scholarly journals The Dynamics of SARS-CoV-2 (RT-PCR) Testing

2021 ◽  
Vol 2021 ◽  
pp. 1-7
Author(s):  
Nicole Joyce ◽  
Lynsey Seim ◽  
Michael Smerina
Keyword(s):  
Diagnostic Testing ◽  
The United States ◽  
In Vitro Diagnostics ◽  
Rt Pcr ◽  
The Public ◽  
Department Of Health ◽  
Federal Food ◽  
In Vitro Diagnostic ◽  
Cautious Interpretation

The COVID-19 pandemic caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is estimated to have affected 6.2 million people in the United States and 27.5 million people worldwide as of September 9, 2020. On February 2, 2020, the Secretary of the Department of Health and Human Services (HHS) determined that the public health emergency justified the development and emergency use of “in vitro diagnostics for the detection and/or diagnosis of the virus that causes COVID-19” by activating the Emergency Use Authorization (EUA) authority under section 564 of the Federal Food, Drug, and Cosmetic Act. Unfortunately, effective mitigation efforts were thwarted early in the outbreak resulting in an expansion of the initial EUA on February 29, 2020, to improve accessibility to in vitro diagnostic testing. Expectantly, the development and deployment of SARS-CoV-2 testing including RT-PCR expanded rapidly in the weeks following the EUA expansion. These newly developed and approved SARS-CoV-2 RT-PCR tests boast impressive positive and negative agreement rates nearing 100%. Despite the exceptionally high rates of agreement, caution is advised as the RT-PCR tests approved under the COVID-19 EUA are in vitro analyses developed with samples artificially doped with SARS-CoV-2 RNA. These tests therefore do not have clinically applicable sensitivity and specificity because they lack a “gold standard” for diagnosis. Here we present three challenging cases requiring cautious interpretation of the newest generation of RT-PCR molecular detection assays, highlighting the major challenges faced by providers treating patients potentially infected with SARS-CoV-2.

scholarly journals Application of the Department of Health and Human Services proposed waived status requirements for in vitro diagnostic testing devices: case study

1997 ◽  
Vol 43 (9) ◽  
pp. 1610-1617 ◽  
Author(s):  
Sharon S Ehrmeyer ◽  
Ronald H Laessig
Keyword(s):  
Reference Range ◽  
Clinical Laboratory ◽  
Health Care Financing ◽  
Diagnostic Testing ◽  
Test System ◽  
Department Of Health ◽  
In Vitro Diagnostic ◽  
Clinical Laboratory Testing

Abstract The CLIA’88 classified all clinical laboratory testing as waived, moderate, or high complexity. The eight original waived tests were characterized as simple, accurate, error-free, risk-free, and suitable for home use by nonlaboratory professionals. The subjective nature of the classification process was challenged immediately. The Clinical Laboratory Improvement Advisory Committee asked the CDC and the Health Care Financing Administration to develop objective criteria that included assessment of performance by field-test and in-house data. We examined the efficacy of the CDC protocol with empirical data from the HemoCue B-Hemoglobin Test System® submission, to assess operator competency, intra-/interoperator and between-site imprecision, and accuracy. Non-laboratory-trained operators demonstrated 2–3% imprecision (40–200 g/L). Accuracy studies yielded a slope of 1.01, an intercept of 3.53 g/L, and r of 1.00 (52–230 g/L). Results met the protocol’s Tonks’ criterion for imprecision (less than one-fourth of the reference range).

In Vitro Diagnostics for COVID-19: State-of-the-Art, Future Directions and Role in Pandemic Response

2021 ◽  
Author(s):  
Sandeep Kumar Vashist ◽  
Subramanian Murugan ◽  
Guiffo Djoko
Keyword(s):  
Point Of Care ◽  
Immunoglobulin A ◽  
The United States ◽  
Immunoglobulin M ◽  
In Vitro Diagnostics ◽  
Rt Pcr ◽  
United States Food ◽  
States Food ◽  
Almost All

There have been tremendous advances in in vitro diagnostics (IVD) for coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Although the confirmatory clinical diagnosis is made by real-time reverse transcriptase polymerase chain reaction (RT-PCR), lateral flow immunoassay (LFIA) based viral antigen (Ag) detection is used for mass population screening at point-of-care (POC) settings. The rapid RT-PCR tests (such as from Cepheid and Bosch) have an assay duration of less than 40 min, while most rapid Ag tests (such as Abbott’s BinaxNOW™ COVID-19 Ag card) have an assay duration of about 15 min. Of interest is the POC molecular test (ID NOW™) from Abbott that takes less than13 min. Similarly, many immunoassays (IAs), i.e., automated chemiluminescent IA (CLIA), manual ELISA, and LFIA, have been developed to detect immunoglobulin G (IgG), immunoglobulin M (IgM), and immunoglobulin A (IgA) produced in subjects after SARS-CoV-2 infection. Many IVD tests have been approved by the United States Food and Drug Administration (FDA) under emergency use authorization (EUA), and almost all IVD tests are Conformité Européenne (CE) certified.

scholarly journals Immunochromatographic assays for COVID-19 epidemiological screening: our experience

2020 ◽  
Author(s):  
Andrea Bartolini ◽  
Margherita Scapaticci ◽  
Marina Bioli ◽  
Tiziana Lazzarotto ◽  
Maria Carla Re ◽  
...  
Keyword(s):  
Healthcare Workers ◽  
World Health ◽  
Rt Pcr ◽  
Serological Screening ◽  
Rapid Assays ◽  
In Vitro Diagnostic ◽  
Biomedical Prevention ◽  
Health Organization ◽  
Performance Validation

In March 2020, the World Health Organization (WHO) declared a pandemic caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Due to the absence of effective treatment or biomedical prevention, understanding potential post infection immunity has important implications for epidemiologic assessments. For this reason, increasing number of in vitro diagnostic companies are developing serological assays to detect antibodies against SARS-CoV-2, but most of them lack the validation by third parties in relation to their quality, limiting their usefulness. We submitted to serological screening by two different immunochromatographic (IC) rapid testing for detection of IgG and IgM against SARS-CoV-2, 151 asymptomatic or minimally symptomatic healthcare workers previously tested positive for SARS-CoV-2 RT-PCR in order to evaluate the performance of rapid assays. Results showed discrepancies between molecular and IC results, and an inconsistency of immunoglobulins positivity patterns when compared to ELISA/CLIA results, highlighting the absolute necessity of assays performance validation before their marketing and use, in order to avoid errors in the results evaluation at both clinical and epidemiological level.

Current nursing practice of point-of-care laboratory diagnostic testing in critical care units

1995 ◽  
Vol 4 (6) ◽  
pp. 429-434 ◽  
Author(s):  
Lamb LSJr ◽  
RS Parrish ◽  
SF Goran ◽  
MH Biel
Keyword(s):  
Critical Care ◽  
Patient Care ◽  
Laboratory Testing ◽  
Point Of Care ◽  
Diagnostic Testing ◽  
Critical Care Nurses ◽  
Point Of Care Testing ◽  
Critical Care Units ◽  
In Vitro Diagnostic

BACKGROUND: The development of user-friendly laboratory analyzers, combined with the need for rapid assessment of critically ill patients, has led to the performance of in vitro diagnostic testing at the point of care by personnel without formal laboratory training. OBJECTIVES: To determine the range of laboratory testing performed by critical care nurses and their attitudes toward this role. METHODS: A survey of critical care nursing consultants was conducted, using a modified Likert scale, to assess objective measures of point-of-care testing practice in critical care units and to determine nurses' attitudes toward the practice of point-of-care testing. Statistical analysis was performed to determine significant trends in responses. RESULTS: Of the units responding to the survey, 35% used critical care nurses exclusively to perform point-of-care testing, 32.5% used laboratory technicians and critical care nurses, and 25% used other personnel. Of critical care nurses performing laboratory testing, 95.5% performed blood glucose analysis; 18.7%, arterial blood gas analysis; 4.5%, electrolyte analysis; 4.5%, hematology profiles; and 22.7%, other testing. Most agreed that stat tests were not reported promptly, thereby necessitating bedside testing. Respondents indicated that they would prefer that laboratory personnel operate in vitro diagnostic equipment and that requirements for critical care nurses to perform laboratory testing detracted from other patient care duties. CONCLUSIONS: Most nurses who perform point-of-care testing responded that it was necessary and helpful in patient management. However, they would prefer, because of their other patient care responsibilities, that laboratory personnel take this responsibility.

Japanese healthcare system: in vitro diagnostic tests and reimbursements

1994 ◽  
Vol 40 (8) ◽  
pp. 1663-1667 ◽  
Author(s):  
A Shimauchi
Keyword(s):  
Healthcare System ◽  
Prescription Drugs ◽  
Diagnostic Tests ◽  
Diagnostic Testing ◽  
Universal Coverage ◽  
Medical Expenditures ◽  
National Medical ◽  
Dental Procedures ◽  
In Vitro Diagnostic

Abstract In 1961, a new and mandatory National Health Insurance plan was enacted in Japan. This healthcare system has succeeded in providing universal coverage while also containing the growth of national medical expenditures (NME) to the rate of growth of the gross national product (GNP), namely, approximately 4-5% annually, for several decades. All Japanese medical procedures, including dental procedures, prescription drugs, and diagnostic tests, are reimbursed by a fee schedule set by the Ministry of Health and Welfare. The combination of strict fee control and low administration costs has kept the Japanese NME growth below that of the GNP. In 1990, NME was 20.6 trillion yen ($187 billion), total diagnostic testing expenditures (DTE) were 2.3 trillion yen, representing 11.2% of national medical expenditures (NME). Of this amount, in vitro diagnostic testing accounted for 1.4 trillion yen, representing 61% of DTE and 6.8% of NME. Annually, 1.8 billion in vitro diagnostic tests are performed.

Regulation of in vitro diagnostics (IVDs) for use in clinical diagnostic laboratories: towards the light or dark in clinical laboratory testing?

2011 ◽  
Vol 49 (12) ◽  
Author(s):  
Emmanuel J. Favaloro ◽  
Mario Plebani ◽  
Giuseppe Lippi
Keyword(s):  
Clinical Laboratory ◽  
Regulatory Process ◽  
Adverse Outcomes ◽  
Personal Health ◽  
In Vitro Diagnostics ◽  
Clinical Diagnostic ◽  
In Vitro Diagnostic ◽  
The Usa ◽  
Clinical Laboratory Testing

AbstractA revised framework for the regulation of in vitro diagnostic devices (IVDs) came into force in Australia on July 1, 2010 that aims to ‘ensure that public and personal health are adequately protected’, but which instead may lead to adverse outcomes in clinical diagnosis and management. The regulatory process aims to regulate all IVDs, including those used by clinical diagnostic laboratories, which are already subject to scrutiny as part of the current laboratory accreditation process. The IVD regulatory process initiated in Australia is similar to that used in Canada, but different to that currently operating in the USA and Europe. However, it is feasible that other countries will in time adopt a similar regulatory framework, given that many countries are involved in the development process. In this opinion paper, the regulatory process for IVDs across several geographies are outlined, as are some benefits and weaknesses of the new regulatory process now applied to Australia, as potentially planned for other regions of the world.

COVID-19 Diagnostic Testing: Lessons Learned for Innovative Product Development During A Public Health Emergency

2020 ◽  
Vol 25 (3) ◽  
Author(s):  
Christopher Lamb
Keyword(s):  
Public Health ◽  
Diagnostic Tests ◽  
Financial Incentives ◽  
Diagnostic Testing ◽  
Adaptive Immune Response ◽  
Lessons Learned ◽  
In Vitro Assays ◽  
Health Crisis ◽  
In Vitro Diagnostic

In response to the Coronavirus Disease-2019 (COVID-19) pandemic, the U.S. Food and Drug Administration (FDA) used its emergency authority through Emergency Use Authorizations (EUAs) to make COVID-19 in vitro diagnostic tests widely available to both diagnose active infection and help identify individuals with an adaptive immune response indicating recent or prior infection. Hundreds of innovative tests were quickly developed under Section IV.D. of FDA’s Policy for Diagnostic Tests for Coronavirus Disease-2019. National reimbursement guidance through Centers for Medicare & Medicaid Services (CMS) provided significant financial incentives to track the endemic and enable healthcare workers and others get back to work more quickly. The US market for tests grew rapidly and the now exceeds $15 billion. However, many issues regarding product quality and availability have plagued the industry and called into question FDA’s policy and regulatory framework for allowing these tests to be commercially available. This paper analyzes the development of COVID-19 in vitro assays and the lessons learned for innovation during a public health crisis.

Preparing for Agroterror: How is the Texas Animal Health Commission Implementing Federal Food Security Regulations?

2015 ◽  
Vol 6 (1) ◽  
Author(s):  
Jordan Hunter
Keyword(s):  
United States ◽  
Food Supply ◽  
Large Scale ◽  
Animal Health ◽  
Health And Safety ◽  
The United States ◽  
United States Government ◽  
Agricultural Industry ◽  
The Public ◽  
Department Of Health

AbstractAgroterrorism is a subform of bioterrorism with the potential to have a crippling impact on both the agricultural industry and the food supply of a nation. A calculated attack using a miniscule amount of pathogenic or disease causing substances on the livestock or crops in one rural community can spread to animals and metropolitan regions much farther away long before any response from state or federal veterinary or agricultural organizations. Although there have been no large-scale agroterrorism attacks in the United States, there have been historical precedents for agricultural biological warfare and recent examples of unintentional or accidental spread of pathogens in the food supply that have threatened the health and safety of the public. Along with an ongoing push for preparedness to prevent a biological attack on the U.S. agricultural industry, there is a great deal of uncertainty and conflict among landowners, farmers, analysts, and politicians about what methods should be implemented to safeguard the public. In response to this possible threat, the United States government has implemented legislation that it considers preemptive in its ability to safeguard the food supply and manage the public health and/or biological crime response in a widespread agroterrorist attack scenario. However, this requires cooperation on both the state and federal levels, and of several agencies including the department of Health, U.S. Department of Agriculture (USDA), Federal Bureau of Investigation, and the Department of Health and Human Services. This paper examines the steps being taken by the USDA in fulfilling the orders of the federal government in response to the looming threat of agroterrorism and how the TAHC works cooperatively with federal agencies and the private agricultural industry to carry out these regulations.

scholarly journals Closing the Regulatory Gap for Synthetic Nicotine

2017 ◽  
Author(s):  
Patricia Zettler ◽  
Natalie Hemmerich ◽  
Micah L. Berman
Keyword(s):  
New Product ◽  
The United States ◽  
Tobacco Product ◽  
The Public ◽  
Comprehensive Plan ◽  
Federal Food ◽  
Potential Benefits ◽  
Definition Of ◽  
Nicotine Regulation ◽  
The U.S

In July 2017 the U.S. Food and Drug Administration (FDA) announced a new “comprehensive plan for tobacco and nicotine regulation.” This plan is focused on making cigarettes less addictive while facilitating the development of alternative nicotine-containing products that are far less harmful. This approach holds promise, and the public health stakes could not be higher—smoking is the leading cause of preventable death in the United States, causing roughly 480,000 deaths per year. But a new product is emerging that could upset the FDA’s plans for a well-balanced regulatory scheme: synthetic nicotine. These products currently fall into a regulatory gap because they fall outside the Federal Food, Drug, and Cosmetic Act’s (FDCA) definition of a tobacco product. If this gap remains in place, it is likely that more companies will exploit it in order to evade regulation, undoing the potential benefits of the FDA’s plan for tobacco and nicotine regulation. This Article argues that the FDA can, and should, address this problem by regulating synthetic nicotine products as drugs. After reviewing the science of nicotine addiction and the FDA’s past and present regulatory schemes for nicotine, it explains how the FDA could establish that synthetic nicotine satisfies the FDCA’s definition of a drug. It concludes with a discussion of the policy benefits of categorizing synthetic nicotine as a drug.Citation: Patricia J. Zettler, Natalie Hemmerich, & Micah L. Berman, Closing the Regulatory Gap for Synthetic Nicotine, 59 B.C. L. Rev. ___ (forthcoming 2018).

Impact of an unusual disulfide transformation on detection of isothermal amplification products

2021 ◽  
Vol 99 (1) ◽  
pp. 79-86
Author(s):  
Kenneth A. Browne ◽  
Amy Chau ◽  
Janice Cline ◽  
Maria Savage
Keyword(s):  
Nucleic Acids ◽  
Diagnostic Testing ◽  
Diagnostic Techniques ◽  
Reduced Form ◽  
Screening Assay ◽  
Viral Pathogens ◽  
Yellow Colour ◽  
In Vitro Diagnostic ◽  
A Minor

Detection of infectious pathogens such as HIV-1, HPV, and SARS-CoV-2 from biospecimens is critical to healthcare. Particularly sensitive and specific diagnostic techniques to accomplish this include molecular amplification and detection tests of nucleic acids from pathogens. Such tests are comprised of reagent compositions to facilitate hybridization of primers and probes that are complementary to specifically amplified sequences of the analyte target. One of these reagents from an isothermal molecular assay occasionally changed its physical appearance over time, generating interest into the cause of the transformation and suitability of the reagent in diagnostic testing. A preliminary hypothesis was that the 2,2′-dithiodipyridine component was the pre-chromophoric compound of its distinctly yellow reduced form, 2-thiopyridine. However, under oxidizing conditions, 2-thiopyridine is a minor constituent of hybridization reagents and not a major contributor to the yellow colour. Instead, a new yellow compound was isolated from coloured hybridization reagent, identified as 1-(2′-pyridyl)-2-thiopyridone and determined to be the result of an intramolecular cyclic rearrangement and sulfur extrusion from 2,2′-dithiodipyridine under acidic and oxidizing conditions. Neither the appearance of 1-(2′-pyridyl)-2-thiopyridone, nor the concomitant depletion of 2,2′-dithiodipyridine reduced the sensitivity or specificity of in vitro diagnostic screening assay results for detecting amplified nucleic acids from viral pathogens, ensuring the safety of tested blood transfusion products.

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