We demonstrate a smartphone integrated handheld (SPEED) digital polymerase chain reaction (dPCR) device for point-of-care application. The device has dimensions of ≈100 × 200 × 35 mm3 and a weight of ≈400 g. It can perform 45 PCR cycles in ≈49 min. The device also features integrated, miniaturized modules for thermal cycling, image taking, and wireless data communication. These functions are controlled by self-developed Android-based applications. The only consumable is the developed silicon-based dPCR chip, which has the potential to be recycled. The device's precision and accuracy are comparable with commercial dPCR machines. We have verified the SPEED dPCR prototype's utility in the testing of severe acute respiratory syndrome coronavirus 2, the detection of cancer-associated gene sequences, and the confirmations of Down syndrome diagnoses. Due to its low upfront capital investment, as well as its nominal running cost, we envision that the SPEED dPCR device will help to perform cancer screenings and non-invasive prenatal tests for the general population. It will also aid in the timely identification and monitoring of infectious disease testing, thereby expediting alerts with respect to potential emerging pandemics.

Central European Institute of Technology Brno University of Technology Purkyňova 123 61300 Brno Czech Republic

Central European Institute of Technology Brno University of Technology Purkyňova 123 61300 Brno Czech Republic; Faculty of Electrical Engineering Brno University of Technology Technická 3058 10 61600 Brno Czech Republic

Institute of Biology and Medical Genetics 1st Faculty of Medicine Charles University and General University Hospital of Prague Albertov 4 12800 Prague Czech Republic

ITD Tech s r o Osvoboditelu 1005 735 81 Bohumín Czech Republic

Ministry of Education Key Laboratory of Micro and Nano Systems for Aerospace School of Mechanical Engineering Northwestern Polytechnical University 127 West Youyi Road Xi'an Shaanxi 710072 PR China

Ministry of Education Key Laboratory of Micro and Nano Systems for Aerospace School of Mechanical Engineering Northwestern Polytechnical University 127 West Youyi Road Xi'an Shaanxi 710072 PR China; Faculty of Electrical Engineering Brno University of Technology Technická 3058 10 61600 Brno Czech Republic

Ministry of Education Key Laboratory of Micro and Nano Systems for Aerospace School of Mechanical Engineering Northwestern Polytechnical University 127 West Youyi Road Xi'an Shaanxi 710072 PR China; Ministry of Education Key Laboratory of Biomedical Information Engineering School of Life Science and Technology Xi'an Jiaotong University Xi'an Shaanxi 710049 PR China

School of Marine Science and Technology Northwestern Polytechnical University Xi'an Shaanxi 710072 PR China

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SPEED: an integrated, smartphone-operated, handheld digital PCR Device for point-of-care testing