References
- Ahmadzadeh, M., Vahidi, H., Mahboubi, A., Hajifathaliha, F., Nematollahi, L., & Mohit, E. (2021). Different respiratory samples for COVID-19 detection by standard and direct quantitative RT-PCR: A literature review. Iranian Journal of Pharmaceutical Research, 20(3), 285–16. https://doi.org/10.22037/ijpr.2021.115458.15383
- Association of Public Health Laboratories. (2023). APHL Response Efforts. Retrieved August 4,2023, from https://www.aphl.org/programs/infectious_disease/SARS-CoV-2/Pages/APHL-response.aspx.
- Azzi, L., Carcano, G., Dalla Gasperina, D., Sessa, F., Maurino, V., & Baj, A. (2021). Two cases of COVID-19 with positive salivary and negative pharyngeal or respiratory swabs at hospital discharge: A rising concern. Oral Diseases, 27(Suppl S3), 707–709. https://doi.org/10.1111/odi.13368
- Azzi, L., Carcano, G., Gianfagna, F., Grossi, P., Gasperina, D. D., Genoni, A., Fasano, M., Sessa, F., Tettamanti, L., Carinci, F., Maurino, V., Rossi, A., Tagliabue, A., & Baj, A. (2020). Saliva is a reliable tool to detect SARS-CoV-2. Journal of Infection, 81(1), e45–e50. https://doi.org/10.1016/j.jinf.2020.04.005
- Charlton, C. L., Babady, E., Ginocchio, C. C., Hatchette, T. F., Jerris, R. C., Li, Y., Loeffelholz, M., McCarter, Y. S., Miller, M. B., Novak-Weekley, S., Schuetz, A. N., Tang, Y.-W., Widen, R., & Drews, S. J. (2018). Practical guidance for clinical microbiology laboratories: Viruses causing acute respiratory tract infections. Clinical Microbiology Reviews, 32(1), e00042–18. https://doi.org/10.1128/CMR.00042-18
- Chen, J. S., Ma, E., Harrington, L. B., Da Costa, M., Tian, X., Palefsky, J. M., & Doudna, J. A. (2018). CRISPR-Cas12a target binding unleashes indiscriminate single-stranded DNase activity. Science: Advanced Materials and Devices, 360(6387), 436–439. https://doi.org/10.1126/science.aar6245
- Chen, J. S., Ma, E., Harrington, L. B., Da Costa, M., Tian, X., Plafesky, J. M., & Doudna, J. A. (2021). Erratum for the report “CRISPR-Cas12a target binding unleashes indiscriminate single-stranded DNase activity”. Science: Advanced Materials and Devices, 371(6531). https://doi.org/10.1126/science.abh0317
- Clerici, B., Muscatello, A., Bai, F., Pavanello, D., Orlandi, M., Marchetti, G. C., Castelli, V., Casazza, G., Costantino, G., & Podda, G. M. (2021). Sensitivity of SARS-CoV-2 detection with nasopharyngeal swabs. Frontiers in Public Health, 8, 593491. https://doi.org/10.3389/fpubh.2020.593491
- Cocco, P., Ayaz-Shah, A., Messenger, M. P., West, R. M., & Shinkins, B. (2020). Target product profiles for medical tests: A systematic review of current methods. BMC Medicine, 18(1), 119. https://doi.org/10.1186/s12916-020-01582-1
- Das, S., Dunbar, S., & Tang, Y. W. (2018). Laboratory diagnosis of respiratory tract infections in children – the state of the art. Frontiers in Microbiology, 9(9), 2478. https://doi.org/10.3389/fmicb.2018.02478
- Dean, D., Swaminathan, S., Kama, M., Goemans, S., Faktaufon, D., Alnabelseya, N., Spelke, D., Kahrizi, K., Black, M., Mitra, D., & Munson, E. (2021). Development and evaluation of a point-of-care test in a low-resource setting with high rates of Chlamydia trachomatis urogenital infections in Fiji. Journal of Clinical Microbiology, 59(7), e0018221. https://doi.org/10.1128/JCM.00182-21
- Defense Advanced Research Projects Agency. (2022). The heilmeier catechism. Retrieved December 21, 2022, from https://www.darpa.mil/work-with-us/heilmeier-catechism:.
- Denkinger, C., Dolinger, D., Schito, M., Wells, W., Cobelens, F., Pai, M., Zignol, M., Cirillo, D. M., Alland, D., Casenghi, M., Gallarda, J., Boehme, C. C., & Perkins, M. D. Target product profile of a molecular drug-susceptibility test for use in microscopy centers. (2015). The Journal of Infectious Diseases, 211(Suppl suppl_2), S39–S49. https://doi.org/10.1093/infdis/jiu682
- Denkinger, C., Kik, S., Cirillo, D., Casenghi, M., Shinnick, T., Weyer, K., Gilpin, C., Boehme, C. C., Schito, M., Kimerling, M., & Pai, M. (2015). Defining the needs for next generation assays for tuberculosis. Journal of Infectious Diseases, 211(Suppl suppl_2), S29–38. https://doi.org/10.10.1093/infdis/jiu821
- Diamandis, E. P. (2015). Theranos phenomenon: Promises and fallacies. Clinical Chemistry and Laboratory Medicine, 53(7), 989–993. https://doi.org/10.1515/cclm-2015-0356
- Drucker, E., & Krapfenbauer, K. (2013). Pitfalls and limitations in translation from biomarker discovery to clinical utility in predictive and personalised medicine. EPMA Journal, 4(1), 4–7. https://doi.org/10.1186/1878-5085-4-7
- Ellume. (2020). Ellume awarded US$30M from U.S. National Institutes of health RADx initiative to accelerate development of rapid COVID-19 diagnostics. Retrieved December 7, 2022, from https://www.ellumehealth.com/news/ellume-awarded-us-30m-from-us-national-institutes-of-health-radx-initiative-to-accelerate-development-of-rapid-covid-19-diagnostics-7-october-2020:.
- Engel, N., Wachter, K., Pai, M., Gallarda, J., Boehme, C., Celentano, I., & Weintraub, R. (2016). Addressing the challenges of diagnostics demand and supply: Insights from an online global health discussion platform. BMJ Global Health, 1(4), e000132. https://doi.org/10.1136/bmjgh-2016-000132
- Esquivel, J. P., Castellarnau, M., Gasso, S., & Sabate, N. (2019). Paper-based batteries as sustainable power source for disposable electronic devices, Smart systems integration. 13th International Conference and Exhibition on Integration Issues of Miniaturized Systems, Barcelona, Spain, pp. 1–4.
- FIND. (2022). A need for novel diagnostics: Meeting the moment. Retrieved December 15, 2022, from https://www.finddx.org/wp-content/uploads/2022/12/20221209_rep_novel_diagnostics_FV_EN.pdf:.
- Food and Drug Administration. (2020a). 85 FR 18250 – for a complete overview of FDA’s COVID-19 EUA efforts related to vaccines. https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization#vaccines.
- Food and Drug Administration. (2020b). 85 FR 7316 – for a complete overview of FDA’s COVID-19 EUA efforts related to IVDs. https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices/in-vitro-diagnostics-euas.
- Food and Drug Administration. (2021). FDA decision summary, K200748. Visby medical sexual health click test. Retrieved December 14, 2022, from https://www.accessdata.fda.gov/cdrh_docs/reviews/K200748.pdf.
- Food and Drug Administration. (2023a). At-homeCOVID-19 antigen tests-take steps to reduce your risk of false negative results: FDA safety communication. Retrieved March 22, 2023, from https://www.fda.gov/medical-devices/safety-communications/home-covid-19-antigen-tests-take-steps-reduce-your-risk-false-negative-results-fda-safety:.
- Food and Drug Administration. (2023b). At-homeCOVID-19 diagnostic tests: frequently asked questions. Retrieved March 22, 2023, from https://www.fda.gov/medical-devices/coronavirus-covid-19-and-medical-devices/home-covid-19-diagnostic-tests-frequently-asked-questions:.
- Food and Drug Administration. (2023c). Drugs and non-vaccine biological products. Retrieved March 22, 2023, from https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization#coviddrugs:.
- The Forum for Collaborative Research. (2015). High-priority target product profile for hepatitis C diagnosis in decentralized settings: Report of a consensus meeting. Retrieved December 8, 2022, from https://forumresearch.org/storage/documents/2015/hcv/hcv-tpp-report17july2015final.pdf.
- Frontiers. (2023). Retrieved March 22, 2023, from https://www.frontiersin.org/research-topics/33459/artificial-intelligence-in-point-of-care-diagnostics:.
- Gal, M., Francis, N., Hood, K., Villacian, J., Goossens, H., Watkins, A., Butler, C. C., & Gupta, V. Matching diagnostics development to clinical need: Target product profile development for a point of care test for community-acquired lower respiratory tract infection. (2018). PloS One, 13(8), e0200531. 2018. https://doi.org/10.1371/journal.pone.0200531
- Genomeweb 360 dx. (2022). FDA reissues EUA for meridian bioscience COVID-19 test after omicron variant trouble. 360Dx. Retrieved December 13, 2022, from https://www.360dx.com/molecular-diagnostics/fda-reissues-eua-meridian-bioscience-covid-19-test-after-omicron-variant#.Y6MhhtXMI2x.
- Genomeweb 360 dx. (2023). Coronavirus test tracker: Commercially available COVID-19 diagnostic tests. 360Dx. Retrieved April 5, 2023, from https://www.360dx.com/coronavirus-test-tracker-launched-covid-19-tests:.
- Griffin, R. (2022). Covid test maker central to US response appoints administrators. Bloomberg Law. Retrieved December 7, 2022, from https://news.bloomberglaw.com/bankruptcy-law/covid-test-maker-ellume-appoints-administrators-in-australia:.
- Hanson, K. E., Caliendo, A. M., Arias, C. A., Hayden, M. K., Englund, J. A., Lee, M. J., Loeb, M., Patel, R., El Alayli, A., Altayar, O., Patel, P., Falck-Ytter, Y., Lavergne, V., Morgan, R. L., Murad, M. H., Sultan, S., Bhimraj, A., & Mustafa, R. A. (2021). The infectious diseases society of America guidelines on the diagnosis of COVID-19: Molecular diagnostic testing. Clinical Infectious Diseases, ciab048. https://doi.org/10.1093/cid/ciab048
- Harvard University. (2023). Sherlock biosciences licenses Wyss Institute’s ambient nucleic acid amplification technology from Harvard to develop highly accurate, low-cost diagnostics for point-of-need. Wyss Institute. Retrieved March 21, 2023, from https://wyss.harvard.edu/news/sherlock-biosciences-licenses-wyss-institutes-ambient-nucleic-acid-amplification-technology-from-harvard-to-develop-highly-accurate-low-cost-diagnostics-for-point-of-need/.
- Health and Human Services. (2023). Health equity in telehealth. Retrieved March 22, 2023, from https://telehealth.hhs.gov/providers/health-equity-in-telehealth?gclid=EAIaIQobChMIsPat-bDw_QIVYxatBh3h1w-PEAAYAyAAEgKLpvD_BwE:.
- Hung, I. F., Cheng, V. C., Wu, A. K., Tang, B. S., Chan, K. H., Chu, C. M., Wong, M. M., Hui, W. T., Poon, L. L., Tse, D. M., Chan, K. S., Woo, P. C., Lau, S. K., Peiris, J. S., & Yuen, K. Y. (2004). Viral loads in clinical specimens and SARS manifestations. Emerging Infectious Diseases, 10(9), 1550–1557. https://doi.org/10.3201/eid1009.040058
- Infectious Diseases Society of America. (2020). IDSA guidelines on the diagnosis of COVID-19: Molecular diagnostic testing. Retrieved December 8, 2022.
- Johnson, M. (2022a). QuidelOrtho continues to see supply chain impacts; Combined Q3 revenues up 54 percent. Genomeweb 360 dx.
- Johnson, M. (2022b). Radx revved up COVID testing development. Will it also change the US Dx ecosystem? Part 1. Genomeweb 360 dx.
- Johnson, M. (2022c). Radx revved up COVID testing development. Will it also change the US Dx ecosystem? Part 2. Genomeweb 360 dx.
- Johnson, M. (2023). Sherlock biosciences expects sense biodetection buy to accelerate commercialization plans. Genomeweb 360Dx.
- Kaminski, M. M., Abudayyeh, O. O., Gootenberg, J. S., Zhang, F., & Collins, J. J. (2021). CRISPR-based diagnostics. Nature Biomedical Engineering, 5(7), 643–656. https://doi.org/10.1038/s41551-021-00760-7
- Kidd, B. A., Hoffman, G., Zimmerman, N., Li, L., Morgan, J. W., Glowe, P. K., Botwin, G. J., Parekh, S., Babic, N., Doust, M. W., Stock, G. B., Schadt, E. E., & Dudley, J. T. (2016). Evaluation of direct-to-consumer low-volume lab tests in healthy adults. Journal of Clinical Investigation, 126(5), 1734–1744. https://doi.org/10.1172/JCI86318
- Landry, M. L., Criscuolo, J., & Peaper, D. R. (2020). Challenges in use of saliva for detection of SARS CoV-2 RNA in symptomatic outpatients. Journal of Clinical Virology, 130, 104567. https://doi.org/10.1016/j.jcv.2020.104567
- Loens, K., Van Heirstraeten, L., Malhotra-Kumar, S., Goossens, H., & Ieven, M. (2009). Optimal sampling sites and methods for detection of pathogens possibly causing community-acquired lower respiratory tract infections. Journal of Clinical Microbiology, 47(1), 21–31. https://doi.org/10.1128/JCM.02037-08
- Memish, Z. A., Al-Tawfiq, J. A., Makhdoom, H. Q., Assiri, A., Alhakeem, R. F., Albarrak, A., Alsubaie, S., Al-Rabeeah, A. A., Hajomar, W. H., Hussain, R., Kheyami, A. M., Almutairi, A., Azhar, E. I., Drosten, C., Watson, S. J., Kellam, P., Cotten, M., & Zumla, A. (2014). Respiratory tract samples, viral load, and genome fraction yield in patients with Middle East respiratory syndrome. The Journal of infectious diseases, 210(10), 1590–1594. https://doi.org/10.1093/infdis/jiu292
- Mikhail, A. (2022). It’s estimated that the majority of seniors don’t take their medications as prescribed. This AI driven personal health assistant could help solve that. Fortune. Retrieved March 22, 2023, from https://fortune.com/well/2022/10/07/renee-ai-driven-personal-health-assistant/.
- Morin, S., Bazarova, N., Jacon, P., & Vella, S. (2018). The manufacturers’ perspective on world health organization prequalification of in vitro diagnostics. Clinical Infectious Diseases, 66(2), 301–305. https://doi.org/10.1093/cid/cix719
- National Institutes of Health. (2023). Radx® tech and ATP programs: Phase 2 awards. Retrieved April 14, 2023, from https://www.nibib.nih.gov/covid-19/radx-tech-program/radx-tech-phase2-awards:.
- Niederberger, M., & Spranger, J. (2020). Delphi technique in health sciences: A map. Frontiers in Public Health, 8, 457. https://doi.org/10.3389/fpubh.2020.00457
- PATH. (2023). Global availability of COVID-19 diagnostic tests. Retrieved April 5, 2023, from https://www.path.org/programs/diagnostics/covid-dashboard-global-availability-covid-19-diagnostic-tests/:.
- Puhach, O., Meyer, B., & Eckerle, I. (2023). SARS-CoV-2 viral load and shedding kinetics. Nature reviews. Microbiology, 21(3), 147–161. https://doi.org/10.1038/s41579-022-00822-w
- Ramachandran, A., & Santiago, J. G. (2021). Enzyme kinetics of CRISPR molecular diagnostics. bioRxiv Analytical Chemistry, 93(20), 7456–7464. https://doi.org/10.1021/acs.analchem.1c00525
- Renzoni, A., Perez, F., Ngo Nsoga, M. T., Yerly, S., Boehm, E., Gayet-Ageron, A., Kaiser, L., & Schibler, M. (2021). Analytical evaluation of Visby medical RT-PCR portable device for rapid detection of SARS-CoV-2. Diagnostics (Basel), 11(5), 813. https://doi.org/10.3390/diagnostics11050813
- Rizk, C. (2019). Sherlock biosciences aims to create Dx Tool for ‘Where testing should be done, but isn’t. Genomeweb.
- Ropes & Gray. (2023). The end of an era: How will terminating the COVID-19 public health emergency affect life sciences. Retrieved March 21, 2023, from https://www.ropesgray.com/en/newsroom/alerts/2023/02/the-end-of-an-era-how-will-terminating-the-covid-19-public-health-emergency-affect-life-sciences:.
- Satyanarayana, M. (2021). Over-the-counter COVID-19 tests make big promises. Do they deliver? Chemical & Engineering News, 99(20), 28–35. https://doi.org/10.1021/cen-09920-cover
- The Signal Path. (2022). TNP #9 - teardown & analysis of an electronic COVID-19 home test kit (ellume). Youtube. Retrieved December 16, 2022.
- Slaymaker, I. M., Mesa, P., Kellner, M. J., Kannan, S., Brignole, E., Koob, J., Feliciano, P. R., Stella, S., Abudayyeh, O. O., Gootenberg, J. S., Strecker, J., Montoya, G., & Zhang, F. (2019). High-resolution structure of Cas13b and biochemical characterization of RNA targeting and cleavage. Cell Reports, 26(13), 3741–3751. https://doi.org/10.1016/j.celrep.2019.02.094
- Slaymaker, I. M., Mesa, P., Kellner, M. J., Kannan, S., Brignole, E., Koob, J., Feliciano, P. R., Stella, S., Abudayyeh, O. O., Gootenberg, J. S., Strecker, J., Montoya, G., & Zhang, F. (2021). Correction: High-resolution structure of Cas13b and biochemical characterization of RNA targeting and cleavage. Cell Reports, 26(13), 3741–3751. https://doi.org/10.1016/j.celrep.2021.108865
- Spencer, S., Thompson, M. G., Flannery, B., Fry, A., & Kraft, C. S. (2019). Comparison of respiratory specimen collection methods for detection of influenza virus infection by reverse transcription-PCR: A literature review. Journal of Clinical Microbiology, 57(9), e00027–19. https://doi.org/10.1128/JCM.00027-19
- Stieber, F., Howard, J., Rao, S. N., Kawamura, L. M., Manissero, D., Love, J., Yang, M., Uchiyama, R., Parsons, S., Miller, C., Douwes, H., McDonald, A., Fairburn, L., & Boyle, J. (2020). First performance report of QIAreach™ anti-SARS-CoV-2 total test, an innovative nanoparticle fluorescence digital detection platform. Journal of Clinical Virology, 133, 104681. https://doi.org/10.1016/j.jcv.2020.104681
- To, K. K., Tsang, O. T., Leung, W. S., Tam, A. R., Wu, T. C., Lung, D. C., Yip, C. C., Cai, J. P., Chan, J. M., Chik, T. S., Lau, D. P., Choi, C. Y., Chen, L. L., Chan, W. M., Chan, K. H., Ip, J. D., Ng, A. C., Poon, R. W. … Yuen, K. Y. (2020). Temporal profiles of viral load in posterior oropharyngeal saliva samples and serum antibody responses during infection by SARS-CoV-2: An observational cohort study. Lancet Infectious Disease, 20(5), 565–574. https://doi.org/10.1016/S1473-3099(20)30196-1
- To, K. K. W., Yip, C. C. Y., Lai, C. Y. W., Wong, C. K. H., Ho, D. T. Y., Pang, P. K. P., Ng, A. C. K., Leung, K. H., Poon, R. W. S., Chan, K. H., Cheng, V. C. C., Hung, I. F. N., & Yuen, K. Y. (2019). Saliva as a diagnostic specimen for testing respiratory virus by a point-of-care molecular assay: A diagnostic validity study. Clinical Microbiology and Infection, 25(3), 372–378. https://doi.org/10.1016/j.cmi.2018.06.009
- Tran, N., & Albahra, S. (2021). Comparison of SARS-CoV-2 specimen types: Nasal Swabs, Nasopharyngeal Swabs and beyond. Retrieved August 4, 2023.https://health.ucdavis.edu/blog/lab-best-practice/comparison-of-sars-cov-2-specimen-types-nasal-swabs-nasopharyngeal-swabs-and-beyond/2021/09
- UK Research and Innovation. (2023). What is the purpose of testing for COVID-19? Retrieved March 22, 2023, from https://coronavirusexplained.ukri.org/en/article/vdt0006:.
- Vandenberg, O., Martiny, D., Rochas, O., Vvan Belkum, A., & Kozlakidis, Z. (2021). Considerations for diagnostic COVID-19 tests. Nature Reviews Microbiology, 19(3), 171–183. https://doi.org/10.1038/s41579-020-00461-z
- Wang, P., & Kricka, L. (2018). Current and emerging trends in point-of-care technology and strategies for clinical validation and implementation. Clinical Chemistry, 64(10), 1439–1452. https://doi.org/10.1373/clinchem.2018.287052
- Wang, L., Yang, S., Yan, X., Liu, T., Feng, Z., & Li, G. (2019). Comparing the yield of oropharyngeal swabs and sputum for detection of 11 common pathogens in hospitalized children with lower respiratory tract infection. Virology Journal, 16(1), 84. https://doi.org/10.1186/s12985-019-1177-x
- Williams, E., Bond, K., Zhang, B., Putland, M., Williamson, D. A., & McAdam, A. J. (2020). Saliva as a Noninvasive Specimen for detection of SARS-CoV-2. Journal of Clinical Microbiology, 58(8), e00776–20. https://doi.org/10.1128/JCM.00776-20
- World Health Organization. (2014). High-priority target product profiles for new tuberculosis diagnostics: Report of a consensus meeting. Retrieved December 21, 2022, from https://apps.who.int/iris/bitstream/handle/10665/135617/WHO_HTM_TB_2014.18_eng.pdf:.
- Zhou, Y., O’Leary, T. J., & Hozbor, D. F. (2021). Relative sensitivity of anterior nares and nasopharyngeal swabs for initial detection of SARS-CoV-2 in ambulatory patients: Rapid review and meta-analysis. PLoS One, 16(7), e0254559. https://doi.org/10.1371/journal.pone.0254559