Are False Positives or Sensitive Tests Responsible For School COVID Spikes? CBS13 Investigates - Troubled State Lab
SACRAMENTO (CBS13) — The Culver City School District has paused COVID testing after they say students got false-positive results from the state's troubled COVID-19 testing lab.
Now, the El Dorado Union School District wants to know if false positives are to blame for the hundreds of quarantined students there. The district says their positivity rate increased 1000% after recently switching to the state lab.
State data reveals the recent positivity rate for tests from the CDPH-PerkinElmer state lab is roughly 60% higher than California's actual positivity rate.
School district administrators are now calling for a state-wide moratorium on asymptomatic PCR testing for student-athletes. Many worry kids are being unnecessarily quarantined when the state's ultra-sensitive COVID test detects old, or irrelevant, levels of virus.
"COVID Just Keeps Taking Stuff Away From Us"
"We were all so excited," Reese recalled, "It was going to be our first week back full time at school."
Instead, just two days after returning to campus, the 15-year-old and her twin sister Riley were pulled out of softball practice and sent home to quarantine for two weeks.
They are among the 215 Oak Ridge High students who were quarantined because they had a so-called close contact with one of 19 positive cases on campus over the past two weeks. A close contact is defined as being within six feet of a positive case for more than 15 minutes within 24 hours.
"This COVID just keeps taking stuff away from us," Reese said, visibly upset.
Like most of the hundreds of quarantined kids in the El Dorado County Union School District, Reese and Riley didn't have symptoms.
Even though El Dorado County is in the "orange tier," which indicates a relatively low positivity rate, state guidelines require weekly negative COVID tests to play indoor sports. In addition to softball, the girls play basketball and their brother is a wrestler.
"We want to play basketball, and the only way that we could was to test. So we did," Reese explained.
Neither sister tested positive for the virus, but their brother, Ryan, did. He had no symptoms but he got a borderline positive result.
Ryan's measure of the virus was a fraction of a point from the positivity cutoff.
Because the girls were considered a close contact to a positive case, they were quarantined too.
"I feel like it's really affecting my mental health," Reese said. "Finally being able to go back to being in-person, then being (quarantined and) stuck in front of a computer and not being able to do any of my sports."
"It breaks my heart," said their mom Pam, wiping away tears.
She questions whether her son's positive result was accurate because it was processed at the troubled state COVID testing lab which is now under investigation by state regulators.
$1.7 Billion Dollar CDPH-PerkinElmer Lab
The state's new $25 million lab and $1.7 billion contract with PerkinElmer was supposed to revolutionize COVID testing in California. PerkinElmer is contracted to staff and run the CDPH lab, using it's own PerkinElmer COVID test.
In February, CBS13 revealed whistleblower allegations from inside the lab, ranging from unlicensed lab techs sleeping the job to incidents of contamination, swapped samples and wrong results.
ALSO READ: CA's Billion-Dollar COVID Testing Lab Under Investigation Following CBS13 Whistleblower Report
The state later acknowledged that its own inspectors previously found "significant deficiencies" at the lab back in December. The lab had until March to address the deficiencies or risk losing its license.
Incidentally, the California Department of Public Health (CDPH) is the agency that issues lab licenses, and it is the state's lab regulator, which means it is investigating its own lab.
The state promised to release its full report on the investigation in mid-March but will now only say the investigation is ongoing.
ALSO READ: Regulators Find 'Significant Deficiencies' At CA COVID Testing Lab – Whistleblowers Respond
PerkinElmer's lucrative no-bid contract to run the so-called "Valencia Branch Lab" (VBL) requires they process up to 150,000 tests a day for a flat fee per test. The more tests processed, the cheaper the rate per test for California taxpayers.
Instead of 150,000, the lab has been processing closer to 12,000 tests per day on average over the past 2 months. Wide-spread school district testing could provide a beneficial boost in testing numbers for the lab.
Troubled State Lab Now Impacting Schools
The state offers financial incentives to schools that use their lab for COVID testing. While many students get their results though a company called Color, it is the state lab that processes the tests.
The CDPH-PerkinElmer contract requires the lab return results in 24-48 hours. During the first week of April, state data indicates that more than a third of their results took longer than 48 hours to process.
ALSO READ: Delayed School COVID Results, Canceled Games and Contamination Concerns
Many of those results belonged to student-athletes across the state and the delay forced schools to cancel football games during an already shortened season with just six games total.
At least one team played without their lab results, relying on last-minute negative results from rapid tests instead. But when they finally got their delayed PCR results from the state lab, one player tested "positive" with the state's highly sensitive test.
As a result of the state's delay, his football team, and the team they played, both had to be quarantined.
The state blamed "routine maintenance" for the delays, but CBS13 obtained internal lab emails between top PerkinElmer lab management, discussing a "contamination issue" that week that "resulted in a halt to production."
Neither CDPH nor PerkinElmer would deny that there was a "contamination issue" when asked.
"With all of the money that's being spent on (the lab), our children deserve better, Pam said.
ALSO READ: Delayed School COVID Results, Canceled Games and Contamination Concerns
Last week, parents called on the state to make its investigation into the lab's "significant deficiencies" public, now more than a month after the state promised to release its report.
"What are they still investigating? If they haven't fixed their problems, how are we supposed to trust them?" asked cheer-mom Michelle Peterson.
"We are due an explanation," added Nevada Union Athletic Director Daniel Crossen who had to cancel his team's game due to delayed results.
"The state owes it to the people of California and to these kids (to release the report)," said Tina Watts, whose son's game was also canceled.
State-Wide School False-Positive Concerns
This week, parents say the issue became even more urgent, after the Culver City School District announced it was suspending testing following "false positives" from the state lab.
In an email to parents, the district's Health Services Coordinator said they had "an unprecedented number of students identified as having either positive or inconclusive (presumed positive) COVID test results."
The district said the students subsequently tested negative with follow-up PCR COVID tests.
"Until we are confident that (the state lab has) identified the source of their errors and the problem is fixed, we will not offer any COVID testing at school," the email read.
In an email to CBS13, LA County Public Health confirmed the false positive results and said that the county cleared the students to return to school after two negative PCR tests, per the county's policy for identifying false positives.
In contrast, El Dorado County Public Health, where Reese and Riley live, says it follows the CDPH state guidance which requires students to quarantine for 10 days, regardless of subsequent negative PCR tests.
ALSO READ: Should School Athletes Use Rapid COVID Tests Instead of State Lab's PCR Test?
According to the Culver City School District, they received the false-positive results during the week of April 11th.
That was the same week that El Dorado Union saw its spike in positive tests and the week after the potential "contamination issue."
1000% Positivity Spike After Switching to State Lab
El Dorado Union School District Superintendent Ron Carruth said his district has seen a 1000% increase in their positivity rate since recently switching to the state's lab.
"We have questions about the accuracy and validity of the test," Superintendent Carruth said.
El Dorado Union asked their county health department to investigate the district's 29 positive results since April 8th, including Ryan's result.
They also reported 20 "inconclusive" and "failed" tests over a 10-day period.
"We think it needs to be looked at before we do greater harm to students who, over the last 13 months, have had so many opportunities taken from them," Carruth said.
False Positives Based on Previous Infection?
Like Culver City, Carruth says their spike in positive tests was among kids with no symptoms who later tested negative. They believe the state's highly sensitive COVID test is detecting leftover dead-virus fragments in kids who were previously exposed to COVID.
For instance, Reese first received a so-called inconclusive or "presumptive positive" result.
According to CDPH, when their highly sensitive PerkinElmer COVID test detects some virus, but not enough virus to warrant a positive result, the lab officially reports the test as inconclusive but tells the patient they are "presumptive positive" and need to re-test.
ALSO READ: Same COVID Test, Different Results: FDA Looking Into State Lab 'Test Result Concerns'
When Reese re-tested, as required by the state, her follow-up up test was negative.
Her twin Riley initially had a negative result, but when she tested again, it came back presumptive positive.
However, Riley also tested positive for the COVID-19 antibodies, indicating that she had a previous infection. PCR tests are known to pick up leftover dead virus from previous infections.
Still, based on their brother Ryan's test, which was a fraction of a point below the positivity threshold, all three siblings were quarantined.
They were told it would not matter if they had subsequent negative tests, they would still need to quarantine for 10 days.
Concerns Over the CDPH-PerkinElmer "Highly Sensitive" Test
Following the Culver City false-positive results, we asked CDPH if other schools were impacted and if they had identified the source of the issue, in addition to several other questions.
CDPH did not answer the questions directly, but instead, boasted that their test is among "the most sensitive tests available, routinely detecting low-level positive cases…that may be missed by other labs and tests."
The agency added, "when it comes to the health of children, educators, and school staff, it is better to be safe than sorry."
However, many worry that the highly sensitive PCR test may be leading to unnecessary quarantines, keeping kids out of school to the detriment of their mental health.
Leading health experts, including Dr. Anthony Fauci, say low-level COVID results aren't likely contagious.
In a 2020 interview with This Week In Virology, Fauci referred to exact same measures of virus that are listed on Ryan's, Reese's and Riley's COVID lab reports, calling them "just dead nucleotides."
"My hypothesis is they're finding the actual genomic information of the virus," said Dr. Mark Pandori, Lab Director for Nevada's State Public Health Lab.
"When you're dealing with specimens in this range, they're so weakly positive it doesn't represent a public health or medical threat, necessarily."
Pandori explained that PCR COVID tests are so sensitive, they can detect insignificant amounts of virus, from contamination or old infections, that don't pose a health threat.
The PerkinElmer test used at the state lab is the most sensitive PCR test on the market.
Valencia Lab Positivity Rate 60% Higher Than CA Positivity Rate
Since it opened in November, the state lab's positivity rate has been consistently higher than California's positivity rate overall.
According to lab data provided by CDPH, in February the lab had a positivity rate of 7.1%. By comparison, according to state data, California's February positivity rate was 4.4% overall.
In March there was a similar spread, even though the positivity rate had dropped significantly. The lab's positivity rate was 3% compared to the state's at 1.9%.
Calling for a Testing Moratorium
As more people are vaccinated or have already had the virus, many believe we should be moving toward rapid antigen testing instead of PCR testing because a positive test that doesn't actually pose a health threat can have significant consequences.
The state's own guidance for discrimination and inappropriate testing notes "PCR tests can remain positive long after an individual is no longer infectious."
"Why are they using such a sensitive test if those levels are irrelevant?" asked Pam.
"We think it needs to be looked at before we do greater harm to students," added Superintendent Carruth. "It doesn't help us going into a competition (if the test detects) somebody who was exposed two months ago but does not have any COVID in their system currently."
The El Dorado Union School District is now calling for a state-wide moratorium on the required PCR testing for asymptomatic student-athletes, asking the state to investigate the high rate of positive tests and revise its guidance.
"We want to make sure we're not doing more harm than good." Carruth said. "We also question whether the PCR test is the right test. We think the antigen test, like college and pro sports, is the test that is most helpful for protecting our students and keeping our environment safe."
For Rees and Riley, the damage is done and it had wide-reaching consequences.
Reese explained, when the sisters were quarantined, "our JV season was canceled because there wasn't enough players."
Even though they never tested positive, their brother's borderline positive result, from the most sensitive test on the market, ultimately had a ripple effect on their whole team.
WATCH THE CBS NEWS SACRAMENTO SPECIAL REPORT
THE COVID LAB: State Secrets Exposed
This 30-Minute Special Report is the culmination of 14 months of reporting that prompted state and federal investigations, resulted in two new pieces of legislation, and shined a spotlight on shocking public health failures that it appeared regulators tried to hide.
Following these reports, lawmakers introduced legislation that is intended to protect whistleblowers and ensure accountability and transparency long after the pandemic is over. The state ultimately terminated its $1.7B COVID contract with PerkinElmer.
