The CapHIV proposal addresses the need to increase the competitiveness of the SME partners by developing a cost-effective method to screen p24 capsid protein for the early diagnosis of HIV infection, a major health and economic threat to the quality of life of European citizens. A group of SMEs, covering the supply chain, have put together this proposal in order to gain the knowledge and resources to realise a CapHIV device exploiting the results of the novel, ultra-sensitive capacitance based sensor technology proposed by providing a fast and reliable early screening method in a cost efficient way.

The most commonly used and widely accessible diagnostic tests and assays rely on the presence of HIV antibodies, but the window period before seroconversion takes place to produce these antibodies in the host can take up to six months. Moreover, newborns cannot be tested with these methods due to maternal antibodies masking their true HIV status. Thus, antibody-detecting approaches have major shortcomings in incidence and infant testing, which are critical components to early treatment and reduced transmission rates. Diagnostic tests targeting antibodies or nucleic acids are also susceptible to false or discordant results due to viral variations.

Hence, of particular interest as a target then is the conserved viral capsid protein, p24 antigen. Under certain conditions, antigen assays can achieve sensitivities that nearly match those of NATs without the need for amplification steps, and the antigen has a much shorter window period than the antibody, allowing it to be much more effective at incidence and infant testing.

There is a need for more advanced and sensitive analyses, and capacitive biosensors have in recent years gained much attention.

The aims of the project are as follows:

  • Develop a rapid, accurate, and portable capacitance-based bioanalytical sensor for the detection of trace concentrations of viral markers for an early diagnose of life-threatening diseases.
  • Design a portable prototype sensor for practical application in field settings and a marketable sensor – chip that is suitable and robust for use in real-world settings and harsh conditions.
  • Thoroughly study the effect of non-specific binding (NSB) in complex sample matrices, while devising a set of protocols, procedures, and strategies for its reduction.
  • Perform scientific studies where spiked and clinical samples will be analyzed.
  • Exploit the potential phage display libraries to quickly generate antibody analogues to be utilized for the detection of new, emerging pandemic threats.
  • Use the accumulated knowledge to develop hardware and software in order to build and validate a field-adopted sensor product that can detect and quantify viral antigens (i.e. p24-antigen) in complex sample matrices in the concentration range of 10-15 – 10-20 moles per liter (<<fg/mL).