Poster Presentation Lorne Infection and Immunity 2020

Development and evaluation of a novel filter paper-based plasma separation device (VL-Plasma) for infectious diseases diagnosis (#186)

Berhan A Haile 1 , Iskandar Azwa 2 , Nishaan Raman 2 , Maria K Bador 2 , Margaret Tan 2 , Jiawei Zhu 3 , Feng Yi 3 , Julian Elliot 4 , Ali Saeidi 5 , Mary L Garcia 1 , Fan Li 1 , Suzanne M Crowe 1 4 , Sneha Saxena 1 , Sue-Ellen Nicholson 6 , Julian Druce 6 , Kathy Jackson 6 , Doris Chibo 6 , Irani Thevarajam 7 , Benjamin Cowie 6 , Joe Sasadeusz 7 , Alan Street 7 , Stanley Luchters 1 4 8 , Jack Richards 1 7 , David A Anderson 1 3
  1. Burnet Institute, Melbourne, VIC, Australia
  2. Infectious Disease Unit, Department of Medicine, Faculty of Medicine, University of Malaya, Kuala Lumpur, Malaysia
  3. Nanjing BioPoint Diagnostics, Nanjing, PR China
  4. Department of Epidemiology and Preventive Medicine, Monash University, Melbourne, Victoria, Australia
  5. Medical Microbiology Department, Faculty of Medicine, University of Malaya, Kuala Lumpur, Malaysia
  6. Victorian Infectious Diseases Reference Laboratory and Doherty Institute, Melbourne, Victoria, Australia
  7. The Royal Melbourne Hospital, Melbourne, Victoria, Australia
  8. International Centre for Reproductive Health, Department of Public Health and Primary Care, Ghent University, Ghent , Belgium

Dried blood spots (DBS) are used in medicine and research, but with the whole blood sample being dried it is not possible to separate the plasma, white blood cells (WBC) and red blood cells (RBC) once the sample reaches the lab. We have developed a simple, lateral-flow device (VL-Plasma®) that separates and dries the RBC, WBC and plasma components of the blood sample. In a clinical trial, VL-Plasma samples gave 100% sensitivity and specificity in molecular tests (viral load) for detection of treatment failure in HIV patients on antiviral therapy, where DBS gave the wrong result more than 50% of the time.

Prompted by this success we optimized the device into second generation intended for recovery of plasma for serological testing of other infectious diseases including vaccine preventable diseases. A prospective clinical validation study has been conducted to evaluate the optimised version of the device compared to the plasma (standard) as well as the conventional DBS to recover anti-tetanus and anti-measles antibodies.

The preliminary results demonstrated very good correlation between the VL-Plasma® and the standard sample (plasma) for detection of anti-Tetanus and anti-measles antibodies. Further analyses are underway including the stability of the antibodies on the device for months at different temperature conditions.

This study has demonstrated that the VL-Plasma device is a promising alternative sample type for diagnosis and/or screening of infectious diseases tests that apply serological methods.

To further its application, we are working with our collaborators in Sri Lanka, Mozambique and PNG using the device to examine pathogen and host genetics, antibody and antigen tests.