An open source, PCR based, point-of-care testing platform.

Abstract

In recent years, point-of-care nucleic acid testing had played an important role in the diagnosis of infectious diseases. Despite its advantages, current point-of-care testing (POCT) platforms were all closed, which hindered researchers from quickly validating the performance of customized reagents. Incompatibility and repeated development of different POCT devices also resulted in the waste of medical resources. In this article, a rotating cartridge with a detachable reagent rack was developed, which provided an open platform in conjunction with a programmable POCT instrument. The system had been confirmed to effectively detect the HPV sample with a concentration of 1000 copies per milliliter and the novel coronavirus nucleic acid control dilution with a concentration of 200 copies per milliliter within 1 h. The cartridge could detect six targets simultaneously and cost less than ten dollars. The square of the correlation coefficients of the fitting line between the dye concentration and the fluorescence intensity all exceeded 0.99. The coefficient of variation (CV) for testing one sample with multiple cartridges or instruments was under 3%, confirming the stability and reliability of system performance. Results of clinical testing further verified its ability to detect multiple viruses, including novel coronavirus, influenza and human papillomavirus. Compared with standard results, the sensitivity reached 100% in the detection of multiple respiratory viruses and HPV viruses while the specificity was above 98% for all targets. The area under the curve (AUC) values for all receiver operating characteristic (ROC) curves exceeded 0.98. These results indicated that this platform had excellent performances and provided a competitive solution for low-cost, open point-of-care nucleic acid testing.