A dry chemistry-based electrochemiluminescence device for point-of-care testing of alanine transaminase.

Liver disease causes serious public health problems because of its high prevalence, particularly affecting low- and middle-income countries. Alanine transaminase (ALT) is considered to be one of the most sensitive indicators for diagnosing liver disease. Although many strategies have been reported for ALT detection, few of them have solved the problem of automatic detection. In this work, for the first time, a dry chemistry-based electrochemiluminescence (DC-ECL) device is developed for point-of-care testing (POCT) of ALT, achieving real sample-to-answer detection. The proposed DC-ECL device consists of the following two components: (a) a DC-ECL chip consisting of the outer shell (including the top cap and pedestal) and detection layer (including the baseplate, electrode pad and carrier pad) and (b) an automatic ECL analyzer mainly including the data processing and instrument control unit, imaging detection unit, electrochemical reaction excitation unit, open detection window unit and rechargeable power supply. Under optimized conditions, the device had a wide detection range (0-1000 U/L), the ECL intensity linearly increased with ALT concentration (5-50 U/L) and logarithmic ALT concentration (50-1000 U/L), and the limit of detection was calculated to be 1.702 U/L. In addition, the DC-ECL device had the ability to measure ALT levels in human serum samples and showed acceptable selectivity, stability and repeatability. These results reveal that the DC-ECL device can overcome the disadvantages of traditional methods for ALT detection (such as high cost and requirement of professional technicians) and potentially opens the door to the development of similar POCT analyzers.

Dry Chemistry-Based Bipolar Electrochemiluminescence Immunoassay Device for Point-of-Care Testing of Alzheimer-Associated Neuronal Thread Protein.

In this study, we developed, for the first time, a novel dry chemistry-based bipolar electrochemiluminescence (ECL) immunoassay device for point-of-care testing (POCT) of Alzheimer-associated neuronal thread protein (AD7c-NTP), where the ECL signals were automatically collected and analyzed after the sample and buffer solutions were manually added onto the immunosensor. The proposed immunoassay device contains an automatic ECL analyzer and a dry chemistry-based ECL immunosensor fabricated with a screen-printed fiber material-based chip and a three-dimensional (3D)-printed shell. Each pad of the fiber material-based chip was premodified with certain reagents for immunoreaction and then assembled to form the ECL immunosensor. The self-enhanced ECL of the Ru(II)-poly-l-lysine complex and the lateral flow fiber material-based chip make the addition of coreactants and repeated flushing unnecessary. Only the sample and buffer solutions are added to the ECL immunosensor, and the process of ECL detection can be completed in about 6 min using the proposed automatic ECL analyzer. Under optimized conditions, the linear detection range for AD7c-NTP was 1 to 104 pg/mL, and the detection limit was 0.15 pg/mL. The proposed ECL immunoassay device had acceptable selectivity, stability, and reproducibility and had been successfully applied to detect AD7c-NTP levels in human urine. In addition, the accurate detection of AD7c-NTP and duplex detection of AD7c-NTP and apolipoprotein E ε4 gene were also validated. It is believed that the proposed ECL immunoassay device may be a candidate for future POCT applications.