Disposable optical sensor chip for medical diagnostics: New ways in bioanalysis

An optical sensor system is described which is particularly well suited for medical point-of-care diagnostics. The system allows for all kinds of immunochemical assay formats and consists of a disposable sensor chip and an optical readout device. The chip is built up from a ground and cover plate with in- and outlet and, between, of an adhesive film with a capillary aperture of 50 mu m. The ground plate serves as a solid phase for the immobilization of biocomponents, In the readout device, an evanescent held is generated at the surface of the ground plate by total internal reflection of a laser beam. This field is used for the excitation of fluorophor markers. The generated fluorescence light is detected by a simple optical setup using a photomultiplier tube. Because of the evanescent field excitation, washing or separation steps can be avoided. With this system the pregnancy hormone chorionic gonadotropin (hCG) could be determined in human serum with a detection limit of 1 ng/mL, Recovery values were 86, 106, and 102\% for 5, 50, and 100 ng/mL hCG, respectively. The SD in repeated measurements (n = 10) was 5.6\%, Furthermore, the feasibility of the system in competitive-type immunoassays was demonstrated for serum theophylline. A linear calibration curve of signal vs theophylline between 1 and 50 mg/L was obtained. Recovery values varied between 118\% (10 mg/L) and 81.0\% (20 mg/L)