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

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.

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

10.20944/preprints202006.0278.v1 ◽

2020 ◽

Cited By ~ 1

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.

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

Srpski medicinski casopis Lekarske komore ◽

10.5937/smclk2-32938 ◽

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.

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

AAS Open Research ◽

10.12688/aasopenres.13059.1 ◽

2020 ◽

Vol 3 ◽

pp. 8 ◽

Cited By ~ 1

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.

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Serological determinants of COVID-19

Biology Direct ◽

10.1186/s13062-020-00276-1 ◽

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”.

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Serological Determinants of COVID-19

10.21203/rs.3.rs-78800/v1 ◽

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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Antibody tests in detecting SARS-CoV-2 infection: a meta-analysis

10.1101/2020.04.22.20074914 ◽

2020 ◽

Cited By ~ 9

Author(s):

Panagiota I Kontou ◽

Georgia G Braliou ◽

Niki L Dimou ◽

Georgios Nikolopoulos ◽

Pantelis G Bagos

Keyword(s):

Diagnostic Tests ◽

Point Of Care ◽

Meta Analysis ◽

High Specificity ◽

Enzyme Linked Immunosorbent Assay ◽

Lower Sensitivity ◽

Serological Tests ◽

Bivariate Method ◽

Acid Test ◽

Antibody Tests

SummaryBackgroundWith the emergence of SARS-CoV-2 and the associated Coronavirus disease 2019 (COVID-19), there is an imperative need for diagnostic tests that can identify the infection. Although Nucleic Acid Test (NAT) is considered to be the gold standard, serological tests based on antibodies could be very helpful. However, individual studies measuring the accuracy of the various tests are usually underpowered and inconsistent, thus, a comparison of different tests is needed.MethodsWe performed a systematic review and meta-analysis following the PRISMA guidelines. We conducted the literature search in PubMed, medRxiv and bioRxiv. For the statistical analysis we used the bivariate method for meta-analysis of diagnostic tests pooling sensitivities and specificities. We evaluated IgM and IgG tests based on Enzyme-linked immunosorbent assay (ELISA), Chemiluminescence Enzyme Immunoassays (CLIA), Fluorescence Immunoassays (FIA) and the point-of-care (POC) Lateral Flow Immunoassays (LFIA) that are based on immunochromatography.FindingsIn total, we identified 38 eligible studies that include data from 7,848 individuals. The analyses showed that tests using the S antigen are more sensitive than N antigen-based tests. IgG tests perform better compared to IgM ones, and show better sensitivity when the samples were taken longer after the onset of symptoms. Moreover, irrespective of the method, a combined IgG/IgM test seems to be a better choice in terms of sensitivity than measuring either antibody type alone. All methods yielded high specificity with some of them (ELISA and LFIA) reaching levels around 99%. ELISA- and CLIA-based methods performed better in terms of sensitivity (90-94%) followed by LFIA and FIA with sensitivities ranging from 80% to 86%.InterpretationELISA tests could be a safer choice at this stage of the pandemic. POC tests (LFIA), that are more attractive for large seroprevalence studies show high specificity but lower sensitivity and this should be taken into account when designing and performing seroprevalence studies.FundingNone

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Detection of anti-SARS-CoV-2 nucleocapsid and spike antibodies in patients with Coronavirus Disease 2019 in Japan.

10.21203/rs.3.rs-700987/v1 ◽

2021 ◽

Author(s):

Hiroshi Furukawa ◽

Shomi Oka ◽

Takashi Higuchi ◽

Miho Yamaguchi ◽

Shota Uchiyama ◽

...

Keyword(s):

Rheumatoid Arthritis ◽

Severe Acute Respiratory Syndrome ◽

Diagnostic Tests ◽

High Sensitivity ◽

Regression Analyses ◽

Serological Testing ◽

National Hospital ◽

Serological Tests ◽

N 93 ◽

And Control

Abstract Objectives Coronavirus Disease 2019 (COVID-19) is caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Serological testing for anti-SARS-CoV-2 nucleocapsid (N) antibodies (Abs) and anti-SARS-CoV-2 spike (S) Abs is performed to detect prior COVID-19 infection. It is still controversial which antibodies are the most sensitive and specific, and which can be detected earliest after infection. Here, we evaluated the results of serological tests of anti-SARS-CoV-2 N and S Abs in Japan.Methods Symptomatic COVID-19 patients (n = 84) and control patients with rheumatoid arthritis (n = 93) were recruited at Tokyo National Hospital. Anti-SARS-CoV-2 N and S Abs were measured by commercial electrochemiluminescence immunoassays.Results The fraction of patients positive for anti-SARS-CoV-2 N and S Abs was highest > 14 days after symptom onset. The frequency of anti-SARS-CoV-2 S Ab positivity at this time (80.4%) tended to be slightly but not significantly lower than anti-SARS-CoV-2 N Ab positivity (84.8%). Optimized cut-off levels for anti-SARS-CoV-2 N and S Ab positivity were lower than the manufacturer's recommended cut-off levels. Using multiple linear regression analyses with anti-SARS-CoV-2 N and S Abs, we created an Ab-index with high sensitivity.Conclusion To increase the sensitivity of serological diagnostic tests for COVID-19, it is suggested that both anti-SARS-CoV-2 N and S Abs should be measured and cut-off levels decreased.

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Magnetic Digital Microfluidics for Point-of-Care Testing: Where Are We Now?

Current Medicinal Chemistry ◽

10.2174/0929867327666200903115448 ◽

2020 ◽

Vol 27 ◽

Author(s):

Yi Zhang

Keyword(s):

System Integration ◽

Diagnostic Tests ◽

Point Of Care ◽

Digital Microfluidics ◽

Controlled Environment ◽

Point Of Care Testing ◽

Microfluidic Platforms ◽

Interface System ◽

Technical Issues ◽

Sample System

: Point-of-care (POC) testing decentralizes the diagnostic tests to the sites near the patient. Many POC tests rely microfluidic platforms for sample-to-answer analysis. Compared to other microfluidic systems, magnetic digital microfluidics demonstrate compelling advantages for POC diagnostics. In this review, we have examined the capability of magnetic digital microfluidics-based POC diagnostic platforms. More importantly, we have categorized POC settings into three classes based on “where is the point”, “who to care” and “how to test”, and evaluated the suitability of magnetic digital microfluidics in various POC settings. Furthermore, we have addressed other technical issues associated with POC testing such as controlled environment, sample-system interface, system integration and information connectivity. We hope this review would provide a guideline for the future development of magnetic digital microfluidics-based platforms for POC testing.

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Defence Medical Rehabilitation Centre (DMRC) COVID-19 Recovery Service

BMJ Military Health ◽

10.1136/bmjmilitary-2020-001681 ◽

2021 ◽

pp. e001681

Author(s):

Oliver O'Sullivan ◽

R Barker-Davies ◽

R Chamley ◽

E Sellon ◽

D Jenkins ◽

...

Keyword(s):

Occupational Medicine ◽

Armed Forces ◽

Acute Illness ◽

Medical Rehabilitation ◽

Rehabilitation Centre ◽

Operational Effectiveness ◽

Mortality And Morbidity ◽

Recovery Service ◽

Significant Mortality

Coronavirus disease 2019 (COVID-19) causes significant mortality and morbidity, with an unknown impact in the medium to long term. Evidence from previous coronavirus epidemics indicates that there is likely to be a substantial burden of disease, potentially even in those with a mild acute illness. The clinical and occupational effects of COVID-19 are likely to impact on the operational effectiveness of the Armed Forces. Collaboration between Defence Primary Healthcare, Defence Secondary Healthcare, Defence Rehabilitation and Defence Occupational Medicine resulted in the Defence Medical Rehabilitation Centre COVID-19 Recovery Service (DCRS). This integrated clinical and occupational pathway uses cardiopulmonary assessment as a cornerstone to identify, diagnose and manage post-COVID-19 pathology.

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Diagnosis of tuberculosis in wildlife: a systematic review

Veterinary Research ◽

10.1186/s13567-020-00881-y ◽

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.

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