A point-of-care test based on electrochemical immunosensor for simultaneous determination of three significant inflammatory markers.
Preterm Premature Rupture of Membranes (PPROM) is a pregnancy complication. In this condition, the sac (amniotic membrane) surrounding the fetus breaks (ruptures) before week 37 of pregnancy. Once the sac breaks, pregnant woman has increased risk for infection. PPROM complicates 3 – 4% of all pregnancies and is up to 1/3 complicated by microbial invasion of the amniotic cavity (MIAC) leading to infection in amniotic fluid (AF) and development of intra-amniotic inflammation. Although this complication is usually asymptomatic, it is a major cause of preterm birth and neonatal morbidity and mortality worldwide. Neonates from these pregnancies are at increased risk of developing neonatal sepsis and impaired psychomotor development and other sometimes lifelong health consequences.
Our invention is point-of-care test (POCT) based on electrochemical immunosensor for simultaneous detection of three inflammatory protein biomarkers with high predictive value in AF collected by amniocentesis. The aim of the test is to confirm intra amniotic inflammation. The entire biosensor consists of an immunosorbent magnetically active microparticles modifed with specific antibody. After capturing the protein biomarker by the immunosorbent, the bioconjugate (IgG antibody conjugated with an electroactive indicator, specifically quantum dots or gold nanoparticles) is added. A final measurable signal proportional to the concentration of the inflammatory protein biomarker is provided by metal ions released from the electroactive indicator. Disposable screen printed three electrode sensors are used for simultaneous electrochemical analysis. Clinical relevance of selected protein biomarkers was determined based on the results of proteomic and antibody studies of AF of pregnant women with PPROM.
Advantages
POCT enables to speed up the process of confirmation or elimination inflammation in AF and can be easily performed and evaluated in minutes beside the patient´s bed and thus enables personalised approach to therapeutic intervention of the pregnant woman. Currently, determining the MIAC is not specific enough and is very time consuming and technically demanding. It is based on combination of cultivation and molecular methods. Further research is focused on test verification in cervicovaginal fluid to avoid amniocentesis.
Technology is owned by University Hospital Hradec Králové together with University of Pardubice. Czech patent applicationPV 2021-401 (priority date 31/08/2021) andPCT application PCT/CZ2022/050080 (priority 21. 08. 2022) was submitted. Technology is currently going throughProof of Concept stage of development. Potential application is IVD test - POCT is intended to be used my medical facilities that take care of pregnant women esp. regional hospitals or perinatology centers.
Intellectual property status
Patent already applied for
Patent application number : PV 2021-401 & PCT/CZ2022/050080
Where : Czech Republic & PCT
Current development status
Proof of Concept
University Hospital Hradec Králové is now one of the largest medical facilities not only in Eastern Bohemia but also throughout the Czech Republic. It is a state-of-the-art facility spanning a wide range of medical fields and serves as a catchment center for approximately 1,000,000 inhabitants from all over the Czech Republic.
More than 41,000 patients are hospitalized every year at the hospital’s 39 workplaces, which include 24 departments and over 1370 beds, with approximately 715,000 outpatients treated annually. The most complex surgical procedures are performed and modern diagnostic and treatment technologies are used. This makes University Hospital Hradec Králové comparable with similar hospitals in Europe.
University Hospital is an important research and educational institution closely connected with the Faculty of Medicine in Hradec Králové.
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