Evaluation of serological tests for detecting SARS-CoV-2 antibodies: implementation in assessing post vaccination status

Background The anti SARS CoV 2 immunological assays have promising applications in the control and surveillance of the current COVID 19 pandemic. Therefore, large number of serological assays are developed in the commercial market to measure SARS CoV 2 antibodies, which requires evaluation before their application in large scale. Objectives To evaluate the performances of commercially available serological assays for detecting SARS CoV 2 antibodies. Methods The study compared the performances of six different methods for detection of antibodies against SARS CoV 2 which includes (i) Genscript SARS CoV 2 surrogate virus neutralization test kit [Test A] (ii) Diasorin SARS CoV 2 S1 S2 IgG detection [Test B] (iii) Alinity SARS CoV 2 IgG II [Test C] (iv) Diasorin SARS CoV 2 TrimericS IgG [Test D] (v) Roche Elecsys Anti SARS CoV 2 cobas [Test E] (vi) AESKULISA (AESKU Enzyme Linked Immunosorbent Assay) [Test F] against the gold standard Plaque Reduction Neutralization Test (PRNT). Results Test E had the highest sensitivity and Test A had the highest specificity The ROC for tests A, C, D and E showed optimum cutoffs that differed from the manufacturers recommendation. Test D had the best performance considering all the performance indicators with the highest agreement with the PRNT results. Parallel testing of test A with test D and test B had the optimum performance. Conclusion Serological assays that are commercially available are very promising and show good agreement with the standard PRNT results. Studies on large samples for optimization of the assay cutoff values and cost effective evaluations on parallel testing methods are needed to make recommendations on these commercial assays.

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Mass Antibody Detection: Can It be An Avenger for Infectivity War against COVID-19

10.20944/preprints202006.0211.v1 ◽

2020 ◽

Author(s):

Sarfaraz Ahmad Ejazi ◽

Sneha Ghosh ◽

Nahid Ali

Keyword(s):

Large Scale ◽

Point Of Care ◽

Cost Effective ◽

Antibody Detection ◽

Serological Tests ◽

Ongoing Research ◽

Molecular Tests ◽

Immunological Assays ◽

Commercial Kits ◽

Vaccination Therapy

The ongoing pandemic of COVID-19 has not only commenced a global health emergency but agitated various aspects of humanity. During this period of crisis researchers over the world have ramped their efforts to constrain the disease in all possible ways whether it is vaccination, therapy, or diagnosis. Since the spread of the disease has not yet elapsed sharing the ongoing research findings could be the key to disease control and management. An early and efficient diagnosis could leverage the outcome until a successful vaccine is developed. Molecular tests both in-house and commercial kits are preferably being used worldwide in the COVID-19 diagnosis. However, the limitation of high prices and lengthy procedures impede their use for mass testing. Keeping the constant rise of infection in mind search for an alternative test that should be cost-effective, simple, and suitable for large scale testing and surveillance is a need of an hour. One such alternative could be the immunological tests. Therefore, in the last few months deluge of immunological rapid tests has been developed and validated across the globe. The objective of the present review is to share the diagnostic performance of various immunological assays reported so far in SARS-CoV-2 case detection. The article consolidated the studies (published and preprints) related to the serological tests such as chemiluminescence, enzyme-linked and lateral flow-based point-of-care tests in COVID-19 diagnosis and updated the current scenario. This review will hopefully be an add-on in COVID-19 research and will contribute to congregate the evidence for decision-making.

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Development of specific immunity in laboratory animals after co-immunization against seasonal influenza and COVID-19

Journal of microbiology epidemiology immunobiology ◽

10.36233/0372-9311-183 ◽

2022 ◽

Vol 98 (6) ◽

pp. 648-656

Author(s):

G. M. Ignatyev ◽

I. A. Leneva ◽

A. V. Atrasheuskaya ◽

L. I. Kozlovskaya ◽

N. P. Kartashova ◽

...

Keyword(s):

Neutralizing Antibodies ◽

Seasonal Influenza ◽

Neutralization Test ◽

Elisa Test ◽

Control Measures ◽

Laboratory Animals ◽

Enzyme Linked Immunosorbent Assay ◽

Post Vaccination ◽

Specific Immunity ◽

Influenza Prevention

Introduction. In clinical practice, the differential diagnosis of COVID-19 can be challenging during the flu season, entailing serious consequences such as delays in appropriate control measures against the SARS-CoV-2 pandemic. Another problem is posed by co-infection of SARS-CoV-2 and influenza virus (IV), which significantly contributes to the severity of the COVID-19 disease. This study was aimed to explore the cross-impact of co-administration of Russian influenza and COVID-19 vaccines on development of specific immunity in laboratory animals.Materials and methods. The study was conducted on BALB/c mice. The animals were inoculated intramuscularly with the vaccine for COVID-19 prevention (CoviVac) and the vaccine for influenza prevention (Flu-M). The sera from the immunized animals were examined separately. Three IV strains were used in the hemagglutination inhibition assay. Antibodies (Abs) against SARS-CoV-2 were detected by an enzyme-linked immunosorbent assay (ELISA). The neutralization test was performed to detect virus neutralizing antibodies against SARS-CoV-2 and IV.Results. Relatively high titers of specific Abs were found in the groups of animals inoculated with one vaccine and with two vaccines concurrently. In the groups of animals inoculated with CoviVac and with two vaccines concurrently, both in the ELISA test and in the neutralization test, the average titers of specific Abs against SARSCoV- 2 did not demonstrate any statistical difference. The group of animals inoculated concurrently with two vaccines demonstrated statistically higher titers of Abs against IV after the second immunization compared to the group of animals inoculated with Flu-M.Discussion. The study has shown that post-vaccination immunity both to IV and to SARS-CoV-2 develops after co-vaccination with two vaccines. The observed enhanced post-vaccination immune response to IV in the coimmunized laboratory animals needs further research.Conclusion. The performed studies suggest the possibility of co-administration of two vaccines to prevent influenza and COVID-19.

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PAH RIS® Soil Test—A Rapid, On-Site Screening Test for Polynuclear Aromatic Hydrocarbons in Soil

Journal of AOAC International ◽

10.1093/jaoac/77.2.466 ◽

1994 ◽

Vol 77 (2) ◽

pp. 466-472 ◽

Cited By ~ 12

Author(s):

Patricia P McDonald ◽

Richard E Almond ◽

James P Mapes ◽

Stephen B Friedman

Keyword(s):

Aromatic Hydrocarbons ◽

Matrix Effects ◽

Cost Effective ◽

Polynuclear Aromatic Hydrocarbons ◽

Detection Methods ◽

Enzyme Linked Immunosorbent Assay ◽

Sample Treatment ◽

Negative Results ◽

Cost Effective Method ◽

Test Kit

Abstract Polynuclear aromatic hydrocarbons (PAHs) are chemicals of concern when they contaminate the environment. Current detection methods (gas chromatography and liquid chromatography) are laborious, time consuming, and expensive. As an alternative, we developed a competitive enzyme-linked immunosorbent assay kit that can be used on site for the detection of PAHs at 1 ppm in soil. The immunoassay kit includes all the components necessary to conduct the analysis in the field. The test consists of 3 major steps: (1) sample treatment; (2) immunoassay, in which the target compound is bound by a specific antibody followed by the development of an indicator color; and (3) interpretation of results. A sample that develops less color than the standard is interpreted as positive (soil sample contaminated with PAHs at ≥1 ppm). Validation studies demonstrated that the assay is sensitive and specific. The assay detects PAH contamination in soil at 1 ppm or greater and specifically detects the 3- and 4-ringed aromatics and most of the 5-and 6-ringed aromatics. PAH-free soil samples gave negative results in the assay at a confidence level of >95%. Matrix effects, interperson, and interlot variations were minimal. The test requires <25 min to complete. The test kit is field compatible and provides a cost effective method for screening soils at risk for PAH contamination.

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FIRST RESULTS OF APPLICATION OF AN ENZYME IMMUNOASSAY IN THE SEROLOGICAL DIAGNOSTICS OF INFECTION CAUSED BY HERPESVIRUS TYPE 7

Russian Clinical Laboratory Diagnostics ◽

10.18821/0869-2084-2019-64-9-530-535 ◽

2019 ◽

Vol 64 (9) ◽

pp. 530-535

Author(s):

Seifaddin Gashimovich Mardanly ◽

V. A. Arsenyeva ◽

A. S. Avdonina ◽

E. A. Amelina ◽

S. S. Mardanly

Keyword(s):

Herpes Virus ◽

Enzyme Linked Immunosorbent Assay ◽

Serological Tests ◽

Herpesvirus Type ◽

Test Kit ◽

First Results ◽

Specific Igg ◽

Herpès Virus ◽

Serological Diagnostics ◽

Human Herpes Virus Type

HHV-7 (Human Herpes virus type 7) is a relatively recently discovered, ubiquitous beta herpes virus. In Russia, the diagnosis of HHV-7 infection is carried out by PCR, which determines the DNA in serum or plasma, if there are clinical indications. Laboratory serological tests for HHV-7 are not performed. Currently, in the scientific literature, information on clinical studies of HHV-7 infection, its epidemiology, and its role in the etiopathogenesis of various diseases is insufficient. This article presents the results of the development of a test kit “ELISA-HHV-7-IgG”, designed to detect specific IgG to HHV-7 by enzyme-linked immunosorbent assay (ELISA). Studies of the sensitivity and specificity of the developed test kit, including potential cross-reactive samples positive for other herpesvirus infections, were carried out. In the context of serological diagnostics, we studied samples of the sera of children (n = 167) and old people (n = 238) for the presence of IgG to HHV-7 with confirmation of the results in the indirect immunofluorescence reaction and the immune blotting reaction. The research results are evidence of the possibility of using the developed test kit for serological diagnosis of HHV-7 infection.

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

Frontiers in Public Health ◽

10.3389/fpubh.2021.766871 ◽

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.

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

10.1101/2020.11.11.20229914 ◽

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.

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Multiple Indirect ELISAs for Serological Detection of SARS-CoV-2 Antibodies

10.20944/preprints202005.0188.v1 ◽

2020 ◽

Author(s):

Abdullah Algaissi ◽

Mohamed A. Alfaleh ◽

Sherif Hala ◽

Turki S. Abujamel ◽

Sawsan S. Alamari ◽

...

Keyword(s):

Antibody Response ◽

Large Scale ◽

Disease Onset ◽

High Specificity ◽

Epidemiological Studies ◽

Cross Reactivity ◽

Enzyme Linked Immunosorbent Assay ◽

Serological Tests ◽

Specificity And Sensitivity ◽

Novel Coronavirus

As the coronavirus disease 2019 (COVID-19), which is caused by the novel coronavirus SARS-CoV-2, continues to spread rapidly around the world, there is an urgent need for validated serological assays to evaluate viral specific antibody responses in COVID-19 patients or recovered individuals. In this study, we established and used indirect Enzyme Linked Immunosorbent Assay (ELISA)-based serological tests to study the antibody response in COVID-19 patients. In order to validate the assays, we determined the cut-off values, sensitivity and specificity of the developed assays using sera collected from COVID-19 patients in Saudi Arabia at different time points after disease onset, as well as sera that are seropositive to other human CoVs; namely MERS-CoV, hCoV-OC43, hCoV-NL63, hCoV-229E, and hCoV-HKU1. The SARS-CoV-2 S1 subunit of the spike glycoprotein and nucleocapsid (N) ELISAs that we developed here not only showed high specificity and sensitivity, but also did not show any cross-reactivity with other CoVs. We also showed that all RT-PCR confirmed COVID-19 patients included in our study developed both virus specific IgM and IgG as early as one week after the onset of disease. The availability of these validated assays will enable us to determine the nature and duration of the antibody response mounted in response to SARS-CoV-2 infection. It will also allow conducting large-scale epidemiological studies to determine evidence of previous exposure to the virus and assess the true extent of virus spread within communities.

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Parvovirus B19 in Croatia: A Large-Scale Seroprevalence Study

Medicina ◽

10.3390/medicina57111279 ◽

2021 ◽

Vol 57 (11) ◽

pp. 1279

Author(s):

Tatjana Vilibic-Cavlek ◽

Irena Tabain ◽

Branko Kolaric ◽

Klara Mihulja ◽

Lana Blazevic ◽

...

Keyword(s):

General Population ◽

Large Scale ◽

Parvovirus B19 ◽

Adult Population ◽

Hemodialysis Patients ◽

Enzyme Linked Immunosorbent Assay ◽

Age Group ◽

Igg Antibodies ◽

Serological Tests ◽

Recent Infection

Background and Objectives: Seroepidemiological studies indicate that parvovirus B19 circulates in all areas of the world, although with some differences. The aim of this study is to analyze the seroprevalence of parvovirus B19 in the Croatian population. Materials and Methods: From 2010 to 2021, 1538 serum samples from different populations were tested for the presence of parvovirus B19 IgM/IgG antibodies. Serological tests were performed using a commercial enzyme-linked immunosorbent assay. Results: IgG antibodies were detected in 986/64.1% of participants with differences (p < 0.001) among the following population groups: 42.4% of children and adolescents, 67.1% of the adult general population, 66.7% of hemodialysis patients, and 65.6% of liver transplant recipients. Seroprevalence increased with age, from 30.0% in the 6 months–9 years age group to 69.0% in the 40–49 years age group, and remained stable thereafter (68.8–73.3%). There was no difference in the seropositivity among males (66.1%) and females (63.1%), as well as the place of residence (suburban/rural 63.9%, urban 64.1%). IgM antibodies (current/recent infection) were found in 61/4.0% of participants with the highest seropositivity in the youngest age group (11.1%). In pregnant women, seroprevalence was higher in women with an unfavorable obstetric history compared with a normal pregnancy (IgG 71.0% vs. 62.6%; IgM 6.5% vs. 2.4%), but these differences were not significant. Logistic regression showed that the adult population had almost three times higher risk of IgG seropositivity compared to children/adolescents (general population OR = 2.777, 95% CI = 2.023–3.812; hemodialysis patients OR = 2.586, 95% CI = 1.531–4.367; and transplant patients OR = 2.717, 95% CI = 1.604–4.603). A one-year increase in age increased the risk of IgG seroprevalence (OR = 1.017; 95% CI = 1.011–1.022). Conclusions: Older age was the main risk factor for IgG seropositivity. Hemodialysis and organ transplantation seem unrelated to the increased parvovirus B19 seroprevalence. The role of parvovirus B19 in the etiology of TORCH infections needs to be studied further.

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Evaluating SARS-CoV-2 spike and nucleocapsid proteins as targets for IgG antibody detection in severe and mild COVID-19 cases using a Luminex bead-based assay

10.1101/2020.07.25.20161943 ◽

2020 ◽

Cited By ~ 1

Author(s):

Joachim Marien ◽

Johan Michiels ◽

Leo Heyndrickx ◽

Karen Kerkhof ◽

Nikki Foque ◽

...

Keyword(s):

Large Scale ◽

Detection Threshold ◽

Neutralizing Antibody ◽

Cost Effective ◽

Antibody Detection ◽

Igg Antibodies ◽

Igg Antibody ◽

Serological Tests ◽

Specific Igg ◽

Antibody Levels

Large-scale serosurveillance of severe acute respiratory syndrome coronavirus type 2 (SARS-CoV-2) will only be possible if serological tests are sufficiently reliable, rapid and inexpensive. Current assays are either labour-intensive and require specialised facilities (e.g. virus neutralization assays), or expensive with suboptimal specificity (e.g. commercial ELISAs). Bead-based assays offer a cost-effective alternative and allow for multiplexing to test for antibodies of other pathogens. Here, we compare the performance of four antigens for the detection of SARS-CoV-2 specific IgG antibodies in a panel of sera that includes both severe (n=40) and mild (n=52) cases, using a neutralization and a Luminex bead-based assay. While we show that neutralising antibody levels are significantly lower in mild than in severe cases, we demonstrate that a combination of recombinant nucleocapsid protein (NP), receptor-binding domain (RBD) and the whole spike protein (S1S2) results in a highly sensitive (96%) and specific (99%) bead-based assay that can detect IgG antibodies in both groups. Although S1-specific IgG levels correlate most strongly with neutralizing antibody levels, they fall below the detection threshold in 10% of the cases in our Luminex assay. In conclusion, our data supports the use of RBD, NP and S1S2 for the development of SARS-CoV-2 serological bead-based assays. Finally, we argue that low antibody levels in mild/asymptomatic cases might complicate the epidemiological assessment of large-scale surveillance studies.

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Recombinant Polypeptide Antigen-Based Immunoglobulin G Enzyme-Linked Immunosorbent Assay for Serodiagnosis of Dengue

Clinical and Vaccine Immunology ◽

10.1128/cvi.00474-06 ◽

2007 ◽

Vol 14 (5) ◽

pp. 641-643 ◽

Cited By ~ 5

Author(s):

Flavia B. Dos Santos ◽

Rita Maria R. Nogueira ◽

Monique R. Q. Lima ◽

Thatiane S. De Simone ◽

Hermann G. Schatzmayr ◽

...

Keyword(s):

Dengue Virus ◽

Immunosorbent Assay ◽

Immunoglobulin G ◽

Cost Effective ◽

Effective Alternative ◽

Enzyme Linked Immunosorbent Assay ◽

Recombinant Polypeptide ◽

Serological Tests ◽

Cost Effective Alternative

ABSTRACT We have developed an indirect enzyme-linked immunosorbent assay for detection of anti-dengue virus (DENV) immunoglobulin G antibodies using four recombinant DENV envelope polypeptides as antigens, which demonstrated a sensitivity of 89.4% and a specificity of 93.3%. These easily produced antigens are a feasible, cost-effective alternative for generating reagents for dengue serological tests.

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