Harmony COVID-19: A ready-to-use kit, low-cost detector, and smartphone app for point-of-care SARS-CoV-2 RNA detection

Panpradist, Nuttada; Kline, Enos; Atkinson, Robert G; Roller, Michael; Wang, Qin; Hull, Ian T; Kotnik, Jack Henry; Oreskovic, Amy; Bennett, Crissa; Leon, Daniel; Lyon, Victoria; Gilligan-Steinberg, Shane; Han, Peter D.; Drain, Paul K.; Thompson, Matthew; Lutz, Barry

doi:10.1126/sciadv.abj1281

Cited by 50 publications

(28 citation statements)

References 38 publications

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“…These approaches have been proven capable of assaying SARS-CoV-2 viral RNA in nasal, nasopharyngeal, or throat swabs at an LOD of 10 to 100 copies per milliliter ( 5 ). Similar figures of merit have also been demonstrated in POC tests such as the CRISPR-Cas–based smartphone-read saliva tests ( 9 ) or, to a less high-performance level, in the RT-LAMP Harmony COVID-19 ( 10 ). While being quantitative with a wide dynamic range, molecular-based POC tests still have not fully addressed key aspects such as portability, simplicity of use, and independence from resource/infrastructure.…”

Section: Introductionsupporting

confidence: 53%

A handheld intelligent single-molecule binary bioelectronic system for fast and reliable immunometric point-of-care testing

et al. 2022

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Molecular tests are highly reliable and sensitive but lack portability and are not simple to use; conversely, easy-to-use antigenic tests still lack high performance. BioScreen combines single-molecule sensitivity and outstanding reliability with ultraportability and simplicity of use. This digital platform is capable of artificial intelligence–based binary classification at the limit of identification of a single marker/virus in 0.1 ml. The diagnostic sensitivity, specificity, and accuracy reach 99.2% as validated through 240 assays, including a pilot clinical trial. The versatile immunometric system can detect the SARS-CoV-2 virus, spike S1, and immunoglobulin G antigen proteins in saliva, blood serum, and swab. BioScreen has a small footprint comprising a disposable cartridge and a handheld electronic reader connected to a smart device. The sample handling is minimal, and the assay time to result is 21 min. Reliable and sensitive self-testing with an ultraportable and easy-to-use diagnostic system operated directly by a patient holds the potential to revolutionize point-of-care testing and early diagnosis.

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Section: Introductionsupporting

confidence: 53%

A handheld intelligent single-molecule binary bioelectronic system for fast and reliable immunometric point-of-care testing

et al. 2022

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“…In-amplification sample lysis and testing with human sample matrix is necessary to further validate this strategy. Assessment of direct detection of contrived samples in nasal matrix and appropriate crude clinical samples is a crucial aspect of ongoing work and was explored in our companion publication ( 14 ) focused on a POC detection platform. This is particularly important for understanding the role of RNAses on assay sensitivity.…”

Section: Discussionmentioning

confidence: 99%

“…While this proposed design and chemistry is amenable to adaptation to most contemporary high-throughput NAAT platforms as is, it is probably best leveraged in a mobile low-resource platform. Sampling, storage, and portable device solutions with additional clinical and experimental evaluation are already under development ( 14 ). These advancements will allow us to eschew infrastructure requirements that have acted as a bottleneck in current testing efforts, and when combined with the robust multiplex chemistry presented here, could act as a practical solution for decentralized testing.…”

Section: Discussionmentioning

confidence: 99%

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Multiplex Target-Redundant RT-LAMP for Robust Detection of SARS-CoV-2 Using Fluorescent Universal Displacement Probes

et al. 2022

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“…Various smartphone-based visual detection techniques, such as optical biosensors, electrochemical biosensors, surface acoustic wave biosensors have been developed [ 133 , 134 ]. In addition, the corresponding smartphone apps have also been developed to record, process and transmit the test data [ 135 , 136 ].…”

Section: Sars-cov-2 Infection Mechanism and Diagnostic Methodsmentioning

confidence: 99%

Visual Detection of COVID-19 from Materials Aspect

Wang

Meng

et al. 2022

Adv. Fiber Mater.

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In the recent COVID-19 pandemic, World Health Organization emphasized that early detection is an effective strategy to reduce the spread of SARS-CoV-2 viruses. Several diagnostic methods, such as reverse transcription-polymerase chain reaction (RT-PCR) and lateral flow immunoassay (LFIA), have been applied based on the mechanism of specific recognition and binding of the probes to viruses or viral antigens. Although the remarkable progress, these methods still suffer from inadequate cellular materials or errors in the detection and sampling procedure of nasopharyngeal/oropharyngeal swab collection. Therefore, developing accurate, ultrafast, and visualized detection calls for more advanced materials and technology urgently to fight against the epidemic. In this review, we first summarize the current methodologies for SARS-CoV-2 diagnosis. Then, recent representative examples are introduced based on various output signals (e.g., colorimetric, fluorometric, electronic, acoustic). Finally, we discuss the limitations of the methods and provide our perspectives on priorities for future test development. Graphical Abstract

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Harmony COVID-19: A ready-to-use kit, low-cost detector, and smartphone app for point-of-care SARS-CoV-2 RNA detection

Abstract: A unique four-plexed RT-LAMP test kit operated by health workers can provide faster, more sensitive results than laboratory tests.

Cited by 50 publications

References 38 publications

A handheld intelligent single-molecule binary bioelectronic system for fast and reliable immunometric point-of-care testing

A handheld intelligent single-molecule binary bioelectronic system for fast and reliable immunometric point-of-care testing

Multiplex Target-Redundant RT-LAMP for Robust Detection of SARS-CoV-2 Using Fluorescent Universal Displacement Probes

Visual Detection of COVID-19 from Materials Aspect

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