scholarly journals A systematic review of the sensitivity and specificity of lateral flow devices in the detection of SARS-CoV-2

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Dylan A. Mistry ◽  
Jenny Y. Wang ◽  
Mika-Erik Moeser ◽  
Thomas Starkey ◽  
Lennard Y. W. Lee
Keyword(s):  
Systematic Review ◽  
Sensitivity And Specificity ◽  
Test Performance ◽  
High Specificity ◽  
World Health Organisation ◽  
Time Frame ◽  
Test Subject ◽  
Lateral Flow ◽  
World Health ◽  
Flow Devices

Abstract Background Lateral flow devices (LFDs) are viral antigen tests for the detection of SARS-CoV-2 that produce a rapid result, are inexpensive and easy to operate. They have been advocated for use by the World Health Organisation to help control outbreaks and break the chain of transmission of COVID-19 infections. There are now several studies assessing their accuracy but as yet no systematic review. Our aims were to assess the sensitivity and specificity of LFDs in a systematic review and summarise the sensitivity and specificity of these tests. Methods A targeted search of Pubmed and Medxriv, using PRISMA principles, was conducted identifying clinical studies assessing the sensitivity and specificity of LFDs as their primary outcome compared to reverse transcriptase polymerase chain reaction (RT-PCR) for the detection of SARS-CoV-2. Based on extracted data sensitivity and specificity was calculated for each study. Data was pooled based on manufacturer of LFD and split based on operator (self-swab or by trained professional) and sensitivity and specificity data were calculated. Results Twenty-four papers were identified involving over 26,000 test results. Sensitivity from individual studies ranged from 37.7% (95% CI 30.6–45.5) to 99.2% (95% CI 95.5–99.9) and specificity from 92.4% (95% CI 87.5–95.5) to 100.0% (95% CI 99.7–100.0). Operation of the test by a trained professional or by the test subject with self-swabbing produced comparable results. Conclusions This systematic review identified that the performance of lateral flow devices is heterogeneous and dependent on the manufacturer. Some perform with high specificity but a great range of sensitivities were shown (38.32–99.19%). Test performance does not appear dependent on the operator. Potentially, LFDs could support the scaling up of mass testing to aid track and trace methodology and break the chain of transmission of COVID-19 with the additional benefit of providing individuals with the results in a much shorter time frame.

scholarly journals A Systematic Review of the Sensitivity and Specificity of Lateral Flow Devices in the Detection of SARS-CoV-2

2021 ◽  
Author(s):  
Dylan A Mistry ◽  
Jenny Y Wang ◽  
Mika-Erik Moeser ◽  
Thomas Starkey ◽  
Lennard YW Lee
Keyword(s):  
Systematic Review ◽  
Sensitivity And Specificity ◽  
Test Performance ◽  
High Specificity ◽  
World Health Organisation ◽  
Time Frame ◽  
Test Subject ◽  
Lateral Flow ◽  
World Health ◽  
Flow Devices

Abstract Background: Lateral flow devices (LFDs) are viral antigen tests for the detection of SARS-CoV-2 that produce a rapid result, are inexpensive and easy to operate. They have been advocated for use by the World Health Organisation to help control outbreaks and break the chain of transmission of COVID-19 infections. There are now several studies assessing their accuracy but as yet no systematic review. Our aims were to assess the sensitivity and specificity of LFDs in a systematic review and summarise the sensitivity and specificity of these tests. Methods: A targeted search of Pubmed and Medxriv, using PRISMA principles, was conducted identifying clinical studies assessing the sensitivity and specificity of LFDs as their primary outcome compared to reverse transcriptase polymerase chain reaction (RT-PCR) for the detection of SARS-CoV-2. Based on extracted data sensitivity and specificity was calculated for each study. Data was pooled based on manufacturer of LFD and split based on operator (self-swab or by trained professional) and sensitivity and specificity data were calculated. Results: Twenty-four papers were identified involving over 26,000 test results. Sensitivity from individual studies ranged from 37.7% (95% CI 30.6-45.5) to 99.2% (95% CI 95.5-99.9) and specificity from 92.4% (95% CI 87.5-95.5) to 100.0% (99.7-100.0). BD Veritor was the best performing manufacturer of LFD with a sensitivity of 99.2% (95% CI 95.5-99.9) and specificity of 100.0% (98.9-100.0). Operation of the test by a trained professional or by the test subject with self-swabbing produced comparable results. Conclusions: This systematic review identified that the performance of lateral flow devices is heterogeneous and dependent on the manufacturer. Some perform with high specificity with reasonable sensitivity. Test performance does appear dependent on the operator. Potentially, LFDs could support the scaling up of mass testing to aid track and trace methodology and break the chain of transmission of COVID-19 with the additional benefit of providing individuals with the results in a much shorter time frame.

scholarly journals Loop-Mediated Isothermal Amplification as Point-of-Care Diagnosis for Neglected Parasitic Infections

2020 ◽  
Vol 21 (21) ◽  
pp. 7981
Author(s):  
Catalina Avendaño ◽  
Manuel Alfonso Patarroyo
Keyword(s):  
Neglected Tropical Diseases ◽  
Point Of Care ◽  
Low Cost ◽  
High Specificity ◽  
World Health Organisation ◽  
Isothermal Amplification ◽  
World Health ◽  
Parasitic Infections ◽  
River Blindness ◽  
Loop Mediated Isothermal Amplification

The World Health Organisation (WHO) has placed twenty diseases into a group known as neglected tropical diseases (NTDs), twelve of them being parasitic diseases: Chagas’ disease, cysticercosis/taeniasis, echinococcosis, food-borne trematodiasis, human African trypanosomiasis (sleeping sickness), leishmaniasis, lymphatic filariasis, onchocerciasis (river blindness), schistosomiasis, soil-transmitted helminthiasis (ascariasis, hookworm, trichuriasis), guinea-worm and scabies. Such diseases affect millions of people in developing countries where one of the main problems concerning the control of these diseases is diagnosis-based due to the most affected areas usually being far from laboratories having suitable infrastructure and/or being equipped with sophisticated equipment. Advances have been made during the last two decades regarding standardising and introducing techniques enabling diagnoses to be made in remote places, i.e., the loop-mediated isothermal amplification (LAMP) technique. This technique’s advantages include being able to perform it using simple equipment, diagnosis made directly in the field, low cost of each test and the technique’s high specificity. Using this technique could thus contribute toward neglected parasite infection (NPI) control and eradication programmes. This review describes the advances made to date regarding LAMP tests, as it has been found that even though several studies have been conducted concerning most NPI, information is scarce for others.

scholarly journals A controlled study on the diagnostic accuracy of panoramic and peri-apical radiography for detecting furcation involvement

2020 ◽  
Author(s):  
Gijsbrecht Jan Berghuis ◽  
Jan Cosyn ◽  
Hugo De Bruyn ◽  
Geert Hommez ◽  
Melissa Dierens ◽  
...  
Keyword(s):  
Diagnostic Accuracy ◽  
Sensitivity And Specificity ◽  
Clinical Experience ◽  
High Sensitivity ◽  
High Specificity ◽  
Weighted Kappa ◽  
Time Frame ◽  
Controlled Study ◽  
Significant Difference ◽  
Furcation Involvement

Abstract Background: The aim of this study was to determine diagnostic accuracy, sensitivity and specificity of panoramic and peri-apical radiography for detecting furcation involvement (1) and to evaluate the possible impact of clinical experience on these diagnostic parameters (2).Methods: Periodontitis patients in need of an implant were retrospectively selected. Inclusion criteria were the presence of a CBCT, panoramic and peri-apical radiograph of the site of interest within a one-year time frame. All furcation sites were classified on the basis of CBCT using Hamp’s index (1975). These data were considered gold standard. Ten experienced examiners and 10 trainees were asked to assess furcation involvement for the same defects on the basis of corresponding panoramic and peri-apical radiographs. Absolute agreement, Cohen’s weighted kappa, sensitivity and specificity were calculated. In addition, ROC-curves were constructed.Results: The study sample included 60 furcation sites in 29 multi-rooted teeth from 17 patients (10 females; mean age 62). On average 20/60 furcations were correctly classified on the basis of panoramic radiography, corresponding to weighted kappa of 0.209 indicative of slight agreement. Respective data for peri-apical radiography were 19/60 and 0.221. When recategorizing FI Grades into ‘no to limited FI’ (FI Grade 0 and I) and ‘advanced FI’ (FI Grade II and III), panoramic and peri-apical radiography showed low sensitivity (0.558 and 0.441, respectively), yet high specificity (0.791 and 0.790, respectively) for identifying advanced FI. Both showed diagnostic value given the area under the ROC-curve amounting to 0.79 and 0.69 for panoramic and peri-apical radiography, respectively. There was no significant difference between experienced periodontists and trainees (P = 0.257 versus P = 0.880).Conclusion: Panoramic and peri-apical radiography are relevant in the diagnosis of FI given high specificity. These are best combined with furcation probing showing high sensitivity. Clinical experience does not seem to improve the accuracy of a radiological diagnosis of furcation sites.Trial Registration: Patients were retrospectively registered.

scholarly journals Baseline results of a living systematic review for COVID-19 funded research projects

2020 ◽  
Vol 5 ◽  
pp. 209 ◽  
Author(s):  
Alice Norton ◽  
Adrian Bucher ◽  
Emilia Antonio ◽  
Nicole Advani ◽  
Henrike Grund ◽  
...  
Keyword(s):  
Systematic Review ◽  
Thematic Analysis ◽  
Research Collaboration ◽  
Descriptive Analysis ◽  
World Health Organisation ◽  
World Health ◽  
Research Projects ◽  
Funded Research ◽  
The World ◽  
Global Research

Background: The coronavirus disease 2019 (COVID-19) has resulted in an unprecedented research response, demonstrating exceptional examples of rapid research and collaboration. There is however a need for greater coordination, with limited resources and the shifting global nature of the pandemic resulting in a proliferation of research projects underpowered and unable to achieve their aims. Methods: The UK Collaborative on Development Research (UKCDR) and Global Research Collaboration for Infectious Disease Preparedness (GloPID-R), two funder coordination groups have collaborated to develop a live database of funded research projects across the world relating to COVID-19. Drawing data continually from their members and further global funding bodies, as of 15th July 2020 the database contains 1,858 projects, funded by 25 funders, taking place across 102 countries. To our knowledge it is one of the most comprehensive databases, covering a wide breadth of research disciplines. The database is aligned to the World Health Organisation (WHO) Global Research Roadmap: 2019 Novel Coronavirus. It is being used by the WHO, governments and multi-lateral policy makers, research funders and researchers. This living systematic review aims to supplement the database by providing an open accessible and frequently updated resource summarising the characteristics of the COVID-19 funded research portfolio. Both descriptive and thematic analysis will be presented and updated frequently to aid interpretation of the global COVID-19 funded research portfolio. Results: In this baseline analysis we provide the first detailed descriptive analysis of the database and focus our thematic analysis on research gaps, study populations and research locations (with a focus on resource-limited countries). Conclusions: This living systematic review will help both funders and researchers to prioritise resources to underfunded areas where there is greatest research need and facilitate further strategic collaboration.

scholarly journals O-BN09 The impact of the Covid-19 pandemic on benign upper GI surgery: The first 12 months at a single centre

2021 ◽  
Vol 108 (Supplement_9) ◽  
Author(s):  
Martin Michel ◽  
Helen Fifer ◽  
Emily Moran ◽  
Felix Hammett ◽  
Clare Bonner ◽  
...  
Keyword(s):  
Waiting Times ◽  
World Health Organisation ◽  
Operative Management ◽  
Time Frame ◽  
World Health ◽  
Activity Levels ◽  
Single Centre ◽  
The Road ◽  
Upper Gi ◽  
The Impact

Abstract Background The road to recovery from the Covid-19 pandemic has started but no-one knows when it will end. 18 months on from the World Health Organisation declaring a global pandemic on the 11th March 2020 this has had a dramatic impact on both acute and elective hospital services. Whilst, quite rightly, the focus has been on prioritising cancer resections during the pandemic, many patients awaiting benign operations are facing lengthy waiting times. The aim of this study was to quantify the impact of the COVID-19 pandemic on benign upper GI surgery at a single centre compared to previous operating activity levels. Methods Retrospective analysis of computerised theatre records for the first 12 months of the pandemic (11th March 2020-11th March 2021) were compared to average historical data (HD) over the last five years (2015-2019) over the same time frame. Benign upper Gi operations included were cholecystectomy, anti-reflux/hiatus hernia repairs, cardiomyotomies and bariatric procedures. Results Conclusions The Covid-19 pandemic has dramatically affected benign upper GI surgery at our unit. Overall total operation numbers were down by 31% when compared to HD (440 vs 641). The largest deficit was in bariatrics where no bariatric surgery was performed during the first 12 months of the pandemic, which has restarted as of July 2021. There was also a 30% reduction in the number of cholecystectomies performed likely due to initial guidance recommending non-operative management at the start of the pandemic. Hiatal work numbers remained consistent. This quantitative study can direct future service delivery and help guide the post-pandemic recovery.

scholarly journals Standard echocardiography versus handheld echocardiography for the detection of subclinical rheumatic heart disease: protocol for a systematic review

BMJ Open ◽  
2018 ◽  
Vol 8 (2) ◽  
pp. e020140 ◽  
Author(s):  
Lisa H Telford ◽  
Leila H Abdullahi ◽  
Eleanor A Ochodo ◽  
Liesl J Zühlke ◽  
Mark E Engel
Keyword(s):  
Systematic Review ◽  
Developing Countries ◽  
Heart Disease ◽  
Diagnostic Accuracy ◽  
Rheumatic Heart Disease ◽  
Sensitivity And Specificity ◽  
Meta Analysis ◽  
High Specificity ◽  
Asymptomatic Patients ◽  
Rheumatic Heart

IntroductionRheumatic heart disease (RHD) is a preventable and treatable chronic condition which persists in many developing countries largely affecting impoverished populations. Handheld echocardiography presents an opportunity to address the need for more cost-effective methods of diagnosing RHD in developing countries, where the disease continues to carry high rates of morbidity and mortality. Preliminary studies have demonstrated moderate sensitivity as well as high specificity and diagnostic odds for detecting RHD in asymptomatic patients. We describe a protocol for a systematic review on the diagnostic performance of handheld echocardiography compared to standard echocardiography using the 2012 World Heart Federation criteria for diagnosing subclinical RHD.Methods and analysisElectronic databases including PubMed, Scopus, Web of Science and EBSCOhost as well as reference lists and citations of relevant articles will be searched from 2012 to date using a predefined strategy incorporating a combination of Medical Subject Heading terms and keywords. The methodological validity and quality of studies deemed eligible for inclusion will be assessed against review specific Quality Assessment of Diagnostic Accuracy Studies 2 criteria and information on metrics of diagnostic accuracy and demographics extracted. Forest plots of sensitivity and specificity as well as scatter plots in receiver operating characteristic (ROC) space will be used to investigate heterogeneity. If possible, a meta-analysis will be conducted to produce summary results of sensitivity and specificity using the Hierarchical Summary ROC method. In addition, a sensitivity analysis will be conducted to investigate the effect of studies with a high risk of bias.Ethics and disseminationEthics approval is not required for this systematic review of previously published literature. The planned review will provide a summary of the diagnostic accuracy of handheld echocardiography. Results may feed into evidence-based guidelines and should the findings of this review warrant a change in clinical practice, a summary report will be disseminated among leading clinicians and healthcare professionals in the field.PROSPERO registration numberCRD42016051261.

scholarly journals Diagnosis of Cryptococcosis and Prevention of Cryptococcal Meningitis Using a Novel Point-of-Care Lateral Flow Assay

2013 ◽  
Vol 2013 ◽  
pp. 1-4 ◽  
Author(s):  
Ashar Dhana
Keyword(s):  
Cryptococcal Meningitis ◽  
Point Of Care ◽  
World Health Organisation ◽  
Lateral Flow ◽  
Sub Saharan Africa ◽  
World Health ◽  
First Case ◽  
Lateral Flow Dipstick ◽  
Life Threatening ◽  
Sub Saharan

Despite access to antiretroviral therapy, mortality from cryptococcal meningitis (CM) is high among persons with advanced HIV infection in sub-Saharan Africa. Cryptococcal antigen (CrAg) is present several weeks to months before the onset of symptoms of meningitis and can be screened to prevent life threatening meningitis. Recently, the World Health Organisation recommended that a new rapid CrAg lateral flow ‘‘dipstick’’ assay (LFA) is to be used to screen HIV-infected persons with CD4 counts of less than 100 cells/µL. In this paper, we describe two cases of cryptococcosis with differing outcomes. In the first case, the new CrAg LFA was used as part of a screen and preemptive treatment strategy to prevent CM. In the second case, our patient had no access to the CrAg LFA and subsequently developed life threatening meningitis. To the best of our knowledge, this is the first case report of cryptococcosis diagnosed using this novel assay.

scholarly journals Implementing lateral flow devices in long-term care facilities: experiences from the Liverpool COVID-19 community testing pilot in care homes— a qualitative study

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Patrick Kierkegaard ◽  
Massimo Micocci ◽  
Anna McLister ◽  
John S. P. Tulloch ◽  
Paula Parvulescu ◽  
...  
Keyword(s):  
Real World ◽  
Test Performance ◽  
Contextual Factors ◽  
Implementation Strategies ◽  
Lateral Flow ◽  
Routine Practice ◽  
Structured Interviews ◽  
Term Care ◽  
The Real ◽  
Flow Devices

Abstract Introduction Antigen-based lateral flow devices (LFDs) offer the potential of widespread rapid testing. The scientific literature has primarily focused on mathematical modelling of their use and test performance characteristics. For these tests to be implemented successfully, an understanding of the real-world contextual factors that allow them to be integrated into the workplace is vital. To address this gap in knowledge, we aimed to explore staff’s experiences of integrating LFDs into routine practice for visitors and staff testing with a view to understand implementation facilitators and barriers. Methods Semi-structured interviews and thematic analysis. Results We identified two main themes and five subthemes. The main themes included: visitor-related testing factors and staff-related testing factors. Subthemes included: restoring a sense of normality, visitor-related testing challenges, staff-related testing challenges, and pre-pilot antecedent factors. Conclusion Our study demonstrates that the real-world implementation of LFDs to test visitors and staff faces significant challenges as a result of several contextual factors negatively affecting the work practice and environment. More comprehensive studies are needed to identify and inform effective implementation strategies to ensure that LFDs can be adopted in an agile way that better supports an already exhausted and morally depleted workforce.

scholarly journals Evaluation of the diagnostic accuracy of lateral flow devices as a tool to diagnose rabies in post-mortem animals

2020 ◽  
Vol 14 (11) ◽  
pp. e0008844
Author(s):  
Kazunori Kimitsuki ◽  
Nobuo Saito ◽  
Kentaro Yamada ◽  
Chun-Ho Park ◽  
Satoshi Inoue ◽  
...  
Keyword(s):  
Sensitivity And Specificity ◽  
Fluorescent Antibody ◽  
Negative Control ◽  
Lateral Flow ◽  
Resource Limited Settings ◽  
Diagnostic Laboratory ◽  
Diagnostic Efficacy ◽  
Resource Limited ◽  
Efficient Detection ◽  
Flow Devices

Implementation of lateral flow devices (LFDs) for rabies antigen detection is expected to improve surveillance through the efficient detection of rabid animals in resource-limited settings; however, the use of LFDs for diagnosis remains controversial because some commercially available kits show low sensitivity. Therefore, we compared the diagnostic efficacy of three LFDs (ADTEC, Bionote, and Elabscience kits) paralleled with the direct fluorescent antibody test (dFAT) using fresh samples and investigated the diagnostic accuracies. To do so, we evaluated rabies-suspected samples submitted to the Regional Animal Disease Diagnostic Laboratory III, Philippines. Furthermore, we conducted real-time RT-PCR and sequencing to measure the accuracy of field laboratory diagnosis. The total number of animals submitted during this study period was 184 cases, including negative control samples. Of these, 53.9% (84 cases) were positive in the dFAT. Dogs were the most common rabies-suspected animal (n = 135). The sensitivities of the ADTEC and Bionote kits were 0.88 (74 cases) and 0.95 (80 cases), respectively. The specificity of both kits was 1.00 (100 cases). Furthermore, the sensitivity and specificity of the ADTEC kit after directly homogenizing the samples in assay buffer without dilution in phosphate-buffered saline (ADTEC kit DM) were 0.94 (79 cases) and 1.00 (100 cases), respectively. By contrast, there were no positive results using the Elabscience kit among all dFAT-positive samples. The sensitivity and specificity of LFDs make these tests highly feasible if properly used. Therefore, LFD tests can be used to strengthen the surveillance of rabies-infected animals in endemic and resource-limited settings.

scholarly journals P-EGS20 Safe emergency laparoscopic cholecystectomy in the first 12 months of the Covid-19 pandemic

2021 ◽  
Vol 108 (Supplement_9) ◽  
Author(s):  
Martin Michel ◽  
Helen Fifer ◽  
Emily Moran ◽  
Felix Hammett ◽  
Madara Kronberga ◽  
...  
Keyword(s):  
Laparoscopic Cholecystectomy ◽  
Operative Time ◽  
Patient Flow ◽  
Demographic Data ◽  
Treatment Options ◽  
World Health Organisation ◽  
Time Frame ◽  
World Health ◽  
First Year ◽  
Healthcare Crisis

Abstract Background The World Health Organisation declared a global pandemic on the 11th March 2020 regarding the COVID-19 infection. This has had a dramatic impact on both acute and elective hospital services that will take a considerable time to recover from. Initial emergency intercollegiate surgical guidance released in March 2020 raised concern regarding laparoscopic surgery and advised to pursue alternative non-surgical or radiological treatment options for the safety of patients and theatre teams. The aim of this study was to assess the safety of emergency laparoscopic cholecystectomy (ELC) for patients presenting to our centre with acute gallstone pathology during the pandemic. Methods Retrospective analysis of all cholecystectomies undertaken in the department during the first year of the pandemic from 11th March 2020 to 11th March 2021. This period encapsulated two recognised peaks of the pandemic in the United Kingdom. Demographic data, elective/emergency, operative time, postop ITU admissions due to COVID and COVID related mortality was collected. Operative numbers and times were compared with historical data (HD) from the previous five years over the same time frame. Results 399 laparoscopic cholecystectomies were performed during the first year of the pandemic which was less than the previous five-year average of 570 cholecystectomies per annum (30% reduction). 247 (61.9%) were performed as an emergency on patients presenting with acute gallstone pathology compared to 35% (HD) performed acutely on average historically. Average age was 56 yrs (16-88 range). Average operative time for ELC during the pandemic was 69 minutes compared to 78 minutes HD (NS). No patients were admitted to ITU with post-operative Covid infections and there were no 30 day post-operative deaths.       Conclusions We performed more ELC’s in the first year of the pandemic compared to the previous five-year average as we were conscious of the inevitable long waiting lists, we would certainly be faced with in the coming months. The Covid-19 pandemic was a global healthcare crisis and one the NHS had never encountered before. At the time there was no high-quality evidence on the safety of laparoscopy on patients presenting acutely. This study adds to the growing body of evidence that with consistent preoperative testing, PPE and appropriate patient flow pathways that emergency laparoscopic cholecystectomies are safe to perform in the current climate.

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