scholarly journals Serology in COVID-19 – Comparison of Two Methods

Author(s):  
Anna Moniuszko-Malinowska ◽  
Wojciech Jelski ◽  
Justyna Dunaj ◽  
Barbara Mroczko ◽  
Piotr Czupryna ◽  
...  

Abstract The aim of our study was to investigate the difference in the anti-SARS-CoV-2 antibodies assessment with two various assays. 127 patients exposed to SARS-CoV-2 were included. Two serological tests were used: SARS-CoV-2 IgG CMIA on the Alinity system (ABBOTT) and LIAISON® SARS-CoV-2 S1/S2 IgG CLIA (DiaSorin). Both assays exhibited 96.85% (123/127 patients) overall compatibility. In 2 cases the positive results in N-based test, were negative in S-based test, and in 2 cases negative results in S-based test were positive in N-based test. Based on the results of our study we concluded that the assessment of anti-SARS-CoV-2 antibodies against N and S protein in population medicine shows comparable usefulness of both tests.

2021 ◽  
Vol 12 ◽  
Author(s):  
Nastya Kharlamova ◽  
Nicky Dunn ◽  
Sahl K. Bedri ◽  
Svante Jerling ◽  
Malin Almgren ◽  
...  

Patients with chronic inflammatory diseases are often treated with immunosuppressants and therefore are of particular concern during the SARS-CoV-2 pandemic. Serological tests will improve our understanding of the infection and immunity in this population, unless they tests give false positive results. The aim of this study was to evaluate the specificity of SARS-Cov-2 serological assays using samples from patients with chronic inflammatory diseases collected prior to April 2019, thus defined as negative. Samples from patients with multiple sclerosis (MS, n=10), rheumatoid arthritis (RA, n=47) with or without rheumatoid factor (RF) and/or anti-cyclic citrullinated peptide antibodies (anti-CCP2) and systemic lupus erythematosus (SLE, n=10) with or without RF, were analyzed for SARS-CoV-2 antibodies using 17 commercially available lateral flow assays (LFA), two ELISA kits and one in-house developed IgG multiplex bead-based assay. Six LFA and the in-house validated IgG assay correctly produced negative results for all samples. However, the majority of assays (n=13), gave false positive signal for samples from patients with RA and SLE. This was most notable in samples from RF positive RA patients. No false positive samples were detected in any assay using samples from patients with MS. Poor specificity of commercial serological assays could possibly be, at least partly, due to interfering antibodies in samples from patients with chronic inflammatory diseases. For these patients, the risk of false positivity should be considered when interpreting results of the SARS-CoV-2 serological assays.


2018 ◽  
Vol 72 ◽  
pp. 1162-1178
Author(s):  
Aleksandra Lewandowicz-Uszyńska ◽  
Piotr Naporowski ◽  
Gerard Pasternak ◽  
Danuta Witkowska

The human immune system’s response to infection is closely related with the type of pathogen. First, a rapid, metabolically inexpensive and non-specific innate immunity is induced, then a specific acquired immunity is activated. In bacterial infections caused by intracellular pathogens, the main role is played by cellular response. In infections caused by bacterial extracellular pathogens, a crucial role is played by antibodies. The clinical symptoms of bacterial and viral infections very often are similar, which is why diagnosing them based only on medical history and physical examination is insufficient. To identify the etiological factors of infections differentiating media, biochemical tests, molecular methods and serological tests are used. The detection of microorganisms or their genetic material can be performed within a short time after the occurrence of an infection. The detection of antibodies is possible only in the appropriate time called the serological window. In a serological diagnostic of infections there are problems with an appropriate interpretation of obtained results. Cross-reactivity can give false positive results for the diagnosis of Chlamydophila pneumonia infection. The problem with the detection of Borrelia burgdorferi infection can be caused by a simultaneous coinfection with different spirochetes, syphilis, mononucleosis or HIV. In serological diagnostics of bacterial infections, the administration of antibiotics to patients before taking serum samples can be responsible for false negative results. Another reason for such results can be a weak humoral response in infected patients. In viral infections, false positive results can be caused by a coinfection of different viruses, especially from the same family or by bacterial or protozoal coinfections or by autoimmune diseases. False-negative results in viral infections often are caused by the early phase of an infection. To properly recognize an etiological factor of infection it is necessary to use an appropriate method, precision of test and collect samples at the appropriate time.


2020 ◽  
Vol 13 (1) ◽  
Author(s):  
Carlos A. Rodríguez-Alarcón ◽  
Diana M. Beristain-Ruiz ◽  
Angélica Olivares-Muñoz ◽  
Andrés Quezada-Casasola ◽  
Federico Pérez-Casio ◽  
...  

Abstract Background Nowadays, Ehrlichia canis receives increasing attention because of its great morbidity and mortality in animals. Dogs in the subclinical and chronic phases can be asymptomatic, and serological tests show cross-reactivity and fail to differentiate between current and past infections. Moreover, there could be low parasitaemia, and E. canis might be found only in target organs, hence causing results to be negative by polymerase chain reaction (PCR) on blood samples. Methods We evaluated by PCR the prevalence of E. canis in blood, liver, spleen, lymph node and bone marrow samples of 59 recently euthanised dogs that had ticks but were clinically healthy. Results In total, 52.55% of the blood PCRs for E. canis were negative, yet 61.30% yielded positive results from tissue biopsies and were as follows: 63.15% from bone marrow; 52.63% from liver; 47.36% from spleen; and 15.78% from lymph node. In addition, 33% had infection in three tissues (spleen, liver and bone marrow). Conclusions Our results show the prevalence of E. canis from tissues of dogs that were negative by blood PCR. Ehrlichia canis DNA in tissue was 30% lower in dogs that tested negative in PCR of blood samples compared to those that were positive. However, it must be taken into account that some dogs with negative results were positive for E. canis in other tissues.


Author(s):  
Anna Moniuszko-Malinowska ◽  
Wojciech Jelski ◽  
Justyna Dunaj ◽  
Barbara Mroczko ◽  
Piotr Czupryna ◽  
...  

Background: The aim of our study was to examine the performance of two assays in detecting SARS-CoV-2 antibodies. Methods: A total of 127 COVID-19 disease contacts from the Infectious Diseases Department were included. Two serological tests were used: SARS-CoV-2 IgG CMIA on the Alinity system (Abbott) and LIAISON® SARS-CoV-2 S1/S2 IgG CLIA (DiaSorin). Results: The assays exhibited a 96.85% (123/127 patients) test result agreement. In two cases, the positive results obtained by SARS-CoV-2 IgG CMIA on the Alinity system (Abbott) were negative based on the LIAISON® SARS-CoV-2 S1/S2 IgG CLIA (DiaSorin) test, and in two cases, negative results from the LIAISON® SARS-CoV-2 S1/S2 IgG CLIA (DiaSorin) test were positive with the SARS-CoV-2 IgG CMIA on the Alinity system (Abbott). Conclusions: Based on the results of our study, we conclude that in population medicine, the assessments of anti-SARS-CoV-2 antibodies after exposure to SARS-CoV-2 virus based on spike protein or nucleocapsid protein show comparable effectiveness.


2020 ◽  
Author(s):  
Nastya Kharlamova ◽  
Nicky Dunn ◽  
Sahl K Bedri ◽  
Svante Jerling ◽  
Malin Almgren ◽  
...  

AbstractObjectivesPatients with chronic inflammatory diseases are often treated with immunosuppressants and therefore are of particular concern during the SARS-CoV-2 pandemic. Serological tests will improve our understanding of the infection and immunity in this population, unless the tests give false positive results. The aim of this study was to evaluate the specificity of SARS-Cov-2 serological assays with samples from patients with chronic inflammatory diseases collected before April 2019, thus defined as negative.MethodsSamples from patients with multiple sclerosis (MS, n=10), rheumatoid arthritis (RA, n=47) with or without rheumatoid factor (RF) and/or anti-cyclic citrullinated peptide antibodies (anti-CCP2) and RF +/- systemic lupus erythematosus (SLE, n=10), were tested with 17 commercially available lateral flow assays (LFA), two ELISA kits and one in-house developed multiplex bead-based assay.ResultsSix LFA and the in-house IgG assay gave the correct negative results for all samples. However, the majority of assays (n=13), gave false positive signal with samples from patients with RA and SLE. This was most notable in RF positive RA samples. MS samples did not give any false positive in any of the assays.ConclusionThe majority of the verified serological assays were sensitive to interfering antibodies in samples from patients with chronic inflammatory diseases and therefore may have poor specificity in this context. For these patients, the risk of false positivity should be considered when interpreting results of the SARS-CoV-2 serological assays.


2007 ◽  
Vol 14 (4) ◽  
pp. 355-361 ◽  
Author(s):  
Kevin Y. Cheng ◽  
Chi-Deu Chang ◽  
Vince A. Salbilla ◽  
Louis V. Kirchhoff ◽  
David A. Leiby ◽  
...  

ABSTRACT The diagnosis of chronic Chagas' disease is generally made by detecting antibodies to Trypanosoma cruzi. Most conventional serological tests are based on lysates of whole parasites or semipurified antigen fractions from T. cruzi epimastigotes grown in culture. The occurrence of inconclusive and false-positive results has been a persistent problem with the conventional assays, and there is no universally accepted gold standard for confirmation of positive test results. We describe here an immunoblot assay for detecting antibodies to T. cruzi in which four chimeric recombinant antigens (rAgs), designated FP3, FP6, FP10, and TcF, are used as target antigens. Each of these rAgs is composed of several antigenically distinct regions and includes repetitive as well as nonrepetitive sequences. Each rAg is coated as a discrete line on a nitrocellulose strip. Assay sensitivity was assessed by testing 345 specimens known to be positive for antibodies to T. cruzi. All 345 of these samples showed two to four reactive test bands in addition to the three on-board control bands that are on each strip. Assay specificity was determined by testing 500 specimens from random U.S. blood donors, all of which gave negative results. Based on the results obtained in this study, we propose the following scheme for interpretation of test results: (i) no bands or a single test band = a negative result; (ii) two or more test bands with at least one band showing intensity of 1+ or higher = a positive result; and (iii) multiple faint test bands (±) = indeterminate result. Based on this scheme, the prototype immunoblot assay showed sensitivity of 100% (n = 345) and specificity of 100% (n = 500). Additionally, all 269 potentially cross-reacting and T. cruzi antibody-negative specimens tested negative in our immunoblot assay. The rAg-based immunoblot assay has potential as a supplemental test for confirming the presence of antibodies to T. cruzi in blood specimens and for identifying false-positive results obtained with other assays.


2020 ◽  
Author(s):  
Anne M. Scheel ◽  
Mitchell Schijen ◽  
Daniel Lakens

When studies with positive results that support the tested hypotheses have a higher probability of being published than studies with negative results, the literature will give a distorted view of the evidence for scientific claims. Psychological scientists have been concerned about the degree of distortion in their literature due to publication bias and inflated Type-1 error rates. Registered Reports were developed with the goal to minimise such biases: In this new publication format, peer review and the decision to publish take place before the study results are known. We compared the results in the full population of published Registered Reports in Psychology (N = 71 as of November 2018) with a random sample of hypothesis-testing studies from the standard literature (N = 152) by searching 633 journals for the phrase ‘test* the hypothes*’ (replicating a method by Fanelli, 2010). Analysing the first hypothesis reported in each paper, we found 96% positive results in standard reports, but only 44% positive results in Registered Reports. The difference remained nearly as large when direct replications were excluded from the analysis (96% vs 50% positive results). This large gap suggests that psychologists underreport negative results to an extent that threatens cumulative science. Although our study did not directly test the effectiveness of Registered Reports at reducing bias, these results show that the introduction of Registered Reports has led to a much larger proportion of negative results appearing in the published literature compared to standard reports.


2021 ◽  
pp. 25-37
Author(s):  
Waldemar Rastawicki ◽  
Klaudia Płaza ◽  
Adam Pietrusiński

Introduction: Lateral flow assays (LFIA) are the technology behind low-cost, simple, rapid and portable detection devices popular in biomedicine. Lately, they are very common used in serodiagnosis of SARS-CoV-2 infections. The aim of the presented study was to assess the usefulness of selected LFIA in serological diagnosis of COVID-19. Methods: The usefulness of seven lateral flow assays in the serodiagnosis of COVID-19 was evaluated (VAZYME, DIAGNOSIS, PCL, INGEZIM, BIOSENSOR, ACCU-TELL, NOVAtest). The study used 107 serum samples obtained from 74 individuals with current SARS-CoV-2 infection confirmed by RT-PCR. The ELISA-IgG (Euroimmun) was used as the reference assay for sensitivity and specificity testing. Results: The highest percentage of positive results was obtained when searching for IgG antibodies with the NOVAtest (40.6%) and DIAGNOSIS (39.2%) sets and the lowest detection for the PCL set - 25.5%. In the case of searching for IgM antibodies in all sets, significantly lower percentages of positive results compared to the IgG class were recorded. In general, all lateral flow assays showed low sensitivity in relation to the Euroimmun ELISA-IgG. The DIAGNOSIS kit (64.5%) was characterized by the highest sensitivity, and the PCL kit was the lowest (38.7%). On the other hand, the specificity of all kits was very high, almost 100% in almost all cases. Conclusions: Lateral flow assays due to their low sensitivity are not suitable for quick diagnosis of the current SARS-CoV-2 infections and cannot be an alternative to genetic or even antigen tests. They may be used only to retrospectively test the presence of IgG antibodies. However, a negative results of LFIA in suspected disease or after vaccination should be confirmed by more sensitive serological tests.


Blood ◽  
2008 ◽  
Vol 112 (11) ◽  
pp. 4720-4720
Author(s):  
Xiaoduan Weng ◽  
Louise Robin ◽  
Marie-lise Audet ◽  
Linda Hébert ◽  
Ginette Lapointe ◽  
...  

Abstract HLA-B27 is a strong diagnostic biomarker as it is found in 90– 95% of ankylosing spondylitis. Routinely, the false-positive results generated by cross-reactivity of HLA-B27 monoclonal antibodies (mAbs) with some other type of HLA-B antigens are problematic. The present study aims at improving the sensitivity and specificity of typing for HLA-B27 by using a more accurate DNA assay. A real time sequence specific primer polymerase chain reaction (PCR-SSP) is performed by using MGB TaqMan oligoprobe and an ABI PRISM™ 7500 sequence detection system. The TaqMan PCR-SSP assay is compared with Immunophenotyping by flow cytometric antigen assay (BD HLA-B27-Kit, clone GS145.2). The results are finally confirmed by sequencing (ABI PRISM ® 3100). As summarised in the table, three methods are identical for clearly positive and negative results. There is 90% concordance for borderline negative results obtained by immunophenotyping with TaqMan PCR-SSC and/or sequencing. However, only 15.4% of borderline positives obtained by immunophenotyping are confirmed as true HLA-B27 positives by sequencing as well as TaqMan PCR-SSC. TaqMan PCR-SSP DNA assay completely correlates with sequencing (gold standard) with 100% PPV and NPV, compared to a PPV of 15% and a NPV of 98% for borderline results by immunophenotyping. Conclusion: when compared with flow cytometric antigen assay, typing HLA-B27 by TaqMan PCR-SSP clearly demonstrates an advantage to better establish the genotype of the patient. Specifically, there is a marked difference for ambitious positive results from immunophenotyping. Moreover, compared to immunophenotyping, there is no need of fresh samples, can test a larger number of samples concomitantly, and reduces technical time as well as cost. N = 52 Immunophenotyping TaqMan PCR-SSP Sequencing Immuno vs Sequencing TaqMan PCR-SSP vs Sequencing Positive 11 11 11 100% 100% Negative 17 17 17 100% 100% Positive (borderline by Immunophenotyping) 13 2 2 15% 100% Negative (borderline ) by Immunophenotyping) 10 9 9 98% 100%


2001 ◽  
Vol 13 (08) ◽  
pp. 953-1034 ◽  
Author(s):  
MARCUS BERG ◽  
CÉCILE DeWITT-MORETTE ◽  
SHANGJR GWO ◽  
ERIC KRAMER

A simple, but not widely known, mathematical fact concerning the coverings of the full Lorentz group sheds light on parity and time reversal transformations of fermions. Whereas there is, up to an isomorphism, only one Spin group which double covers the orientation preserving Lorentz group, there are two essentially different groups, called Pin groups, which cover the full Lorentz group. Pin(1, 3) is to O(1, 3) what Spin(1, 3) is to SO(1, 3). The existence of two Pin groups offers a classification of fermions based on their properties under space or time reversal finer than the classification based on their properties under orientation preserving Lorentz transformations — provided one can design experiments that distinguish the two types of fermions. Many promising experimental setups give, for one reason or another, identical results for both types of fermions. These negative results are reported here because they are instructive. Two notable positive results show that the existence of two Pin groups is relevant to physics: • In a neutrinoless double beta decay, the neutrino emitted and reabsorbed in the course of the interaction can only be described in terms of Pin(3, 1). • If a space is topologically nontrivial, the vacuum expectation values of Fermi currents defined on this space can be totally different when described in terms of Pin(1, 3) and Pin(3, 1). Possibly more important than the two above predictions, the Pin groups provide a simple framework for the study of fermions; it makes possible clear definitions of intrinsic parities and time reversal; it clarifies colloquial, but literally meaningless, statements. Given the difference between the Pin group and the Spin group it is useful to distinguish their representations, as groups of transformations on "pinors" and 'spinors", respectively. The Pin(1, 3) and Pin(3, 1) fermions are twin-like particles whose behaviors differ only under space or time reversal. A section on Pin groups in arbitrary spacetime dimensions is included.


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