Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing) has been granted WHO Prequalification - A Step Towards Global Access
Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing) achieved World Health Organisation (WHO) Prequalification, known as WHO PQ, on 17 December 2025. Meeting WHO PQ's stringent assessment standards is a testament to Flowflex's commitment to high quality in COVID-19 testing. With this recognition, Flowflex COVID-19 rapid test kits can now be supplied to more regions worldwide, particularly in low- and middle-income countries, helping to expand access to trusted diagnostic tools.
For individuals and families, this provides added assurance that the test kits meet international quality and safety standards. Organisations and individuals can purchase Flowflex SARS-CoV-2 Antigen Rapid Test kits with greater peace of mind, knowing that the product has been evaluated by a global health authority.
About WHO Prequalification
The World Health Organisation is a United Nations agency that sets global health guidelines and standards. WHO Prequalification is an international programme that assesses the quality, safety, and performance of medical devices and products. Being WHO-prequalified means that international health organisations and government bodies have greater confidence in the product.
Evaluation for In-Vitro Diagnostics (IVD) devices like Flowflex COVID-19 self-test kit includes:
- Accuracy and sensitivity of the test in detecting COVID-19
- Manufacturing quality and consistency
- Ease of use and clarity of instructions
- Stability across various environmental conditions.
Overview of Flowflex SARS-CoV-2 Rapid Test
Flowflex's WHO-prequalified COVID-19 test is suitable for simple self-testing at home and for use in community or organisational settings. The test results are ready in 15 minutes, and the kit can be used without medical training. It is also approved by the European Commission, Australia Therapeutic Goods Association (TGA), Health Canada, and Singapore's Health Sciences Authority (HSA), which means it is trusted by many regions worldwide. Flowflex rapid test kits are manufactured with strict quality control and support timely detection, contributing to improved public health monitoring.
A milestone for Global Health
With Flowflex COVID-19 rapid antigen test kit now WHO prequalified, it marks a step forward in improving access to health diagnostics worldwide. Flowflex can now support organisations and government agencies by providing better pandemic preparedness, improved monitoring, and faster detection. Flowflex remains committed to making easy-to-use diagnostic solutions accessible to people everywhere.