed their own tests. But since they had not been approved by the FDA, their results were not considered valid.  

Hospital labs had criticized the approval process in a letter to Congress Friday, according to The Washington Post.

“This regulatory process is significantly more stringent than that required for every other virus” that the labs test for, the letter said.

New FDA policy

On Saturday, the FDA issued a new policy allowing these labs to develop their own assays, and issued instructions for how to validate the tests.

“This approval will expedite wait time and improve New York’s ability to more effectively manage the coronavirus situation as it unfolds,” New York Governor Andrew Cuomo said in a statement.

Rather than needing to send tests to Atlanta, or even to a state health lab, tests will be available at local hospitals or commercial labs.

“The closer we can put it towards patients, the better it’ll be for clinicians,” Nuzzo, of Johns Hopkins, said.

Washington State Reports 1st Coronavirus Death in US

U.S. President Donald Trump said the United States was prepared for any circumstance arising from the coronavirus outbreak as U.S. health officials reported the first U.S. death from the virus.
Trump said Saturday at a White House news conference that the victim was a “medically high-risk” man in his late 50s who died overnight in Washington State.
While he said additional coronavirus cases in the United States were “likely” he said, “there is no reason to panic at all.”

Director of the U.S. Centers for Disease Control and Prevention Robert Redfield said there was “no evidence of a link to travel” in the case of the Washington State patient who died.
The governor of Washington state, Jay Inslee, declared a state of emergency Saturday, directing state agencies to use “all resources necessary” to respond to the virus outbreak.

Inslee in a statement originally described the patient who died in Washington as a man, but later described the individual as “a Washingtonian.”
The White House Saturday also announced tightened travel restrictions to Iran to include any foreign national who has visited the country in the last 14 days. Additionally, it raised to the highest level a travel advisory to avoid Italy and South Korea, countries most affected by the virus other than China.

Virus spreading

The coronavirus continued to spread Saturday amid growing concern over the possibility it could trigger a global recession and the World Health Organization’s decision to raise its impact risk alert to “very high.”

China reported Saturday that manufacturing activity declined dramatically in February, as the virus slowed the world’s second largest economy.

Global stock prices finished the week sharply lower Friday, ending one of the worst weeks for world markets since the 2008 financial crisis.

New cases worldwide

Qatar reported its first case of the virus Saturday, three days after leader Emir Sheikh Tamim bin Hamad al-Thani ordered the evacuation of its citizens from Iran, the Middle East’s epicenter of the outbreak.

France announced 16 new coronavirus cases Saturday and a temporary ban on all public gatherings of more than 5,000 people, one day after Mexico, Nigeria, New Zealand, Lithuania, Belarus, Azerbaijan and Iceland reported their first cases.

In Italy, the civil protection agency said eight more patients had died, bringing the total deaths in the country to 29.

The U.S. Food and Drug Administration moved Saturday to accelerate hospitals’ abilities to test for the deadly virus. The agency issued guidelines “enabling laboratories to use tests they develop faster in order to achieve more rapid testing capacity in the United States.”

A fourth case of the virus was reported Friday in a person who had no known history of travel to a country experiencing an outbreak of the disease, known as COVID-19, or no known close contact with an infected person. U.S. health authorities said they were waiting for confirmation of testing results. There are more than 60 confirmed cases in the U.S.

WHO raises risk assessment

The World Health Organization raised its global risk assessment of the coronavirus to its highest level on Friday.

“We have now increased our assessment of the risk of spread and the risk of impact of COVID-19 to very high at global level,” WHO chief Tedros Adhanom Ghebreyesus told reporters.

The outbreak appeared to be easing in China, where the virus originated. China’s National Health Commission reported 427 new cases and 47 deaths Saturday. China has a total of 79,251 cases.

South Korea, the hardest-hit country outside China, reported the biggest surge Saturday with 813 new cases, raising the total to 3,150.

Iran confirmed 593 cases and 43 deaths, the highest death toll outside China.

The WHO said Saturday that more than 85,000 people worldwide have been infected in nearly 60 countries and that virus-related deaths topped 2,900.

Closures, restrictions

The worldwide outbreak has led government and companies around the globe to implement closures and restrictions.

Switzerland canceled next week’s Geneva international car show, an important event for the auto industry. Amazon.com, the world’s largest online retailer, told its employees to defer all nonessential travel.

In Japan, Tokyo Disneyland and Universal Studios Japan announced closures. Japanese Prime Minister Shinzo Abe has ordered schools to close at least through March.

The United States and South Korea called off joint military drills.

In Germany, about 1,000 people are being quarantined in the country’s most populous state. The number of confirmed cases in Europe’s biggest economy exceeded 50.(Voa News)