Home blood collection for COVID-19 serology testing

Production and validation of a home blood collection system for COVID-19 serology tests

Project

This project aims to develop and produce a finger blood collection system that meets all legal requirements and is ready for certification. Next, it is validated whether COVID-19 serology tests can reliably be performed from a blood sample collected with this system.

Anticipated social and economic impact

To overcome the COVID-19 epidemic and to unlock the society, insights in the individual and population immunisation status with or without available vaccination is key. It is expected that enabling a home blood collection for COVID-19 diagnostics and thereby avoiding a visit to a hospital for a blood collection, reduces the time wasted by patients, reduces the number of necessary healthcare professionals needed for blood collections and avoids contamination risks related to COVID-19 diagnostics. It also enables large scale sample collection for, amongst others, COVID-19 serology thereby contributing to the unlocking of society.

Conceptualisation

At the National Cancer Institute, a home blood collection system has been developed that enables the collection of a blood sample by oneself from the finger at home. The collected blood sample is then send to the accredited medical laboratory and can be analysed by the high-end systems available and is performed under supervision of the medical experts. This way, already available and validated tests well as the laboratory infrastructure systems  available are used. This should enable easy and direct operation and implementation.

Deliverables

This projects consists of 5 work packages (WP) that aim to i) understand all legal and technical requirements for market entry, ii) produce final system, iii) design final test kit and user manual, iv) validation of suitability of final product for COVID-19 serology tests and v) to obtain a first draft of a scientific manuscript.

Summary
This project aims to develop and produce a final finger blood collection system that meets all legal requirements for certification and is technically validated for best practices COVID-19 serology tests readily available on medical laboratories.
Technology Readiness Level (TRL)
4 - 7
Time period
8 months
Partners