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

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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Comparison of Coombs Gel Test with ELISA and Standard Tube Agglutination Tests Used in Serological Diagnosis of Brucellosis

Infectious Diseases and Clinical Microbiology ◽

10.36519/idcm.2019.0024 ◽

2020 ◽

Vol 2 (1) ◽

pp. 1-7 ◽

Cited By ~ 1

Author(s):

Cigdem Akalan Kuyumcu ◽

Serpil Erol ◽

Rıza Adaleti ◽

Seniha Senbayrak ◽

Secil Deniz ◽

...

Keyword(s):

Sensitivity And Specificity ◽

Diagnostic Tests ◽

Serological Test ◽

High Sensitivity ◽

Serological Diagnosis ◽

Control Groups ◽

Serum Samples ◽

Serological Tests ◽

Reliable Test ◽

And Control

Objective: Serological tests are the most commonly used tests in the diagnosis of brucellosis; however, each serological test has some drawbacks. In this study, we aimed to determine the value of the Brucella Coombs gel test (BCGT) in the serological diagnosis of brucellosis in comparison with Standard tube agglutination (STA) and ELISA tests. Materials and Methods: The study included 42 patients who were considered to have brucellosis as a preliminary diagnosis. BCGT, Brucella-IgM/IgG ELISA, and STA tests were performed from serum samples of the patients. The correlation of the diagnostic tests was analyzed using Cohen’s Kappa Analysis. Results: Twenty-seven (64.2%) of 42 patients were diagnosed with brucellosis according to their medical history and clinical and serological tests. The sensitivity and specificity of BCGT to diagnose brucellosis was 96.2%, and 100%, respectively. The sensitivity and specificity for the diagnosis of brucellosis 62.9% and 100% for STA, respectively; 33.3% and 66.6% for Brucella-IgM; and 66.6% and 100% for Brucella-IgG. BCGT was significantly correlated with STA (κ= 0.590) and Brucella-IgG (κ=0.539) Conclusion: BCGT can be utilized as a simple and reliable test in the diagnosis of brucellosis with high sensitivity and specificity. Nevertheless, the sensitivity and specificity of BCGT should be demonstrated by comprehensive studies, including culture-confirmed cases and control groups.

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Markers of the early stage of rheumatoid arthritis

Diagnostyka Laboratoryjna ◽

10.5604/01.3001.0008.2523 ◽

2016 ◽

Vol 51 (4) ◽

pp. 305-314

Author(s):

Beata Polińska ◽

Joanna Matowicka-Karna ◽

Halina Kemona

Keyword(s):

Rheumatoid Arthritis ◽

Human Population ◽

Early Stage ◽

Clinical Signs ◽

High Sensitivity ◽

Unknown Etiology ◽

Serological Tests ◽

Citrullinated Peptide ◽

Peptide Antibodies

Rheumatoid arthritis (RA) is a chronic, autoimmune connective tissue disease of unknown etiology. RA affects about 1% of the human population, women suffer three times more often than men, with the peak incidence between the age of 40 to 50. The up-to-date criteria from 2010 for the diagnosis of RA include: occurrence and duration of clinical signs, indicators of inflammation and serological tests. Neopterin, a protein released by macrophages, is a sensitive indicator of inflammation and the severity of RA. Regarding the serological tests, anti-cyclic citrullinated peptide antibodies represent a well-known marker with the specificity for RA of about 98%. The antibodies may be present in the serum of patients even a few years before the first clinical signs of the disease, heralding erosive changes in the joints and more severe course of RA. The literature also contains reports about autoantibodies anti-CarP and anti-Sa/ anti-MCV, which may occur in people with pain and swelling of joints and precede full-blown development of RA as well as reflect disease activity. Serological diagnosis of RA may be supported by some genetic tests based on PCR for detecting mutations e.g. C1858T in the PNPN22 gene. In turn, the quantitative analysis of different classes of miRNAs seems justified in order to better classify patients showing symptoms of RA. Further studies are needed that take into account the role of different markers in the development of RA, and confirm the high sensitivity and specificity of these markers in the diagnosis of the disease.

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Coronavirus Disease 2019 (COVID-19) Diagnostics: a Primer

Dental Update ◽

10.12968/denu.2020.47.9.761 ◽

2020 ◽

Vol 47 (9) ◽

pp. 761-765

Author(s):

Lakshman Samaranayake ◽

Niraj Kinariwala ◽

RAPM Perera

Keyword(s):

Severe Acute Respiratory Syndrome ◽

Diagnostic Tests ◽

Clinical Diagnostics ◽

Serological Testing ◽

Accurate Identification ◽

Community Infection

The Coronavirus disease 2019 (COVID-19) pandemic, caused by the severe acute respiratory syndrome coronavirus 2 (SARSCoV-2), seems to have spared no single community. Rapid and accurate identification of COVID-19 patients are the mainstay for breaking the chain of community infection and controlling the pandemic. There are now a bewildering array of diagnostic tests available to detect COVID-19 at various stages of infection. In this, the fourth article in the COVID-19 Commentary series, we describe the basics of current clinical diagnostics, including molecular and serological testing approaches, and summarize their advantages and limitations.

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

Diagnostics ◽

10.3390/diagnostics10070453 ◽

2020 ◽

Vol 10 (7) ◽

pp. 453 ◽

Cited By ~ 13

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.

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COMPARISON OF PERFORMANCE CHARACTERISTICS BETWEEN LATERAL FLOW, ELISAAND ELECTROCHEMILUMINESCENCE IMMUNOASSAYS FOR THE DETECTION OF SARS-COV-2 ANTIBODIES AMONG HEALTHCARE WORKERS

10.36106/ijsr/0101617 ◽

2021 ◽

pp. 45-48

Author(s):

Shincy M R ◽

Vandana Govindan ◽

Sudhakar H H ◽

Padmapriya K ◽

Venkatesha V T ◽

...

Keyword(s):

Severe Acute Respiratory Syndrome ◽

Healthcare Workers ◽

Care Pathway ◽

Point Of Care ◽

High Sensitivity ◽

Central Research ◽

Serum Samples ◽

Igg Antibody ◽

Human Igg ◽

Serological Tests

Background: The detection of SARS-CoV-2 IgG is important to determine the course of COVID-19. Medical professionals and researchers have been urging the need for wide and rapid testing of citizens in order to plan measures that can contain the spread of the virus. Antibody tests play an important role throughout the patient care pathway and are vital for the management and surveillance of the virus. Although RTPCR is considered to be the gold standard, serological tests based on antibodies could be very helpful for on-time detection. We performed one to one assessment of electrochemiluminescence immunoassay, enzyme immunoassay (EIAs), and point-of-care lateral ow assay (POCTs) to detect severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) IgG antibody. Materials and Methods: 611 healthcare workers were recruited between November and December 2020 at Central Research Laboratory, KIMS. ® Collected serum samples were analysed using three commercially available assays: the Elecsys , Anti-SARS CoV-2 Human IgG ELISA, the Standard Q IgG/IgM combo assay following the manufacturer's protocol to measure the IgG titer of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Results:The kits displayed a sensitivity of 91.8%, 79.5% ,61.2% and a specicity of 80.2%, 64.1% ,61.7% in order. Conclusion: ® Our results indicate a high sensitivity and specicity for the Elecsys assay compared to Anti-SARS CoV-2 Human IgG ELISA, the Standard Q IgG/IgM combo assays.

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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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Detection of anti-SARS-CoV-2 antibodies in patients with rheumatoid arthritis.

10.21203/rs.3.rs-112294/v1 ◽

2020 ◽

Author(s):

Shomi Oka ◽

Takashi Higuchi ◽

Hiroshi Furukawa ◽

Kota Shimada ◽

Atsushi Hashimoto ◽

...

Keyword(s):

Rheumatoid Arthritis ◽

Rheumatoid Factor ◽

Serological Test ◽

Rheumatoid Factors ◽

National Hospital ◽

Serum Samples ◽

Igg Rheumatoid Factor ◽

Electrochemiluminescence Immunoassay ◽

N 93 ◽

Prior Infection

Abstract Objectives: The severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) causes coronavirus disease 2019 (COVID-19) and the outbreak of COVID-19 was reported in December 2019 in Wuhan, China. Serological test is conducted to discriminate prior infection of SARS-CoV-2. The influence of auto-antibodies on the results of anti-SARS-CoV-2 antibodies was investigated in a few studies. Here, we investigated whether the results of anti-SARS-CoV-2 antibodies would be modified in patients with rheumatoid arthritis (RA). Methods: Patients with RA were recruited at Sagamihara National Hospital from July 2014 to October 2015 (n=38, 2014 cohort) and at Tokyo National Hospital from June to October 2020 (n=93, 2020 cohort). Anti-SARS-CoV-2 antibodies were measured in collected sera from these RA patients by electrochemiluminescence immunoassay (ECLIA) or immunochromatographic assay (ICA). Results: Anti-SARS-CoV-2 antibodies were not detected in all the samples form RA patients in both cohorts by the ECLIA. However, anti-SARS-CoV-2 antibodies were detected in the serum samples from three (7.9%) in 2014 cohort by the ICA and fifteen (16.1%) in 2020 cohort. The IgM rheumatoid factor levels were increased in RA patients with IgM anti-SARS-CoV-2 antibodies by ICA compared with RA without any anti-SARS-CoV-2 antibodies (mean ± standard deviation [IU/ml], 1223.0 ± 1308.7 vs. 503.6 ± 1947.2, P=0.0101). The levels of IgG rheumatoid factor were also upregulated in RA patients with IgM anti-SARS-CoV-2 antibodies by ICA (4.0 ± 0.7 vs. 2.4 ± 0.9, P=0.0013). Conclusion: The results of IgM anti-SARS-CoV-2 antibody by the ICA would be modified by IgM or IgG rheumatoid factors in RA patients.

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Lehetőségek és buktatók a SARS-CoV-2-antigén és az ellene termelt antitestek kimutatásában

Orvosi Hetilap ◽

10.1556/650.2021.32210 ◽

2021 ◽

Vol 162 (15) ◽

pp. 563-570

Author(s):

Melinda Medgyaszai ◽

Zalán Péterfi ◽

Anna Valkó

Keyword(s):

Immune Response ◽

Immune System ◽

Severe Acute Respiratory Syndrome ◽

Infectious Diseases ◽

Human Body ◽

Scientific Knowledge ◽

Diagnostic Tests ◽

Serological Testing ◽

Medical Opinion ◽

Over Time

Összefoglaló. A koronavírus-betegség 2019 (COVID–19)-pandémia komoly kihívás elé állította nemcsak a mikrobiológiai laboratóriumokat, hanem az eredmények interpretálásában a klinikumban dolgozó kollégákat is. Az orvostudomány specializált világában az immunológiai és a fertőző betegségekkel kapcsolatos ismeretek az antimikrobás terápiás megoldások sikeressége, valamint a széles körű vakcináció miatt az idők folyamán számos szakterületen háttérbe szorultak, felfrissítésük sürgető és elengedhetetlen része a pandémiával való megküzdésnek. A diagnosztikai vizsgálatok fontos eszközei a járvány megfékezésének, illetve a betegek ellátásának, azonban a vírus és az emberi szervezet interakciójának megértése elengedhetetlenül szükséges a korrekt epidemiológiai és gyógyászati véleményalkotáshoz. Jelen cikkünk az orvosi gyakorlat számára foglalja össze a súlyos akut légzőszervi szindrómát okozó koronavírus-2 (SARS-CoV-2) kimutatására, valamint az immunrendszer specifikus immunválaszának szerológiai vizsgálatára irányuló, gyakorlatban használatos módszereket, azok helyét, szerepét és értékelésük szempontjait a tudomány jelen állása szerint. Orv Hetil. 2021; 162(15): 563–570. Summary. The coronavirus disease 2019 (COVID-19) pandemic posed a serious challenge not only for microbiology laboratories, but also for the clinicians in interpretation of the results. In the specialized world of medicine, knowledge of immunological and infectious diseases has been relegated to the background in many disciplines over time due to the success of antimicrobial therapies and widespread vaccination, so updating them is an urgent and essential part of the fight against the pandemic. Diagnostic tests are important tools for controlling the epidemic and caring for patients, but understanding the interaction between the virus and the human body is essential to form a correct epidemiological and medical opinion. This paper summarizes the medical methods for the detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and the serological testing of the specific immune response of the immune system, their place, role and criteria of their evaluation according to current scientific knowledge. Orv Hetil. 2021; 162(15): 563–570.

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Role of high sensitivity C - Reactive protein and some of heavy metals in patients with rheumatoid arthritis

10.36295/asro.2020.231604 ◽

2020 ◽

Vol 23 (16) ◽

Author(s):

Nashwan S. Albabawaty ◽

Ali Y. Majid ◽

Mohammed H. Alosami ◽

Halla G. Mahmood

Keyword(s):

Rheumatoid Arthritis ◽

Heavy Metals ◽

High Sensitivity ◽

C Reactive Protein ◽

Reactive Protein

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Use of β-D-glucan in diagnosis of suspected Pneumocystis jirovecii pneumonia in adults with HIV infection

International Journal of STD & AIDS ◽

10.1177/09564624211022247 ◽

2021 ◽

pp. 095646242110222

Author(s):

Thomas Juniper ◽

Chris P Eades ◽

Eliza Gil ◽

Harriet Fodder ◽

Killian Quinn ◽

...

Keyword(s):

Predictive Value ◽

Diagnostic Tests ◽

Elevated Serum ◽

Clinical Information ◽

High Sensitivity ◽

Pneumocystis Pneumonia ◽

Pneumocystis Jirovecii Pneumonia ◽

Alternative Diagnosis ◽

Positive Threshold ◽

Sensitivity Specificity

Objectives: An elevated serum (1-3)-β-D-glucan (BDG) concentration has high sensitivity for a diagnosis of Pneumocystis pneumonia (PCP) in people with HIV (PWH). At the current manufacturer-recommended positive threshold of 80 pg/mL (Fungitell), specificity for PCP is variable and other diagnostic tests are required. We evaluated the utility of serum BDG for diagnosis of suspected PCP in PWH at three inner-London hospitals to determine BDG concentrations for diagnosis and exclusion of PCP. Methods: From clinical case records, we abstracted demographic and clinical information and categorised patients as having confirmed or probable PCP, or an alternative diagnosis. We calculated sensitivity, specificity and positive predictive value (PPV) of serum BDG concentrations >400 pg/mL and negative predictive value (NPV) of BDG <80 pg/mL. Results: 76 patients were included; 29 had laboratory-confirmed PCP, 17 had probable PCP and 30 had an alternative diagnosis. Serum BDG >400 pg/mL had a sensitivity of 83%, specificity of 97% and PPV 97% for diagnosis of PCP; BDG <80 pg/mL had 100% NPV for exclusion of PCP. Conclusions: In PWH with suspected PCP, BDG <80 pg/mL excludes a diagnosis of PCP, whereas BDG concentrations >400 pg/mL effectively confirm the diagnosis. Values 80–400 pg/mL should prompt additional diagnostic tests.

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