The aim of the project is to develop a method for the diagnosis of the two most oncogenic types of human papillomavirus (HPV) HPV type 16 and HPV type 18 that does not require a full procedure for isolation of genetic material from a throat/saliva swab, along with the initial validation of the HPV 16 and HPV 18 diagnostic kit based on genetic identification using Real-Time LAMP – Real-Time Loop Mediated Isothermal Amplification.
Thanks to a simplified sample procedure technique, it will be possible to use an approach known as Direct-LAMP – simplifying the tedious process of isolating genetic material.
The test kit will include:
- Buffer kit for sample storage and/or accelerated isolation of genetic material.
- MasterMix (mixture containing all components of the amplification reaction except for the sample to be analyzed and possibly water) for detection of the two most oncogenic HPV types containing all necessary components of the assay (including strand displacement polymerase, dNTPs, UDG) and possibly an internal control targeting human DNA.
- Positive control of the test – cDNA for HPV 16 and HPV 18 genomic fragments and human genetic material amplified at the amplification stage.
Implementation of the Project is planned for 10 months and has been divided into 3 tasks:
- Task 1. Work on the development of a set of buffers for sample storage and/or accelerated isolation of genetic material.
- Task 2. Work on reducing the amplification time of genetic material in the Direct assay to less than 15 min.
- Task 3. Work on the analysis of compatibility of the diagnostic kit with leading Real-Time PCR thermocyclers.
The described R&D Project will be carried out within the PoC phase.
R&D activities will be carried out in Poland; their results will be subject to protection, among others, in the territory of Poland.