The Battle of the Test Kits: Government vs. Companies in a High-Stakes Legal Showdown

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In a legal clash that could reshape the landscape of healthcare procurement, the British government is locked in a fierce dispute with two companies over allegedly faulty COVID-19 test kits. The saga unfolds as the Department of Health and Social Care (DHSC) seeks a staggering £145 million refund for test kits it claims were "unfit for public use." 

 

It all began in the aftermath of the first COVID-19 lockdown, when the DHSC scrambled to secure testing solutions to combat the raging pandemic. Enter Primer Design Ltd and Novacyt, two companies that inked a contract with the government in September 2020, pledging to deliver thousands of 'Exsig' COVID kits per week until January 2021, at a cost nearing £146 million.

 

But what seemed like a lifeline soon turned into a nightmare. The DHSC alleges that the tests, intended to be a crucial tool in the fight against the virus, failed at an "unacceptable rate" due to design and manufacturing defects. According to Adam Heppinstall KC, representing the DHSC, the failure rate was so dire that it posed a grave threat to public health, with the potential for false negatives endangering lives.

 

The crux of the government's argument lies in the assertion that the Exsig tests lacked robustness, rendering them unsuitable for widespread use. They point to damning evidence from the Technologies Validation Group (TVG), which flagged concerns about the test kits' efficacy. In November 2020, the verdict was clear: the Exsig kits were deemed unfit for purpose, never seeing the light of day within the NHS.

 

However, the companies vehemently deny these allegations, launching a counteroffensive against the government's claims. Andrew Twigger KC, representing Primer Design Ltd and Novacyt, contends that the evidence of test failures is "seriously and obviously flawed." He argues that the tests were effective and that any shortcomings were either exaggerated or misinterpreted.

 

Twigger's defense hinges on dissecting the TVG's analysis, alleging errors and inconsistencies in the assessment of the test results. He maintains that once these discrepancies are rectified, the Exsig kits' sensitivity exceeds 100%, casting doubt on the government's robustness claim.

 

As the legal battle unfolds in the hallowed halls of the High Court, the implications reverberate far beyond the courtroom. At stake is not only a hefty sum of taxpayer money but also the integrity of healthcare procurement processes in the face of unprecedented challenges. The outcome of this showdown could set a precedent for future contracts, influencing how governments worldwide approach the procurement of vital medical supplies.

 

But amidst the legal jousting and finger-pointing, one question looms large: what about the public's trust? In an era where confidence in government actions is already strained, revelations of defective test kits only serve to deepen skepticism. As the hearing continues, both sides must reckon with not just financial restitution but also the restoration of faith in public health measures.

 

2024-05-02

 

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[Robert Paulson]

Test no good. Why am I not surprised

[TallGuyJohninBKK]

High-risk patients with COVID symptoms should use PCR rather than rapid tests, study suggests

Study findings that reveal a sensitivity of 47% for COVID-19 rapid antigen tests (RATs) compared with reverse-transcription polymerase chain reaction (RT-PCR) tests during Omicron variant predominance should prompt clinicians to consider using the latter test in high-risk patients eligible for antiviral drugs, the authors say.

...

"Clinicians should be aware of the lower sensitivity of antigen testing compared with RT-PCR, which might lead to false-negative results," the authors wrote. "This finding has implications for timely initiation of SARS-CoV-2 antiviral treatment, when early diagnosis is essential; clinicians should consider RT-PCR for persons for whom antiviral treatment is recommended. 

 

"Alternatively, if RT-PCR tests are not available or accessible, clinicians and patients should follow FDA's [Food and Drug Administration's] serial antigen testing recommendations to help optimize diagnostic test performance," they added.

 

(more)

 

https://www.cidrap.umn.edu/covid-19/high-risk-patients-covid-symptoms-should-use-pcr-rather-rapid-tests-study-suggests

 

[Robert Paulson]

We didn’t even have the testing right. Really stop to think about that. Peoples entire lives were going down the tubes, and for nothing 

[TallGuyJohninBKK]

Everyone understood all along that the rapid tests were not as accurate at the PCR tests. But early on in the pandemic, the testing demand was huge and sufficient PCR capacity simply didn't exist. So they ended up going to the mass market with the best alternative they had. The rapid tests worked to a reasonable extent, particularly if repeated as recommended, just not as well as the other kind.

 

As cited two posts above:

 

"Alternatively, if RT-PCR tests are not available or accessible, clinicians and patients should follow FDA's [Food and Drug Administration's] serial antigen testing recommendations to help optimize diagnostic test performance," they added.

 

[Robert Paulson]

These test kits were probably about as accurate as Stephen hawking with a bow and arrow