Workplaces in South West Could be Affected by Incorrect PCR COVID Results  

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• Workplaces in South West Could be Affected by Incorrect PCR COVID Results  

19 October 2021

COVID-19 testing has been suspended at a centre in Wolverhampton, after reports that up to 43,000 people may have been wrongly given negative results.

The errors were discovered at Immensa Health Clinic in Wolverhampton.

Potentially, several thousand people with COVID-19 may have unknowingly entered workplaces or other public areas.

The ipaper last week reported that rising numbers of people were testing negative on a PCR test after receiving a positive lateral flow result.

The UK Health Security Agency confirmed that investigations are underway into the precise cause.

Around 400,000 samples have been processed through the lab, the vast majority of which will have been negative results, but an estimated 43,000 people may have been given incorrect negative PCR test results between 8 September and 12 October, mostly in the South West of England.

The NHS Test and Trace programme is contacting the people that could still be infectious to advise them to take another test. Close contacts who are symptomatic will also be advised to take a test.

Andrea Riposati, CEO of Immensa Health Clinic Ltd, said: “We are fully collaborating with UKHSA on this matter. Quality is paramount for us. We have proudly analysed more than 2.5 million samples for NHS Test and Trace, working closely with the great teams at the Department of Health and Social Care (DHSC) and UKHSA. We do not wish this matter or anything else to tarnish the amazing work done by the UK in this pandemic.”

False Results in South West of England

News of the false-negative tests has led some people in the South West area to fear that they may have been affected and have unknowingly passed the virus on in their workplaces or to families and friends.

The BBC spoke to a family in West Berkshire who, after receiving negative PCR results after positive lateral flow results in late September and early October, continued normal activities. Graham Loader said: "I completely trusted the PCR so I feel bad for all the people I’ve been in contact with."

The Effect on Employers and Statutory Sick Pay

The UK’s testing facilities have formed a vital part in the country’s efforts to bring employees back to workplaces, with employers encouraged to minimise the spread of infection by encouraging regular testing.

An employee who tests positive and is self-isolating as result should receive statutory sick pay, if eligible. If a person wishes to self-isolate because they are in doubt of the accuracy of a PCR test and fear they have had a false-negative result, the guidance is unclear.

There is also currently no advice for employers who need to manage the potential scenario where a person who falsely tested negative for COVID-19 has entered a workplace.

Robust Quality Management is the Only Way for Confidence in Results

Chris Stanley, Chief Scientist, at Circular1 Health, explains why PCR testing is widely accepted as the "gold standard" of COVID-19 testing, and how credible PCR laboratories should function:

"For Circular1 Health, building a COVID-19 testing service around quality that customers can depend on is paramount. Providing a service for the critical industry – our major client base being nuclear, energy and defence organisations, has been paramount from the word go. It’s not easy to get right and we have built an intensive, multi-layered framework, with continuous improvement measures in place to enable essential workers to enter workplaces safely:

1. The PCR test is the widely accepted ‘gold standard’ :

• It measures more than one virus gene, to give confidence that it is the SARS-CoV-2 virus that is being detected
• It has in-built controls to ensure that the test has been run correctly

2. Surrounding this is a quality assurance structure created towards process management and control. The laboratory running PCR has Standard Operating Procedures (SOPs) that control the treatment of the sample, running of the test and analysis and reporting of results. These are our ‘rule book’. They’re supported by regular analysis of internal and external quality assurance samples (IQA and EQA), the latter from accredited schemes. Our Quality Control team, external to the laboratory regularly reviews protocols and procedures. It’s vital that these are separate functions – Laboratory Operations and Quality – with the latter providing independent oversight.

3. Above this is UKAS – the national accreditation body - that inspects the laboratory operations and quality management, issuing an accreditation to the ISO15189 standard for Medical Laboratories – renewed regularly following 6 monthly inspections.

This is the investment and commitment that, we believe, must be in place for a credible PCR laboratory. The reporting of the positivity rate is expected to match the UKHSA COVID-19 prevalence data – that’s the measure of an independent laboratory’s performance."

Picture: a photograph of a gloved hand holding a COVID-19 test vial

Article written by Ella Tansley | Published 19 October 2021

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