Annette Wilkinson, Director of Business Development and Service, Lisa Manze, Director of Group Laboratory Operations and Mike Gandy, Group Scientific Officer, give their overview of how Sonic Healthcare UK is addressing this increasingly important area.

Over the past 20 years, TDL has been at the forefront of self-collect pathology services. During this time, the range of sample types collected and the repertoire of tests being performed has equally expanded. Our ability to provide self-collected pathology services now plays an important role for our clients and their patients, enabling sample collection in a safe, home, patient-friendly environment.

The importance of self-collect pathology services was highlighted during the Covid-19 pandemic with the introduction of self-collected throat and nasal swabs for PCR testing across the world. This acute need illustrated the value of these services, enabling both an accurate diagnosis for individuals, whilst also enabling population screening at scale, supporting the needs of patients and healthcare professionals.

From our Manchester and North London fulfilment centres we distribute more than half a million self-collect kits each year. These kits range from TDL Tiny capillary blood collections, swabs, urine, and stool for a range of areas including sexual health, lifestyle, gastrointestinal health and pre-admission screening.


A period of transition

Over the past two years we have gradually transitioned our internal kit assembly operation to a new manufacturing partner. The main drive for this change has been the requirement to have our self-collection kits manufactured to ISO13485, the accreditation standard for manufacturing medical devices, and in line with European IVD regulations. This process has given us the opportunity to look closely at our kits, collection devices and test repertoire to make sure that the tests we perform on samples collected at home retain the same high standards as those taken in-clinic by healthcare professionals.

As part of this transition, we have reviewed all our kit componentry to ensure the most robust offering, and where possible aligned supplier collection devices with specific assays to ensure a validated end-to-end sample to result offering. In the areas of sexual health this has enabled efficiency gains by eliminating the need for the transfer of swabs and urine samples to secondary tubes before they are placed on analysers. In microbiology, we have transitioned to liquid media. This allows for better flexibility for our culture and PCR pathways for pre-admission screening. It has also refined and improved our test menu ensuring that the tests we perform are comparable to their venous counterparts and stable on their journey to the laboratory.

The transformation programme has become a significant team effort, involving teams across the company; specifically electronic request form production and kit distribution.

In addition, other areas of the organisation who have contributed to the initiative have been governance, validation, finance, design for kit design and artwork and website material and last, but importantly not least, the laboratory teams, who are handling and processing thousands of small samples every day together with the clinical team who have advised on safety and suitable for patients to collect samples themselves.


Looking ahead

The next stage of the self-collection kit programme is to ensure we have the correct regulatory framework to provide these kits outside the UK mainland, with emphasis on Northern Ireland and Republic of Ireland.

We will then move across to our healthcare professional kits, which play an equally important role within the organisation, but which are reviewed and considered differently by the regulator. We will continue to work closely with colleagues across the business as these next steps develop.