scholarly journals Rapid Antigen Tests for Influenza: Rationale and Significance of the FDA Reclassification

2018 ◽  
Vol 56 (10) ◽  
Author(s):  
Daniel A. Green ◽  
Kirsten StGeorge

ABSTRACT Rapid antigen tests for influenza, here referred to as rapid influenza diagnostic tests (RIDTs), have been widely used for the diagnosis of influenza since their introduction in the 1990s due to their ease of use, rapid results, and suitability for point of care (POC) testing. However, issues related to the diagnostic sensitivity of these assays have been known for decades, and these issues gained greater attention following reports of their poor performance during the 2009 influenza A(H1N1) pandemic. In turn, significant concerns arose about the consequences of false-negative results, which could pose significant risks to both individual patient care and to public health efforts. In response to these concerns, the FDA convened an advisory panel in June 2013 to discuss options to improve the regulation of the performance of RIDTs. A proposed order was published on 22 May 2014, and the final order published on 12 January 2017, reclassifying RIDTs from class I to class II medical devices, with additional requirements to comply with four new special controls. This reclassification is a landmark achievement in the regulation of diagnostic devices for infectious diseases and has important consequences for the future of diagnostic influenza testing with commercial tests, warranting the prompt attention of clinical laboratories, health care systems, and health care providers.

2013 ◽  
Vol 7 (07) ◽  
pp. 499-506 ◽  
Author(s):  
Daouda Coulibaly ◽  
Ndahwouh T Nzussouo ◽  
Hervé A Kadjo ◽  
Youssouf Traoré ◽  
Daniel K Ekra ◽  
...  

Introduction: During the 2009 influenza A(H1N1) pandemic (pH1N1), different methods were promoted to reduce the spread of influenza, including respiratory etiquette and vaccination. To identify knowledge gaps about influenza and to plan the vaccination campaign against the pandemic in Côte d’Ivoire, a survey was conducted among health-care providers (HCPs) to assess their knowledge about influenza and their willingness to be vaccinated. Methodology: A cross-sectional survey was performed in the city of Abidjan on 16-18 February 2010, in the three university teaching hospitals, a randomly selected general hospital, and two randomly selected private clinics. In face-to-face interviews, 383 health-care professionals were asked questions about their knowledge of influenza, means of influenza prevention, and their willingness to be vaccinated. Data analysis, both univariate and multivariate, was performed using SPSS. Results: Willingness to be vaccinated against pH1N1 was 80% (n = 284), and 83% of the HCPs would recommend the vaccine to others. The respiratory mode of transmission of influenza was known by 85% (n = 295) of the participants and 50% (n = 174) believed that seasonal influenza virus and pH1N1 virus were different. In a multivariate model, the factors significantly associated with willingness to receive pH1N1vaccine were fear of pH1N1 disease (OR = 2.1; IC = 1.02-4.35), having only a high school education (OR = 8.28; IC = 2.04-33.60), and feeling at risk to contract pH1N1 (OR = 11.43; IC = 4.77-27.38). Conclusion: The willingness to be vaccinated against influenza A (H1N1) by health professionals is real.


2009 ◽  
Vol 3 (11) ◽  
pp. 811-816 ◽  
Author(s):  
Felicia Tulloch ◽  
Ricardo Correa ◽  
Gladys Guerrero ◽  
Rigoberto Samaniego ◽  
Mariana Garcia ◽  
...  

Introduction: In April 2009, a novel influenza A (H1N1) virus was identified in patients from Mexico and the United States.  From 8 May through 25 June 2009, in the Republic of Panama, 467 cases infected with the same virus were identified, 13 of which were hospitalized at the Santo Tomas Hospital in Panama City. Up to the date of this report, no deaths have been reported in Panama. This study presents the first thirteen cases of Influenza A (H1N1) 2009 that were hospitalized in Panama City. Methodology: The Santo Tomas Hospital (HST), a third-level institution of the Ministry of Health (MINSA) for adult health care (patients above the age of 14), was designated as the reference center for treating these cases. For this purpose, the norms and criteria established by the system were followed and every patient (case) presenting flu-like symptoms was included (fever equal or greater than 38ºC (100.4ºF), cough, sore throat, rhinorrhea, lethargy in children under the age of one, and respiratory distress). Results: Seventy-six patients were hospitalized as suspected cases for infection with the influenza A H1N1 2009 virus, of which 13 (17.1%) were confirmed as positive. The clinical picture was characterized by fever (100%), cough (92.3%), rhinorrhea (69.2%), malaise (53.8%), headache (53.8%), and only one case presented gastrointestinal symptoms (diarrhoea).  The male:female ratio was 1:2.2. Conclusion:  The knowledge and technology translation previously acquired through courses to the HST health care providers were the key in controlling the first influenza A (H1N1) 2009 cases.


2010 ◽  
Vol 88 (4) ◽  
pp. 589-593 ◽  
Author(s):  
Joanne Embree

The pattern of illness associated with the first wave of the pandemic influenza A H1N1 (swine flu) in the spring and early summer of 2009 in regions of the province of Manitoba in Canada was more severe, on a population basis, than any other northern hemisphere jurisdiction outside of Mexico City. Manitoba accounted for 50% of intensive care admissions and 25% of pediatric admissions, but only 6.5% of deaths, attributable to the virus in Canada during the first wave. Activation and use of emergency response protocols embedded within the routine health authority management system and good communication between the diagnostic laboratory, public health, and health care practitioners was effective in coping with the sudden need for hospitalization of large numbers of children and young adults with severe respiratory illness over a short time period. Early treatment with oseltamivir was associated with a shorter duration of hospitalization among children. Intensive education of health care providers, patients, and visitors, along with close monitoring of infection prevention and control practices, were instrumental in preventing both nosocomial and health care worker infections.


2018 ◽  
Vol 09 (04) ◽  
pp. 772-781 ◽  
Author(s):  
Meghan Reading ◽  
Dawon Baik ◽  
Melissa Beauchemin ◽  
Kathleen Hickey ◽  
Jacqueline Merrill

Background Patient-generated health data (PGHD) collected digitally with mobile health (mHealth) technology has garnered recent excitement for its potential to improve precision management of chronic conditions such as atrial fibrillation (AF), a common cardiac arrhythmia. However, sustained engagement is a major barrier to collection of PGHD. Little is known about barriers to sustained engagement or strategies to intervene upon engagement through application design. Objective This article investigates individual patient differences in sustained engagement among individuals with a history of AF who are self-monitoring using mHealth technology. Methods This qualitative study involved patients, health care providers, and research coordinators previously involved in a randomized, controlled trial involving electrocardiogram (ECG) self-monitoring of AF. Patients were adults with a history of AF randomized to the intervention arm of this trial who self-monitored using ECG mHealth technology for 6 months. Semistructured interviews and focus groups were conducted separately with health care providers and research coordinators, engaged patients, and unengaged patients. A validated model of sustained engagement, an adapted unified theory of acceptance and use of technology (UTAUT), guided data collection, and analysis through directed content analysis. Results We interviewed 13 patients (7 engaged, 6 unengaged), 6 providers, and 2 research coordinators. In addition to finding differences between engaged and unengaged patients within each predictor in the adapted UTAUT model (perceived ease of use, perceived usefulness, facilitating conditions), four additional factors were identified as being related to sustained engagement in this population. These are: (1) internal motivation to manage health, (2) relationship with health care provider, (3) supportive environments, and (4) feedback and guidance. Conclusion Although it required some modification, the adapted UTAUT model was useful in understanding of the parameters of sustained engagement. The findings of this study provide initial requirement specifications for the design of applications that engage patients in this unique population of adults with AF.


2020 ◽  
Vol 11 (4) ◽  
pp. 7
Author(s):  
Jillian Reardon ◽  
Jamie Yuen ◽  
Timothy Lim ◽  
Richard Ng ◽  
Barbara Gobis

The COVID-19 pandemic has generated an unprecedented level of interest in, and uptake of, technology-enabled virtual health care delivery as clinicians seek ways to safely care for patients with physical distancing. This paper describes the UBC Pharmacists Clinic’s technical systems and lessons learned using enabling technology and the provision of virtual patient care by pharmacists.    Of 2036 scheduled appointments at the clinic in 2019, only 1.5% of initial appointments were conducted virtually which increased to 64% for follow-up appointments. Survey respondents (n = 18) indicated an overall high satisfaction with the format, quality of care delivery, ease of use and benefits to their overall health. Other reports indicate that the majority of patients would like the option to book appointments electronically, email their healthcare provider, and have telehealth visits, although a small minority (8%) have access to virtual modes of care. The Clinic team is bridging the technology gap to better align virtual service provision with patient preferences. Practical advice and information gained through experience are shared here.  As the general population and health care providers become increasingly comfortable with video conferencing as a result of COVID-19, it is anticipated that requests for video appointments will increase, technological barriers will decrease and conditions will enable providers to increase their virtual care capabilities. Lessons learned at the Clinic have application to pharmacists in both out-patient and in-patient care settings.   Article Type: Clinical Experience


2009 ◽  
Vol 12 (11) ◽  
pp. 995-1008 ◽  
Author(s):  
Elizabeth A. Ayello ◽  
Kathleen Leask Capitulo ◽  
Caroline E. Fife ◽  
Evonne Fowler ◽  
Diane L. Krasner ◽  
...  

2016 ◽  
Vol 25 (Sup1) ◽  
pp. S3-S23
Author(s):  
Phil Davies

Background Despite the implementation of prevention strategies, pressure ulcers (PUs) continue to be a challenging health problem for patients (and their carers), clinicians and health-care providers. One area of growing interest is the use of prophylactic dressings (which were originally designed for the treatment of PUs and other wound types) as a component of standard prevention measures. Over the past few years, a large amount of scientific and clinical data relating to this subject has been published in peer-reviewed journals and presented at international meetings and conferences. A substantial proportion of these data relate to one group of dressings: multi-layer foam dressings with Safetac, which are manufactured by Mölnlycke Health Care (Gothenburg, Sweden). This evidence pool has influenced the experts involved in updating the Clinical Practice Guideline, produced by the National Pressure Ulcer Advisory Panel, European Pressure Ulcer Advisory Panel and Pan Pacific Pressure Injury Alliance, on the prevention and treatment of PUs. The updated Guideline, published in 2014, recommends that, as part of their PU prevention regimens, clinicians should consider applying prophylactic dressings to bony prominences in anatomical areas that are frequently subjected to friction and shear. Aims A literature review was undertaken to identify clinical data from the entire evidence hierarchy, as well as scientific data from laboratory studies, on the use of multi-layer foam dressings with Safetac in the prevention of pressure ulceration. Method The MEDLINE (National Library of Medicine, Bethesda, US) and EMBASE (Elsevier BV, Amsterdam, Netherlands) bibliographic databases were searched. In addition, abstract books and proceedings documents relating to national and international conferences were scanned in order to identify presentations (i.e. oral, e-posters and posters) of relevance to the review. Results Clinical and health economic experts have undertaken numerous studies, including randomised controlled trials, to assess the efficacy and cost-effectiveness of using multi-layer foam dressings with Safetac as a component of standard PU prevention strategies. The results of these studies indicate that the application of multi-layer foam dressings containing Safetac can reduce the occurrence of PUs on anatomical locations such as the sacrum and the heel, and underneath medical devices. Scientists have also developed and used laboratory methods to gain a better understanding of how prophylactic dressings work. The results of these studies indicate that the composition of foam dressings containing Safetac (i.e. their multi-layer structure) sets them apart from other dressings due to their ability to mediate the effects of physical forces (i.e. pressure, friction and shear) and control microclimate, all of which contribute to pressure ulceration. Conclusion The evidence pool clearly indicates that the prophylactic use of multi-layer foam dressings with Safetac as a component of standard prevention measures is beneficial to the clinician, the health-care provider and the patient. It should be noted that the findings outlined in this review may not be transferable to other products as their makeup and components are likely to differ significantly from those of multi-layer foam dressings with Safetac. As the importance of evidence-based practice and the need for cost-effective care continues to grow, clinicians and provider should carefully consider this point when selecting prophylactic dressings for PU prevention.


Author(s):  
Ralitsa Akins ◽  
Hoi Ho

Abstract Advances in computer technology, hardware and software have made ultrasound a diagnostic imaging technique of choice in certain areas of medicine or specialties such as obstetrics and gynecology. In teaching and training of obs/gyne ultrasonography, medical educators can utilize different forms of clinical simulators: traditional standardized patients and standard ultrasound diagnostic equipment, computer-based simulators, ultrasound simulators or ultrasound simulators with manikins. The popularity of a simulator is determined not only by its features, ease of use and cost, but also by its available learning modules and applications. Technology in ultrasound and computers are rapidly advancing in enhancing the quality and miniaturizing ultrasound machines. Portable and handheld ultrasound equipments are quickly becoming indispensable diagnostic instruments in different health care settings especially the emergency rooms and physician offices. Concerns, however, remain related to the lack of competence of health care providers in using and interpreting results of ultrasound studies, and the needs to standardize the training in ultrasonography. It is important to have access to one or more ultrasound simulators; however, it is even more important to establish and integrate fundamental structure of training ultrasonography into the main training curriculum of undergraduate, graduate, and postgraduate medical education.


2006 ◽  
Vol 92 (1) ◽  
pp. 7-10
Author(s):  
Marianne Jansen ◽  
Leonard B. Bell ◽  
Michel A. Sucher ◽  
Kimbal E. Cooper ◽  
James D. Stoehr

ABSTRACT Aftercare monitoring programs for health care professionals with documented substance abuse problems are managed differently by various states and their respective licensing boards. Many programs have reported surreptitious alcohol use as a significant concern, yet there is no clear indication of the best methods for detecting alcohol use since the detection of ethanol is difficult due to its limited half-life in saliva, urine and serum. Ethyl glucuronide (EtG), a minor metabolite of alcohol metabolism, is only present in urine when alcohol has been consumed. EtG testing may therefore improve the detection of alcohol use by health care professionals in monitored aftercare programs. This study compared urine ethanol (Medpro B panel) and urine EtG in specimens from 126 clients enrolled in Arizona’s physician health aftercare monitoring program. Each client was tested twice per month for a two-month period in 2004. Of the 504 tests, there were no positive urine ethanol results using a standard, lab determined minimum cutoff level of 20mg/dL. There were four positive EtG results (one percent positive rate) using a minimum cutoff level of 100ng/mL. The four positive EtG results imply the presence of four false negative urine ethanol results. Therefore, the results suggest that the EtG test is more sensitive for alcohol detection and should be considered for future improvements in the testing and monitoring of health care providers enrolled in aftercare programs.


2020 ◽  
Author(s):  
Dr Nadia ◽  
Saima Dil ◽  
Naveed Ullah Khan ◽  
Rana Jawad Asghar ◽  
Farida Khudaidad Khan ◽  
...  

BACKGROUND Background: Globally 5-10%adults and 20-30%children are affected by influenza annually. Annual epidemics result in 3-5million cases of serious illness and approximately500,000 deaths. In 2008 a sentinel lab-based influenza surveillance network was established in Pakistan in collaboration with CDC having objectives to assess trends of Influenza-like-Illness(ILI) and Severe Acute Respiratory Illness(SARI). OBJECTIVE Objectives: To assess burden of disease, identify risk factors, and recommend control measures. METHODS Methods: A cross-sectional study was conducted based on influenza surveillance data obtained from NICLP from September 2017 to February 2018.Study was done from the data records and samples of suspected ILI patients received from hospitals of Islamabad and Rawalpindi. A case was defined as sudden onset of fever of ≥ 38 C° and cough, with onset within last 10 days. Samples were tested at NICLP for confirmation by RT-PCR. Frequencies were calculated and data analyzed as per time, place and person RESULTS Results: A total of 1500 samples were received out of which 435(29%) were found positive. Among positive samples 246(56.5%) were Influenza-A(H1N1) pdm09,165(38%) were Influenza-A(H3N1) and 24(5.5%) were influenza B.Mean age was 39 years(range 40 days-80 years)while maximum cases were reported from age group 30-39 years(n=77)followed by 50-59 years(n=59).Males were predominant 256(58.8%). Among cases, 21(4.8%) healthcare workers. Travel history was found in 21(4.8%) cases while 35(8%) cases had contact with influenza patients and 14(3.2%) had contact with birds. Among positive cases 262(60%) were reported from Rawalpindi. Majority of cases were reported in January (277) followed by February (112). 31.4% met SARI case definition. Median hospital stay was 5days.During hospitalization 124(26.3%) were ICU admissions, out of them 2(0.42%) were on ventilator, 83(17.6%) were mechanically ventilated. Prevalence of influenza in reported cases was 0.01%.Six confirmed cases died with Case Fatality Rate=1.27%. CONCLUSIONS Conclusion Most cases reported were of Influenza-A (H1N1) pdm09. Based on the results, policy for inclusion of flu vaccination on annual basis is recommended for health care providers and general community.


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