scholarly journals COVID-19 Serological Tests: How Well Do They Actually Perform?

2020 ◽  
Author(s):  
Abdi Ghaffari ◽  
Robyn Meurant ◽  
Ali Ardakani
Keyword(s):  
Diagnostic Tests ◽  
High Performance ◽  
Large Scale ◽  
Point Of Care ◽  
Herd Immunity ◽  
Serological Testing ◽  
Serological Tests ◽  
Mortality And Morbidity ◽  
Global Pandemic ◽  
Initial Discovery

In only a few months after initial discovery in Wuhan, China, SARS-CoV-2 and the associated COVID-19 disease has become a global pandemic causing significant mortality and morbidity. In the absence of vaccines and effective therapeutics, reliable serological testing can be a key element of public health policy to control further spread of the disease and gradually ease quarantine measures. However, prior to launch of large-scale seroprevalence studies to assess herd immunity, it is critical to understand the limits and potential of current SARS-CoV-2 serological tests on the market. In this study, we provide an overview of serological testing and conduct a systematic review of independent evaluations of SARS-CoV-2 serological tests performance. Our findings show significant variability in the accuracy of marketed tests and highlight several lab-based and point-of-care rapid diagnostic tests with high performance level in detecting SRAS-CoV-2 specific antibodies. The findings of this review highlight the need for ongoing independent evaluations of commercialized COVID-19 diagnostic tests.

scholarly journals COVID-19 Serological Tests: How Well Do They Actually Perform?

Diagnostics ◽  
2020 ◽  
Vol 10 (7) ◽  
pp. 453 ◽  
Author(s):  
Abdi Ghaffari ◽  
Robyn Meurant ◽  
Ali Ardakani
Keyword(s):  
Diagnostic Tests ◽  
Public Health Policy ◽  
Point Of Care ◽  
Serological Testing ◽  
Serological Tests ◽  
Actual Performance ◽  
Mortality And Morbidity ◽  
Global Pandemic ◽  
Initial Discovery ◽  
Significant Mortality

In only a few months after initial discovery in Wuhan, China, SARS-CoV-2 and the associated coronavirus disease 2019 (COVID-19) have become a global pandemic causing significant mortality and morbidity and implementation of strict isolation measures. In the absence of vaccines and effective therapeutics, reliable serological testing must be a key element of public health policy to control further spread of the disease and gradually remove quarantine measures. Serological diagnostic tests are being increasingly used to provide a broader understanding of COVID-19 incidence and to assess immunity status in the population. However, there are discrepancies between claimed and actual performance data for serological diagnostic tests on the market. In this study, we conducted a review of independent studies evaluating the performance of SARS-CoV-2 serological tests. We found significant variability in the accuracy of marketed tests and highlight several lab-based and point-of-care rapid serological tests with high levels of performance. The findings of this review highlight the need for ongoing independent evaluations of commercialized COVID-19 diagnostic tests.

scholarly journals Diagnosis of tuberculosis in wildlife: a systematic review

2021 ◽  
Vol 52 (1) ◽  
Author(s):  
Jobin Thomas ◽  
Ana Balseiro ◽  
Christian Gortázar ◽  
María A. Risalde
Keyword(s):  
Systematic Review ◽  
Test Performance ◽  
Diagnostic Tests ◽  
Large Scale ◽  
Diagnostic Techniques ◽  
Review Literature ◽  
Meat Industry ◽  
Post Mortem ◽  
Serological Tests ◽  
Ongoing Research

AbstractAnimal tuberculosis (TB) is a multi-host disease caused by members of the Mycobacterium tuberculosis complex (MTC). Due to its impact on economy, sanitary standards of milk and meat industry, public health and conservation, TB control is an actively ongoing research subject. Several wildlife species are involved in the maintenance and transmission of TB, so that new approaches to wildlife TB diagnosis have gained relevance in recent years. Diagnosis is a paramount step for screening, epidemiological investigation, as well as for ensuring the success of control strategies such as vaccination trials. This is the first review that systematically addresses data available for the diagnosis of TB in wildlife following the Preferred Reporting Items of Systematic Reviews and Meta-Analyses (PRISMA) guidelines. The article also gives an overview of the factors related to host, environment, sampling, and diagnostic techniques which can affect test performance. After three screenings, 124 articles were considered for systematic review. Literature indicates that post-mortem examination and culture are useful methods for disease surveillance, but immunological diagnostic tests based on cellular and humoral immune response detection are gaining importance in wildlife TB diagnosis. Among them, serological tests are especially useful in wildlife because they are relatively inexpensive and easy to perform, facilitate large-scale surveillance and can be used both ante- and post-mortem. Currently available studies assessed test performance mostly in cervids, European badgers, wild suids and wild bovids. Research to improve diagnostic tests for wildlife TB diagnosis is still needed in order to reach accurate, rapid and cost-effective diagnostic techniques adequate to a broad range of target species and consistent over space and time to allow proper disease monitoring.

scholarly journals Limitations of rapid serological testing for SARS-CoV-2 in non-vaccinated patients in acute cardiac care

2021 ◽  
Vol 2 (3) ◽  
pp. 302-305
Author(s):  
Mihajlo Viduljević ◽  
Marija Polovina ◽  
Milika Ašanin ◽  
Igor Mrdović
Keyword(s):  
False Negative ◽  
Immunological Response ◽  
Cardiac Care ◽  
Cardiovascular Disorders ◽  
Serological Testing ◽  
Serological Tests ◽  
Negative Results ◽  
Global Pandemic ◽  
False Negative Results ◽  
The City

In December 2019 in the city of Wuhan, in China, the first cases of infection caused by the new SARS-CoV-2 virus appeared, and later on, the disease caused by this virus was named COVID-19. Shortly after this, on March 11 th , 2020, the WHO characterized COVID-19 as a global pandemic. The symptoms of COVID-19 and acute cardiovascular disorders (e.g., heart failure, pulmonary embolism or myocardial ischemia) frequently overlap, which poses a challenge for the establishing of a differential diagnosis in clinical practice. Rapid serological tests, which detect IgM and IgG classes of antibodies for SARS-CoV 2, have been developed with the primary purpose of screening the population's immunological response to the SARS-CoV-2 virus. However, rapid serological tests are often used outside their original purpose, i.e., for the triage of possibly infected, non-vaccinated individuals, because they offer quick results, which may be particularly relevant in emergency settings. If serological testing is used to guide the admission of non-vaccinated patients with acute cardiovascular disorders to either an isolation unit for suspected COVID-19 positive individuals, or to hospital facilities for non-infected patients, it is important to recognize its limitations, in order to reduce the risk of false-positive or false-negative results. Hence, appropriate patient selection and cautious test interpretation is necessary to avoid misdiagnosis. The aim of this paper is to illustrate how serological testing may be used as a screening tool to inform the management of non-vaccinated patients with acute cardiovascular disorders requiring urgent hospital admission. As an illustration, we describe two clinical situations, in which serological testing produced meaningful results.

scholarly journals Point-of-Care Diagnostic Tools for Surveillance of SARS-CoV-2 Infections

2021 ◽  
Vol 9 ◽  
Author(s):  
Dhanasekaran Sakthivel ◽  
David Delgado-Diaz ◽  
Laura McArthur ◽  
William Hopper ◽  
Jack S. Richards ◽  
...  
Keyword(s):  
Large Scale ◽  
Clinical Symptoms ◽  
Point Of Care ◽  
Cost Effective ◽  
Nucleic Acid Amplification ◽  
Diagnostic Tools ◽  
Rt Pcr ◽  
Serological Tests ◽  
Polymerase Chain ◽  
Effective Public Health

Severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) is a recently emerged and highly contagious virus that causes coronavirus disease 2019 (COVID-19). As of August 24, 2021, there were more than 212 million confirmed COVID-19 cases and nearly 4.4 million deaths reported globally. Early diagnosis and isolation of infected individuals remains one of the most effective public health interventions to control SARS-CoV-2 spread and for effective clinical management of COVID-19 cases. Currently, SARS-CoV-2 infection is diagnosed presumptively based on clinical symptoms and confirmed by detecting the viral RNA in respiratory samples using reverse transcription polymerase chain reaction (RT-PCR). Standard RT-PCR protocols are time consuming, expensive, and technically demanding, which makes them a poor choice for large scale and point-of-care screening in resource-poor settings. Recently developed isothermal nucleic acid amplification tests (iNAAT), antigen and/or serological tests are cost-effective to scale COVID-19 testing at the point-of-care (PoC) and for surveillance activities. This review discusses the development of rapid PoC molecular tools for the detection and surveillance of SARS-CoV-2 infections.

scholarly journals Point-of-Care Diagnostic Tests for Detecting SARS-CoV-2 Antibodies: A Systematic Review and Meta-Analysis of Real-World Data

2020 ◽  
Vol 9 (5) ◽  
pp. 1515 ◽  
Author(s):  
Matteo Riccò ◽  
Pietro Ferraro ◽  
Giovanni Gualerzi ◽  
Silvia Ranzieri ◽  
Brandon Michael Henry ◽  
...  
Keyword(s):  
Systematic Review ◽  
Diagnostic Tests ◽  
Large Scale ◽  
Point Of Care ◽  
Meta Analysis ◽  
Rapid Diagnostic Tests ◽  
Diagnostic Methods ◽  
Rt Pcr ◽  
Real World Data ◽  
Healthcare Facilities

SARS-CoV-2 is responsible for a highly contagious infection, known as COVID-19. SARS-CoV-2 was discovered in late December 2019 and, since then, has become a global pandemic. Timely and accurate COVID-19 laboratory testing is an essential step in the management of the COVID-19 outbreak. To date, assays based on the reverse-transcription polymerase chain reaction (RT-PCR) in respiratory samples are the gold standard for COVID-19 diagnosis. Unfortunately, RT-PCR has several practical limitations. Consequently, alternative diagnostic methods are urgently required, both for alleviating the pressure on laboratories and healthcare facilities and for expanding testing capacity to enable large-scale screening and ensure a timely therapeutic intervention. To date, few studies have been conducted concerning the potential utilization of rapid testing for COVID-19, with some conflicting results. Therefore, the present systematic review and meta-analysis was undertaken to explore the feasibility of rapid diagnostic tests in the management of the COVID-19 outbreak. Based on ten studies, we computed a pooled sensitivity of 64.8% (95%CI 54.5–74.0), and specificity of 98.0% (95%CI 95.8–99.0), with high heterogeneity and risk of reporting bias. We can conclude that: (1) rapid diagnostic tests for COVID-19 are necessary, but should be adequately sensitive and specific; (2) few studies have been carried out to date; (3) the studies included are characterized by low numbers and low sample power, and (4) in light of these results, the use of available tests is currently questionable for clinical purposes and cannot substitute other more reliable molecular tests, such as assays based on RT-PCR.

scholarly journals Comparative analysis of three point-of-care lateral flow immunoassays for detection of anti-SARS-CoV-2 antibodies in COVID-19 confirmed healthcare workers

2020 ◽  
Author(s):  
Danielle Dias Conte ◽  
Joseane Mayara Almeida Carvalho ◽  
Luciano Kleber de Souza Luna ◽  
Klinger Soares Faíco-Filho ◽  
Ana Helena Perosa ◽  
...  
Keyword(s):  
Healthcare Workers ◽  
Large Scale ◽  
Point Of Care ◽  
Antibody Test ◽  
Cost Effective ◽  
Lateral Flow ◽  
Rt Pcr ◽  
Serum Samples ◽  
Igg Antibody ◽  
Serological Tests

AbstractSince the Coronavirus Disease 2019 (COVID-19) pandemic, Brazil has the third-highest number of confirmed cases and the second-highest number of recovered patients. SARS-CoV-2 detection by real-time RT-PCR is the gold standard in certified infrastructured laboratories. However, for large-scale testing, diagnostics should be fast, cost-effective, widely available, and deployed for the community, such as serological tests based on lateral flow immunoassay (LFIA) for IgM/IgG detection. We evaluated three different commercial point-of-care (POC) LFIAs for anti-SARS-CoV-2 IgM and IgG detection in capillary whole blood of 100 healthcare workers (HCW) previously tested by RT-PCR: 1) COVID-19 IgG/IgM BIO (Bioclin, Brazil), 2) Diagnostic kit for IgM/IgG Antibody to Coronavirus (SARS-CoV-2) (Livzon, China); and 3) SARS-CoV-2 Antibody Test (Wondfo, China). A total of 84 positives and 16 negatives HCW were tested. The data was also analyzed by the number of days post symptoms (DPS) in three groups: <30 (n=26), 30-59 (n=42), and >59 (n=16). Overall detection was 85.71%, 47.62%, and 44.05% for Bioclin, Livzon, and Wondfo, respectively, with a specificity of 100%, and 98.75% for Livzon on storage serum samples. Bioclin was more sensitive (p<0.01), regardless of the DPS. Thus, the Bioclin can be used as a POC test to monitor SARS-CoV-2 seroconversion in HCW.

scholarly journals Current and emerging diagnostic tests available for the novel COVID-19 global pandemic

2020 ◽  
Vol 3 ◽  
pp. 8 ◽  
Author(s):  
Gerald Mboowa
Keyword(s):  
Diagnostic Tests ◽  
Point Of Care ◽  
World Health ◽  
The Novel ◽  
Global Pandemic ◽  
The Us ◽  
The Status ◽  
Novel Coronavirus ◽  
Health Organization ◽  
Point Of Care Tests

On March 11, 2020 the World Health Organization (WHO) upgraded the status of the coronavirus disease 2019 (COVID-19) outbreak from epidemic to a global pandemic. This infection is caused by a novel coronavirus, SARS-CoV-2. Several rapid diagnostic tests have been developed at an astonishing pace; however, COVID-19 requires more highly specific rapid point-of-care diagnostic tests. This review describes the currently available testing approaches, as well as the available test assays including the Xpert® Xpress SARS-CoV-2 test (takes ~45 min) and Abbott ID COVID-19 test (5 min) as easy to use point-of-care tests for diagnosis of novel COVID-19 that have so far received the US Food and Drug Administration emergency use authorizations clearance. This review is correct as of the date published and will be updated as more diagnostic tests come to light.

Serological antibody testing in the COVID-19 pandemic: their molecular basis and applications

2020 ◽  
Vol 48 (6) ◽  
pp. 2851-2863
Author(s):  
Jiayue-Clara Jiang ◽  
Yan Zhang
Keyword(s):  
Antibody Response ◽  
Molecular Basis ◽  
Molecular Mechanisms ◽  
Vaccine Development ◽  
Point Of Care ◽  
Herd Immunity ◽  
Contact Tracing ◽  
Antibody Testing ◽  
Serological Tests ◽  
Molecular Tests

The ongoing COVID-19 pandemic has placed an overwhelming burden on the healthcare system, and caused major disruption to the world economy. COVID-19 is caused by SARS-CoV-2, a novel coronavirus that leads to a variety of symptoms in humans, including cough, fever and respiratory failure. SARS-CoV-2 infection can trigger extensive immune responses, including the production of antibodies. The detection of antibody response by serological testing provides a supplementary diagnostic tool to molecular tests. We hereby present a succinct yet comprehensive review on the antibody response to SARS-CoV-2 infection, as well as molecular mechanisms behind the strengths and limitations of serological antibody tests. The presence of antibodies can be detected in patient sera within days post symptom onset. Serological tests demonstrate superior sensitivity to molecular tests in some periods of time during disease development. Compared with the molecular tests, serological tests can be used for point-of-care testing, providing faster results at a lower cost. Commercially available serological tests show variable sensitivity and specificity, and the molecular basis of these variabilities are analysed. We discuss assays of different complexities that are used to specifically quantitate neutralising antibodies against SARS-CoV-2, which has important implications for vaccine development and herd immunity. Furthermore, we discuss examples of successful applications of serological tests to contact tracing and community-level sero-surveying, which provide invaluable information for pandemic management and assessment.

scholarly journals Serological determinants of COVID-19

2020 ◽  
Vol 15 (1) ◽  
Author(s):  
Annalisa Noce ◽  
Maria Luisa Santoro ◽  
Giulia Marrone ◽  
Cartesio D’Agostini ◽  
Ivano Amelio ◽  
...  
Keyword(s):  
Gold Standard ◽  
Point Of Care ◽  
Standard Test ◽  
Serological Tests ◽  
Point Of Care Test ◽  
Global Pandemic ◽  
Chemiluminescent Immunoassay ◽  
Low Sensitivity ◽  
Short Time

Abstract Background Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection spreaded rapidly worldwide, as far as it has become a global pandemic. Therefore, the introduction of serological tests for determination of IgM and IgG antibodies has become the main diagnostic tool, useful for tracking the spread of the virus and for consequently allowing its containment. In our study we compared point of care test (POCT) lateral flow immunoassay (FIA) vs automated chemiluminescent immunoassay (CLIA), in order to assess their specificity and sensibility for COVID-19 antibodies detection. Results We find that different specificities and sensitivities for IgM and IgG tests. Notably IgM POCT FIA method vs CLIA method (gold standard) has a low sensitivity (0.526), while IgG POCT FIA method vs CLIA method (gold standard) test has a much higher sensitivity (0.937); further, with respect of IgG, FIA and CLIA could arguably provide equivalent information. Conclusions FIA method could be helpful in assessing in short time, the possible contagiousness of subjects that for work reasons cannot guarantee “social distancing”.

scholarly journals Serological Determinants of COVID-19

2020 ◽  
Author(s):  
Annalisa Noce ◽  
Maria Luisa Santoro ◽  
Giulia Marrone ◽  
Cartesio D’Agostini ◽  
Ivano Amelio ◽  
...  
Keyword(s):  
Gold Standard ◽  
Point Of Care ◽  
Standard Test ◽  
Serological Tests ◽  
Point Of Care Test ◽  
Global Pandemic ◽  
Chemiluminescent Immunoassay ◽  
Low Sensitivity ◽  
Short Time

Abstract Background: Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection spreaded rapidly worldwide, as far as it has become a global pandemic. Therefore, the introduction of serological tests useful for the determination of IgM and IgG antibodies, it has become the main diagnostic tool, useful for tracking the spread of the virus and consequently its containment. In our study we compared point of care test (POCT) lateral flow immunoassay (FIA) vs automated chemiluminescent immunoassay (CLIA), in order to assess their specificity and sensibility against COVID-19 antibodies detection. Results: We find that different specificities and sensitivities for IgG and IgM tests. Notably IgM POCT FIA method vs CLIA method (gold standard) has a low sensitivity (0.526), while POCT FIA method vs CLIA method (gold standard) test has a much higher sensitivity (0.937); further, with respect of IgG, FIA and CLIA could arguably provide the same information. Conclusions: FIA method could be helpful in assessing in short time, the possible contagiousness of subjects that for work reasons cannot guarantee “social distancing”.

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