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 Evaluation of nine commercial SARS-CoV-2 immunoassays

2020 ◽  
Author(s):  
Ria Lassaunière ◽  
Anders Frische ◽  
Zitta B. Harboe ◽  
Alex C.Y. Nielsen ◽  
Anders Fomsgaard ◽  
...  
Keyword(s):  
Vaccine Development ◽  
Rank Order ◽  
Point Of Care ◽  
Epidemiological Studies ◽  
Contact Tracing ◽  
Clinical Samples ◽  
Serum Samples ◽  
Serological Tests ◽  
Barr Virus ◽  
Tract Infections

AbstractDue to urgency and demand, numerous severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) immunoassays are rapidly being developed and placed on the market with limited validation on clinical samples. Thorough validation of serological tests are required to facilitate their use in the accurate diagnosis of SARS-CoV-2 infection, confirmation of molecular results, contact tracing, and epidemiological studies. This study evaluated the sensitivity and specificity of nine commercially available serological tests. These included three enzyme-linked immunosorbent assays (ELISAs) and six point-of-care (POC) lateral flow tests. The assays were validated using serum samples from: i) SARS-CoV-2 PCR-positive patients with a documented first day of disease; ii) archived sera obtained from healthy individuals before the emergence of SARS-CoV-2 in China; iii) sera from patients with acute viral respiratory tract infections caused by other coronaviruses or non-coronaviruses; and iv) sera from patients positive for dengue virus, cytomegalovirus and Epstein Barr virus. The results showed 100% specificity for the Wantai SARS-CoV-2 Total Antibody ELISA, 93% for the Euroimmun IgA ELISA, and 96% for the Euroimmun IgG ELISA with sensitivities of 90%, 90%, and 65%, respectively. The overall performance of the POC tests according to manufacturer were in the rank order of AutoBio Diagnostics > Dynamiker Biotechnology = CTK Biotech > Artron Laboratories > Acro Biotech ≥ Hangzhou Alltest Biotech. Overall, these findings will facilitate selection of serological assays for the detection SARS-CoV-2-specific antibodies towards diagnosis as well as sero-epidemiological and vaccine development studies.

scholarly journals Regional Difference in Seroprevalence of SARS-CoV-2 in Tokyo: Results from the community point-of-care antibody testing

2020 ◽  
Author(s):  
Morihito Takita ◽  
Tomoko Matsumura ◽  
Kana Yamamoto ◽  
Erika Yamashita ◽  
Kazutaka Hosoda ◽  
...  
Keyword(s):  
Regional Difference ◽  
Point Of Care ◽  
Herd Immunity ◽  
Antibody Testing ◽  
Igg Antibody ◽  
Community Based ◽  
Entire Cohort ◽  
Control And Prevention ◽  
Specific Igg ◽  
Polymerase Chain

AbstractThe serosurvey is an alternative way to know the magnitude of the population infected by coronavirus disease 2019 (COVID-19) since the expansion of capacity of the polymerase chain reaction (PCR) to detect the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) was delayed. We herein report seroprevalence of COVID-19 accessed in the two community clinics in Tokyo. The point-of-care immunodiagnostic test was implemented to detect the SARS-CoV-2 specific IgG antibody in the peripheral capillary blood. The overall positive percentage of SARS-CoV-2 IgG antibody is 3.83% (95% confidence interval: 2.76-5.16) for the entire cohort (n =1,071). The central Tokyo of 23 special wards exhibited a significantly higher prevalence compared to the other area of Tokyo (p =0.02, 4.68% [95%CI: 3.08-6.79] versus 1.83 [0.68-3.95] in central and suburban Tokyo, respectively). The seroprevalence of the cohort surveyed in this study is low for herd immunity, which suggests the need for robust disease control and prevention. A community-based approach, rather than state or prefectural levels, is of importance to figure out profiles of the SARS-COV-2 outbreak.

scholarly journals Geographical Profiles of COVID-19 Outbreak in Tokyo: An Analysis of the Primary Care Clinic–Based Point-of-Care Antibody Testing

2020 ◽  
Vol 11 ◽  
pp. 215013272094269 ◽  
Author(s):  
Morihito Takita ◽  
Tomoko Matsumura ◽  
Kana Yamamoto ◽  
Erika Yamashita ◽  
Kazutaka Hosoda ◽  
...  
Keyword(s):  
Primary Care ◽  
Point Of Care ◽  
Herd Immunity ◽  
Primary Care Clinic ◽  
The Other ◽  
Cumulative Number ◽  
Antibody Testing ◽  
Care Clinic ◽  
Entire Cohort ◽  
Pcr Test

Introduction: The primary care clinic plays a major role in triage for coronavirus disease 2019 (COVID-19), where seroprevalence in the setting of primary care clinic remains less clear. As a point-of-care immunodiagnostic test for the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the serosurvey represents an alternative to the polymerase chain reaction (PCR) test to measure the magnitude of COVID-19 outbreak in the communities lacking sufficient diagnostic capability for PCR testing. Methods: We assessed seropositivity for the SARS-CoV-2 IgG between April 21 and May 20, 2020, at 2 primary care clinics in Tokyo, Japan. Results: The overall positive percentage of SARS-CoV-2 IgG was 3.83% (95% confidence interval [CI]: 2.76-5.16) for the entire cohort (n = 1071). The 23 special wards of central Tokyo exhibited a significantly higher prevalence compared with the other areas of Tokyo after classification by residence ( P = .02, 4.68% [3.08-6.79] vs 1.83 [0.68-3.95] in central and suburban Tokyo, respectively). In central Tokyo, the southern area showed the highest seroprevalence compared with the other areas (7.92% [3.48-15.01]), corresponding to the cumulative number of confirmed COVID-19 patients by PCR test reported by the Tokyo Metropolitan Government. Conclusion: The seroprevalence surveyed in this study was too low for herd immunity, suggesting the need for robust disease control and prevention. A regional-level approach, rather than state- or prefectural-level, could be of importance in ascertaining detailed profiles of the COVID-19 outbreak.

scholarly journals Challenges of community point-of-care antibody testing for COVID-19 herd-immunity in Japan

QJM ◽  
2020 ◽  
Vol 113 (11) ◽  
pp. 785-786 ◽  
Author(s):  
M Takita ◽  
T Matsumura ◽  
K Yamamoto ◽  
E Yamashita ◽  
K Hosoda ◽  
...  
Keyword(s):  
Point Of Care ◽  
Herd Immunity ◽  
Antibody Testing

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

2020 ◽  
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.

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 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 The SARS-CoV-2 pandemic: remaining uncertainties in our understanding of the epidemiology and transmission dynamics of the virus, and challenges to be overcome

2021 ◽  
Vol 11 (6) ◽  
Author(s):  
Roy M. Anderson ◽  
Carolin Vegvari ◽  
T. Déirdre Hollingsworth ◽  
Li Pi ◽  
Rosie Maddren ◽  
...  
Keyword(s):  
Vaccine Development ◽  
Viral Evolution ◽  
Herd Immunity ◽  
Viral Transmission ◽  
Mass Vaccination ◽  
Basic Reproductive Number ◽  
Contact Tracing ◽  
Reproductive Number ◽  
Modern World ◽  
Individual Country

Great progress has been made over the past 18 months in scientific understanding of the biology, epidemiology and pathogenesis of SARS-CoV-2. Extraordinary advances have been made in vaccine development and the execution of clinical trials of possible therapies. However, uncertainties remain, and this review assesses these in the context of virus transmission, epidemiology, control by social distancing measures and mass vaccination and the effect on all of these on emerging variants. We briefly review the current state of the global pandemic, focussing on what is, and what is not, well understood about the parameters that control viral transmission and make up the constituent parts of the basic reproductive number R 0 . Major areas of uncertainty include factors predisposing to asymptomatic infection, the population fraction that is asymptomatic, the infectiousness of asymptomatic compared to symptomatic individuals, the contribution of viral transmission of such individuals and what variables influence this. The duration of immunity post infection and post vaccination is also currently unknown, as is the phenotypic consequences of continual viral evolution and the emergence of many viral variants not just in one location, but globally, given the high connectivity between populations in the modern world. The pattern of spread of new variants is also examined. We review what can be learnt from contact tracing, household studies and whole-genome sequencing, regarding where people acquire infection, and how households are seeded with infection since they constitute a major location for viral transmission. We conclude by discussing the challenges to attaining herd immunity, given the uncertainty in the duration of vaccine-mediated immunity, the threat of continued evolution of the virus as demonstrated by the emergence and rapid spread of the Delta variant, and the logistics of vaccine manufacturing and delivery to achieve universal coverage worldwide. Significantly more support from higher income countries (HIC) is required in low- and middle-income countries over the coming year to ensure the creation of community-wide protection by mass vaccination is a global target, not one just for HIC. Unvaccinated populations create opportunities for viral evolution since the net rate of evolution is directly proportional to the number of cases occurring per unit of time. The unit for assessing success in achieving herd immunity is not any individual country, but the world.

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