The moment news broke Saturday that SalivaDirect had received approval from the Food and Drug Administration, the new Covid-19 testing technology was hailed as a game changer and sparked questions about the Pac-12 and Big Ten canceling their 2020 football seasons too soon.
Developed by the Yale School of Public Health — with an assist from the NBA and its players association — SalivaDirect will allow for cheap, frequent testing once mass production ramps up this fall.
The Pac-12 needs cheap testing.
It needs frequent testing, too.
Should the presidents have voted to delay the season, rather than cancel?
Would the medical experts have given different advice if their report had been submitted after SalivaDirect received approval?
“People are asking: ‘Did we pull the plug too soon?’ I don’t think so,” Dr. Kim Harmon, a member of the Pac-12’s medical team and associate physician for Washington’s football program, told the Hotline on Sunday evening.
“SalivaDirect still has to go to the lab.”
For all the potential benefits, SalivaDirect doesn’t solve the Pac-12’s timing trouble.
In their 12-page report — the document led to the vote to cancel the season — the medical experts wrote in boldface type:
“Athletes should be tested within 24 hours of competition to ensure they are not infectious while competing.”
SalivaDirect, Harmon explained, is a PCR test that must be processed in a lab with a PCR machine.
The Pac-12 already has all that: It has PCR tests available, and it has contracted with a lab that possesses a PCR machine.
But more than 24 hours are needed for shipping and processing time.
The conference couldn’t be sure that the results of PCR tests administered on Friday would be received in time for kickoff on Saturday.
“There is nothing special about that test,’’ Harmon said of SalivaDirect. “We have PCR tests, but to do everything is logistically difficult.”
Harmon said no Pac-12 campus currently has the full complement of resources needed to process PCR tests on site, which would eliminate the shipping time.
“We’re in the middle of a pandemic with high viral prevalence,” she said. “It will take a lot of testing: More than once a week, more than twice a week and in a lot of places, more than three times per week.”
There’s one way to combine frequency with speed: Point-of-care tests, which are antigen-based and have one-hour turnaround times.
The medical advisors’ report included this passage:
“In addition to RT-PCR tests, antigen and other tests are being developed. Antigen tests assess for viral proteins, are POC tests, and results are typically available in under an hour. The sensitivity (the ability to detect virus when present) is generally lower than RT-PCR, but these tests will typically detect individuals with infectious viral loads who can then be immediately isolated. An alternative strategy to PCR testing is to use less sensitive POC tests more frequently or as an adjunct to RT-PCR testing. There is a trade-off between the sensitivity and specificity of a test and the turn-around time. With more frequent testing, POC testing is preferred.”
Harmon stressed that no single issue drove the medical advisory’s board’s recommendation that the conference not proceed with contact activities or competition.
“I would hope people understand that we want to play,’’ she said. “The whole time we were planning for best case, and that’s why we put out the schedule (July 31), but we knew we could face the worst case.
“It’s not like we were trying to figure out how to shut the sports down. It was painful. It was awful.”
The combination of obstacles included:
— Myocarditis (inflammation of the heart muscle).
“Hopefully, in the next one or two months, we’ll have a better idea of how often it happens,’’ she said of the condition, which has been found in athletes who test positive.
“Myocarditis definitely raised the bar in terms of our concern, but it hasn’t changed the basic issue, which is the prevalence of Covid-19.”
— Absence of quick-turn testing.
“For this to be successful,” Harmon said, “we feel the need to test players before the game.
“If we can test them the morning of the game and it’s negative, there’s a low likelihood they’re infectious. They have a chance to play and not spread the disease.”
— Quarantine rules.
Current CDC protocol recommends quarantining individuals who are in close contact — within six feet for at least 15 minutes — with someone who tests positive.
What counts as a close contact?
The definition differs by the county across the Pac-12.
“It doesn’t make sense to me that a left tackle could test positive and you’d have to take out (quarantine) both teams,” she said. “The defensive end? Maybe. The guard and the tight end? Maybe.
“We need consensus on is what is a high-risk contact.”
But the bottom line with all of it … with the testing speed and the myocarditis concerns and the quarantine protocols and the likelihood that the situation would be unchanged in one or two months … was the unknown.
“It’s uncertain risk,’’ Harmon said. “You can put 99 white balls in a tub with one red ball, and if you draw the red ball, you die. We know that risk.
“But right now, we can’t tell you how many red balls are in there.”