Dave Shenin, The Washington Post: July 10, 2020
The idea at first sounded logical, practical, even inspired: To launch a 2020 season in the midst of a pandemic, Major League Baseball would convert a Utah lab it normally uses for anti-doping testing into a testing lab for the novel coronavirus. The benefits: an established relationship and the assurance that MLB would not be diverting critical resources from the general public.
But a little more than a week into summer camp training, as baseball careens toward a scheduled July 23 Opening Day, MLB’s testing process has been beset by problems, threatening to undermine players’ confidence in the safety of playing under these trying circumstances.
Test results, which MLB had hoped to turn around in 24 hours, have in some cases taken more than 72 hours to arrive, forcing multiple teams to cancel workouts this week. There have been reports of at least one false positive and one test being lost, in both cases sidelining a player as it is sorted out. And the Utah lab, Sports Medicine Research and Testing Laboratory, subcontracted two weeks ago with a second lab at Rutgers University, with MLB’s blessing, to speed up and streamline the process, according to a person familiar with the league’s testing program.
While most of the problems have stemmed from the collection and logistics side of the process, exacerbated by closures over the Independence Day weekend, the overall effect has been to place MLB in damage-control mode over its testing process — a daunting development as the sport seeks to guide as many as 1,800 players and hundreds of additional staffers through a three-week training camp, a 60-game regular season and a full postseason.
If the testing system is flawed, players and others have asked, is it really safe to play in 2020?
In a statement on July 6, MLB said it collected 3,740 samples from intake screening — which players and staff had to take upon arrival and pass before being allowed into stadiums — between June 27 and July 3, and that SMRTL had reported results for 98 percent of the samples by the end of July 5.
In response to the delays blamed largely on the holiday weekend, MLB said the lab would be operating “on a seven-day-a-week schedule from July 5 through the end of the World Series.”
The early stumbles, however, have increased the scrutiny on baseball’s intricate and ambitious testing plan, which is charged with obtaining, shipping and analyzing around 14,000 samples each week, and turning around those results quickly — ideally within 24 hours, but at most 48.
The margin of error, essentially, is zero, as one large outbreak could scuttle the season.
In cnducting the lab tests, SMRTL uses the “pooling” method, in which a small number of saliva samples are combined and tested as one in the interest of efficiency; only in the event of a positive result are the individual samples tested separately to pinpoint the source of the positive. The pooling method is endorsed by the FDA, which on June 29 released guidelines for labs using it in coronavirus testing.
The FDA didn’t approve the first EUA for a saliva-based coronavirus test until mid-April; before that, nearly all tests relied on a nasopharyngeal swab.
SMRTL’s specific test has yet to gain the approval of the FDA, but after validating its test in the lab — through what it called “rigorous” studies — it has filed an Emergency Use Authorization with the agency, which is pending. FDA approval for a diagnostic test requires proof of accuracy and typically takes months or even years to receive. However, since the onset of the coronavirus pandemic, the FDA has allowed labs to sell tests that have been validated in lab testing for up to 15 days before they must submit an EUA application.
The FDA’s current approval process, however, is a “very skimpy” one compared with the process used before the coronavirus pandemic, said Diana Zuckerman, president of the National Center for Health Research and a Washington Nationals season ticket holder.
“Normally,” she said, “you wouldn’t even be allowed to sell these tests until the FDA has approved them.”
Read the full article here