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

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.

scholarly journals COMPARISON OF PERFORMANCE CHARACTERISTICS BETWEEN LATERAL FLOW, ELISA AND ELECTROCHEMILUMINESCENCE IMMUNOASSAYS FOR THE DETECTION OF SARS-COV-2 ANTIBODIES AMONG HEALTHCARE WORKERS

2021 ◽  
Author(s):  
M R Shincy ◽  
Vandana Govindan ◽  
H H Sudhakar ◽  
V T Venkatesha ◽  
K Padmapriya ◽  
...  
Keyword(s):  
Severe Acute Respiratory Syndrome ◽  
Healthcare Workers ◽  
Care Pathway ◽  
Point Of Care ◽  
Lateral Flow ◽  
Central Research ◽  
Serum Samples ◽  
Igg Antibody ◽  
Human Igg ◽  
Serological Tests

ABSTRACTBackgroundMedical professionals and researchers have been urging the need for wide and rapid testing of citizens in order to plan measures that can contain the spread of the virus. Antibody tests play an important role throughout the patient care pathway and are vital for the management and surveillance of the virus. Although RT-PCR is considered as the gold standard, serological tests based on antibodies are helpful for on-time detection. We performed one to one assessment of point-of-care lateral flow assay (POCTs), enzyme immunoassay (EIAs), electrochemiluminescence immunoassay (CLIA), to detect severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) IgG antibody.Materials and Methods611 healthcare workers were recruited between November and December 2020 at Central Research Laboratory, KIMS. Collected serum samples were analysed according to manufacturer’s protocol. The Standard Q IgG/IgM combo assay, Anti-SARS CoV-2 Human IgG ELISA, and the Elecsys® to measure the IgG titer of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).ResultsThe kits displayed a sensitivity of 61.2%,79.5%, 91.8% and specificity of 61.7%,64.1%,80.2% for the Standard Q IgG/IgM combo assay, Anti-SARS CoV-2 Human IgG ELISA, and the Elecsys® in order.ConclusionOur results indicate high sensitivity and specificity for the Elecsys® assay compared to Anti-SARS CoV-2 Human IgG ELISA, the Standard Q IgG/IgM combo assay.

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

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.

scholarly journals COMPARISON OF PERFORMANCE CHARACTERISTICS BETWEEN LATERAL FLOW, ELISAAND ELECTROCHEMILUMINESCENCE IMMUNOASSAYS FOR THE DETECTION OF SARS-COV-2 ANTIBODIES AMONG HEALTHCARE WORKERS

2021 ◽  
pp. 45-48
Author(s):  
Shincy M R ◽  
Vandana Govindan ◽  
Sudhakar H H ◽  
Padmapriya K ◽  
Venkatesha V T ◽  
...  
Keyword(s):  
Severe Acute Respiratory Syndrome ◽  
Healthcare Workers ◽  
Care Pathway ◽  
Point Of Care ◽  
High Sensitivity ◽  
Central Research ◽  
Serum Samples ◽  
Igg Antibody ◽  
Human Igg ◽  
Serological Tests

Background: The detection of SARS-CoV-2 IgG is important to determine the course of COVID-19. Medical professionals and researchers have been urging the need for wide and rapid testing of citizens in order to plan measures that can contain the spread of the virus. Antibody tests play an important role throughout the patient care pathway and are vital for the management and surveillance of the virus. Although RTPCR is considered to be the gold standard, serological tests based on antibodies could be very helpful for on-time detection. We performed one to one assessment of electrochemiluminescence immunoassay, enzyme immunoassay (EIAs), and point-of-care lateral ow assay (POCTs) to detect severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) IgG antibody. Materials and Methods: 611 healthcare workers were recruited between November and December 2020 at Central Research Laboratory, KIMS. ® Collected serum samples were analysed using three commercially available assays: the Elecsys , Anti-SARS CoV-2 Human IgG ELISA, the Standard Q IgG/IgM combo assay following the manufacturer's protocol to measure the IgG titer of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Results:The kits displayed a sensitivity of 91.8%, 79.5% ,61.2% and a specicity of 80.2%, 64.1% ,61.7% in order. Conclusion: ® Our results indicate a high sensitivity and specicity for the Elecsys assay compared to Anti-SARS CoV-2 Human IgG ELISA, the Standard Q IgG/IgM combo assays.

scholarly journals Clinical validation of a point-of-care antibody test for COVID-19

2020 ◽  
Author(s):  
Monila Patel ◽  
Yogesh Lakhotia ◽  
Sneha Shah ◽  
Nilay Suthar ◽  
Cherry Shah ◽  
...  
Keyword(s):  
Confidence Interval ◽  
Sensitivity And Specificity ◽  
Significant Role ◽  
Point Of Care ◽  
Antibody Test ◽  
Lateral Flow ◽  
Clinical Validation ◽  
Rt Pcr ◽  
Antibody Tests ◽  
Spike Proteins

AbstractThe objective of this study was to evaluate the performance of a lateral flow antibody test for COVID-19, approved for use in India. Although many point-of-care antibody tests are available globally, they have been subjected to limited clinical validation. This has led to suboptimal outcomes in the field, where antibody tests play a significant role in tracking the immunity of individuals and communities. In this study an antibody test, ImmunoQuick that recognizes antibodies to the Nucleocapsid and Spike proteins of SARS CoV-2 was tested in 100 symptomatic patients with a positive or negative diagnosis of COVID-19, based on RT-PCR results. The overall sensitivity of the test was found to be 86.1% (95% CI: 76.4% to 92.8%) and specificity 100% (95% confidence interval: 73.5% to 100%). The sensitivity reached a peak of 95.7% with samples taken 17 days after the onset of symptoms. Overall, the sensitivity and specificity of the test are sufficient for assessing seroprevalence.

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.

EVALUATION OF PERFORMANCE OF NINE SEROLOGICALASSAYS FOR THE DETECTION OF SARS-COV-2 ANTIBODIES.

2021 ◽  
pp. 60-62
Author(s):  
Tagajdid Mohamed Rida ◽  
Konzi Clémence ◽  
El Kochri Safae ◽  
Elannaz Hicham ◽  
Abi Rachid ◽  
...  
Keyword(s):  
Clinical Performance ◽  
Current Knowledge ◽  
False Negative ◽  
Antibody Test ◽  
Antibody Detection ◽  
Rt Pcr ◽  
Igg Antibody ◽  
Serological Tests ◽  
Blood Samples ◽  
Test Kit

Introduction: Currently, polymerase chain reaction (PCR) based viral RNAdetection is the standard for COVID-19 diagnosis [2]. Though, RNA testing based on throat or nasopharyngeal swabs has shown a number of false-negative results. Antibody detection tests have been developed to detect specic antibodies, IgM and IgG, to SRAS-CoV-2 virus. The clinical relevance of these tests is still under evaluation and is highly related to their clinical performance. Our objective is to assess analytical performances of nine SARS-CoV-2 antibodies immunoassays. Materiel and Method: We collected 80 blood samples from PCR-conrmed COVID-19 patients diagnosed in our Virology department (20 samples collected at day 10 after the onset of symptoms, 60 collected after day 14 following the onset of symptoms) and 20 blood samples from patients SARS-CoV-2 RT-PCR negative. All sera were tested with nine SARS-CoV-2 antibodies immunoassays ARCHITECT SARS-CoV-2 IgG® (Abbott), COVID-19 VIRCLIA® IgG MONOTEST (Vircell), COVID-19 VIRCLIA® IgM+IgA MONOTEST (Vircell), COVID-19 ELISA IgG® (Vircell), COVID-19 ELISA IgM+IgA® (Vircell), Elecsys® Anti-SARS-CoV-2 (Roche), FREND® COVID-19 IgG/IgM Duo (NanoEntek), COVID-PRESTO® (AAZ) and COVID-19 (SARS-CoV-2) IgM/IgG Antibody Test Kit® (Labnovation Technologies). Results: Sensitivity of tests increases once the seroconversion to anti-SARS-CoV-2 IgG positive in most individuals occurs toward the end of week 2 post-infection. COVID-19 PRESTO had the best accuracy in our study showing 100% sensitivity after day 14 following the onset of symptoms. All of the tests had a specicity of 100%. Conclusion: Serological tests are sensitive for the latest stages of COVID-19 infection. Recommendations on using SRAS-COV-2 antibody detection tests are continuously improving based on current knowledge of host antibody responses during infection. They are of great value in cases presenting COVID-19 symptoms with negative RT-PCR.

scholarly journals Correlation of SARS-CoV-2 Neutralizing Antibodies to an Automated Chemiluminescent Serological Immunoassay

2020 ◽  
Author(s):  
David G Grenache ◽  
Chunyan Ye ◽  
Steven B Bradfute
Keyword(s):  
Neutralizing Antibodies ◽  
Large Scale ◽  
Antibody Test ◽  
Negative Control ◽  
Standard Test ◽  
Serum Samples ◽  
Serological Tests ◽  
Signal Value ◽  
Positive Antibody ◽  
Chemiluminescent Immunoassay

Abstract Introduction Neutralizing antibodies (NAbs) are capable of binding to a virus to render it incapable of infection. The ability of commercially available SARS-CoV-2 serological tests to detect NAbs has not been widely reported. We sought to correlate the antibodies detected by an automated chemiluminescent immunoassay with NAbs. Methods Residual serum samples from 35 patients that had a positive antibody test using the LIAISON® SARS-CoV-2 S1/S2 IgG chemiluminescent immunoassay and 2 antibody-negative control sera were tested for NAbs using a plaque reduction neutralization test (PRNT). Results NAbs were detected in 66% (23/35) of the antibody-positive samples. The immunoassay signal value ranged from 21.7 to 131.3 AU/mL (median, 90.5) with significant correlation between it and the PRNT (r = 0.61, P = 0.002). In the samples without NAbs, the immunoassay signal ranged from 16.3 to 66.2 AU/mL (median, 27.2). An immunoassay signal cutoff of &gt;41 AU/mL was 91% sensitive and 92% specific for the detection of NAbs. Discussion It is important that correlates of immunity to SARS-CoV-2 be identified and NAbs are considered to be central indicators of such. PRNT is the gold-standard test for identifying NAbs but it cannot be used for large-scale testing of populations. It is necessary to establish relationships between it and widely used commercial serological assays for SARS-CoV-2.

scholarly journals 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

2020 ◽  
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.

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 Rapid Screening Diagnosis of SARS-COV-2 Infection With IgM-igG Combined Antibody Test Using Peripheral Blood

2020 ◽  
Author(s):  
Zhengtu Li ◽  
Shaoqiang Li ◽  
Youwei Wang ◽  
Yongkang Liao ◽  
Hui Chen ◽  
...  
Keyword(s):  
Peripheral Blood ◽  
Healthcare Workers ◽  
Antibody Test ◽  
Rapid Screening ◽  
Rt Pcr ◽  
Serum Samples ◽  
Asymptomatic Carriers ◽  
Test Characteristics ◽  
And Control ◽  
Close Contacts

Abstract Background Rapid and convenient screening for identification of SARS-CoV-2 infected individuals are key to prevent and control this pandemic. Methods The peripheral blood samples were collected from coronavirus disease 2019 (COVID-19) patients and asymptomatic carriers to evaluate the test characteristics of the IgM-IgG combined assay for SARS-CoV-2 compared to that of serum samples and enzyme-linked immuno sorbent assay (ELISA). Close contacts, healthcare workers and workforces were recruited and screened using this assay. Results The sensitivity of the rapid IgM-IgG combined antibody test for SARS-CoV-2 using peripheral blood (sued as a POCT) was 97.0% and the specificity was 99.2%, which was consistent with the result obtained using serum sample (consistency is about 100%). Furthermore, this POCT assay also can detect IgM and IgG antibodies of SARS-CoV‐2 in asymptomatic carriers, with 19 of the 20 RT-PCR confirmed asymptomatic carriers testing positive. Therefore, this POCT assay was used for population screening of SARS-CoV-2 infection diagnosis. First, it found 4 positive close contacts among the 10 cases, and there were three IgM positive cases and one IgG positive case among them. It is worth noting that the IgM positive cases also tested positive for the nucleic acid of the SARS-CoV-2. Second, there was one IgM positive assay among the 63 healthcare workers, but RT-PCR of SARS CoV-2 was negative. Third, for workforces screening, there were no positive cases. Conclusions The IgM-IgG combined antibody test of SARS-CoV-2 can be used as a POCT for rapid screening of SARS-CoV-2 infection.

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