scholarly journals A Prospective Study to Evaluate the Clinical Performance of A Novel MultitargetBased Antigen Test on the Detection of SARS-CoV-2 in Symptomatic PopulationComparison to Nuclear Acid-Based Tests

2021 ◽  
Vol 6 (1) ◽  
Author(s):  
Yu W ◽  
Rao E ◽  
Wan DD ◽  
Patterson C ◽  
Wan DD ◽  
...  
Keyword(s):  
Health Care ◽  
Health Care Providers ◽  
Nasal Swab ◽  
Clinical Performance ◽  
Performance Characteristics ◽  
Care Providers ◽  
Swab Sample ◽  
Antigen Test ◽  
Rt Pcr ◽  
Clinical Sensitivity

The study was designed to evaluate the clinical performance characteristics of the First Sign® SARS-CoV-2 Antigen Test, a visual read lateral flow immunoassay (W.H.P.M., Inc.). Individuals presenting at the study sites were evaluated by health care providers for COVID-19 symptoms and sequentially enrolled. The standard of care nasopharyngeal swab sample was first collected for RT-PCR testing. Participant self-collection nasal swab sample was then obtained for the Antigen Test. The clinical performance characteristics of the study device were calculated by comparing participant study device test result recorded at the point of care with the participant matched RT-PCR results provided by qualified CLIA high complexity laboratories. A total of 128 symptomatic adult participants were included in the study, of which 46.8% (60/128) were determined to be RT-PCR positive for SARS-CoV-2. The mean comparator cycle threshold value (Ct) for RT-PCR positive participants included in the study was Ct 25 (range Ct 18-Ct 39). The First Sign® SARS-CoV-2 Antigen Test demonstrated an overall clinical sensitivity of 96.7% (58/60) and a clinical specificity of 98.5% (67/68) when compared with EUA RT-PCR comparator results for the detection of SARS-CoV-2 in symptomatic individuals within 5 days of symptom onset. The clinical sensitivity for samples with RT-PCR Ct<30 was 100% (48/48), 90% (10/12) for samples with RT-PCR Ct ≥ 30, and 98.2% (55/56) for samples with RT-PCR Ct ≤ 34. Study results indicate that during the initial phase of infection, when upper respiratory viral loads and viral shedding levels are typically highest, an observed anterior nasal swab self-collected by the patient and applied to the First Sign® SARS-CoV-2 Antigen Test may be as effective in detecting the presence of SARS-CoV-2 in symptomatic individuals as a EUA RT-PCR assay. Additionally, the ability to obtain a low-cost qualitative result within 15 minutes, combined with the simplicity of the anterior nasal self-sampling procedure, may dramatically increase testing efficiency while significantly reducing risk to health care providers by minimizing or eliminating the need for close contact with the patient.

scholarly journals Usability of an At-Home Anterior Nares SARS-CoV-2 RT-PCR Sample Collection Kit: Human Factors Feasibility Study (Preprint)

2021 ◽  
Author(s):  
Laura E Strong ◽  
Irene Middendorf ◽  
Michelle Turner ◽  
David K Edwards V ◽  
Varun Sama ◽  
...  
Keyword(s):  
Health Care ◽  
Human Factors ◽  
Nasal Swab ◽  
Medical Laboratory ◽  
Written Feedback ◽  
Swab Sample ◽  
Sample Collection ◽  
Rt Pcr ◽  
Nasal Swab Sample ◽  
At Home

BACKGROUND Readily available testing for SARS-CoV-2 is necessary to mitigate COVID-19 disease outbreaks. At-home collection kits, in which samples are self-collected without requiring a laboratory or clinic visit and sent to an external laboratory for testing, can provide convenient testing to those with barriers to access. They can prevent unnecessary exposure between patient and clinical staff, increase access for patients with disabilities or remote workers, and decrease burdens on health care resources, such as provider time and personal protective equipment. Exact Sciences developed an at-home collection kit for samples to be tested to detect SARS-CoV-2 that includes an Instructions for Use (IFU) document, which guides people without prior experience on collecting a nasal swab sample. Demonstrating successful sample collection and usability is critical to ensure that these samples meet the same high-quality sample collection standards as samples collected in clinics. OBJECTIVE The aim of this study was to determine the usability of a SARS-CoV-2 at-home nasal swab sample collection kit. METHODS A human factors usability study was conducted with 30 subjects without prior medical, laboratory, or health care training and without COVID-19 sample self-collection experience. Subjects were observed while they followed the IFU for the at-home sample collection portion of the SARS-CoV-2 test in a setting that simulated a home environment. IFU usability was further evaluated by requiring the subjects to complete a survey, answer comprehension questions, provide written feedback, and respond to questions from the observer about problems during use. RESULTS All 30 subjects successfully completed the sample collection process, and all 30 samples were determined by reverse transcription–polymerase chain reaction (RT-PCR) testing to meet quality standards for SARS-CoV-2 testing. The subjects’ written feedback and comments revealed several recommendations to improve the IFU. CONCLUSIONS The study demonstrated the overall usability of an at-home SARS-CoV-2 collection kit. Various feedback mechanisms provided opportunities to improve the wording and graphics for some critical tasks, including placing the label correctly on the tube. A modified IFU was prepared based on study outcomes.

Introducing Health System Change Strategies to Policy Makers

2014 ◽  
Vol 3 (2) ◽  
pp. 1-14
Author(s):  
Brian T. Collopy
Keyword(s):  
Health Care ◽  
Patient Care ◽  
Health Care Providers ◽  
Health Care Policy ◽  
Clinical Performance ◽  
Care Providers ◽  
Clinical Indicators ◽  
Policy Makers ◽  
Comparative Feedback ◽  
Indicator Sets

In a world first, for accreditation programs, Clinical Indicators (clinical performance measures) were introduced into the Australian Council on Healthcare Standards (ACHS) accreditation process 21 years ago. The resulting national clinical database now receives data from over 740 health care organisations (HCOs) on 22 indicator sets, for different medical disciplines, containing almost 400 separate indicators. HCOs receive aggregate and peer comparative feedback and the types of action by HCOs in response to their results include further data reviews, policy/procedure changes, education programs, new appointments and equipment changes. Favourable data trends in patient care are evident and, with some indicators, cost avoidance can be demonstrated. Revision of the indicator sets is an essential task to ensure continued relevance to clinicians. The Federal Government response to a study in which patient care in Australian hospitals was, prematurely, judged to compare poorly with care in the USA (and later the UK) resulted in the establishment of The Australian Commission on Safety and Quality in Health Care which has now embarked upon a separate program of hospital-based outcome indicators, as have other health care providers. Advice is provided from the literature and personal experience on issues of presentation of material to health care policy makers.

scholarly journals Evaluation of the Panbio™ rapid antigen test for SARS-CoV-2 in primary health care centers and test sites

2020 ◽  
Author(s):  
Oana Bulilete ◽  
Patricia Lorente ◽  
Alfonso Leiva ◽  
Eugenia Carandell ◽  
Antonio Oliver ◽  
...  
Keyword(s):  
Health Care ◽  
Primary Health Care ◽  
Predictive Value ◽  
Close Contact ◽  
Performance Characteristics ◽  
Antigen Test ◽  
Rt Pcr ◽  
Predictive Values ◽  
Primary Health ◽  
Test Kit

AbstractBackgroundRapid antigen tests (Ag-RDT) are emerging as new diagnostic tools for COVID-19 and real-world evaluations are needed to establish their performance characteristics.Main objectiveTo evaluate the accuracy of the Panbio™ Ag-RDT at primary health care (PHC) centers and test sites in symptomatic patients and close contacts, using the Reverse-Transcription Polymerase Chain Reaction (RT-PCR) test as the gold standard.MethodsThis was a prospective diagnostic study conducted in four PHC centers and two test sites in Mallorca, Spain. Consecutive patients older than 18 years, attending the sites for RT-PCR testing either for suggestive symptoms of infection or a close contact, were included. Two nasopharyngeal samples were collected, one for RT-PCR and the other was processed on-site using the Panbio™ rapid antigen test kit for SARS-CoV-2. The sensitivity and specificity were calculated using RT-PCR as the reference, and the predictive values using the pretest probability results for each analyzed group.ResultsA total of 1369 participants were included; mean age 42.5 ± 14.9 years and 54.3% women. The overall prevalence was 10.2%. Most participants (70.6%) presented within 5 days of the onset of symptoms or close contact, and more than 70% had high viral loads. The overall sensitivity was of 71.4% (95% CI: 63.1%, 78.7%), the specificity of 99.8% (95% CI: 99.4%, 99.9%), the positive predictive value of 98.0% (95% CI: 93.0%, 99.7%) and a negative predictive value of 96.8% (95% CI: 95.7%, 97.7%). The sensitivity was higher in symptomatic patients, in those arriving within 5 days since symptom onset and in those with high viral load.ConclusionAg-RDT had relatively good performance characteristics in suspected symptomatic patients within five days since the onset of symptoms. However, our results concludes that a negative Ag-RDT in these settings must be considered as presumptive.

scholarly journals Comparison of SARS-CoV-2 Detection by Rapid Antigen and by Three Commercial RT-qPCR Tests: A Study from Martin University Hospital in Slovakia

2021 ◽  
Vol 18 (13) ◽  
pp. 7037
Author(s):  
Zuzana Dankova ◽  
Elena Novakova ◽  
Maria Skerenova ◽  
Veronika Holubekova ◽  
Vincent Lucansky ◽  
...  
Keyword(s):  
Health Care ◽  
Health Care Providers ◽  
Predictive Value ◽  
Global Economy ◽  
National Level ◽  
University Hospital ◽  
Care Providers ◽  
Antigen Test ◽  
Virus Shedding ◽  
Prophylactic Measures

The global pandemic of coronavirus disease 2019 (COVID-19) caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is having a tremendous impact on the global economy, health care systems and the lives of almost all people in the world. The Central European country of Slovakia reached one of the highest daily mortality rates per 100,000 inhabitants in the first 3 months of 2021, despite implementing strong prophylactic measures, lockdowns and repeated nationwide antigen testing. The present study reports a comparison of the performance of the Standard Q COVID-19 antigen test (SD Biosensor) with three commercial RT-qPCR kits (vDetect COVID-19-MultiplexDX, gb SARS-CoV-2 Multiplex-GENERI BIOTECH Ltd. and Genvinset COVID-19 [E]-BDR Diagnostics) in the detection of infected individuals among employees of the Martin University Hospital in Slovakia. Health care providers, such as doctors and nurses, are classified as “critical infrastructure”, and there is no doubt about the huge impact that incorrect results could have on patients. Out of 1231 samples, 14 were evaluated as positive for SARS-CoV-2 antigen presence, and all of them were confirmed by RT-qPCR kit 1 and kit 2. As another 26 samples had a signal in the E gene, these 40 samples were re-isolated and subsequently re-analysed using the three kits, which detected the virus in 22, 23 and 12 cases, respectively. The results point to a divergence not only between antigen and RT-qPCR tests, but also within the “gold standard” RT-qPCR testing. Performance analysis of the diagnostic antigen test showed the positive predictive value (PPV) to be 100% and negative predictive value (NPV) to be 98.10%, indicating that 1.90% of individuals with a negative result were, in fact, positive. If these data are extrapolated to the national level, where the mean daily number of antigen tests was 250,000 in April 2021, it points to over 4700 people per day being misinterpreted and posing a risk of virus shedding. While mean Ct values of the samples that were both antigen and RT-qPCR positive were about 20 (kit 1: 20.47 and 20.16 for Sarbeco E and RdRP, kit 2: 19.37 and 19.99 for Sarbeco E and RdRP and kit 3: 17.47 for ORF1b/RdRP), mean Ct values of the samples that were antigen-negative but RT-qPCR-positive were about 30 (kit 1: 30.67 and 30.00 for Sarbeco E and RdRP, kit 2: 29.86 and 31.01 for Sarbeco E and RdRP and kit 3: 27.47 for ORF1b/RdRP). It confirms the advantage of antigen test in detecting the most infectious individuals with a higher viral load. However, the reporting of Ct values is still a matter of ongoing debates and should not be conducted without normalisation to standardised controls of known concentration.

scholarly journals Measuring Quality in Emergency Medical Services: A Review of Clinical Performance Indicators

2012 ◽  
Vol 2012 ◽  
pp. 1-7 ◽  
Author(s):  
Mazen J. El Sayed
Keyword(s):  
Health Care ◽  
Emergency Medical Services ◽  
Health Care Providers ◽  
Performance Indicators ◽  
Clinical Performance ◽  
Medical Services ◽  
Care Providers ◽  
Quality Initiatives ◽  
Control Programs ◽  
Emergency Medical

Measuring quality in Emergency Medical Services (EMSs) systems is challenging. This paper reviews the current approaches to measuring quality in health care and EMS with a focus on currently used clinical performance indicators in EMS systems (US and international systems). The different types of performance indicators, the advantages and limitations of each type, and the evidence-based prehospital clinical bundles are discussed. This paper aims at introducing emergency physicians and health care providers to quality initiatives in EMS and serves as a reference for tools that EMS medical directors can use to launch new or modify existing quality control programs in their systems.

Malpractice & Negligence: Cal. Supreme Court Clarifies Negligence Provisions under State’s Elder Abuse Act

1999 ◽  
Vol 27 (2) ◽  
pp. 203-203
Author(s):  
Kendra Carlson
Keyword(s):  
Health Care ◽  
Supreme Court ◽  
Health Care Providers ◽  
Elder Abuse ◽  
Skilled Nursing Facility ◽  
Pressure Sores ◽  
Care Providers ◽  
Nursing Facility ◽  
Skilled Nursing ◽  
The Supreme Court

The Supreme Court of California held, in Delaney v. Baker, 82 Cal. Rptr. 2d 610 (1999), that the heightened remedies available under the Elder Abuse Act (Act), Cal. Welf. & Inst. Code, §§ 15657,15657.2 (West 1998), apply to health care providers who engage in reckless neglect of an elder adult. The court interpreted two sections of the Act: (1) section 15657, which provides for enhanced remedies for reckless neglect; and (2) section 15657.2, which limits recovery for actions based on “professional negligence.” The court held that reckless neglect is distinct from professional negligence and therefore the restrictions on remedies against health care providers for professional negligence are inapplicable.Kay Delaney sued Meadowood, a skilled nursing facility (SNF), after a resident, her mother, died. Evidence at trial indicated that Rose Wallien, the decedent, was left lying in her own urine and feces for extended periods of time and had stage I11 and IV pressure sores on her ankles, feet, and buttocks at the time of her death.

Using Technology to Improve Access to Health Care for Culturally and Linguistically Diverse Populations

2012 ◽  
Vol 19 (3) ◽  
pp. 71-76 ◽  
Author(s):  
Pauline A. Mashima
Keyword(s):  
Health Care ◽  
Health Care Providers ◽  
Access To Health Care ◽  
Underserved Populations ◽  
Linguistically Diverse ◽  
Care Providers ◽  
Department Of Health ◽  
Use Of Technology ◽  
Access To Health ◽  
Improve Access

Important initiatives in health care include (a) improving access to services for disadvantaged populations, (b) providing equal access for individuals with limited or non-English proficiency, and (c) ensuring cultural competence of health-care providers to facilitate effective services for individuals from diverse racial and ethnic backgrounds (U.S. Department of Health and Human Services, Office of Minority Health, 2001). This article provides a brief overview of the use of technology by speech-language pathologists and audiologists to extend their services to underserved populations who live in remote geographic areas, or when cultural and linguistic differences impact service delivery.

Interdisciplinary Therapy Assessments for the Older Adult

2012 ◽  
Vol 17 (1) ◽  
pp. 11-16
Author(s):  
Lynn Chatfield ◽  
Sandra Christos ◽  
Michael McGregor
Keyword(s):  
Older Adults ◽  
Health Care ◽  
Standardized Testing ◽  
Health Care Providers ◽  
Outcome Measurement ◽  
Care Providers ◽  
Patient Centered ◽  
Screening Process ◽  
Evidenced Based ◽  
Changing Economy

In a changing economy and a changing industry, health care providers need to complete thorough, comprehensive, and efficient assessments that provide both an accurate depiction of the patient's deficits and a blueprint to the path of treatment for older adults. Through standardized testing and observations as well as the goals and evidenced-based treatment plans we have devised, health care providers can maximize outcomes and the functional levels of patients. In this article, we review an interdisciplinary assessment that involves speech-language pathology, occupational therapy, physical therapy, and respiratory therapy to work with older adults in health care settings. Using the approach, we will examine the benefits of collaboration between disciplines, an interdisciplinary screening process, and the importance of sharing information from comprehensive discipline-specific evaluations. We also will discuss the importance of having an understanding of the varied scopes of practice, the utilization of outcome measurement tools, and a patient-centered assessment approach to care.

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