Smartphone-Based High-Throughput Fiber-Integrated Immunosensing System for Point-of-Care Testing of the SARS-CoV-2 Nucleocapsid Protein

Abstract
To control the coronavirus disease 2019 (COVID-19) pandemic, there is an urgent need for simple, rapid, and reliable detection methods to identify severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection, especially in community hospitals or clinical centers. The SARS-CoV-2 nucleocapsid protein (NP) is an important index for diagnosis of COVID-19. Here, we proposed a smartphone-based high-throughput fiber-integrated immunosensing system (HFIS) for detecting the SARS-CoV-2 NP in serum samples within 45 min. For the testing of NP standards, the linear detection range was 7.8-1000 pg/mL, the limit of detection was 7.5 pg/mL, and the cut-off value was 8.923 pg/mL. Twenty-five serum samples from clinically diagnosed COVID-19 patients and 100 negative control samples from healthy blood donors were tested for SARS-CoV-2 NP by HFIS, and the obtained results were compared with those of ELISA and Simple Western analysis. The results showed that the HFIS sensitivity and specificity were 72% [95% confidence interval (CI): 52.42-85.72%] and 100% (95% CI: 96.11-100%), respectively, which significantly correlated with those from the commercial ELISA kit and Simple Western analysis. This portable high-throughput HFIS assay could be an alternative test for detecting SARS-CoV-2 NP in blood samples on site.
Keywords: SARS-CoV-2 nucleocapsid protein; high-throughput detection; optical fiber; smartphone; track-etched membrane.

All Keywords
【저자키워드】 SARS-CoV-2 nucleocapsid protein, Smartphone, Optical fiber, high-throughput detection, track-etched membrane., 【초록키워드】 COVID-19, coronavirus disease, SARS-CoV-2, Coronavirus disease 2019, coronavirus, pandemic, hospital, Infection, severe acute respiratory syndrome Coronavirus, ELISA, nucleocapsid protein, Protein, Sensitivity and specificity, limit of detection, Smartphone, Community, membrane, optical, Optical fiber, Analysis, COVID-19 patient, confidence interval, acute respiratory syndrome, 95% CI, acute respiratory syndrome coronavirus, serum samples, acute respiratory syndrome coronavirus 2, Blood samples, blood sample, cut-off value, ELISA kit, SARS-CoV-2 nucleocapsid, healthy blood donors, serum sample, clinical centers, simple, tested, identify, negative control sample, significantly, clinically, diagnosed, linear, correlated, diagnosis of COVID-19, healthy blood donor, the SARS-CoV-2, 【제목키워드】 Testing, System, the SARS-CoV-2,

{{{ 추상적인 }}} 코로나바이러스 질병 2019(COVID-19) 범유행을 통제하기 위해, 특히 커뮤니티 병원 또는 임상에서 중증 급성 호흡기 증후군 코로나바이러스 2(SARS-CoV-2) 감염을 식별하기 위한 간단하고 신속하며 신뢰할 수 있는 탐지 방법이 시급히 필요합니다. 센터. SARS-CoV-2 뉴클레오캡시드 단백질(NP)은 코로나19 진단에 중요한 지표입니다. 여기에서 우리는 45분 이내에 혈청 샘플에서 SARS-CoV-2 NP를 검출하기 위한 스마트폰 기반 고처리량 섬유 통합 면역 감지 시스템(HFIS)을 제안했습니다. NP 표준 테스트의 경우 선형 검출 범위는 7.8-1000pg/mL, 검출 한계는 7.5pg/mL, 컷오프 값은 8.923pg/mL였습니다. 코로나19 임상 진단을 받은 환자의 혈청 검체 25개와 건강한 헌혈자의 음성대조군 검체 100개를 대상으로 HFIS를 통해 SARS-CoV-2 NP에 대한 검사를 실시했으며, 얻은 결과를 ELISA 및 Simple Western 분석 결과와 비교했다. 그 결과 HFIS 민감도와 특이도는 각각 72%[95% 신뢰구간(CI): 52.42-85.72%]와 100%(95% CI: 96.11-100%)로, 상용차와 유의한 상관관계를 보였다. ELISA 키트 및 Simple Western 분석. 이 휴대용 고처리량 HFIS 분석은 현장 혈액 샘플에서 SARS-CoV-2 NP를 검출하기 위한 대체 테스트가 될 수 있습니다. {{ 키워드: }} SARS-CoV-2 뉴클레오캡시드 단백질; 높은 처리량 감지; 광섬유; 스마트 폰; 트랙 에칭 멤브레인.