| Background:With the improvement of living condition,people are paying more and more attention to their own health problems,and the demand for in vitro diagnostic technology,especially rapid diagnostic technology that can be used in the field,is also growing.In recent years,due to increasingly powerful functions and increasing popularity,smarthones have been widely used in the field of in vitro diagnostics.Objective:Develop novel types of smartphone-based immunosensing diagnosis systems and apply them to clinical verification.MethodsTwo kinds of portable immunosensor detection platforms based on smartphones were developed:(1)Designed and developed a smartphone based enzyme-linked immunochromatographic sensor(ELICS).The manufacturing and detection process of this sensor system were optimized,and the carcinoembryonic antigen(CEA)was detected to determine its feasibility in clinical diagnosis.(2)A high-throughput smartphone-based fibre-optical immunosensor system was designed and developed,and a supporting smartphone application(APP)program was designed.The manufacturing and assembly process of the composition structure has been optimized,.Then the system was integrated to detect and analyze the SARS-CoV-2 IgG and nucleocapsid protein(N protein).Results(1)A low-cost and reliable ELICS platform based on smartphones was successfully established.The portable sensor system is composed of a specially designed disposable immunochromatographic device and a result reader,which are performed on the immunochromatographic device.Immunoassay and enzyme coloration are used to form a biosensing channel,and the transmitted light intensity result can be directly read by the smart phone's ambient light sensor.For CEA,the linear detection range(LDR)is 0.031-1.95 ng/ml,and the detection limit(LOD)is 0.016 ng/ml,and it can be used for real-time detection of clinical samples.The detection results have good correlation with conventional ELISA results.(2)Successfully established a smartphone-based optical fibre-optical immunosensing platform that can be used for high-throughput detection.The standard instrument is composed of two parts,using the high-efficiency filtration and low-adsorption characteristics of TE membrane,and with the immune microspheres to perform high-throughput rapid immunoassay and generate color signals,and then use the excellent light guiding characteristics of the optical fibre-optical to concentrate the transmitted light signals together.Thus,the smartphone can be used to capture a large number of signals at close range,and the result data processing and analysing can be performed with the designed APP.For the clinical samples of sars-cov-2 binding antibody detection,the results were well correlated with ELISA,and the detection rate is higher,there was no need for complicated washing and incubation steps;For N protein standard detection,the LDR was 7.8-1000 pg/ml,and the LOD was 7.5 pg/ml,which was more sensitive than traditional ELISA and had a wider linear range.And it can be used for real-time detection of clinical samples,and the detection results have a good correlation with the results of Simple western.Discussion(1)The proposed elics platform device is small,and can realize more rapid and direct digital quantitative detection for small batch samples.(2)The proposed HFIS platform is highly sensitive,portable and easy to operate,which is suitable for rapid trace detection and analysis of large quantities of samples.Both of the developed smartphone-based immunosensing platforms can achieve rapid detection,and do not rely on large instruments,have high sensitivity,low production and use costs,and are suitable for on-site detection.Both have good platform applicability,they have good application prospects in clinical diagnosis and preliminary screening,personalized medicine,environmental monitoring,food safety testing and other fields by changing the corresponding antibodies or ligands. |
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