Serology assessment of antibody response to SARS-CoV-2 in patients with COVID-19 by rapid IgM/IgG antibody test

The coronavirus disease 2019 (COVID-19) pandemic has created a global health- and economic crisis. Lifting confinement restriction and resuming to normality depends greatly on COVID-19 immunity screening. Detection of antibodies to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) which causes COVID-19 by serological methods is important to diagnose a current or resolved infection. In this study, we applied a rapid COVID-19 IgM/IgG antibody test and performed serology assessment of antibody response to SARS-CoV-2. In PCR-confirmed COVID-19 patients (n=45), the total antibody detection rate is 92% in hospitalized patients and 79% in non-hospitalized patients. We also studied antibody response in relation to time after symptom onset and disease severity, and observed an increase in antibody reactivity and distinct distribution patterns of IgM and IgG following disease progression. The total IgM and IgG detection is 63% in patients with < 2 weeks from disease onset; 85% in non-hospitalized patients with > 2 weeks disease duration; and 91% in hospitalized patients with > 2 weeks disease duration. We also compared different blood sample types and suggest a potentially higher sensitivity by serum/plasma comparing with whole blood measurement. To study the specificity of the test, we used 69 sera/plasma samples collected between 2016-2018 prior to the COVID-19 pandemic, and obtained a test specificity of 97%. In summary, our study provides a comprehensive validation of the rapid COVID-19 IgM/IgG serology test, and mapped antibody detection patterns in association with disease progress and hospitalization. Our study supports that the rapid COVID-19 IgM/IgG test may be applied to assess the COVID-19 status both at the individual and at a population level.

Download Full-text

Performance verification of anti-SARS-CoV-2-specific antibody detection by using four chemiluminescence immunoassay systems

Annals of Clinical Biochemistry International Journal of Laboratory Medicine ◽

10.1177/0004563220963847 ◽

2020 ◽

Vol 57 (6) ◽

pp. 429-434

Author(s):

Yafang Wan ◽

Zhijie Li ◽

Kun Wang ◽

Tian Li ◽

Pu Liao

Keyword(s):

False Positive ◽

Detection System ◽

False Positive Rate ◽

Antibody Test ◽

The Other ◽

Antibody Detection ◽

Igg Antibody ◽

Chi Square ◽

Chemiluminescence Immunoassay ◽

Chi Square Test

Objectives The purpose of the current study was to evaluate the analytical performance of seven kits for detecting IgM/IgG antibodies against coronavirus (SARS-CoV-2) by using four chemiluminescence immunoassay systems. Methods Fifty patients diagnosed with SARS-CoV-2 infection and 130 controls without coronavirus infection from the General Hospital of Chongqing were enrolled in the current retrospective study. Four chemiluminescence immunoassay systems, including seven IgM/IgG antibody detection kits for SARS-CoV-2 (A_IgM, A_IgG, B_IgM, B_IgG, C_IgM, C_IgG and D_Ab), were employed to detect antibody concentrations. The chi-square test, the receiver operating characteristic (ROC) curve and Youden’s index were determined to verify the cut-off value of each detection system. Results The repeatability verification results of the A, B, C and D systems are all qualified. D_Ab performed best (92% sensitivity and 99.23% specificity), and B_IgM performed worse than the other systems. Except for the A_IgM and C_IgG systems, the optimal diagnostic thresholds and cut-off values of the other kits and their recommendations are inconsistent with each other. B_IgM had the worst AUC, and C_IgG had the best diagnostic accuracy. More importantly, the B_IgG system had the highest false-positive rate for testing patients with AIDS, tumours and pregnancies. The A_IgM system test showed the highest false-positive rates among elderly individuals over 90 years old. COVID-2019 IgM/IgG antibody test systems exhibit performance differences. Conclusions The Innodx Biotech Total Antibody serum diagnosis kit is the most reliable detection system for anti-SARS-CoV-2 antibodies, which can be used together with nucleic acid tests as an alternative method for SARS-CoV-2 detecting.

Download Full-text

Real-world evaluation of a novel technology for quantitative simultaneous antibody detection against multiple SARS-CoV-2 antigens in a cohort of patients presenting with COVID-19 syndrome

The Analyst ◽

10.1039/d0an01066a ◽

2020 ◽

Vol 145 (16) ◽

pp. 5638-5646 ◽

Cited By ~ 4

Author(s):

Andrew M. Shaw ◽

Christopher Hyde ◽

Blair Merrick ◽

Philip James-Pemberton ◽

Bethany K. Squires ◽

...

Keyword(s):

Antibody Response ◽

Real World ◽

Antibody Detection ◽

Igg Antibody ◽

Novel Technology

An evaluation of a rapid portable gold-nanotechnology measuring SARS-CoV-2 IgM, IgA and IgG antibody response to spike 1 (S1), spike 2 (S) and nucleocapsid (N) antigens using serum from 74 RNA(+) patients and RNA(+) 47 control patients.

Download Full-text

Evaluation of Six Commercial Point-of-Care Tests for Diagnosis of Acute Dengue Infections: the Need for Combining NS1 Antigen and IgM/IgG Antibody Detection To Achieve Acceptable Levels of Accuracy

Clinical and Vaccine Immunology ◽

10.1128/cvi.05285-11 ◽

2011 ◽

Vol 18 (12) ◽

pp. 2095-2101 ◽

Cited By ~ 102

Author(s):

Stuart D. Blacksell ◽

Richard G. Jarman ◽

Mark S. Bailey ◽

Ampai Tanganuchitcharnchai ◽

Kemajittra Jenjaroen ◽

...

Keyword(s):

Dengue Fever ◽

Sensitivity And Specificity ◽

Dengue Infection ◽

Antibody Test ◽

Antibody Detection ◽

Sample Collection ◽

Igg Antibody ◽

Igm Antibody ◽

Ns1 Antigen ◽

Antibody Tests

ABSTRACTSix assays were evaluated in this study to determine their suitability for the diagnosis of acute dengue infection using samples from 259 Sri Lankan patients with acute fevers (99 confirmed dengue cases and 160 patients with other confirmed acute febrile illnesses): (i) the Merlin dengue fever IgG & IgM combo device (Merlin), (ii) the Standard Diagnostics Dengue Duo nonstructural 1 (NS1) antigen and IgG/IgM combo device (Standard Diagnostics, South Korea), (iii) the Biosynex Immunoquick dengue fever IgG and IgM (Biosynex, France) assay, (iv) the Bio-Rad NS1 antigen strip (Bio-Rad, France), (v) the Panbio Dengue Duo IgG/IgM Cassette (Inverness, Australia), and (vi) the Panbio dengue NS1 antigen strip (Inverness, Australia). The median number of days of fever prior to admission sample collection was 5 days (interquartile range, 3 to 7 days). Sensitivity and specificity of the NS1 antigen tests ranged from 49 to 59% and from 93 to 99%, respectively, and sensitivity and sensitivity of the IgM antibody test ranged from 71 to 80% and from 46 to 90%, respectively. Combining the NS1 antigen and IgM antibody results from the Standard Diagnostics Dengue Duo test gave the best compromise of sensitivity and specificity (93% and 89%, respectively) and provided the best sensitivity in patients presenting at different times after fever onset. The Merlin IgM/IgG antibody tests correctly classified 64% and 86% of the primary and secondary dengue infection cases, respectively, and the Standard Diagnostics IgM/IgG antibody tests correctly classified 71% and 83% of the primary and secondary dengue infection cases, respectively. This study provides strong evidence of the value of combining dengue antigen- and antibody-based test results in the rapid diagnostic test (RDT) format for the acute diagnosis of dengue.

Download Full-text

Multiple Antigenic Peptide-Based Vaccines Targeting Ixodes ricinus Neuropeptides Induce a Specific Antibody Response but Do Not Impact Tick Infestation

Pathogens ◽

10.3390/pathogens9110900 ◽

2020 ◽

Vol 9 (11) ◽

pp. 900

Author(s):

Consuelo Almazán ◽

Ladislav Šimo ◽

Lisa Fourniol ◽

Sabine Rakotobe ◽

Jérémie Borneres ◽

...

Keyword(s):

Antibody Response ◽

Ixodes Ricinus ◽

Antigenic Peptide ◽

Tick Feeding ◽

Igg Antibody ◽

Individual Level ◽

Multiple Antigenic Peptide ◽

New Strategy ◽

The Individual ◽

Antibody Levels

Synthetic peptide vaccines were designed to target the neuropeptides innervating Ixodes ricinus salivary glands and hindgut and they were tested for their capacity to afford protective immunity against nymphs or larvae and Anaplasma phagocytophilum-infected nymph infestation, in mice and sheep, respectively. In both models, the assembly of SIFamide (SIFa) or myoinhibitory peptide (MIP) neuropeptides into multiple antigenic peptide constructs (MAPs) elicited a robust IgG antibody response following immunization. Nevertheless, no observable detrimental impact on nymphs was evidenced in mice, and, unfortunately, the number of engorged nymphs on sheep was insufficient for firm conclusions to be drawn, including for bacterial transmission. Regarding larvae, while vaccination of the sheep did not globally diminish tick feeding success or development, analyses of animals at the individual level revealed a negative correlation between anti-SIFa and MIP antibody levels and larva-to-nymph molting success for both antigens. Our results provide a proof of principle and precedent for the use of MAPs for the induction of immunity against tick peptide molecules. Although the present study did not provide the expected level of protection, it inaugurates a new strategy for protection against ticks based on the immunological targeting of key components of their nervous system.

Download Full-text

Impact of Treatment Regimens on Antibody Response to the SARS-CoV-2 Coronavirus

Frontiers in Immunology ◽

10.3389/fimmu.2021.580147 ◽

2021 ◽

Vol 12 ◽

Author(s):

Yufeng Shang ◽

Tao Liu ◽

Jingfeng Li ◽

Natasha Mupeta Kaweme ◽

Xinghuan Wang ◽

...

Keyword(s):

Critical Illness ◽

Antibody Response ◽

Multivariable Analysis ◽

Antibody Test ◽

Antibody Responses ◽

Systematic Evaluation ◽

Igg Antibody ◽

Treatment Regimens ◽

Asymptomatic Patients ◽

The Impact

The coronavirus disease 2019 (COVID-19) is widely spread and remains a global pandemic. Limited evidence on the systematic evaluation of the impact of treatment regimens on antibody responses exists. Our study aimed to analyze the role of antibody response on prognosis and determine factors influencing the IgG antibodies’ seroconversion. A total of 1,111 patients with mild to moderate COVID-19 symptoms admitted to Leishenshan Hospital in Wuhan were retrospectively analyzed. A serologic SARS-CoV-2 IgM/IgG antibody test was performed on all the patients 21 days after the onset of symptoms. Patient clinical characteristics were compared. In the study, 42 patients progressed to critical illness, with 6 mortalities reported while 1,069 patients reported mild to moderate disease. Advanced age (P = 0.028), gasping (P < 0.001), dyspnea (P = 0.024), and IgG negativity (P = 0.006) were associated with progression to critical illness. The mortality rate in critically ill patients with IgG antibody was 6.45% (95% CI 1.12–22.84%) and 36.36% (95% CI 12.36–68.38%) in patients with no IgG antibody (P = 0.003). Symptomatic patients were more likely to develop IgG antibody responses than asymptomatic patients. Using univariable analysis, fever (P < 0.001), gasping (P = 0.048), cancer (P < 0.001), cephalosporin (P = 0.015), and chloroquine/hydroxychloroquine (P = 0.021) were associated with IgG response. In the multivariable analysis, fever, cancer, cephalosporins, and chloroquine/hydroxychloroquine correlated independently with IgG response. We determined that the absence of SARS-CoV-2 antibody IgG in the convalescent stage had a specific predictive role in critical illness progression. Importantly, risk factors affecting seropositivity were identified, and the effect of antimalarial drugs on antibody response was determined.

Download Full-text

A high-throughput microsphere-based immunoassay of anti-SARS-CoV-2 IgM testing for COVID-19 diagnostics

PLoS ONE ◽

10.1371/journal.pone.0248444 ◽

2021 ◽

Vol 16 (9) ◽

pp. e0248444

Author(s):

Dayu Zhang ◽

Tianyang Xu ◽

Eric Chu ◽

Aiguo Zhang ◽

Jinwei Du ◽

...

Keyword(s):

High Throughput ◽

High Sensitivity ◽

Cross Reactivity ◽

Antibody Detection ◽

Serum Samples ◽

Igg Antibody ◽

Igm Antibody ◽

Percent Agreement ◽

Novel Coronavirus ◽

The Individual

The pandemic of novel coronavirus disease COVID-19 is rapidly expanding across the world. A positive result of antibody tests suggests that the individual has potentially been exposed to SARS-CoV-2, thus allowing to identify asymptomatic infections and determine the seroprevalence in a given population. The aim of this study was to evaluate the performances of a newly developed high throughput immunoassay for anti-SARS-CoV-2 IgM antibody detection on the Luminex MAGPIX platform. Clinical agreement studies were performed in 42 COVID-19 patient serum samples and 162 negative donor serum/plasma samples. Positive percent agreement (PPA) was 42.86% (95% CI: 9.90% to 81.59%), 71.43% (95% CI: 29.04% to 96.33%), and 28.57% (95% CI: 13.22% to 48.67%) for samples collected on 0–7 days, 8–14 days, and 2–8 weeks from symptom onset, respectively. Negative Percent Agreement (NPA) was 97.53% (95% CI: 93.80% to 99.32%). There was no cross-reactivity with the SARS-CoV-2 IgG antibody. Hemoglobin (200 mg/dL), bilirubin (2 mg/dL), triglyceride (250 mg/dL) and EDTA (10 mM) showed no significant interfering effect on this assay. In conclusion, an anti-SARS-CoV-2 IgM antibody assay with high sensitivity and specificity has been developed. With the high throughput, this assay will speed up the anti-SARS-CoV-2 IgM testing.

Download Full-text

Serological responses to SARS-CoV-2 following non-hospitalised infection: clinical and ethnodemographic features associated with the magnitude of the antibody response

10.1101/2020.11.12.20230763 ◽

2020 ◽

Author(s):

Adrian M Shields ◽

Sian E Faustini ◽

Marisol Perez-Toledo ◽

Sian Jossi ◽

Joel D Allen ◽

...

Keyword(s):

Antibody Response ◽

Healthcare Workers ◽

Venous Blood ◽

Antibody Detection ◽

Spike Glycoprotein ◽

University Hospitals ◽

Igg Antibody ◽

White Ethnicity ◽

Moderate Disease ◽

Care Workers

AbstractObjectiveTo determine clinical and ethnodemographic correlates of serological responses against the SARS-CoV-2 spike glycoprotein following mild-to-moderate COVID-19.DesignA retrospective cohort study of healthcare workers who had self-isolated due to COVID-19.SettingUniversity Hospitals Birmingham NHS Foundation Trust, UK (UHBFT).Participants956 health care workers were recruited by open invitation via UHBFT trust email and social media.InterventionParticipants volunteered a venous blood sample that was tested for the presence of anti-SARS-CoV-2 spike glycoprotein antibodies. Results were interpreted in the context of the symptoms of their original illness and ethnodemographic variables.ResultsUsing an assay that simultaneously measures the combined IgG, IgA and IgM response against the spike glycoprotein (IgGAM), the overall seroprevalence within this cohort was 46.2% (n=442/956). The seroprevalence of immunoglobulin isotypes was 36.3%, 18.7% and 8.1% for IgG, IgA and IgM respectively. IgGAM identified serological responses in 40.6% (n=52/128) of symptomatic individuals who reported a negative SARS-CoV-2 PCR test. Increasing age, non-white ethnicity and obesity were independently associated with greater IgG antibody response against the spike glycoprotein. Self-reported fever and fatigue were associated with greater IgG and IgA responses against the spike glycoprotein. The combination of fever and/or cough and/or anosmia had a positive predictive value of 92.3% for seropositivity.Conclusions and relevanceAssays employing combined antibody detection demonstrate enhanced seroepidemiological sensitivity and can detect prior viral exposure even when PCR swabs have been negative. We demonstrate an association between known ethnodemographic risk factors associated with mortality from COVID-19 and the magnitude of serological responses in mild-to-moderate disease. The combination of cough, and/or fever and/or anosmia identifies the majority of individuals who should self-isolate for COVID-19.

Download Full-text

A High-throughput Microsphere-based Immunoassay of Anti-SARS-CoV-2 IgM Testing for COVID-19 Diagnostics

10.1101/2021.01.22.20249050 ◽

2021 ◽

Author(s):

Dayu Zhang ◽

Tianyang Xu ◽

Eric Chu ◽

Aiguo Zhang ◽

Jinwei Du ◽

...

Keyword(s):

High Throughput ◽

High Sensitivity ◽

Cross Reactivity ◽

Antibody Detection ◽

Serum Samples ◽

Igg Antibody ◽

Igm Antibody ◽

Percent Agreement ◽

Novel Coronavirus ◽

The Individual

ABSTRACTThe pandemic of novel coronavirus disease COVID-19 is rapidly expanding across the world. A positive result of antibody tests suggests that the individual has potentially been exposed to SARS-CoV-2, thus allowing to identify asymptomatic infections and determine the seroprevalence in a given population. The aim of this study was to evaluate the performances of a newly developed high throughput immunoassay for anti-SARS-CoV-2 IgM antibody detection on the Luminex MAGPIX platform. Clinical agreement studies were performed in 42 COVID-19 patient serum samples and 162 negative donor serum/plasma samples. Positive percent agreement (PPA) was 42.86% (95% CI: 9.90% to 81.59%), 71.43% (95% CI: 29.04% to 96.33%), and 28.57% (95% CI: 13.22% to 48.67%) for samples collected on 0-7 days, 8-14 days, and 2-8 weeks from symptom onset, respectively. Negative Percent Agreement (NPA) was 97.53% (95% CI: 93.80% to 99.32%). There was no cross-reactivity with the SARS-CoV-2 IgG antibody Hemoglobin (200 mg/dL), bilirubin (2 mg/dL), triglyceride (250 mg/dL) and EDTA (10 mM) showed no significant interfering effect on this assay. In conclusion, an anti-SARS-CoV-2 IgM antibody assay with high sensitivity and specificity has been developed. With the high throughput, this assay will speed up the anti-SARS-CoV-2 IgM testing.

Download Full-text

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

10.36106/ijsr/1335520 ◽

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.

Download Full-text

Comparative evaluation of SARS-CoV-2 IgG assays against nucleocapsid and spike antigens

Human Antibodies ◽

10.3233/hab-210440 ◽

2021 ◽

pp. 1-5

Author(s):

Mitra Rezaei ◽

Mohammadhadi Sadeghi ◽

Alireza Korourian ◽

Payam Tabarsi ◽

Mihan Porabdollah ◽

...

Keyword(s):

Antibody Response ◽

Symptom Onset ◽

Disease Onset ◽

Early Time ◽

Igg Antibody ◽

Cell Percentage ◽

Percent Positivity ◽

Severity Of The Disease ◽

Nucleoprotein N ◽

Antibody Levels

BACKGROUND: There are few studies to compare antibody response against anti-spike (S) and anti- nucleoprotein (N) SARS-CoV-2. OBJECTIVE: The aim of this study was to evaluate the IgG antibody production against S and N antigens of the virus and their correlation with the time and severity of the disease. METHODS: The IgG antibodies against S and N antigens of SARS-CoV-2 in serum specimens 72 symptomatic patients who tested real-time reverse transcription polymerase chain reaction positive for SARS-CoV-2 were detected using the ELISA technique. Different antibody response was compared and the correlation with the time from disease onset and the severity was evaluated. RESULTS: Forty-eight of 72 (67%) patients tested positive for anti-SARS-CoV-2 antibodies, while 24 (33%) did not have detectable antibodies. Comparison of antibody levels for N and S antibodies showed that they correlate with each other well (r= 0.81; P< 0.001). However, sensitivity of anti-S SARS-CoV-2 IgG and anti-N SARS-CoV-2 IgG was 30% and 60%, during the first 7 days after symptom onset (r= 0.53; P= 0.111), but increased to 73% and 68% at more than 1-week post symptom onset (r= 0.89, P= 0.111), respectively. Cases with positive IgG response showed a decreased CD8 cell percentage compared to the negative IgG groups (26 ± 14 vs. 58 ± 32, p= 0.066 in anti-N IgG group and 28 ± 15 vs. 60 ± 45, p= 0.004 in anti-S IgG group, respectively). CONCLUSION: Nearly one-third of the confirmed COVID-19 patients had negative serology results. Lower percent positivity at early time points after symptom onset (less than 1 week) was seen using anti-S SARS-COV-2 IgG kit compare to the anti-N SARS-CoV-2 IgG; therefore, clinicians should interpret negative serology results of especially anti-S SARS-CoV-2 IgG with caution.

Download Full-text