Tens of thousands of Americans may have used Covid and pregnancy tests made at a filthy, Chinese-run biolab that housed dangerous viruses like HIV and malaria.
The research facility was busted earlier this year in the sleepy California town of Reedley, where investigators found disease-riddled mice and hundreds of samples of pathogens, blood, and dubious chemicals piled up in storage boxes and fridges.
The lab was run by Universal Meditech Inc, a company with strong ties to China, which made unlicensed Covid and pregnancy tests sold across Texas and California as far back as October 2021.
Dr William Schaffner, a professor of infectious diseases at Vanderbilt University, told DailyMail.com there was a contamination risk because the tests were made ‘in an environment that’s extraordinarily bad.’
Earlier this year the FDA recalled 56,300 Universal Meditech Covid tests that were sold across the two states tests earlier this year because they had never obtained approval to be sold in the first place.
The recall announcement issued in February did not mention contamination and the agency declined to give additional details when approached by DailyMail.com.
Universal Meditech, the firm that initially maintained the many samples of infectious agents, had been manufacturing Covid tests without approval from the Food and Drug Administration, which must approve both the product and the facility at which it was manufactured
Several of the 32 freezers containing biological materials and dangerous pathogens found were malfunctioning, as power had been cut to the building
Investigators also found containers of plasma and blood of unknown origin and for unknown purposes
The FDA, which regulates medical devices as well as the facilities where they’re produced, did not disclose how many of those 56,300 unapproved tests actually made it into the hands of consumers.
Dr Schaffner said: ‘Could there be in the packaging, also, potentially some surface contamination with an infectious agent? I suppose that’s possible in an environment that’s as extraordinarily bad as this one’.
He added: ‘You cannot imagine that a diagnostic test, which has to adhere to certain performance characteristics, could be produced in an environment that’s so sloppy that you could rely on the results.
Dr William Schaffner, an expert in infectious diseases at Vanderbilt University Medical Center, described the recently obtained photos of the lab as ‘sloppy’ and ‘slovenly’ but stopped short of saying there was a bioterrorism threat
‘You would get false positives, false negatives, and the results would simply be unreliable.’
Now, residents of Reedley, home to about 25,000 people, are concerned about possibly contaminated tests, confused, and frustrated at the local government’s perceived inaction, given that the lab was discovered in December 2022 but only raided earlier this spring.
An online forum for residents of Reedley has shown the level of concern and outrage over the situation.
One resident named Ruby Rodriguez said: ‘How is it that they did know? So any business comes in and pays and that’s it no follow up really? Someone needs to answer to this.’
People are also clamoring for answers about who the lab employees were – records of employees have been withheld from officials – and what level of risk there was of an employee either mistakenly or knowingly introducing a pathogen to the residents of Reedley and the surrounding Fresno county.
Reedley resident Cristina Aleman said: ‘There is more to it… We just know what they want us to know… I DONT FEEL LIKE THEY KEPT ME SAFE !’
Another resident named Melissa Womack Barry addressed city manager Nicole Zieba directly: ‘Why weren’t the citizens of Reedley notified by mail or the local newspaper for that matter? And what is the correct date of discovery? Was anything coming out of that illegal garden hose hook up? It wasn’t even surrounded by keep out signs or hazardous chemicals warning. I feel so let down by our city and county officials and there’s nothing political in my feelings.
‘They all knew about this and we the people had no clue what was happening in our town. You knew about this Nicole and kept it secret until it was finally revealed by a local news outlet out of Fresno. Was there even an open to the public Reedley City Council meeting? So many questions regarding this biological waste disposal and we can’t even get the truth! We can do better Reedley!’
A third person, Rosemary Martinez, said: ‘This is so scary and how many other buildings are out there that are no longer used by the packing houses that were once used? Who knows what else might be out there? We need to move on this and find out.
‘I sure hope and pray we were not exposed from anything that has been there for who knows how long. Very very disturbing!!’
The origins of the lab and who ran it are still becoming clear as city and county investigations progress.
If government entities do have additional details regarding the origins and purpose of the lab, they are keeping them close to the vest, with the Food and Drug Administration as well as the California Department of Public Health telling DailyMail.com they do not discuss ongoing investigations with the press.
Prior to occupying the Reedley warehouse under the company name Prestige BioTech, lab workers and those allegedly responsible for the facility including Xiuquin Yao, president of the firm, had relocated hundreds of lab materials from a separate facility in the city of Fresno owned by the now-bankrupt Universal Meditech Inc.
The now-defunct Universal Meditech was acquired by Prestige, its biggest creditor, which resettled without a license in the Reedley warehouse.
Investigators who inspected the facility in March discovered Covid and pregnancy tests there, suggesting the lab was still making and possibly distributing them.
Among the viruses and bacteria that were labeled, inspectors found hepatitis B and C, dengue, HIV, two strains of the herpes virus, respiratory syncytial virus (RSV), tuberculosis, meningitis, rubella, coronavirus, and malaria.
A wide array of vials in the facility were also identified as containing biomaterials, including blood and tissue from unidentified sources, as well as many other unlabeled chemicals.
Among hundreds of vials of infectious viruses and bacteria, many of which were stored improperly in shoddy freezers, were samples of malaria, shown here, alongside Chinese characters. Other infectious agents found included strains of the herpes virus, the bacterium that causes meningitis, chlamydia, Covid-19, and HIV
The nondescript warehouse was identified by a code enforcement officer who happened to be passing by when they saw a garden hose located where it should not have been
Infectious disease experts have posed the possibility that the ‘slovenly’ lab flagrantly disregarded stringent requirements for infection control all labs must follow, potentially opening the door to flawed and contaminated diagnostic tests and infectious agents settling on the outer packaging of the test.
Experts want answers as to what researchers were doing in the sprawling warehouse on I street in the city of Reedley, which was first identified by an eagle-eyed code enforcement officer in December 2022 who noticed a garden hose sticking out of the building where it should not have been.
Dr Schaffner told DailyMail.com: ‘When you’re dealing with infectious agents, you have to do so in a rigorous fashion that’s been approved so that you don’t put the workers, the environment, and the surrounding neighborhood at any kind of risk at all.
‘And so there are very rigorous infection control policies and procedures that should have been undertaken by this laboratory, which, just looking at the pictures, clearly was not the case.
‘Workers in this laboratory could themselves become infected. And when they go home and engage in activities in the larger communities, potentially spread some of these infectious agents not only to themselves and their own families, but to neighbors with whom they have contact’.
Infectious disease doctors have told DailyMail.com the contents found at the lab are not the type that could be leveraged as a bioweapon, which would typically require a substance like anthrax or botulism.
Dr Amesh Adalja, Senior Scholar at the Johns Hopkins Center for Health Security, told DailyMail.com: ‘It’s unclear what was going on there, but I don’t think any of those things are evidence of anything nefarious. They found organisms that are dangerous but not the ones that would be used for sinister purposes.
‘There are lots of labs that have operated that have not had very good biosafety. It could be that this was kind of a laboratory that was trying to take advantage of Covid-19 diagnostic testing money out there and it didn’t work out.’
And in fact, Dr Schaffner pointed out that the lab conditions depicted in images obtained by DailyMail.com were so ‘absolutely abject, and totally slovenly’, the idea that researchers could have created anything resembling an accurate Covid or pregnancy test or something more nefarious is highly unlikely: ‘they could not achieve their goals by working in this laboratory’.
Dr Schaffner added: ‘If you’re developing diagnostic tests, therapeutics, whatever you’re trying to do, you have to work in an exceedingly precise fashion so that you can carefully replicate your findings and demonstrate that whatever your goals are, they have been achieved in a rigorous and reproducible fashion.
‘And you can’t do that in an environment such as this has been described. The whole circumstance, the more you think about it, the more bizarre this whole circumstance becomes’.
Residents are not the only once concerned about possible environmental contamination from the lab.
Experts fear for public safety given the possibility of a leaked pathogen and a scarcity of details from the state and federal government.
Dr Monica Gandhi, an infectious disease expert and director of the University of California San Francisco’s Center for AIDS Research, said: ‘This was a very disturbing news story.
‘Given the potential for such laboratories to accidentally unleash agents that can endanger the public, we need regulation to ensure biosafety is maintained at all times in laboratories around the world studying infectious pathogens’.