Nanotechnologies / Materials
Medical & healthcare, Smart devices

Development of a rapid testing platform
for infectious diseases
Department of Bio-Nanotechnology, SANKEN (The Institute of Scientific and Industrial Science)
Professor Masateru Taniguchi
https://researchmap.jp/read0076413

Abstract
We demonstrate that after 5 minutes of measurement, AI nanopores can detect SARS-CoV-2 in saliva with a sensitivity and specificity of 90% and 96%, respectively. The test method using AI nanopores can also identify SARS-CoV-2 variants with high accuracy.
The AI nanopore platform enables the development of new rapid
tests for infectious diseases simply by changing the nanopore diameter and the training data.

single measurement. The integrated system of nanopores, AI, andIT will instantly inform users of the time, location, and type of an infectious disease, thereby guarding the safety, security, and healthof societies worldwide (Fig. 3).

Nanotechnologies / Materials▍ Background & Results
Tests for infectious diseases caused by viruses and bacteria
commonly employ methods based on antigen–antibody reactionsor the polymerase chain reaction (PCR). Although the antigen–antibody test is simple and rapid, it has low sensitivity and specificity;
the PCR test has high-sensitivity and specificity but requires askilled pretreatment and is often time-consuming. The developmentof simple, high-sensitivity, high-specificity, high-throughput, lowcost, and rapid tests for infectious diseases is urgently demanded.
Nanopores are through-holes fabricated on a silicon substrateusing semiconductor technology (Fig.1). When a virus or bacterium
passes through a nanopore, it initiates a single ionic current-time
waveform specific to that entity, which contains information about
the volume, structure, and surface charge of the virus or bacterium. As AI can distinguish waveforms that are difficult to distinguishwith the human eye, it can identify the type of virus or bacterium on
an individual level.
Using AI nanopores (a fusion of AI and nanopores), we successfully discriminated cultured SARS-CoV, MERS-CoV, SARS-CoV, andHCoV-229E with high accuracy. We also accurately discriminatedcultured influenza A viruses (type A) and SARS-CoV-2. After filtrating saliva samples collected from patients, we learned and tested
PCR-positive and PCR-negative samples using AI nanopores(Fig. 2). Pretreatment by filtration alone retained many contaminants in both the positive and negative clinical specimens. We developed and implemented a machine learning method that extracts
viral waveforms from the contaminant-derived waveforms. The sensitivity and specificity improved with measurement time, reaching
90% and 96%, respectively, after 5 minutes of measurement.

Fig. 1

Fig. 2▍ Significance of the research and Future perspective
Testing platforms that can respond immediately to new infectious-disease outbreaks will play a role in minimizing the spreadof infectious diseases and economic losses. On AI nanopore platforms, viruses and bacteria can be tested simply by adjusting thenanopore diameter and training data to suit the test target, after asimple filtration pretreatment.
The currently developed AI nanopore platform can be constructed into an integrated device using semiconductor technology,
paving the way for infectious-disease testing using a smartphone.
The device can test for a wide variety of viruses and bacteria with aFig. 3

P a t e n t Japanese Patent No. 6971499, 6985687, 6807529, 6638913, 6762494, 6719773
Taniguchi, Masateru et al. Combining machine learning and nanopore construction creates an artificial intelligence nanopore for coronavirus detection.
Tr e a t i s eNat. Commun. 2021, 12, p. 3726, doi: 10.1038/s41467-021-24001-2
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L http://www.bionano.sanken.osaka-u.ac.jp
K e y w o r d infectious diseases, rapid testing, nanopores, AI