scholarly journals Detection of SARS-CoV-2 antibodies using commercial assays and seroconversion patterns in hospitalized patients

2020 ◽  
Author(s):  
E Tuaillon ◽  
K Bolloré ◽  
A Pisoni ◽  
S Debiesse ◽  
C Renault ◽  
...  
Keyword(s):  
Point Of Care ◽  
Marked Point ◽  
Humoral Response ◽  
Hospitalized Patients ◽  
Antibody Detection ◽  
Serological Tests ◽  
Molecular Tests ◽  
Antibody Assays ◽  
Point Of Care Tests ◽  
Kinetics Of

AbstractSARS-CoV-2 antibody assays are needed for serological surveys and as a complement to molecular tests to confirm COVID-19. However, the kinetics of the humoral response against SARS-CoV-2 remains poorly described and relies on the performance of the different serological tests.In this study, we evaluated the performance of six CE-marked point-of-care tests (POC) and three ELISA assays for the diagnosis of COVID-19 by exploring seroconversions in hospitalized patients who tested positive for SARS-CoV-2 RNA.Both the ELISA and POC tests were able to detect SARS-CoV-2 antibodies in at least half of the samples collected seven days or more after the onset of symptoms. After 15 days, the rate of detection rose to over 80% but without reaching 100%, irrespective of the test used. More than 90% of the samples collected after 15 days tested positive using the iSIA and Accu-Tell® POC tests and the ID.Vet IgG ELISA assay. Seroconversion was observed 5 to 12 days after the onset of symptoms. Three assays suffer from a specificity below 90% (EUROIMMUN IgG and IgA, UNscience, Zhuhai Livzon).The second week of COVID-19 seems to be the best period for assessing the sensitivity of commercial serological assays. To achieve an early diagnosis of COVID-19 based on antibody detection, a dual challenge must be met: the immunodiagnostic window period must be shortened and an optimal specificity must be conserved.

scholarly journals Recent Advances and Novel Approaches in Laboratory-Based Diagnostic Mycology

2021 ◽  
Vol 7 (1) ◽  
pp. 41
Author(s):  
Lewis P. White ◽  
Jessica S. Price
Keyword(s):  
Point Of Care ◽  
Serological Tests ◽  
Just Culture ◽  
Diagnostic Strategies ◽  
Phenotypic Resistance ◽  
Molecular Tests ◽  
Lateral Flow Assays ◽  
Improve Patient Management ◽  
Point Of Care Tests ◽  
Improve Patient

What was once just culture and microscopy the field of diagnostic mycology has significantly advanced in recent years and continues to incorporate novel assays and strategies to meet the changes in clinical demand. The emergence of widespread resistance to antifungal therapy has led to the development of a range of molecular tests that target mutations associated with phenotypic resistance, to complement classical susceptibility testing and initial applications of next-generation sequencing are being described. Lateral flow assays provide rapid results, with simplicity allowing the test to be performed outside specialist centres, potentially as point-of-care tests. Mycology has responded positively to an ever-diversifying patient population by rapidly identifying risk and developing diagnostic strategies to improve patient management. Nowadays, the diagnostic repertoire of the mycology laboratory employs classical, molecular and serological tests and should be keen to embrace diagnostic advancements that can improve diagnosis in this notoriously difficult field.

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

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.

scholarly journals Performance of SARS-CoV-2 Serology tests: Are they good enough?

2020 ◽  
Author(s):  
Isabelle Piec ◽  
Emma English ◽  
M Annette Thomas ◽  
Samir Dervisevic ◽  
William D Fraser ◽  
...  
Keyword(s):  
Sensitivity And Specificity ◽  
Respiratory Infections ◽  
Point Of Care ◽  
False Negative ◽  
Rapid Test ◽  
Diagnostic Sensitivity ◽  
Medical Community ◽  
Antibody Detection ◽  
Serological Tests ◽  
Negative Results

AbstractBackgroundIn the emergency of the SARS-CoV-2 pandemic, great efforts were made to quickly provide serology testing to the medical community however, these methods have been introduced into clinical practice without the complete validation usually required by the regulatory organizations.MethodsSARS-CoV-2 patient samples (n=43) were analysed alongside pre-pandemic control specimen (n=50), confirmed respiratory infections (n=50), inflammatory polyarthritis (n=22) and positive for thyroid stimulating immunoglobulin (n=30). Imprecision, diagnostic sensitivity and specificity and concordance were evaluated on IgG serologic assays from EuroImmun, Epitope Diagnostics (EDI), Abbott Diagnostics and DiaSorin and a rapid IgG/IgM test from Healgen.ResultsEDI and EuroImmun imprecision was 0.02-14.0% CV. Abbott and DiaSorin imprecision (CV) ranged from 5.2% - 8.1% and 8.2% - 9.6% respectively. Diagnostic sensitivity of the assays were 100% (CI: 80-100%) for Abbott, EDI and EuroImmun and 95% (CI: 73-100%) for DiaSorin at ≥14 days post PCR. Only the Abbott assay had a diagnostic specificity of 100% (CI: 91-100%). EuroImmun cross-reacted in 3 non-SARS-CoV-2 respiratory infections and 2 controls. The DiaSorin displayed more false negative results and cross-reacted in six cases across all conditions tested. EDI had one cross-reactive sample. The Healgen rapid test showed excellent sensitivity and specificity. Overall, concordance of the assays ranged from 76.1% to 97.9%.ConclusionsSerological tests for SARS-CoV-2 showed good analytical performance. The head-to-head analysis of samples revealed differences in results that may be linked to the use of nucleocapsid or spike proteins. The point of care device tested demonstrated adequate performance for antibody detection.

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 Persistence of Anti-SARS-CoV-2 Antibodies Depends on the Analytical Kit: A Report for Up to 10 Months after Infection

2021 ◽  
Vol 9 (3) ◽  
pp. 556 ◽  
Author(s):  
Julien Favresse ◽  
Christine Eucher ◽  
Marc Elsen ◽  
Constant Gillot ◽  
Sandrine Van Eeckhoudt ◽  
...  
Keyword(s):  
Antibody Detection ◽  
Serological Response ◽  
Dynamic Changes ◽  
Significant Difference ◽  
Antibody Assays ◽  
Long Term Follow Up ◽  
Clinically Significant ◽  
Kinetics Of

Several studies have described the long-term kinetics of anti-SARS-CoV-2 antibodies but long-term follow-up data, i.e., >6 months, are still sparse. Additionally, the literature is inconsistent regarding the waning effect of the serological response. The aim of this study was to explore the temporal dynamic changes of the immune response after SARS-CoV-2 infection in hospitalized and non-hospitalized symptomatic patients over a period of 10 months. Six different analytical kits for SARS-CoV-2 antibody detection were used. Positivity rates, inter-assay agreement and kinetic models were determined. A high inter-individual and an inter-methodology variability was observed. Assays targeting total antibodies presented higher positivity rates and reached the highest positivity rates sooner compared with assays directed against IgG. The inter-assay agreement was also higher between these assays. The stratification by disease severity showed a much-elevated serological response in hospitalized versus non-hospitalized patients in all assays. In this 10-month follow-up study, serological assays showed a clinically significant difference to detect past SARS-CoV-2 infection with total antibody assays presenting the highest positivity rates. The waning effect reported in several studies should be interpreted with caution because it could depend on the assay considered.

scholarly journals Progress and Challenges towards Point-of-Care Diagnostic Development for Dengue

2017 ◽  
Vol 55 (12) ◽  
pp. 3339-3349 ◽  
Author(s):  
Junxiong Pang ◽  
Po Ying Chia ◽  
David C. Lye ◽  
Yee Sin Leo
Keyword(s):  
Point Of Care ◽  
Storage Conditions ◽  
Antibody Detection ◽  
Advantages And Disadvantages ◽  
Public Health Significance ◽  
Clinical Presentations ◽  
Health Significance ◽  
User Friendly ◽  
Point Of Care Tests ◽  
Detection Strategies

ABSTRACTDengue detection strategies involve viral RNA, antigen, and/or antibody detection. Each strategy has its advantages and disadvantages. Optimal, user-friendly, rapid diagnostic tests based on immunochromatographic assays are pragmatic point-of-care tests (POCTs) in regions where dengue is endemic where there are limited laboratory capabilities and optimal storage conditions. Increasingly, there is a greater public health significance for a multiplexing assay that differentiates dengue from Zika or pathogens with similar clinical presentations. Although there have been many assay/platform developments toward POCTs, independent validation and implementation remain very limited. This review highlights the current key progress and challenges toward the development of a dengue POCT.

scholarly journals Laboratory Diagnostics in COVID-19: What We Know So Far

2020 ◽  
Author(s):  
Siti Zulaikha Zakariah ◽  
Tengku Zetty Maztura Tengku Jamaluddin ◽  
Hasni Mahayidin ◽  
Zuraihan Dahari ◽  
Rosni Ibrahim
Keyword(s):  
Point Of Care ◽  
Medical Science ◽  
High Sensitivity ◽  
Contact Tracing ◽  
Laboratory Diagnostics ◽  
Technological Advancement ◽  
Rt Pcr ◽  
Serological Tests ◽  
S 100 ◽  
Point Of Care Tests

COVID-19 took the world by storm in early 2020 which rapidly escalated to a pandemic of unprecedented proportions. Containment of the outbreak requires a robust public health system of surveillance, contact tracing and laboratory preparedness. Technological advancement in molecular diagnosticshas helped identify patients in the initial stages of the outbreak. RT-PCR remains the gold standard in COVID-19 testing. However, as the pandemic continues, there is need for rapid and point of care tests (POCT) for mass screening and rapid decision making. Current serological tests and POCT have high sensitivity but need to be interpreted with caution. This review aims to discuss current laboratory tests available for the diagnosis of COVID-19. Bangladesh Journal of Medical Science Vol.19(0) 2020 p. S 93-S 100

scholarly journals Performance of SARS-CoV-2 serology tests: Are they good enough?

PLoS ONE ◽  
2021 ◽  
Vol 16 (2) ◽  
pp. e0245914
Author(s):  
Isabelle Piec ◽  
Emma English ◽  
Mary Annette Thomas ◽  
Samir Dervisevic ◽  
William D. Fraser ◽  
...  
Keyword(s):  
Sensitivity And Specificity ◽  
Respiratory Infections ◽  
Point Of Care ◽  
False Negative ◽  
Rapid Test ◽  
Diagnostic Sensitivity ◽  
Medical Community ◽  
Antibody Detection ◽  
Serological Tests ◽  
Negative Results

In the emergency of the SARS-CoV-2 pandemic, great efforts were made to quickly provide serology testing to the medical community however, these methods have been introduced into clinical practice without the complete validation usually required by the regulatory organizations. SARS-CoV-2 patient samples (n = 43) were analyzed alongside pre-pandemic control specimen (n = 50), confirmed respiratory infections (n = 50), inflammatory polyarthritis (n = 22) and positive for thyroid stimulating immunoglobulin (n = 30). Imprecision, diagnostic sensitivity and specificity and concordance were evaluated on IgG serologic assays from EuroImmun, Epitope Diagnostics (EDI), Abbott Diagnostics and DiaSorin and a rapid IgG/IgM test from Healgen. EDI and EuroImmun imprecision was 0.02–14.0% CV. Abbott and DiaSorin imprecision (CV) ranged from 5.2%–8.1% and 8.2%–9.6% respectively. Diagnostic sensitivity of the assays was 100% (CI: 80–100%) for Abbott, EDI and EuroImmun and 95% (CI: 73–100%) for DiaSorin at ≥14 days post PCR. Only the Abbott assay had a diagnostic specificity of 100% (CI: 91–100%). EuroImmun cross-reacted in 3 non-SARS-CoV-2 respiratory infections and 2 controls. The DiaSorin displayed more false negative results and cross-reacted in six cases across all conditions tested. EDI had one cross-reactive sample. The Healgen rapid test showed excellent sensitivity and specificity. Overall, concordance of the assays ranged from 76.1% to 97.9%. Serological tests for SARS-CoV-2 showed good analytical performance. The head-to-head analysis of samples revealed differences in results that may be linked to the use of nucleocapsid or spike proteins. The point of care device tested demonstrated adequate performance for antibody detection.

The laboratory diagnosis of Syphilis

2021 ◽  
Author(s):  
Ferris Satyaputra ◽  
Stephanie Hendry ◽  
Maxwell Braddick ◽  
Pirathaban Sivabalan ◽  
Robert Norton
Keyword(s):  
Congenital Syphilis ◽  
Point Of Care ◽  
Treponema Pallidum ◽  
Laboratory Diagnosis ◽  
Nucleic Acid Amplification ◽  
Current Status ◽  
Serological Tests ◽  
Flocculation Test ◽  
The Many ◽  
Point Of Care Tests

Syphilis is a multisystem infection caused by the spirochaete Treponema pallidum. Currently, cases of possible syphilis are commonly investigated using the treponemal serological tests T. pallidum IgG chemiluminescence immunoassay (CLIA) and the T. pallidum particle agglutination (TPPA). The non-treponemal rapid plasma reagin (RPR) flocculation test is used to assess disease activity. There has been a resurgence of syphilis diagnoses in Australia. Large foci of infection have been identified in isolated communities. The remoteness of these locations, in conjunction with the particular socio-cultural characteristics of the population, pose unique challenges to the traditional diagnostic and treatment paradigms for syphilis. As a consequence of this increased incidence of syphilis, there has been interest in the utility of point of care tests (POCT), nucleic acid amplification tests (NAAT), the role of IgM testing in suspected congenital syphilis, and the laboratory investigation of possible neurosyphilis. This review looks at the current status of traditional serological assays and provides an update on more recent methods. It assesses the published literature in this area and makes recommendations for the rational use of pathology testing to aid in the diagnosis of the many facets of syphilis.

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