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Read my post 90604 on this page.
GENVIRO S. WILL GET “RUO” APPROVAL EXEMPTION: Section 520(g) of the FD&C Act, 21 U.S.C. 360j(g), provides for the exemption of devices intended for investigational use from certain requirements of the Act if such devices comply with the procedures and conditions prescribed by that section and by regulation. For example, devices intended for investigational use that meet applicable requirements may be exempted from premarket notification and premarket approval requirements.
THIS LOOKS REALLY GOOD II. Regulatory Requirements for Research Use Only and Investigational Use Only IVD products Section 520(g) of the FD&C Act, 21 U.S.C. 360j(g), provides for the exemption of devices intended for investigational use from certain requirements of the Act if such devices comply with the procedures and conditions prescribed by that section and by regulation. For example, devices intended for investigational use that meet applicable requirements may be exempted from premarket notification and premarket approval requirements of sections 510, 515, 520(g)(2)(A) of the Act (21 U.S.C. 360, 360e, 21 U.S.C. 360j(g)(2)(A)); see also 21 CFR 812.1(a). A product’s intended use refers to the “objective intent” of those responsible for labeling the product.4 Intent is determined by such persons’ expressions or may be shown by the circumstances surrounding the distribution of the article.5
Device Investigations Subject to IDE Regulation
FDA's investigational device exemption (IDE) regulation is found at 21 CFR part 812. Under 21 CFR 812.5, investigational devices must bear a label that states the following: "CAUTION--Investigational device. Limited by Federal (or United States) law to investigational use." The labeling may not represent that the device is safe or effective for the purposes for which it is being investigated. 21 CFR 812.5(b). The IDE regulation also prohibits certain conduct by sponsors and investigators pertaining to the investigation and distribution of investigational devices, among other practices. See 21 CFR 812.7. https://www.fda.gov/media/87374/download
FDA RUO LOOKS GOOD. I. Introduction: https://www.fda.gov/media/87374/download
FDA is issuing this guidance document to provide the current thinking of the Center for Devices and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER) on when in vitro diagnostic (IVD) products1 are properly labeled “for research use only” (RUO) or “for investigational use only” (IUO)2. FDA is concerned that the distribution of unapproved and uncleared IVD products labeled RUO or IUO, but intended for purposes other than research or investigation (for example, for clinical diagnostic use3), has led, in some cases, to the clinical diagnostic use of products with unproven performance characteristics, and with manufacturing controls that are
1 “In vitro diagnostic products are those reagents, instruments, and systems intended for use in the diagnosis of disease or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae. Such products are intended for use in the collection, preparation, and examination of specimens taken from the human body. These products are devices as defined in section 201(h) of the Federal Food, Drug, and Cosmetic Act (the act), and may also be biological products subject to section 351 of the Public Health Service Act.” Title 21, Code of Federal Regulations (CFR), section 809.3(a).
2 This guidance is only intended to apply to IVD products that have not been approved, cleared or licensed for any use, and it is not intended to address off-label uses of any approved, cleared or licensed products.
3 Throughout this guidance document, references to “clinical diagnostic use” and “use in clinical diagnosis” include use in making medical treatment decisions.
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inadequate to ensure consistent manufacturing of the finished product. Use of such tests for clinical diagnostic purposes may mislead healthcare providers and cause serious adverse health consequences to patients, who are not aware that they are being diagnosed with or treated based on the results of tests with research or investigational products. FDA is issuing this guidance to clarify the requirements applicable to RUO and IUO IVD products, including that RUO and IUO labeling must be consistent with the manufacturer’s intended use of the device.
FDA's guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the Agency's current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidances means that something is suggested or recommended, but not required.
II. Regulatory Requirements for Research Use Only and Investigational Use Only IVD products
Section 520(g) of the FD&C Act, 21 U.S.C. 360j(g), provides for the exemption of devices intended for investigational use from certain requirements of the Act if such devices comply with the procedures and conditions prescribed by that section and by regulation. For example, devices intended for investigational use that meet applicable requirements may be exempted from premarket notification and premarket approval requirements of sections 510, 515, 520(g)(2)(A) of the Act (21 U.S.C. 360, 360e, 21 U.S.C. 360j(g)(2)(A)); see also 21 CFR 812.1(a). A product’s intended use refers to the “objective intent” of those responsible for labeling the product.4 Intent is determined by such persons’ expressions or may be shown by the circumstances surrounding the distribution of the article.5
Device Investigations Subject to IDE Regulation
FDA's investigational device exemption (IDE) regulation is found at 21 CFR part 812. Under 21 CFR 812.5, investigational devices must bear a label that states the following: "CAUTION--Investigational device. Limited by Federal (or United States) law to investigational use." The labeling may not represent that the device is safe or effective for the purposes for which it is being investigated. 21 CFR 812.5(b). The IDE regulation also prohibits certain conduct by sponsors and investigators pertaining to the investigation and distribution of investigational devices, among other practices. See 21 CFR 812.7.
Device Investigations Exempt from IDE Regulation
Investigations of diagnostic devices that meet the criteria at section 812.2(c)(3) are exempt from the regulations at 21 CFR 812, with the exception of section 812.119. The criteria at section 812.2(c)(3) include specifying that testing:
4 See, 21 CFR 801.4 5 See, id.
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• be non-invasive,
• not require an invasive sampling procedure that presents a significant risk,
• not by design or intention introduce energy into a subject, and
• not be used as a diagnostic procedure without confirmation of the diagnosis by
another, medically established diagnostic product or procedure.
The criteria in section 812.2(c)(3) also include compliance with labeling requirements section CFR 809.10(c), which exempts shipments and other deliveries of IVDs from certain labeling requirements if either (1) the device complies with part 812, or (2) the investigation is not subject to part 812 and one of the following conditions is met:
(i) For a product in the laboratory research phase of development, and not represented as an effective in vitro diagnostic product, all labeling bears the statement, prominently placed: "For Research Use Only. Not for use in diagnostic procedures.''
(ii) For a product being shipped or delivered for product testing prior to full commercial marketing (for example, for use on specimens derived from humans to compare the usefulness of the product with other products or procedures which are in current use or recognized as useful), all labeling bears the statement, prominently placed: "For Investigational Use Only. The performance characteristics of this product have not been established.''
For purposes of this guidance document, "labeled RUO" refers to IVD products labeled in accordance with section 809.10(c)(2)(i); "labeled IUO" refers to IVD products labeled in accordance with section 809.10(c)(2)(ii) unless otherwise specified. Examples of products that meet the criteria for these designations are provided in Section III.
Because these products are exempt from most regulatory controls, it is important that they are not distributed for clinical diagnostic uses.
Mere placement of an RUO or IUO label on an IVD product does not render the device exempt from otherwise applicable clearance, approval, or other requirements. FDA may determine that the device is intended for use in clinical diagnosis based on other evidence, including how the device is marketed.
In general, if evidence shows that an IVD product is inappropriately labeled RUO or IUO, and that the product does not qualify for an investigational device exemption under 520(g) of the Act, and is not cleared, approved, or 510(k)-exempt, the device would be misbranded under sections 502(a) and 502(o) of the Act, 21 U.S.C. 352(a), 352(o), and adulterated under section 501(f) of the Act, 21 U.S.C. 351(f).
NEW PHOTO. NEWS!:
The feasibility study required by the FDA is to clear the devices for Investigational purposes. And the photo illustrates this. IT LOOKS LIKE WERE GETTING FDA CLEARANCE. THE CONFIDENCE LEVEL IS HIGH!Photo of DECN’s Covid-19 Saliva Swift Kit test kits received in US that includes package of 25 test strips, a sample test strip in the foreground, a saliva collection tube, meter reader with adapter and package box. For investigational and testing purposes only. pic.twitter.com/ubILubc96q
— Covid Swift Kit (@covidswiftkit) August 13, 2020
READ: WE WILL GET CE MARK: https://healthmanagement.org/c/healthmanagement/issuearticle/two-paths-for-medical-device-approval-fda-vs-ce
“Several factors influence the length of time it takes for a medical device, particularly a new device, to reach its end user. One is the time it takes medical manufacturers to navigate regulatory demands, proving a device’s safety and effectiveness before it gets to market. In terms of these demands, companies routinely face one simple but weighty decision: should they seek the United States’ Food and Drug Administration (FDA) approval or the European CE mark?
Two Approaches
The choice is not necessarily an either/or, of course, but many companies don’t have the resources to pursue both approvals at once. The differences between the two approaches stem from a central divide: the U.S. approach assesses the device’s effectiveness as well as its risk of harm; the CE mark, on the other hand, affirms simply that the product “meets high safety, health and environmental protection requirements” (European Commission 2015). Ideally then the U.S. approval would ensure not only that the product poses no harm to consumers, but also that it does what it claims to do. Critics of the FDA system argue instead that this goal adds time and unpredictability to the approval process without in fact establishing the effectiveness of the device.
Measurable Differences
Congress established the framework of the FDA’s current regulatory system in the Medical Device Amendments of 1976, with major modifications occurring in the 1990s (Rados 2006). However, the last major change to the medical device review, the Medical Device User Fee and Stabilization Act (MDUFSA) of 2005, merely added the requirement of a fee for medical device manufacturers seeking FDA clearance. The proceeds of the fee were meant to hire additional staff to improve the process (Rados 2006). Critics say it is overdue for reform.
For medical devices, the FDA assigns new products a classification of I, II or III, with Class III devices requiring a far more stringent trial process, the Premarket Approval Process or PMA than those in Class I or II. The classification is based on the degree of harm the device might pose and the specificity of its indications for use (U.S. Food and Drug Administration 2014a). However, only the truly novel device will require a PMA. If the manufacturer can prove “substantial equivalence” to a product already on the market, the device needs only to gain a less rigorous form of clearance, the 510(k).
A 2014 paper in the Journal of the American Medical Association (JAMA) called out as well an “underexamined third way for a device to reach the market [is] via the ‘supplement’ process, used for modifications of devices originally approved through a PMA” (Rome et al. 2014). They found that most “new device models are deemed safe and effective without requiring new clinical data”, even when those new models “involve significant design changes” (Rome et al. 2014).
Indeed, a 2011 Institute of Medicine committee recommended that the FDA eliminate the 510(k) altogether: “Rather than continuing to modify the 35-year-old 510(k) process, the IOM concludes that the FDA’s finite resources would be better invested in developing an integrated premarket and postmarket regulatory framework that provides a reasonable assurance of safety and effectiveness throughout the device life cycle” (Institute of Medicine of the National Academies 2011).
Timeframe
With its many exemptions and various tracks, the FDA’s approval process is widely considered more cumbersome and less clear than the CE marking process. A 2012 report by the Boston Consulting group quantified as much, analysing approvals “for the most innovative and potentially risky medical technologies”
(those requiring PMA) from 2000 through 2011. They concluded that “the same devices have been approved and made available to patients in Europe three or more years before devices are approved in the U.S” (Boston Consulting group 2012).
Effects
Calling the FDA approval process for Class III devices “confusing and repetitive,” the study’s authors identified a troubling trend for the U.S. population: “sustained approval differences are encouraging companies to favour innovations that will serve European markets and reducing the incentive to innovate for the specific needs of the U.S” (Boston Consulting group 2012).
This very outcome has been tacitly acknowledged by the FDA. On 22 April 2014 the FDA proposed an expedited premarket approval process for devices addressing unmet medical needs (U.S. Food and Drug Administration 2014b). The FDA’s Medical Device Reimbursement Task Force, created in December 2013, shares the goal of promoting innovation and getting important devices to market. The group aims to “shorten the time medical device manufacturers wait before health plans will pay for products after they’re approved”—a critical barrier that manufacturers face even after completing their FDA submissions. “We recognize that the mere fact the FDA approves or clears a device is not equivalent with patients getting access to that device,” said Murray Sheldon, associate director of technology and innovation at the FDA (Dickson 2013).”
Look at first two EUA’s on this (Individual EUAs for Molecular Diagnostic Tests for SARS-CoV-2) list. NOW LOOK AT THE ONLY TWO ANTIGEN TEST EUAs ON THIS LIST: Individual EUAs for Antigen Diagnostic Tests for SARS-CoV-2
Outbreaks hit schools across the South
https://www.washingtonpost.com/nation/2020/08/13/coronavirus-covid-live-updates-us/
COVID-19 death rates reveal states that failed: New York and New Jersey
https://nypost.com/2020/08/12/covid-19-death-rates-reveal-ny-and-nj-are-states-that-failed-the-test/
Coronavirus is revealing broken America’s economy really is
https://www.theguardian.com/news/datablog/2020/apr/06/coronavirus-american-reaction-economy-covid-19
READ NOW IT MAKES SENSE: 3. Definitions and Scope
https://www.fda.gov/media/81784/download
For the purposes of this guidance, clinical study types are defined as follows:3
? An early feasibility study is a limited clinical investigation of a device early in
development, typically before the device design has been finalized, for a specific indication (e.g., innovative device for a new or established intended use, marketed device for a novel clinical application). It may be used to evaluate the device design concept with respect to initial clinical safety and device functionality in a small number of subjects (generally fewer than 10 initial subjects) when this information cannot practically be provided through additional nonclinical assessments or appropriate nonclinical tests are unavailable. Information obtained from an early feasibility study may guide device modifications. An early feasibility study does not necessarily involve the first clinical use of a device.
? A first in human (FIH) study is a type of study in which a device for a specific indication is evaluated for the first time in human subjects. This document only discusses FIH studies that meet the definition of an early feasibility study.
? A traditional feasibility study is a clinical investigation that is commonly used to capture preliminary safety and effectiveness information on a near-final or final device design to adequately plan an appropriate pivotal study. Because the study of a near-final or final device design takes place later in development than an early feasibility study, FDA would expect to see more nonclinical (or prior clinical) data in a traditional feasibility study IDE application.4 A traditional feasibility study does not necessarily need to be preceded by an early feasibility study.
? A pivotal study is a clinical investigation designed to collect definitive evidence of the safety and effectiveness of a device for a specified intended use, typically in a statistically justified number of subjects. It may or may not be preceded by an early and/or a traditional feasibility study.
Early feasibility studies may be conducted for multiple reasons, such as obtaining initial insights into:
? the clinical safety of the device-specific aspects of the procedure;
? whether the device can be successfully delivered, implanted or used;
? operator technique challenges with device use;
? human factors (e.g., difficulties in comprehending procedural steps);
? the clinical safety of the device (e.g., evaluation of device-related serious adverse events);
? whether the device performs its intended purpose (e.g., mechanical function, making
intended measurements);
3 In this guidance, the term ‘feasibility’ is considered synonymous with ‘pilot.’ For consistency purposes, ‘feasibility’ is the term that should be used in reference to the types of clinical studies that precede the pivotal study phase.
4 Additional nonclinical testing could be completed concurrent with conducting the early feasibility study if needed to support the conduct of a traditional feasibility or pivotal study.
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Contains Nonbinding Recommendations
? device failures;
? patient characteristics that may impact device performance (e.g., anatomical limitations);
and
? therapeutic parameters (e.g., energy applied, sizing, dose released) associated with device
use.
Unlike traditional feasibility studies, which are focused on providing initial clinical safety and effectiveness information for a near final or final device design or capturing data to guide the development of a pivotal study, early feasibility studies have a broader purpose. Early clinical experience obtained from an early feasibility study increases the efficiency of the device development process, as it may be used to:
? identify appropriate modifications to the procedure or device; ? optimize operator technique;
? refine the intended use population;
? refine nonclinical test plans or methodologies; and
develop subsequent clinical study protocols
READ “Early feasibility studies allow for early clinical evaluation of devices to provide proof of principle and initial clinical safety data. These studies may be appropriate early in device development when clinical experience is necessary because nonclinical testing methods are not available or adequate to provide the information needed to advance the developmental process. https://www.fda.gov/media/81784/download THIS IS WHY BERMAN CAME DOWN ON THE FDA.
READ: Investigational Device Exemptions for Early Feasibility Medical Device Clinical Studies, Including Certain First in Human (FIH) Studies.
https://www.fda.gov/media/81784/download
This document is intended to provide guidance to FDA staff, clinicians, medical device innovators, and industry on the development and review of Investigational Device Exemption (IDE) applications for early feasibility studies of significant risk devices.1 Early feasibility studies allow for early clinical evaluation of devices to provide proof of principle and initial clinical safety data. These studies may be appropriate early in device development when clinical experience is necessary because nonclinical testing methods are not available or adequate to provide the information needed to advance the developmental process. As with all clinical studies, initiation of an early feasibility study must be justified by an appropriate benefit-risk analysis and adequate human subject protection measures.
UNTIL BERMAN PROVES THAT HE HAS THE GOODS I WILL “PUT HIM TO THE TEST.” THE ELECTROCHEMICAL IMPEDANCE ARTICLES THAT I POST CORRELATE TO THE IMPEDANCE FUNCTIONALITY FOR VIRAL DETECTION AND ADDITIONAL MEDICAL PURPOSES THAT ARE WIDELY RECOGNIZED AND KNOWN. BUT I DO NOT APPRECIATE BERMAN’S EXCESSIVELY EXAGGERATED AND INFLATED PRESS RELEASES THAT ATTRACTED THE ATTENTION OF THE SEC. BERMAN DID NOT ACT WISELY. AND BY DOING THAT, BERMAN DID NOT EXPRESS ANY CONSIDERATION FOR SHAREHOLDER INTERESTS. BUT DECN DOES HAVE THE TECHNOLOGY IMPLEMENTED FOR THE GLUCOSE TESTS. AND THAT CAN BE CONFIGURED FOR VIRUS DETECTION.
Wall Street Journal: https://www.wsj.com/market-data/quotes/DECN/research-ratings
READ THIS: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7247998/
Electrochemical detection of viruses and antibodies: A mini review
IT WILL; DECN HAS IT: Perspectives of Biosensors Integrated Point of Care Testings for Personalized Screening of Coronavirus Disease
http://phantomsfoundation.com/ONLINE/Biosensors2020/Abstracts/Biosensors2020_Li.pdf
Accuracy of U.S. coronavirus data thrown into question as decline in testing skews drop in new cases https://www.cnbc.com/2020/08/12/accuracy-of-us-coronavirus-data-thrown-into-question-as-decline-in-testing-skews-drop-in-new-cases.html
Forget about vaccine: Robert Koch Institute withdraws optimistic vaccine claim:
https://www.dw.com/en/coronavirus-germanys-robert-koch-institute-withdraws-optimistic-vaccine-claim/a-54542513
IF OVERSEA TESTING RESULTS ARE AS BERMAN REPORTED/PURPORTED, CE MARK IS IMMINENT.
“The FDA continues to help facilitate innovation in test development, thereby enhancing Americans’ access to COVID-19 tests,” said FDA Commissioner Stephen M. Hahn, M.D. “The recommendations provided today are intended to help get tests to market that are simple enough to use at home, similar to a pregnancy test. We hope that with the innovation we’ve seen in test development, we could see tests that you could buy at a drug store, swab your nose or collect saliva, run the test, and receive results within minutes at home, once these tests become available. These types of tests will be a game changer in our fight against COVID-19 and will be crucial as the nation looks toward reopening.”
The template includes recommendations for validation when a sample is to be collected and analyzed, and results are to be returned without the need to send a sample to a lab for analysis. The template also gives recommendations for validation of tests that are intended to be made available over-the-counter, that is, without a prescription.
https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-posts-new-template-home-and-over-counter-diagnostic-tests-use-non
If Berman is conducting tests successfully overseas, then why wait for feasibility tests?
Regulation medical devices outside European Union https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3326589/
THIS IS ANOTHER BERMAN LIE: “the company's testing overseas is showing that both Covid-19 Swift Kits, for blood and saliva, complete their assays in 10.5 seconds or less, proving that true "rapid" testing is achievable. And, because our testing is based on our diabetes testing model using a meter and strip, just as important is its scalability, a key ingredient necessary to meet the nation's testing needs. DECN has been continuing its testing efforts overseas.” IF THIS IS TRUE, THEN BERMAN WOULD NOT HAVE A PROBLEM VIDEO DOCUMENTING THE INDICATED TESTS.
Buy rating: Given the current short-term trend, the stock is expected to rise 91.95% during the next 3 months and, with 90% probability hold a price between $0.50 and $0.85 at the end of this period.
https://stockinvest.us/technical-analysis/DECN
VOTE FOR BERMAN’S REMOVAL FROM THE BIO AND ANY AFFILIATION WITH DECN OR PHARMA TECH SOLUTIONS.
READ: “All tested products meet requirements. The procedure utilising the Bactometer, provides a rapid and accurate system for the determination of bacterial content. The results of validation carried out during this study indicate, possibility to use impedimetric method alternatively to traditional methods.” https://www.biomerieux.com/en/biomerieux-receives-ce-mark-certification-ivd-products-maketed-european-union
Remember the last open letter? Berman still continued with amendments after he blasted the FDA in that letter.
READ: Zilico Receives CE Mark, https://www.medgadget.com/2013/10/zilico-receives-ce-mark-for-zedscan-i.html WE GOT THIS; DEFINITELY.
All Bullish; .38 support. http://www.stockta.com/cgi-bin/analysis.pl?symb=DECN&cobrand=&mode=stock
...and came back. I WANT TO BE HERE FOR THIS TECHNOLOGY.
FDA CLEARANCE AND CE MARK IMMINENT. DIAGNOSTIC GLUCOSE TESTS ARE APPROVED FOR HOME, USING THE SAME ELECTROCHEMICAL IMPEDANCE. BERMAN ALSO HAS 10.5 SECOND TESTING OVERSEAS, THAT WILL GAIN CE MARK. I WOULDN’T WORRY ABOUT THE OPEN LETTER. IT IS ADDRESSING ILLOGICAL AND HYPOCRITICAL ISSUES THAT ARE EMBEDDED IN THE FDA GUIDANCE.
...”The FDA needs to act quicker. That means reducing burdensome sensitivity requirements as has been suggested by many well-respected experts and instead focusing more on time to result reporting (speed) and costs. It also means considering the elimination of wasteful, time consuming and unproductive regulations in order to cut through the red tape. Guidelines should be constructed to include testing that can actually be accomplished by lay, at-home users. Our elected officials took such actions on behalf of all Americans when their willingness to safely relax burdensome regulations helped deliver a record economy and employment.
If we are to get this virus under control, it's going to take that same level of resolve and flexibility to deliver rapid testing results. As reported in the New York Times on August 7, 2020, "Experts are revising their views on the best methods to detect infections, setting aside long-held standards so that the spread of the virus can be more quickly tracked and contained […] The best chance to rein in the sprawling outbreaks in the United States now, experts say, requires widespread adoption of less accurate tests, as long as they're administered quickly and often enough." We firmly believe that GenViro! Swift kits will help alleviate the need to adopt less accurate tests while still reporting Covid-19 test results in an anticipated 10.5 seconds. Some have even suggested we need a "Manhattan Project" approach to attacking this virus. We cannot afford to let such regulations get in our way.” Lives and our economy are at stake. https://finance.yahoo.com/news/decn-ceo-releases-open-letter-142000916.html
“...the company's testing overseas is showing that both Covid-19 Swift Kits, for blood and saliva, complete their assays in 10.5 seconds or less, proving that true "rapid" testing is achievable.”
I’M BACK FOR THE LIGHT SPEED ROCKET RIDE!
“Further measurements were performed for those electric field strengths at nd frequency while varying the concentrations of baculovirus, TMV, and influenza A (H1N1) virus solutions. The data clearly showed that the virus concentration can be quantified by the impedance value. Furthermore, the three virus types could be distinguished by plotting the phase at 100 kHz against the phase of the peak value of the imaginary component of the impedance for each virus type
The results nevertheless show that the proposed nonlinear impedance spectroscopy method may achieve a sensitivity comparable to that of PCR and immunodetection systems. The response time to sweep the frequency for each measurement was about a few minutes, which will be enough fast for the continuous monitoring of environment. One of the large remaining issues is to evaluate the detection and identification ability of some specific viruses from the heterogeneous mixture of crude sample. That is the universal challenge for any types of biosensing methods, and also the future work to put this method into practical use.” https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4563260/
“Potentially, the sensing circuit might be able to be connected to a cell phone,” says Gongalsky. This would avoid the current requirement for expensive impedance analysing equipment.
The initial focus on a specific strain of influenza virus was driven by the serious seasonal outbreaks of influenza that hit Russia, especially Moscow with its very high population density.
“Now the study will get even more personal, as the Covid-19 disease spreads through Russia, and the wider world,” project supervisor Liubov Osminkina concludes.
Looking to the possibilities of new viral threats, the researchers point out that the procedure may be especially useful in the early days of an epidemic, as conventional tests can take longer to develop. https://www.journals.elsevier.com/results-in-materials/news/seeking-simpler-tests-for-viruses