scholarly journals Performance of Commercially Available Rapid Serological Assays for the Detection of SARS-CoV-2 Antibodies

Pathogens ◽  
2020 ◽  
Vol 9 (12) ◽  
pp. 1067
Author(s):  
Anwar M. Hashem ◽  
Rowa Y. Alhabbab ◽  
Abdullah Algaissi ◽  
Mohamed A. Alfaleh ◽  
Sharif Hala ◽  
...  
Keyword(s):  
Severe Acute Respiratory Syndrome ◽  
Significant Variation ◽  
High Specificity ◽  
Lateral Flow ◽  
Igg Antibodies ◽  
Rt Pcr ◽  
Standard Methods ◽  
Specific Antibodies ◽  
Time Points

The coronavirus disease 2019 (COVID-19) pandemic, caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), continues to spread globally. Although several rapid commercial serological assays have been developed, little is known about their performance and accuracy in detecting SARS-CoV-2-specific antibodies in COVID-19 patient samples. Here, we have evaluated the performance of seven commercially available rapid lateral flow immunoassays (LFIA) obtained from different manufacturers, and compared them to in-house developed and validated ELISA assays for the detection of SARS-CoV-2-specific IgM and IgG antibodies in RT-PCR-confirmed COVID-19 patients. While all evaluated LFIA assays showed high specificity, our data showed a significant variation in sensitivity of these assays, which ranged from 0% to 54% for samples collected early during infection (3–7 days post symptoms onset) and from 54% to 88% for samples collected at later time points during infection (8–27 days post symptoms onset). Therefore, we recommend prior evaluation and validation of these assays before being routinely used to detect IgM and IgG in COVID-19 patients. Moreover, our findings suggest the use of LFIA assays in combination with other standard methods, and not as an alternative.

scholarly journals Performance of Commercially Available Rapid Serological Assays for The Detection of SARS-CoV-2 Antibodies

2020 ◽  
Author(s):  
Anwar M Hashem ◽  
Rowa Y Y Rowa Y Alhabbab ◽  
Abdullah Algaissi ◽  
Mohamed A Alfaleh ◽  
Sharif Hala ◽  
...  
Keyword(s):  
Severe Acute Respiratory Syndrome ◽  
Significant Variation ◽  
High Specificity ◽  
Lateral Flow ◽  
Lateral Flow Immunoassay ◽  
Specific Antibodies ◽  
Time Points ◽  
Igm Antibodies ◽  
Specific Igg ◽  
High Degree

Abstract Background: The Coronavirus Disease 2019 (COVID-19) pandemic, caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), continues to spread globally. Although several commercial SARS-CoV-2 rapid serological assays have been developed, little is known about their performance and accuracy in detecting SARS-CoV-2 specific antibodies in COVID-19 patient samples. Method: We have evaluated the performance of seven commercially available rapid lateral flow immunoassay (LFIA) serological assays obtained from different manufacturers, and compared them to in-house developed and validated ELISA assays for the detection of SARS-CoV-2 specific IgG and IgM antibodies in COVID-19 patients. Results: While all evaluated LFIA assays showed high specificity, our data showed a significant variation in sensitivity of these assays in which it ranged from 0 to 54% for samples collected early during infection (3-7 days post symptoms onset) and from 54 to 88% for samples collected at later time points during infection (8-27 days post symptoms onset). Conclusion: Commercially available LFIA assays for detection of SARS-CoV-2 specific antibodies may be specific and show high degree of variation in their sensitivity. Further evaluations and validation of rapid serological assays is needed before being routinely used in detecting IgM and IgG in COVID-19 patients.

scholarly journals Antibody response and viraemia during the course of severe acute respiratory syndrome (SARS)-associated coronavirus infection

2004 ◽  
Vol 53 (5) ◽  
pp. 435-438 ◽  
Author(s):  
Weijun Chen ◽  
Zuyuan Xu ◽  
Jingsong Mu ◽  
Ling Yang ◽  
Haixue Gan ◽  
...  
Keyword(s):  
Severe Acute Respiratory Syndrome ◽  
Antibody Response ◽  
Time Course ◽  
Recovery Phase ◽  
Antibody Responses ◽  
Igg Antibodies ◽  
Rt Pcr ◽  
Blood Samples ◽  
Convalescent Phase ◽  
Coronavirus Infection

To understand the time-course of viraemia and antibody responses to severe acute respiratory syndrome-associated coronavirus (SARS-CoV), RT-PCR and ELISA were used to assay 376 blood samples from 135 SARS patients at various stages of the illness, including samples from patients who were in their early convalescent phase. The results showed that IgM antibodies decreased and became undetectable 11 weeks into the recovery phase. IgG antibodies, however, remained detectable for a period beyond 11 weeks and were found in 100 % of patients in the early convalescent phase. SARS-CoV viraemia mainly appeared 1 week after the onset of illness and then decreased over a period of 1 month, becoming undetectable in the blood samples of the convalescent patients. At the peak of viraemia, viral RNA was detectable in 75 % of blood samples from patients who were clinically diagnosed with SARS 1 or 2 weeks before the test.

scholarly journals Tips for a reduction of false positives in manual RT-PCR diagnostics of SARS-CoV-2

Bionatura ◽  
2021 ◽  
Vol 3 (3) ◽  
pp. 1948-1954
Author(s):  
Francisco J. Alvarez ◽  
Mariela Perez-Cardenas ◽  
Marco Gudiño ◽  
Markus P. Tellkamp
Keyword(s):  
Severe Acute Respiratory Syndrome ◽  
High Specificity ◽  
False Positives ◽  
Rt Pcr ◽  
Manual Operation ◽  
Laboratory Techniques ◽  
Specificity And Sensitivity ◽  
The World ◽  
Pcr Diagnostics ◽  
Positive Results

RT-PCR is the standard gold technique for testing the presence of RNA of the coronavirus causing Severe Acute Respiratory Syndrome (SARS-CoV-2) due to its high specificity and sensitivity. Despite its general use and reliability, no lab in the world is immune to the generation of false positives. These errors cause a loss of confidence in the technique's power and damage the image of laboratories. More importantly, they can take a toll on tested individuals and have economic, psychological, and health-associated effects. Most false positives are caused during a manual operation inside the laboratory. However, not much has been published about the errors associated with particular laboratory techniques used to detect the virus since the beginning of the actual pandemic. This work precisely reflects on events that occur during manual RT-PCR diagnostics in a COVID-19 laboratory, providing tips for reducing false-positive results.

scholarly journals Clinical Evaluation of a COVID-19 Antibody Lateral Flow Assay using Point of Care Samples

2020 ◽  
Author(s):  
Won Lee ◽  
Steven Straube ◽  
Ryan Sincic ◽  
Jeanne A. Noble ◽  
Juan Carlos Montoy ◽  
...  
Keyword(s):  
Predictive Value ◽  
Point Of Care ◽  
Acute Infection ◽  
High Specificity ◽  
Lateral Flow ◽  
Lateral Flow Immunoassay ◽  
Onset Date ◽  
Rt Pcr ◽  
Serum Samples ◽  
Antibody Positivity

ABSTRACTIntroductionThe ongoing SARS-CoV-2 pandemic has spurred the development of numerous point of care (PoC) immunoassays. Assessments of performance of available kits are necessary to determine their clinical utility. Previous studies have mostly performed these assessments in a laboratory setting, which raises concerns of translating findings for PoC use. The aim of this study was to assess the performance of a lateral flow immunoassay for the detection of SARS-CoV-2 antibodies using samples collected at PoC.MethodOne lateral flow immunoassay (Humasis® COVID-19 IgG/IgM) was tested. In total, 50 PCR RT-PCR positive and 52 RT-PCR negative samples were collected at PoC. Fifty serum specimens from Dec 2018 to Feb 2019 were used as controls for specificity. Serum samples collected between Dec 2019 to Feb 2020 were used as additional comparators. Clinical data including symptom onset date was collected from patient history and the medical record.ResultsThe overall sensitivity for the kit was 74% (95% CI: 59.7% -85.4%). The sensitivity for IgM and IgG detection >14 days after date of onset was 88% (95% CI: 68.8% -97.5%) and 84% (95% CI: 63.9% – 95.5%), with a negative predictive value (NPV) of 94% for IgM (95% CI: 83.5% - 98.8%) and 93% for IgG (95% CI: 81.8% - 97.9%). The overall specificity was 94% (95% CI: 83.5% - 98.8%). The Immunoglobulin specific specificity was 94% for IgM (95% CI: 83.5% - 98.8%) and 98% for IgG (95% CI: 89.4% - 100.0%), with a positive predictive value (PPV) of 88% for IgM (95% CI: 68.8% - 97.5%) and 95% for IgG (95% CI: 77.2% - 99.9%) respectively for samples collected from patients >14 days after date of onset. Specimen collected during early phase of COVID-19 pandemic (Dec 2019 to Feb 2020) showed 11.8% antibody positivity, and 11.3% of PCR-negative patients demonstrated antibody positivity.DiscussionHumasis® COVID-19 IgG/IgM LFA demonstrates greater than 90% PPV and NPV for samples collected 14 days after the onset of symptoms using samples collected at PoC. While not practical for the diagnosis of acute infection, the use of the lateral flow assays with high specificity may have utility for determining seroprevalence or seroconversion in longitudinal studies.

scholarly journals Prevalence of Immunoglobulin G (IgG) Against Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) and Evaluation of a Rapid MEDsan IgG Test in Children Seeking Medical Care

2020 ◽  
Author(s):  
Klara M Posfay-Barbe ◽  
Diego O Andrey ◽  
Julien Virzi ◽  
Patrick Cohen ◽  
Fiona Pigny ◽  
...  
Keyword(s):  
Severe Acute Respiratory Syndrome ◽  
Medical Care ◽  
Diagnostic Test ◽  
Rapid Diagnostic Test ◽  
Infection Rate ◽  
Immunoglobulin G ◽  
Gold Standard ◽  
Igg Antibodies ◽  
Rt Pcr ◽  
Seropositivity Rate

Abstract In 208 children seeking medical care, the seropositivity rate of anti–SARS-CoV-2 IgG antibodies was 8.7%, suggesting an infection rate similar to that observed in adults but >100-fold the incidence of RT-PCR–confirmed pediatric cases. Compared with the gold-standard combined ELISA + immunofluorescence, the MEDsan IgG rapid diagnostic test performed accurately.

scholarly journals Persisting antibody response to SARS-CoV-2 in a local Austrian population

2020 ◽  
Author(s):  
Dennis Ladage ◽  
Delia Rösgen ◽  
Clemens Schreiner ◽  
Dorothee Ladage ◽  
Christoph Adler ◽  
...  
Keyword(s):  
Severe Acute Respiratory Syndrome ◽  
Antibody Response ◽  
Igg Antibodies ◽  
Specific Antibodies ◽  
Follow Up Study ◽  
Population Immunity ◽  
Global Pandemic ◽  
Iga Antibodies ◽  
Austrian Population

The severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has caused a global pandemic. The prevalence and persistence of antibodies following a peak SARS-CoV-2 infection provides insights into the potential for some level of population immunity. In June 2020 we succeeded in testing almost half of the population of an Austrian township with a higher incidence for COVID-19 infections. Now we performed a follow-up study to reassess the prevalence of SARS-CoV-2-specific IgA and IgG antibodies. In 121 people, including 68 participants of the previous study we found the prevalence of IgG and IgA antibodies remaining remarkably stable with 84% of our cohort prevailing SARS-CoV-2-specific antibodies, which is only a slight decrease from 93% four months before. Most patients with confirmed COVID-19 seroconvert, potentially providing immunity to reinfection. Our results suggest a stable antibody response that we observed for at least six months post infection with implications for developing strategies for testing and protecting the population.

scholarly journals Persisting Antibody Response to SARS-CoV-2 in a Local Austrian Population

2021 ◽  
Vol 8 ◽  
Author(s):  
Dennis Ladage ◽  
Delia Rösgen ◽  
Clemens Schreiner ◽  
Dorothee Ladage ◽  
Christoph Adler ◽  
...  
Keyword(s):  
Severe Acute Respiratory Syndrome ◽  
Antibody Response ◽  
Igg Antibodies ◽  
Specific Antibodies ◽  
Follow Up Study ◽  
Population Immunity ◽  
Global Pandemic ◽  
Iga Antibodies ◽  
Austrian Population

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) caused a global pandemic recently. The prevalence and persistence of antibodies following a peak SARS-CoV-2 infection provides insights into the potential for some level of population immunity. In June 2020, we succeeded in testing almost half of the population of an Austrian town with a higher incidence of COVID-19 infection. We performed a follow-up study to reassess the prevalence of SARS-CoV-2-specific IgA and IgG antibodies with 68 participants of the previous study. We found that the prevalence of IgG or IgA antibodies remained remarkably stable, with 84% of our cohort prevailing SARS-CoV-2-specific antibodies (only a slight decrease from 93% 4 months before). In most patients with confirmed COVID-19 seroconversion potentially provides immunity to reinfection. Our results suggest a stable antibody response observed for at least 6 months post-infection with implications for developing strategies for testing and protecting the population.

scholarly journals Prevalence of Current and Past SARS-CoV-2 Infections among Police Employees in Poland, June–July 2020

2020 ◽  
Vol 9 (10) ◽  
pp. 3245 ◽  
Author(s):  
Mariusz Gujski ◽  
Mateusz Jankowski ◽  
Jarosław Pinkas ◽  
Waldemar Wierzba ◽  
Piotr Samel-Kowalik ◽  
...  
Keyword(s):  
Severe Acute Respiratory Syndrome ◽  
Police Officers ◽  
Igg Antibodies ◽  
Rt Pcr ◽  
Cross Sectional Survey ◽  
Serological Tests ◽  
Cross Sectional ◽  
Igg Index ◽  
Civilian Employees ◽  
June July

Background: Coronavirus disease 2019 (COVID-19) is caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). We aimed to determine the prevalence of current and past SARS-CoV-2 infections among police employees. Methods: This cross-sectional survey was undertaken among 5082 police employees from Mazowieckie Province, Poland. RT-PCR testing for current SARS-CoV-2 infection and serological tests (ELISA) for the presence of anti-SARS-CoV-2 IgM+IgA and IgG antibodies were performed. Results: All RT-PCR tests were negative. The anti-SARS-CoV-2 IgM+IgA index was positive (>8) in 8.9% of participants, including 11.2% women and 7.7% men (p < 0.001). Equivocal IgM+IgA index (6–8) was found in 9.8% of participants, including 11.9% women and 8.7% men (p < 0.001). The IgG index was positive (>6) in 4.3% and equivocal (4–6) in 13.2% of participants. A higher odds of positive IgM+IgA index was found in women vs. men (OR: 1.742) and police officers vs. civilian employees (OR: 1.411). Participants aged ≥60 years had a higher odds of positive IgG index vs. those aged 20–29 years (OR: 3.309). Daily vaping also increased the odds of positive IgG index (OR: 2.058). Conclusions: The majority of Polish police employees are seronegative for SARS-CoV-2 infection. Vaping and older age (≥60 years) were associated with a higher risk of SARS-CoV-2 infection.

scholarly journals Recovery from COVID-19 in a B-cell-depleted multiple sclerosis patient

2020 ◽  
Vol 26 (10) ◽  
pp. 1261-1264 ◽  
Author(s):  
Hannah Wurm ◽  
Kate Attfield ◽  
Astrid KN Iversen ◽  
Ralf Gold ◽  
Lars Fugger ◽  
...  
Keyword(s):  
Multiple Sclerosis ◽  
Severe Acute Respiratory Syndrome ◽  
Antibody Response ◽  
B Cell ◽  
Symptom Onset ◽  
B Lymphocyte ◽  
Viral Clearance ◽  
Igg Antibodies ◽  
Specific Antibodies ◽  
Anti Cd20

Approximately 200,000 multiple sclerosis (MS) patients worldwide receive B-cell-depleting immunotherapy with rituximab (anti-CD20), which eliminates the ability to generate an antibody response to new infections. As severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)–specific antibodies might help viral clearance, these patients could be at risk of severe complications if infected. Here, we report on an MS patient who had received rituximab for ~3 years. The patient was examined 5 days before the onset of coronavirus disease 2019 (COVID-19) symptoms and was admitted to the hospital 2 days after. She recovered 14 days after symptom onset despite having a 0% B lymphocyte count and not developing SARS-CoV-2 immunoglobulin G (IgG) antibodies.

scholarly journals Evaluation and Validation of an Enzyme-Linked Immunosorbent Assay and an Immunochromatographic Test for Serological Diagnosis of Severe Acute Respiratory Syndrome

2004 ◽  
Vol 11 (4) ◽  
pp. 699-703 ◽  
Author(s):  
Ming Guan ◽  
Kwok Hung Chan ◽  
J. S. Malik Peiris ◽  
See Wai Kwan ◽  
Siu Yan Lam ◽  
...  
Keyword(s):  
Severe Acute Respiratory Syndrome ◽  
Immunosorbent Assay ◽  
Clinical Symptoms ◽  
Rapid Test ◽  
High Specificity ◽  
Clinical Samples ◽  
Enzyme Linked Immunosorbent Assay ◽  
Immunochromatographic Test ◽  
Detection Rates ◽  
Specific Antibodies

ABSTRACT A newly developed severe acute respiratory syndrome (SARS)-specific enzyme-linked immunosorbent assay (ELISA) was further validated to confirm cutoff values and evaluate its diagnostic performance with clinical samples. In parallel, an immunochromatographic test was also evaluated. A total of 227 clinical serum specimens collected from SARS patients were used in the study, together with 385 samples from healthy donors. By use of an immunofluorescent (IF) test as the “gold standard, ” both the ELISA and the immunochromatographic test were able to detect immunoglobulin G antibodies to SARS not only from late-convalescent-stage samples (>21 days from the onset of clinical symptoms), as previously established, but also from early-acute-phase samples (1 to 10 days from onset). The ELISA, using an optical density (OD) of 0.25 as its cutoff value, produced the best sensitivity while maintaining high specificity. It detected SARS-specific antibodies in 58, 70, 75, and 95%, respectively, of the four groups of samples collected from patients 1 to 10 days, 11 to 20 days, 21 to 30 days, and more than 30 days after the onset of clinical symptoms. Similarly, the immunochromatographic test detected SARS-specific antibodies in 55, 68, 81, and 79% of the four groups, respectively. The overall specificities for the ELISA and the rapid test were 99.5 and 97.7%, respectively. Although the positive correlation observed between the ELISA OD values and the IF titers was moderate (r = 0.6915; P < 0.001), the detection rates of both the ELISA and the rapid test were found well in agreement with the IF titers.

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