About TDL's sample collection kits
Our UKCA-marked kits are manufactured using high quality components and assembled within the UK, specifically using a quality system for medical device manufacture (ISO13485:2016).
The TDL TinyTM capillary blood and TDL Self-Collect sample kits cover a wide range of diagnostic and screening tests. These sample collection kits are not at-home test kits. TDL kits facilitate samples to be collected at home and returned to the laboratory for testing using Royal Mail Tracked 24 postal service. Results are returned directly to the healthcare organisation, doctor or managing healthcare professional, not to the patient.
TDL TinyTM blood samples can be combined with other TDL Self-Collect sample types (urine, stool and swabs). TDL TinyTM blood samples can be combined with other TDL Self-Collect sample types (urine, stool and swabs). Tests with available UKCA marked kits are listed here.
Different tests require varying amounts of sample volume, or special handling, which means that although certain tests can be carried out from capillary tubes, many tests simply cannot be achieved from these smaller sample volumes. Additionally, out of range, abnormal or positive test results should be confirmed with a confirmatory venous sample.
The TDL TinyTM capillary blood collection kits are designed to collect samples from skin puncture using lancets. Sample type colour coded microtainers show the 600 microlitres upper fill line. Upon receipt in the laboratory these samples are centrifuged and provide a volume of c.250 – 300 microlitres of serum/plasma (depending on the tube type used).
Instructions for sample collection are enclosed in each collection kit. The most successful outcomes are collected by patients who give best attention to the instructions provided, and who collect blood drops sufficient to fill the microtainer tube(s) in their kit. .
A completed request form, or specially provided tube labels must be returned with the collected sample. Results will always be sent to the requesting healthcare organisation, doctor or managing healthcare professional.
Quality is key
- Components: verified for the specific intended use of the kit and linked to the accredited tests performed in the laboratory.
- Instructions: monitored for ease of use, version controlled, with regular feedback for ongoing improvement.
- Quality: Management of technical files, regulatory submissions and manufactured to the required ISO:13485 medical device manufacturing standards.
- Supply: Assembled within the UK. Both individual kit fulfilment services and larger size kit orders are available.
- Security: Test kits are security sealed.
- Accompanying information: Request forms cannot be inserted into the sealed kits. An accompanying envelope (TDL will provide) or other clearly visible method must be sent with each kit to clearly display the request form.
- Laboratory testing: Verified diagnostic tests performed in an ISO:15189 accredited clinical laboratory
Distribution
TDL’s UKCA marked kits are registered with the MHRA and for distribution in the UK only. Kits required for distribution to Northern Ireland (NI) and the European Union (EU) would need to be CE marked under European legislation and are required to be registered with the Competent Authority responsible for each territory.
This is a requirement for both direct, distributed and online sales. Any requirements for distribution to other non-EU territories should consider and follow the required medical device legislation on a region by region basis.
As part of TDL’s distribution to clients or direct fulfilment to patients, TDL will keep a record of kit lot number. In the event of a faulty component and the need for a product recall this provides full traceability of kits and their respective components. Clients performing their own fulfilment distribution are required to manage their own onward lot number traceability.
Transport Compliance
TDL’s kits utilise primary, secondary and outer packaging combinations which are compliant with UN3373, PI650 and ADR transport regulations, including pressure test compliance to 95KPa.
Multi-lingual translations
In the UK depending on the region of operation, it may be necessary to provide kits with a language translation. Consideration should be given to ethnic minority communities where English is not a first language and translation may help to support sample collection.
In addition, in particular for UK devolved nations where there is active legislation across public bodies to ensure the ongoing protection and use of local languages (the Welsh Language Act 1993 and Welsh Language Measure 2011).
If kit distribution is required within the EU, there is a requirement for the translation of labelling, instructions for use, packaging and user manuals into their designated language(s). Typically, sections of documentation and critical information related to safety must be translated.
Warnings and precautions
As part of each kit’s instructions for use there is a warnings and precautions section which details important information for both the managing healthcare organisation and healthcare professional, and the end patient user. This includes relevant safety information, contraindications for use and laboratory acceptance criteria. Please familiarise yourself with the warning and precautions section of the relevant kits.
Sustainability
The Doctors Laboratory, as part of Sonic Healthcare’s global network of diagnostic laboratories, is committed to reducing carbon emissions, waste and investing in renewable energy. Underpinning social and environmental sustainability is a strong corporate governance framework and a culture of Medical Leadership that promotes integrity and ethical behaviour.
Sustainability within our TDL Self-Collect range is important to us and an area for continuous review and improvement. Our self-collect kit boxes are manufactured from a mixture of recycled corrugated paperboard with a virgin outer layer and our kit boxes and sleeves are fully recyclable and use water based inks. TDL’s biological waste is disposed using regulated pathways for medical waste management.