scholarly journals Towards effective diagnostic assays for COVID-19: a review

2020 ◽  
Vol 73 (7) ◽  
pp. 370-377 ◽  
Author(s):  
Marietjie Venter ◽  
Karin Richter

Countries globally are affected by the COVID-19 pandemic, with nearly two million cases and 120 000 deaths occurring within 4 months of the discovery of the severe acute respiratory syndrome coronavirus-2 in December 2019 in China. Accurate diagnoses of cases is key in managing the pandemic by identification, isolation and treatment of patients and defining the epidemiology of the virus. By mid-January 2020, a scientist from China published the full genome of the virus, which facilitated the development of accurate molecular diagnostic assays. By the end of January 2020, the WHO, in collaboration with laboratories in Asia, Europe and the USA, published several real-time reverse transcriptase PCR (rtRT-PCR) protocols that allowed identification of cases and development of commercial assays. Clinical investigations facilitated development of accurate case definition and guidance for laboratories on the optimum specimens and procedures for diagnoses. Currently, laboratory-based rtRT-PCR is the recommended test for diagnoses of acute cases to ensure patients can be identified and isolated and to facilitate the public health response. However, due to delays in diagnoses, severe shortage of tests and laboratory capacity, point-of-care molecular or antigen tests are becoming more attractive. Although serological tests are not suitable for diagnoses of acute cases, they are important to define epidemiological questions, including attack rate in the population, and to identify immune individuals. This review aimed to summarise the current available information for diagnoses of cases and to aid laboratories and healthcare workers to select the best assays and procedures.

2021 ◽  
Vol 18 (1) ◽  
Author(s):  
Kristin E. Schneider ◽  
Glenna J. Urquhart ◽  
Saba Rouhani ◽  
Ju Nyeong Park ◽  
Miles Morris ◽  
...  

Abstract Background Naloxone distribution programs have been a cornerstone of the public health response to the overdose crisis in the USA. Yet people who use opioids (PWUO) continue to face a number of barriers accessing naloxone, including not knowing where it is available. Methods We used data from 173 PWUO from Anne Arundel County, Maryland, which is located between Baltimore City and Washington, DC. We assessed the prevalence of recently (past 6 months) receiving naloxone and currently having naloxone, the type(s) of the naloxone kits received, and the perceived ease/difficultly of accessing naloxone. We also assessed participants knowledge of where naloxone was available in the community. Results One third (35.7%) of participants had recently received naloxone. Most who had received naloxone received two doses (72.1%), nasal naloxone (86.9%), and education about naloxone use (72.1%). Most currently had naloxone in their possession (either on their person or at home; 78.7%). One third (34.4%) believed naloxone was difficult to obtain in their community. Only half (56.7%) knew of multiple locations where they could get naloxone. The health department was the most commonly identified naloxone source (58.0%). Identifying multiple sources of naloxone was associated with being more likely to perceive that naloxone is easy to access. Discussion Our results suggest that additional public health efforts are needed to make PWUO aware of the range of sources of naloxone in their communities in order to ensure easy and continued naloxone access to PWUO.


2019 ◽  
Vol 16 (1) ◽  
Author(s):  
Beth E. Meyerson ◽  
Carrie A. Lawrence ◽  
Summer Dawn Cope ◽  
Steven Levin ◽  
Christopher Thomas ◽  
...  

Abstract Background Community pharmacies are important for health access by rural populations and those who do not have optimum access to the health system, because they provide myriad health services and are found in most communities. This includes the sale of non-prescription syringes, a practice that is legal in the USA in all but two states. However, people who inject drugs (PWID) face significant barriers accessing sterile syringes, particularly in states without laws allowing syringe services programming. To our knowledge, no recent studies of pharmacy-based syringe purchase experience have been conducted in communities that are both rural and urban, and none in the Southwestern US. This study seeks to understand the experience of retail pharmacy syringe purchase in Arizona by PWID. Methods An interview study was conducted between August and December 2018 with 37 people living in 3 rural and 2 urban Arizona counties who identified as current or former users of injection drugs. Coding was both a priori and emergent, focusing on syringe access through pharmacies, pharmacy experiences generally, experiences of stigma, and recommendations for harm reduction services delivered by pharmacies. Results All participants reported being refused syringe purchase at pharmacies. Six themes emerged about syringe purchase: (1) experience of stigma and judgment by pharmacy staff, (2) feelings of internalized stigma, (3) inconsistent sales outcomes at the same pharmacy or pharmacy chain, (4) pharmacies as last resort for syringes, (5) fear of arrest for syringe possession, and (6) health risks resulting from syringe refusal. Conclusions Non-prescription syringe sales in community pharmacies are a missed opportunity to improve the health of PWID by reducing syringe sharing and reuse. Yet, current pharmacy syringe sales refusal and stigmatization by staff suggest that pharmacy-level interventions will be necessary to impact pharmacy practice. Lack of access to sterile syringes reinforces health risk behaviors among PWID. Retail syringe sales at pharmacies remain an important, yet barrier-laden, element of a comprehensive public health response to reduce HIV and hepatitis C among PWID. Future studies should test multilevel evidence-based interventions to decrease staff discrimination and stigma and increase syringe sales.


2015 ◽  
Vol 53 (4) ◽  
pp. 1406-1410 ◽  
Author(s):  
Ashley V. Kondas ◽  
Victoria A. Olson ◽  
Yu Li ◽  
Jason Abel ◽  
Miriam Laker ◽  
...  

A public health response relies upon rapid and reliable confirmation of disease by diagnostic assays. Here, we detail the design and validation of two variola virus-specific real-time PCR assays, since previous assays cross-reacted with newly identified cowpox viruses. The assay specificity must continually be reassessed as other closely related viruses are identified.


2006 ◽  
Vol 7 (1) ◽  
pp. 9 ◽  
Author(s):  
Russ Bulluck ◽  
Pat Shiel ◽  
Phil Berger ◽  
David Kaplan ◽  
Greg Parra ◽  
...  

Phytophthora ramorum (Pram) is a pathogen of regulatory concern in the USA, and accurate diagnostics is a key component in the response to potential pathogen outbreaks. Although the molecular diagnostic protocols used in regulatory programs have been evaluated using regulatory samples, to date, no direct comparison of these methods has been analyzed within a nursery setting. A block of 300 camellia plants within a California nursery known to be infested with Pram was simultaneously assayed for visual symptoms, growth medium pH, and moss presence as well as culture isolation and molecular analysis prior to plant destruction. Disease symptoms such as foliar lesions and leaf drop were recorded for each plant prior to foliar and growth medium sampling. All diagnostic assays were highly correlated with one another and disease symptoms, with nested PCR having the best correlation with symptoms, followed by Real-Time PCR then culture. No correlation with disease or diagnostic assays was observed with moss presence or medium pH. Analysis of results allowed diagnostic sensitivity and specificity of the assays to be determined and the performance of each method for diagnosis of Phytophthora spp. or Phytophthora ramorum in camellia tissues and associated potting medium could be compared. Accepted for publication 12 July 2006. Published 16 October 2006.


2018 ◽  
Author(s):  
Sanchita Bhadra ◽  
Miguel A. Saldaña ◽  
Hannah Grace Han ◽  
Grant L. Hughes ◽  
Andrew D. Ellington

AbstractWe have developed a generalizable ‘smart molecular diagnostic’ capable of accurate point-of-care (POC) detection of variable nucleic acid targets. Our one-pot isothermal assay relies on multiplex execution of four loop-mediated isothermal amplification reactions, with primers that are degenerate and redundant, thereby increasing the breadth of targets while reducing the probability of amplification failure. An easy-to-read visual answer is computed directly by a multi-input Boolean OR gate signal transducer that uses degenerate strand exchange probes to assess any combination of amplicons. We demonstrate our platform by using the same assay to detect divergent Asian and African lineages of the evolving Zika virus (ZIKV), while maintaining selectivity against non-target viruses. Direct analysis of biological specimens proved possible, with 20 virions / µl being directly detected in human saliva within 90 minutes, and crudely macerated ZIKV-infected Aedes aegypti mosquitoes being identified with 100% specificity and sensitivity. The ease-of-use with minimal instrumentation, broad programmability, and built-in fail-safe reliability make our smart molecular diagnostic attractive for POC use.


2004 ◽  
Vol 40 (5) ◽  
pp. 376-384 ◽  
Author(s):  
Paul Berdoulay ◽  
Julie K. Levy ◽  
Patti S. Snyder ◽  
Michael J. Pegelow ◽  
Jennifer L. Hooks ◽  
...  

Serological tests were performed on 380 cats with necropsy-confirmed heartworm status to compare the performance of currently available commercial laboratory and point-of-care heart-worm serological tests in a heartworm-endemic area. Overall, antigen tests detected 79.3% to 86.2% of heartworm infections and were highly specific. Most cats with false-negative antigen tests had a single male worm. Antibody tests detected 62.1% to 72.4% of heartworm infections and had a wider range of false-positive results (1.4% to 19.1%) than antigen tests (0.3% to 2.0%). Serological tests for feline heartworm infection varied in diagnostic performance. Combining results from antigen and antibody tests achieved greater sensitivity than using either test alone.


2019 ◽  
Vol 220 (Supplement_4) ◽  
pp. S175-S181 ◽  
Author(s):  
Alicia R Feagins ◽  
Jeni Vuong ◽  
Katya Fernandez ◽  
Berthe M Njanpop-Lafourcade ◽  
Jason M Mwenda ◽  
...  

Abstract Laboratories play critical roles in bacterial meningitis disease surveillance in the African meningitis belt, where the highest global burden of meningitis exists. Reinforcement of laboratory capacity ensures rapid detection of meningitis cases and outbreaks and a public health response that is timely, specific, and appropriate. Since 2008, joint efforts to strengthen laboratory capacity by multiple partners, including MenAfriNet, beginning in 2014, have been made in countries within and beyond the meningitis belt. Over the course of 10 years, national reference laboratories were supported in 5 strategically targeted areas: specimen transport systems, laboratory procurement systems, laboratory diagnosis, quality management, and laboratory workforce with substantial gains made in each of these areas. To support the initiative to eliminate meningitis by 2030, continued efforts are needed to strengthen laboratory systems.


2021 ◽  
Vol 11 (1) ◽  
Author(s):  
S. J. C. Pallett ◽  
S. J. Denny ◽  
A. Patel ◽  
E. Charani ◽  
N. Mughal ◽  
...  

AbstractSevere Acute Respiratory Syndrome coronavirus 2 (SARS-CoV-2) has become a global pandemic. Case identification is currently made by real-time polymerase chain reaction (PCR) during the acute phase and largely restricted to healthcare laboratories. Serological assays are emerging but independent validation is urgently required to assess their utility. We evaluated five different point-of-care (POC) SARS-CoV-2 antibody test kits against PCR, finding concordance across the assays (n = 15). We subsequently tested 200 patients using the OrientGene COVID-19 IgG/IgM Rapid Test Cassette and find a sensitivity of 74% in the early infection period (day 5–9 post symptom onset), with 100% sensitivity not seen until day 13, demonstrating inferiority to PCR testing in the infectious period. Negative rate was 96%, but in validating the serological tests uncovered potential false-negatives from PCR testing late-presenting cases. A positive predictive value (PPV) of 37% in the general population precludes any use for general screening. Where a case definition is applied however, the PPV is substantially improved (95.4%), supporting use of serology testing in carefully targeted, high-risk populations. Larger studies in specific patient cohorts, including those with mild infection are urgently required to inform on the applicability of POC serological assays to help control the spread of SARS-CoV-2 and improve case finding of patients that may experience late complications.


2022 ◽  
Author(s):  
Xinsheng Nan ◽  
Sven Hoehn ◽  
Patrick Hardinge ◽  
Shrinivas N Dighe ◽  
John Ukeri ◽  
...  

The COVID-19 pandemic continues to pose a threat to the general population. The ongoing vaccination programs provide protection to individuals and facilitate the opening of society and a return to normality. However, emergent and existing SARS-CoV-2 variants capable of evading the immune system endanger the efficacy of the vaccination strategy. To preserve the efficacy of SARS-CoV-2 vaccination globally, aggressive and effective surveillance for known and emerging SARS-CoV-2 Variants of Concern (VOC) is required. Rapid and specific molecular diagnostics can provide speed and coverage advantages compared to genomic sequencing alone, benefitting the public health response and facilitating VOC containment. In this work, we expand the recently developed SARS-CoV-2 CRISPR-Cas detection technology (SHERLOCK) to allow rapid and sensitive discrimination of VOCs, that can be used at point of care and/or implemented in the pipelines of small or large testing facilities, and even determine proportion of VOCs in pooled population-level wastewater samples. This technology aims to complement the ongoing sequencing efforts to allow facile and, crucially, rapid identification of individuals infected with VOCs to help break infection chains. Here, we show the optimisation of our VarLOCK assays (Variant-specific SHERLOCK) for multiple specific mutations in the S gene of SARS-CoV-2 and validation with samples from the Cardiff University Testing Service. We also show the applicability of VarLOCK to national wastewater surveillance of SARS-CoV-2 variants. In addition, we show the rapid adaptability of the technique for new and emerging VOCs such as Omicron.


2020 ◽  
Vol 30 (Supplement_5) ◽  
Author(s):  
R Ohannessian ◽  
S Yaghobian

Abstract On 30 January 2020, the WHO declared a Public Health Emergency of International Concern (PHEIC) for the COVID-19 outbreak. On 7 March 2020, there were more than 100,000 confirmed cases in 88 countries. Telemedicine, otherwise known as telehealth, has been used at small scale in past outbreaks, including previous coronavirus outbreaks (SARS; MERS) and other PHEICs (Ebola; Zika). The objective was to describe the global larger scale use and practicality of telehealth in the COVID-19 outbreak. The 2015 conceptual framework of telemedicine during an outbreak for epidemiological assessment and clinical management (Ohannessian R.) was used to describe the use cases. A multi-country analysis from China, France, USA and UK was performed with a literature review using official institution websites, grey literature, media/business reports, as scientific articles were not yet published. Video and chat consultations were used for symptomatic patient assessments through private telehealth providers in all countries. In the USA, the Telehealth Services During Certain Emergency Periods Act of 2020 was voted by the Congress on 4 March 2020 to suspend restrictive rules of Medicare funding for telehealth home consultations. Triage via online auto-questionnaires were created by private providers and public authorities. In the UK, from 26 February to 2 March, 70,000 enquiries were made to a dedicated NHS111 online service. In China, teleradiology networks were also used for diagnostic of COVID-19 cases. Video consultation was used in France to monitor home isolated patients and non COVID-19 patients, to avoid risks of exposure. Telehealth has been useful to the COVID-19 outbreak but efforts to better describe cases and evaluate impact on the public health response should be promoted. National and international health authorities should be aware of the opportunities offered by telehealth during outbreaks, and may consider its integration in public health emergencies preparedness plans. Key messages Telehealth was useful for the public health response to COVID19 outbreak. Telehealth should be integrated into public health preparedness plans.


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