Early detection of cancer and cardiovascular diseases (CVD) is very important to increase the survival rate of patients in critical conditions. Therefore, it is necessary to have a reliable detection tool for cardiac and cancer markers which could probe a combination of biomarkers towards a highly accurate diagnosis and provide a multi-parametric detection system. Several methods are available but they still hold several limitations concerning portability, sensitivity and cost effectiveness. In order to overcome these problems, a point-of-care hand-held diagnostic device was developed. This technology is a hand-held point-of-care diagnostic device that incorporates a lab-on-a-chip module with interdigitated capacitive biosensors for label-free detection of multiple cancer and cardiovascular disease biomarkers. Interdigitated capacitive (IDC) sensors previously developed by our researchers for the detection of multiple CVD and cancer biomarkers, has been extended to a fast, low-cost hand-held point-of-care diagnostic device. For this purpose, a novel circular IDC-based biosensor in 2x6 capacitive arrays capable of detecting a panel of biomarkers present in human serum is designed, fabricated and verified. The developed prototype comprises of a capacitive bio-detection chip, a sensitive capacitive readout electronics enclosed in a hand-held unit and a data analysis software calculating the quantity of biomarkers using previously stored reference database for different concentrations of each biomarker.
The device uses pre-activated ready-to-use cartridges, composed of capacitive biosensors, which can be stored 3 months under optimal conditions, and is capable of on-site diagnosis and can report the result in less than 30 minutes. The device is verified with 16 real patient blood samples for 6 different disease biomarkers. The capacitance value of the IDC sensors has better sensitivity and specificity for detection of both CVD and cancer biomarkers as compared to the earlier reported methods. The hand-held unit is designed in a way that it enables the easy use of pre-activated cartridges and ensures a reliable connection with IDC sensor. The hand-held unit also incorporates a small computer that the software runs on and a touch-screen to control the operation of the device and to display the results on the screen. The software calculates the new concentrations of the biomarkers dropped on IDC sensor by utilizing the previously stored data for different concentrations of each disease biomarker. The device allows for fast, on-site, low cost and accurate diagnosis and prognosis of cancer and cardiovascular diseases.
The device does not compete with advanced, expensive laboratory tests in terms of accuracy. It is intended to be used in first-level health facilities, areas that have limited access or no access to advanced laboratory tests. Target biomarkers used for the verification of this point-of-care hand-held diagnostic device, which are indicative of CVD and cancer, are BNP (CVD), SAA (cancer), IL-6 (CVD and cancer), Fibrinogen (CVD and cancer), Troponin-I (CVD) and TNF-α (cancer). These biomarkers are tested with real blood samples. However, the developed device is not limited to the listed biomarkers. With further studies, it is possible to expand the list of the biomarkers detectable with the device.
A prototype point-of-care hand-held diagnostic device was developed to detect cancer and CVD target biomarkers. The device incorporates interdigitated capacitive sensors in a storable cartridge that can be inserted into the device. The device can detect multiple biomarkers simultaneously and display the results in less than 30 minutes. The cartridges can be pre-activated with the target antibodies and can be stored 3 months under optimum conditions. The prototype device was verified for 6 different target biomarkers as representatives of cancer and CVD indicators with 16 real patient blood samples. The results are compared with the reported results of the medical center and show that the device is a promising device that is suitable for fast, on-site and low-cost scanning of patients for cancer and CVD.