Plasma separator device for HIV viral load testing (VLPlasma®)

This project aims to develop and validate a simple device to collect plasma from whole blood for medical testing.

2018-2020

The VLPlasma® was developed based on lateral flow technology. Each device has a strip composed of three membranes: glass fiber, nitrocellulose membrane, and filter paper which can trap erythrocyte, leukocyte, and collect cell-free plasma from human blood, respectively. This strip is housed within a specially designed cartridge that protects the sample during drying and transport, and allows users to easily pull out the filter paper (cell-free dried plasma) for elution and testing.

The device was CE marked in August 2020. Results of a clinical study to validate the use of this device for HIV viral load (VL) testing among 200 HIV patients in Malaysia showed that the device correctly identified 100% patients who failed treatment (VL>1000 copies/ml), outperformed a conventional dried sampling method (Dried blood spot/DBS) for HIV viral load testing.

Routine HIV viral load testing is the preferred method for monitoring patients’ response to treatment. The complexity of and laboratory resources required for collection, storage and transportation of fresh plasma samples have limited the availability of and patients’ access to HIV viral load testing particularly in low-resource settings. The conventional alternative sampling method (DBS) may reduce the accuracy of viral load testing due to the inclusion of blood cells and associated viral RNA and provial DNA.

The availability and use of the The VLPlasma® will help to address this challenge, contributing to the global progress towards ending HIV/AIDS by 2030.