All antigen and molecular COVID tests will need to pass validation

On 28 July 2021, the UK government made it a legal requirement to seek validation for antigen and molecular COVID-19 detection tests. These in-vitro diagnostic devices intended for sale on the UK market are regulated under the Medical Devices (Coronavirus Test Device Approvals) (Amendment) Regulations 2021.

This requirement came in response to the discovery of several COVID-19 tests available on the market not meeting their stated performance. In pursuit of providing accurate information to the consumers, and in order to maintain a high-level performance of the tests, the first validation stage was introduced the 1st of September 2021 applicable for all antigen and molecular COVID-19 tests. Tests already on the UK market were given a grace period to pass the validation by the  31st of October 2021, given they had applied for the validation before 1st of September. Therefore, as of 1st of November 2021, no antigen or molecular COVID-19 test that have not passed the first validation stage can be placed on the UK market.

  • Which devices must be validated?

are subject to approval, whether they are designed for use in a laboratory, at point of care, near-patient, or for home use (self-test).

Exceptions apply for the tests supplied to:

  • The Secretary of State;
  • a devolved public health body; or
  • a health service body pursuant to an existing contract concluded before 01/09/2021.

 

  • What does the validation entail?

STAGE 1: Desktop reviewAPPLICABLE NOW

The desktop review assesses the evidence submitted by the supplier against a minimum required data set, preventing products that are below the expected standards from progressing to the market. The assessment is done in 3 steps:

  • A scientific adviser reviews the submitted evidence;
  • The desktop review assurance group assesses the submission;
  • The regulatory approvals committee considers it.

Your devices are not yet validated through desktop review?  – Follow this guide and

 

STAGE 2: Laboratory validation – APPLICATION DATE TBA

Laboratory validation is performed by a UKHSA appointed central laboratory provider and the validation test incorporates:

  • Comparison of the performance of the new test with that of a ‘gold-standard’ comparator molecular-based test;
  • Using a minimum set of samples from uninfected, asymptomatic and symptomatic individuals to ensure representation of performance across a range of viral loads;
  • Testing how sensitive the new test is to interference from other known pathogens and its lower limit for detection of coronavirus components.

Curious? Read more about the Laboratory Validation here!

 

TIMELINE

STAGE 1 – desktop review

For new devices to be placed on the UK market – validation must be passed before placing the devices on the market.

If a device was already sold on the UK market and there has already been an application for its validation before 1 September 2021 – this stage must be passed successfully by 31 October.

Therefore – as of 1 November, NO antigen or molecular COVID-19  detection test may be placed on the UK market without going through STAGE 1 of the validation process: desktop review process. Anyone placing unvalidated test products on the market after October 31 will face sanctions.

STAGE 2 – laboratory validation  

Laboratory validation is still at a proposal stage and yet to be adopted by the UK Government.

The latter has indicated that once the legislation will come into force, devices that already passed STAGE 1 – Desktop Review will obtain a 2-month grace period to comply.

 

There is the exception for tests to be used by

  • The Secretary of State;
  • a devolved public health body; or
  • a health service body supplied pursuant to an existing contract

Covid tests supplied to public health institutions following a contract concluded before 01/09/2021, do not have to be approved by DHSC (the reason is that there is already a validation process within the procurement process for NHS bodies).

Are you a COVID-19 test manufacturer placing your devices on the UK market? Contact us now and we will assist you in your path to compliance!

Andra Perv

Regulatory Affairs Department

20.10.2021

Should you like to appoint Obelis UK as your UK RP, or if you simply need guidance on your UK documentation, please do not hesitate to contact us.

Get in Touch

References

Department of Health and Social Care (2021). Validation of COVID-19 tests: laboratory validation. Retrieved on 19/10/2021 from https://www.gov.uk/government/consultations/validation-of-covid-19-tests-laboratory-validation/validation-of-covid-19-tests-laboratory-validation

Department of Health and Social Care (2021). UK market for COVID-19 detection devices: call for evidence Department of Health and Social Care (2021). Retrieved on 19/10/2021 from https://www.gov.uk/government/consultations/uk-covid-19-device-product-market-call-for-evidence/uk-market-for-covid-19-detection-devices-call-for-evidence

Department of Health and Social Care (2021). COVID-19 test approval – step 2: process for desktop review. Retrieved on 19/10/2021 from https://www.gov.uk/government/publications/assessment-and-procurement-of-coronavirus-covid-19-tests/covid-19-test-approval-step-2-process-for-desktop-review

Department of Health and Social Care (2021). COVID-19 test approval: how to apply. Retrieved on 19/10/2021 from https://www.gov.uk/guidance/covid-19-test-approval-how-to-apply

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