Development of biotechnological tools for molecular screening to increase transfusion safety in blood banks
Summary of the technology offered
Researchers from the Human Virology Laboratory have developed systems that are sensitive and specific for the detection of HCV, HBV and HIV-1 strains circulating in our region and meet the requirements for molecular screening of blood donors. The developed assays present common analytical formats for different viruses, which include detection with non-radioactive probes and revealed with colorimetric assays. This format allows the analysis of a large number of samples and the automation of screening processes.
The same research group has developed a competitive internal control (CIC) that allows verifying the efficiency of both sample processing and amplification processes and molecular detection of RNA virus.
CIC is an RNA packed into phage particles in which phage sequences were replaced by the primers used in the detection of the target virus.
Brief description of the technology offered
The Nucleic Acid Amplification Test (NAAT) in donor screening is primarily directed to the detection of the virus in the initial phase of infection, when antibodies against the virus are undetectable. Its application in mini-pools or individual samples has reduced the window period, with respect to HIV. The NAAT systems, which are presented in this offering, are based on PCR assays (HBV) and RT-PCR (HCV, HIV-1) with the utilization of CIC.
The CIC is a recombinant Qß coliphage bearing primers widely used for the detection of a target virus, it is safe for the laboratorists, RNAse-resistant and stable at 4°C. This reagent is an essential component of molecular detection assays for diagnosis and blood donors screening. The strategy used for its development has the flexibility of introducing a variety of different RNA sequences and could be adapted to the detection or real-time applications of other RNA pathogens of clinical significance or any other RNA target.
- Molecular diagnosis in virology.
- Molecular diagnosis in gastroenterology.
- Epidemiological studies.
- The NAAT systems developed were designed to require a sustainable cost. To do this, the optimizations of the prototype tests were performed using the most economic equipment for the extraction of nucleic acids available in Argentina.
- Cost reduction in diagnosis: the development of these systems, when properly validated, can replace expensive commercial systems.
- Increment in transfusion safety in the public and private sectors.
- Possibility of carrying out NAAT multiplex system for simultaneous detection of RNA from HCV and HIV-1.
- Possibility of application using mini-pools.
- Possibility to adapt to the new knowledge that appears in literature.
- Independence of the importation process of most reagents.
- Thereare systems developed using the new technologies in viral diagnosis.
- Learning by doing and interacting.
State of development
- Available for demonstration in public and private health effectors.
- Tested in the laboratory.
- Developmental phase.
State of intellectual property
Details of potential operating or partnership agreements
- Technical cooperation for testing new applications and adaptation to specific needs of public and private health effectors.
- Joint Venture.
- Technical support.
- Joint collaboration with health effectors to increase transfusion safety.
Dr. Adriana Giri