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lab-on a disc for point-of-care infection diagnostics

   

30, 887898. We can add several lines in this region of the strip to check for different analytes from the same sample simultaneously (Xu et al., 2014; Yen et al., 2015). Available online at: https://www.fda.gov/media/136148/download. 19. Smartphone technology can be transformative to the deployment of lab-on-chip diagnostics. Biosens. 40. Detection zone, a porous layer usually made of nitrocellulose membrane that allows interaction of antigen and antibody or DNA/RNA hybridization. Lateral flow immunoassay integrated with competitive and sandwich models for the detection of aflatoxin M1 and Escherichia coli O157:H7 in milk.

This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The most frequently used lateral flow strips are paper based (Estrela et al., 2016). In this review, we discuss various commercially available point-of-care diagnostics and their underlying technology. Fabrication of laser printed microfluidic paper-based analytical devices (LP-PADs) for point-of-care applications. Chem. Z., Parker, G., Kinsel, G. R., and Shamsi, M. H. (2019). doi: 10.1016/j.mimet.2015.08.011, Craw, P., and Balachandran, W. (2012). (2016). Lab Chip 13, 22102251. Coronavirus Disease 2019 (COVID-19) Frequently Asked Questions. Cellex Inc. has also developed a CLIA waived lateral flow technology based rapid test called qSARS-CoV-2 Rapid test, to detect IgM and IgG antibodies from serum or whole blood samples within 1520 min (Etherington, 2020). (2018). With the ongoing COVID-19 pandemic, Xpert Xpress SARS-Cov2 test by Cepheid was the first to be approved by FDA for coronavirus testing and can produce results in about 45 min (Opollo et al., 2018). 141, 111448. doi: 10.1016/j.bios.2019.111448, Lee-Lewandrowski, E., Corboy, D., Lewandrowski, K., Sinclair, J., McDermot, S., and Benzer, T. I. Anal Bioanal Chem. Trends Biotechnol. Polymers are inexpensive and microchannels are created by embossing and molding (Saha et al., 2017b, 2019). Both systems then send quantified results to the clinic via wireless communication.

TrAC Trends Analy. Clin. Patterned paper as a platform for inexpensive, low-volume, portable bioassays. Parida, MM, Dash, PK, and Shukla, J. A comparison of optical, electrochemical, magnetic, and colorimetric point-of-care biosensors for infectious disease diagnosis. Clear Blue Digital Pregnancy Test was the first FDA approved digitized test to have been launched in the market in 2003 (Etherington, 2020). Biomicrofluidics 6, 113011130113. ^AccessBio Inc. CARESTART Covid-19. Available online at: https://www.alere.com/en/home/product-details/id-now.html. doi: 10.1016/j.diagmicrobio.2006.07.017, Ghosh, R., Gopalakrishnan, S., Savitha, R., Renganathan, T., and Pushpavanam, S. (2019). An at-home blood-glucose monitoring system uses electrochemical technology to measure glucose in fresh whole blood.

Trends Biotechnol. Lab-on-fiber technology is suitable for diagnostics in low resource settings, as they are low-cost and need very small volumes of samples (Ricciardi et al., 2015). LFA strips are widely being used in point-of-care testing (POCT). Nucleic Acid Amplification (NAAT). Lateral Flow Assay (LFA) and (b.) (2014). In this section, we discuss a few of these, including some rapid point-of-care based tests. Biotechnol., 15 January 2021, Commonly Used Fabrication Techniques For POCT Devices, Other Microfluidic POCT Diagnostics Platforms, https://doi.org/10.3389/fbioe.2020.602659, https://www.biofiredx.com/products/the-filmarray-panels/#blood-culture, https://www.meridianbioscience.com/platform/molecular/alethia, https://www.biomerieux-diagnostics.com/nuclisens-easyqr, https://www.fda.gov/media/136525/download, https://www.alere.com/en/home/product-details/id-now.html, https://www.sec.gov/Archives/edgar/data/882365/000091205702038057/a2090815zex-99_1.htm#toc_ka8573_6, https://www.pointofcare.abbott/us/en/offerings/istat/istat-test-cartridges, https://www.pointofcare.abbott/us/en/offerings/istat/istat-handheld#testing, https://www.accessdata.fda.gov/cdrh_docs/reviews/K050574.pdf, https://www.stat-technologies.com/wp-content/uploads/2019/04/Afinion-2-Analyzer-User-Manual-.pdf, https://www.siemens-healthineers.com/en-us/diabetes/reagents/dca-microalbumin-creatinine-acr-urine, https://www.siemens-healthineers.com/en-us/diabetes, https://www.pixel.labcorp.com/at-home-test-kits/covid-19-test-home-collection-kit, https://www.fda.gov/media/136148/download, https://www.fda.gov/medical-devices/emergency-situations-medical-devices/faqs-testing-sars-cov-2, https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices/vitro-diagnostics-euas, https://www.fda.gov/media/137886/download, https://www.fda.gov/media/140777/download, https://www.cdc.gov/coronavirus/2019-ncov/symptoms-testing/testing.html, https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-first-antigen-test-help-rapid-detection-virus-causes, https://diagnostics.roche.com/global/en/c/covid-19-pandemic.html, https://diagnostics.roche.com/us/en/products/params/elecsys-il-6.html, https://www.thermofisher.com/us/en/home/clinical/clinical-genomics/pathogen-detection-solutions/coronavirus-2019-ncov/genetic-analysis/taqpath-rt-pcr-covid-19-kit.html, https://www.fda.gov/media/140444/download, https://www.rutgers.edu/news/new-rutgers-saliva-test-coronavirus-gets-fda-approval, https://www.med-technews.com/features/the-butterfly-effect-how-a-silicon-chip-is-easing-ultrasound/, https://app-avention-com.stanford.idm.oclc.org/company/f42f7829-f181-368f-9eb5-ac40426e3c7e#report/company_summary, https://app-avention-com.stanford.idm.oclc.org/company/cfa224ae-ad40-30db-89f9-034c8122f3da#report/company_summary, https://www.crunchbase.com/organization/sandstone-diagnostics#section-funding-rounds, https://app-avention-com.stanford.idm.oclc.org/company/f20f8b3c-811d-306c-bd5f-b339ee4b8ac3#report/company_summary, https://www.meridianbioscience.com/platform/molecular/revogene/, https://www.crunchbase.com/organization/hesperos#section-investors, https://www.fda.gov/medical-devices/letters-health-care-providers/potential-false-positive-results-antigen-tests-rapid-detection-sars-cov-2-letter-clinical-laboratory, https://www.med-technews.com/features/developing-diagnostics-challenges-and-opportunities-during-c/, https://techcrunch.com/2020/03/24/mesa-biotech-gains-emergency-fda-approval-for-rapid-point-of-care-covid-19-test/, https://www.genepoc-diagnostics.com/technology/, https://www.grandviewresearch.com/press-release/global-point-of-care-diagnostics-market, Creative Commons Attribution License (CC BY), Genome Technology Center, School of Medicine, Stanford University, Palo Alto, CA, United States. Analy. Rep. 9:7896. doi: 10.1038/s41598-019-44455-1, Ghosh, S., Aggarwal, K., Vinitha, T. U., Nguyen, T., Han, J., and Ahn, C. H. (2020). 16. Development of multiplexed infectious disease lateral flow assays: challenges and opportunities. Chem. 35, 728742. Even though FDA recently gave emergency use authorization to several at-home specimen collection kits Pixel by LabCorp16, SARS-CoV-2 MALDI-TOF Assay by Ethos Laboratories17, KPMAS Covid-19 test by Kaiser Permanente Mid-Atlantic States18 none of them have been approved by the FDA yet19. The immune cartridges contain the assay reagents and a sample well. (2020). cobas poc pcr antigen swab droptech 360dx reizen genomeweb reiscertificaat and transmitted securely. Some of the limitations of/challenges with using LFA tests, are: (a.) Sickle SCAN at home test determines sickle cell trait and aids in diagnosis of Sickle cell disease (POCT Market Forecast, 2020). MeSH Lab Chip 12, 211834. (2015).

EJIFCC 25, 134153. An easy to use, portable blood analyzer system introduced by Abbott, it utilizes disposable cartridge technology to provide rapid lab quality results within minutes. Biosens Bioelectron. Available from: https://cellexcovid.com/. (2018). 86, 56115614. ^Ethos Laboratories SARS-CoV-2 MALDI-TOF Assay. doi: 10.1016/j.bios.2011.10.019, Weigl, B., Domingo, G., Labarre, P., and Gerlach, J. Molecular and immunological diagnostic tests of COVID-19: current status and challenges. Some recent examples of LOAD systems for molecular diagnostics in which some or all steps of the assays are integrated on a disc, including pathogen enrichment, nucleic acid extraction, amplification, and detection, are discussed in detail. Isothermal nucleic acid amplification technologies for point-of-care diagnostics: a critical review. Chip 9, 27592762. ^Butterfly's Ultrasound-on-a-chi. Available online at: https://app-avention-com.stanford.idm.oclc.org/company/f42f7829-f181-368f-9eb5-ac40426e3c7e#report/company_summary. doi: 10.3390/s151129569, Chen, J., Zhou, Y., Wang, D., He, F., Rotello, V. M., Carter, K. R., et al.

The test can give results within 30 min (Opollo et al., 2018). The site is secure. Unlike smartphone based diagnostics, several components are needed to put together a wearable POCT (a.) doi: 10.1016/j.jbiomech.2016.12.033, Saha, A. K., Osmulski, P., Dallo, S. F., Gaczynska, M., Huang, T. H., and Ramasubramanian, A. K. (2017b). Isothermal amplification and quantification of nucleic acids and its use in microsystems. Commercialization of microfluidic point-of-care diagnostic devices. Available online at: https://www.cdc.gov/coronavirus/2019-ncov/symptoms-testing/testing.html. Available online at: https://www.sec.gov/Archives/edgar/data/882365/000091205702038057/a2090815zex-99_1.htm#toc_ka8573_6. (2015). doi: 10.1016/0002-9343(56)90103-6, Su, W., Gao, X., Jiang, L., and Qin, J. PLoS ONE 13:e0209778. (2012). Fabrication of microfluidic systems in poly(dimethylsiloxane). GenePOC, a Canadian company now part of Meridian Biosciences, uses automated cartridge based microfluidic technology for disease diagnosis and early detection. Chem. B. Serological Tests: Also called antibody blood tests, these check for past infection by detecting antibodies our body may have developed in response to COVID-1918. Interfaces 2, 17221728. LFA Strip Components. Thread as a versatile material for low-cost microfluidic diagnostics. Loop mediated isothermal amplification: an innovative gene amplification technique for animal diseases. ^Sandstone Diagnostics, Company Profile 2. Gut 66, 250257. These are further of two types: i. Molecular Tests: Also called viral tests or nucleic acid amplification tests (NAATs), these are based on either RT-PCR or isothermal amplification (LAMP) technology to detect the RNA of novel coronavirus from a patient's respiratory sample18.

Binx IO is the first FDA approved PCR amplification based rapid diagnostic test to detect sexually transmitted infections such as chlamydia and gonorrhea within 30 min5. Patterning of channels can be done in three ways - (a.) Open Public Health J. Considering the urgent need for cost-effective and reliable POC infection diagnostic tools, especially in the current pandemic crisis, the current limitations and future directions of fast and broad adaptation in real-world settings are also discussed. The .gov means its official. Rep. 7:1360. doi: 10.1038/s41598-017-01558-x, Tay, A., Pavesi, A., Yazdi, S. R., Lim, C. T., and Warkiani, M. E. (2016). Polymerase Chain Reaction (PCR) on a chip - A miniaturized version of the conventional PCR which requires three different temperatures to amplify (Niemz et al., 2011) or (b.) Infect. Eng. Developing a new POCT requires significant capital investment and therefore, fundraising and the choice of market is another challenge that needs to be overcome in order to bring new technology into the market. Sensors 19:554. doi: 10.3390/s19030554, Hsu, H.-L., Chuang, C.-C., Liang, C.-C., Chiao, D.-J., Wu, H.-L., Wu, Y.-P., et al. 12, 342368. doi: 10.1007/10_2019_104, Kilic, T., Weissleder, R., and Lee, H. (2020). official website and that any information you provide is encrypted Vet. Comparison of the use of comprehensive point-of-care test panel to conventional laboratory process in emergency department. We hope the new insight and promise of LOAD systems for POC infection diagnostics presented in this Account can spark new ideas and inspire further research and development to create better healthcare systems for current and future pandemics. The annual sales generate around 61 K USD41,42. Nat. ^Pixel, Labcor. Etherington, D. (2020). J. Eliminating the need of highly skilled professionals and complicated protocols, point-of-care tests remain an urgent need to fight the active pandemic situation (Augustine et al., 2020; Joung et al., 2020). PDMS microfluidics: a mini review. Soc. Med. Whole blood is sampled into the slot using a simple finger stick13. Biosens. Polymer Sci. There are 14 top in-vitro diagnostic (IVD) companies controlling 70% of the market. Analy. Feng, S., Caire, R., Cortazar, B., Turan, M., Wong, A., and Ozcan, A. Most current standard in vitro diagnostic (IVD) protocols for infectious diseases are sensitive but time-consuming and require sophisticated laboratory equipment and specially trained personnel. Nucleic Acid Amplification. 87, 853857. (2020). Available online at: https://www.accessdata.fda.gov/cdrh_docs/reviews/K050574.pdf. doi: 10.1038/nature05448, Walker, F. M., and Hsieh, K. (2019). (2014). 22. ^ID Now FDA. Available online at: https://www.google.com/glass/tech-specs/. The HemoCue technique is based on optical measuring microcuvette of small volume and a short light path11. doi: 10.1002/anie.200603817, McDonald, J. C., Duffy, D. C., Anderson, J. R., Chiu, D. T., Wu, H., Schueller, O. J. Table 1 summarizes current tests available for COVID-19. The importance of POCT is considerably amplified in the trying times of the COVID-19 pandemic. (2015). doi: 10.1039/c1lc20336c, Saha, A. K., Dallo, S. F., Detmar, A. L., Osmulski, P., Gaczynska, M., Huang, T. H., et al. Lab Chip 8, 19992014 doi: 10.1039/b811314a, Weltin, A., Kieninger, J., Enderle, B., Gellner, A.-K., Fritsch, B., and Urban, G. A. Available online at: https://www.pixel.labcorp.com/at-home-test-kits/covid-19-test-home-collection-kit. This molecular diagnostic test targets orf1ab, spike protein and nucleocapsid protein genes and can facilitate 96 samples per assay25. The technical principle of this assay was derived from lateral fixation tests, which were used to diagnose rheumatoid arthritis in 1956 (Singer and Plotz, 1956). Sci. Sandwich LFA and (2.) ^Athelas, Company Profile 2. 18.

2021 Mar 15;176:112905. doi: 10.1016/j.bios.2020.112905. 8600 Rockville Pike Several studies have shown that use of POCT diagnostics reduce overall per patient cost, length of stay in hospitals and provide faster results as compared to a traditional laboratory testing. A new microchannel capillary flow assay (MCFA) platform with lyophilized chemiluminescence reagents for a smartphone-based POCT detecting malaria. Rapid and visual detection of 2019 novel coronavirus (SARS-CoV-2) by a reverse transcription loop-mediated isothermal amplification assay. ^The COVID Tracking Project. 38. A quantitative lateral flow assay to detect complement activation in blood. doi: 10.1021/ac60033a032, Naeimirad, M., Abuzade, R., Babaahmadi, V., and Dabirian, F. (2019). Unlike conventional pump-based fluid actuation, the centrifugal force generated by spinning the disc induces liquid pumping and no external fluidic interconnects are required. Hemorheol. ^Testing for COVID-19 | CDC. 30. sample handling component, (b.) A LFA strip usually consists of the following components: i. 1:e78. Biophys. 46, 13181320. Lab-on-fiber technology: a new vision for chemical and biological sensing. Bioelectron. 7. Biosens. ^Cellex Inc. Lab Chip 15, 16381641. doi: 10.1039/C7CS00730B, Yen, C.-W., de Puig, H., Tam, J. O., Gmez-Mrquez, J., Bosch, I., Hamad-Schifferli, K., et al. doi: 10.1016/j.bios.2017.07.070, Carrio, A., Sampedro, C., Sanchez-Lopez, J. L., and Pimienta, M. (2015). This technology has shown consistent reproducibility & specificity with rapid outcomes. 4, 11621178. doi: 10.1039/c3lc41255e, Xu, Y., Liu, Y., Wu, Y., Xia, X., Liao, Y., and Li, Q. Biosens. Diagnostic performance and usability of the VISITECT CD4 semi-quantitative test for advanced HIV disease screening. ^DCA Vantage System. (2020). doi: 10.1371/journal.pone.0230453, Niemz, A., Ferguson, T. M., and Boyle, D. S. (2011). 39, 485493. Requirements for high impact diagnostics in the developing world. ^Hesperos Inc Company Profile 1. Principles of point of care culture, the spatial care path, and enabling community and global resilience: enabling community and global resilience. Xiao M, Tian F, Liu X, Zhou Q, Pan J, Luo Z, Yang M, Yi C. Adv Sci (Weinh). However, this technology has evolved over time with digital pregnancy tests as the next generation tests.

Rev. Available online at: https://www.med-technews.com/features/the-butterfly-effect-how-a-silicon-chip-is-easing-ultrasound/. Reliable, inexpensive, and rapid diagnostic tools are essential to control and prevent the spread of infectious diseases. Even in USA, there was lack of appropriate Government support in developing diagnostics for COVID-19 detection. Soc. Detection of gluten immunogenic peptides in the urine of patients with coeliac disease reveals transgressions in the gluten-free diet and incomplete mucosal healing. Available online at: https://app-avention-com.stanford.idm.oclc.org/company/cfa224ae-ad40-30db-89f9-034c8122f3da#report/company_summary. In Vitro Diagnostics: Technologies and Global Markets in M2 Presswire. The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest. doi: 10.1016/j.bios.2016.04.021, Li, X., Ballerini, D. R., and Shen, W. (2012).

^Butterfly iQ - Ultrasound, ultra-simplified. Micromachines 10:481. doi: 10.3390/mi10070481, Saeed, M., Ahmad, M., Iram, S., Riaz, S., Akhtar, M., and Aslam, M. (2017). Cartridges range from lactate to cardiac markers to endocrinology. Nucleic acid amplification using a conventional PCR requires complex & bulky equipment for thermal cycling, higher power consumption and longer turn-around times (Lee et al., 2019); (b.) 242, 502510. ^EUA, FDA. GeneXpert systems by Cepheid is a near POCT NAAT that relies on hemi-nested qualitative PCR. doi: 10.1016/j.tibtech.2017.03.013, Ding, X., Wu, W., Zhu, Q., Zhang, T., Jin, W., and Mu, Y. 2021 Nov 2;54(21):3979-3990. doi: 10.1021/acs.accounts.1c00438. Using filter paper and paraffin, the concept of microfluidic channels on paper was first introduced by Mller and Clegg (1949). Towards an ultra-rapid smartphone- connected test for infectious diseases. Different types of reporter labels - gold nanoparticles, fluorescence quenching labels, quantum dots can be used (Estrela et al., 2016). Lateral flow technology has also been used in detection of various bioterrorism pathogens and toxins such as Bacillus anthracis (Cox et al., 2015), Francisella tularemia (Pillai et al., 2020), Yersinia pestis (Hsu et al., 2018), Clostridium botulinum (Gessler et al., 2007), and Staphylococcal enterotoxin B (Parida et al., 2020). Alethia is a LAMP based diagnostic platform which can not only be used for C. difficile, Strep B, and Streptococcus A, but also other infections such as HSV 1&2, Mycoplasma, Pertussis, and CMV (Gene POC Technology, 2019). Would you like email updates of new search results? Wherein, the antibody or nucleic acid hybrid specific to the sample is immobilized on the test line and the control line consists of a secondary sample recognition element. 9:e1001306. ^Hesperos Inc Company Profile 2. Antigen Tests: Also called rapid diagnostic tests, these detect specific proteins on the surface of the virus. Rutgers University. doi: 10.1021/acsomega.6b00188, Health Care. 83, 177192.

Biotechnol. 31, 212218. Sample preparation involves chemical or enzymatic lysis, nucleic acid purification followed by elution. 18:43. doi: 10.1186/s12873-018-0198-x, Kanter, J., Telen, M. J., Hoppe, C., Roberts, C. L., Kim, J. S., and Yang, X. doi: 10.1039/C4LC00142G, Estrela, P., Katarzyna Koczula, M., and Gallotta, A. A., Xie, S., Olowookere, O. O., et al. Health Secur. Available online at: https://www.biofiredx.com/products/the-filmarray-panels/#blood-culture. 18, 8395. Whereas, Nitrocellulose is used to make LFAs (Yetisen et al., 2013).

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