Long-Term Longitudinal Evaluation of Six Commercial Immunoassays for the Detection of IgM and IgG Antibodies against SARS CoV-2 (original) (raw)
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Japanese Journal of Infectious Diseases, 2022
Comparative validation data and clinical performance data are essential for the reliable interpretation of SARS-CoV-2 antibody test results. This study aimed to assess the performance of six SARS-CoV-2 IgG immunoassays in different disease severity settings. Four automated chemiluminescence immunoassays Access (Beckman Coulter), Architect (Abbott), Atellica-IM (Siemens) and Elecsys (Roche) and two ELISA assays (SARS-CoV-2 IgG-S1-based and NCP IgG, Euroimmun) were evaluated in 143 patients and 50 pre-pandemic control sera. Accuracy and precision tests were performed for validation. Overall sensitivity differed between 73.38-88.65%, being higher in spike protein-based assays. Specificity was > 98% in all immunoassays. IgG response was lower for the samples taken <20 days post-symptom onset (87.30%) than for the samples taken >20 days postsymptom onset (94.80%). Higher rate of antibody was detected in the clinically moderate disease group. In the asymptomatic and mild group more antibody positivity was detected with spike protein-based assays. Clinical performance of the immunoassays differs according to disease severity and antigen targeted; moderate disease leading to highest rate of IgG response. All the assays tested were eligible for the detection of SARS-CoV-2 IgG however, spike-based assays revealed relatively higher sensitivity than the nucleoprotein-based assays particularly in the asymptomatic and mild disease severity.
Journal of Medical Virology, 2021
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection has proven to be extremely contagious and has spread rapidly all over the world. A key aspect in limiting the virus diffusion is to ensure early and accurate diagnosis. Serological assays could be an alternative in increasing testing capabilities, particularly when used as part of an algorithmic approach combined with molecular analysis. The aim of this study was to evaluate the diagnostic accuracy of a second generation chemiluminescent automated immunoassay able to detect anti-SARS-CoV-2 immunoglobulin G (IgG) and immunoglobulin M (IgM) antibodies. Data are carried out on healthy subjects and other infectious diseases pre-pandemic sera, as controls, and on two different coronavirus disease 2019 hospitalized patient groups (early and late infection time). Data obtained have been analyzed in terms of precision, linearity, sensitivity and specificity. Specificities are: 100% for anti-SARS-CoV-2 IgG and 98% for anti-SARS-CoV-2 IgM, in all patient groups. Sensitivities are: 97%, 100%, and 98% for anti-SARS-CoV-2 IgG and 87%, 83%, and 86% for anti-SARS-CoV-2 IgM in the early infection, in the late infection and in the total patient group, respectively. The Mindray anti-SARS-CoV-2 IgG and IgM assays demonstrated higher sensitivity and specificity, indicating that IgG and IgM simultaneous detection is useful even in the early phases of infection.
European Journal of Clinical Microbiology & Infectious Diseases
In response to the rapidly evolving of SARS-CoV-2 infection, numerous serological tests have been developed but their sensitivity and specificity are unclear. We collected serum samples of patients and health-care professionals to assess the accuracy of chemiluminescent (CLIA) and two lateral flow immunochromatographic assays (LFIA) to determine IgG and IgM antibodies to SARS-CoV-2 virus. We calculated the φ correlation for qualitative results and test accuracy, adopting the following case definition: either real-time-PCR positivity or serological positivity with at least two different tests. We analyzed 259 samples, obtaining strong correlation between CLIA and both LFIA for IgG (φ=0.9), and moderate correlation for IgM (φ=0.6). For patients, the sensitivity was suboptimal for all methods (CLIA 81%, LFIA A 85%, LFIA B 78%), while it was poor in asymptomatic health-care workers (CLIA 50%, LFIA A 50%, LFIA B 33%). Overall, CLIA is more sensitive and specific for the determination of both IgG and IgM, whilst both LFIA methods reported good sensitivity and specificity for IgG, but scarce sensitivity for the IgM determination. The determination of SARS-CoV-2-specific IgG is useful to detect infection 6 days from symptom onset.
Japanese Journal of Infectious Diseases
Comparative validation and clinical performance data are essential for the reliable interpretation of severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) antibody test results. This study aimed to assess the performance of six SARS-CoV-2 IgG immunoassays in the context of different disease severities. Four automated chemiluminescence immunoassays (Access [Beckman Coulter], Architect [Abbott], Atellica-IM [Siemens], and Elecsys [Roche]) as well as two ELISA assays (SARS-CoV-2 IgG-S1-based and NCP IgG [Euroimmun]) were evaluated using samples from 143 patients as well as 50 pre-pandemic control serum samples. Accuracy and precision tests were performed for validation purposes. Overall sensitivity ranged between 73.38-88.65% and was higher in spike protein-based assays, while the specificity was ≥98% in all immunoassays. The clinical performance of the immunoassays differed depending on disease severity and target antigen. For instance, the IgG response was lower for samples taken <20 days post-symptom onset (87.30%) compared with those taken ≥20 days post-symptom onset (94.80%). Moreover, moderate disease levels led to the highest levels of IgG. Higher levels of antibodies were detected in the clinically moderate disease group. In asymptomatic and mild groups, more antibody positivity was detected with spike protein-based assays. All the assays tested could be used to detect SARS-CoV-2 IgG. However, spikebased assays revealed relatively higher sensitivity rates than nucleoprotein-based assays, particularly in cases of asymptomatic and mild disease.
Validation of a commercially available SARS-CoV-2 serological Immunoassay
Aims: To validate the diagnostic accuracy of a Euroimmun SARS-CoV-2 IgG and IgA immunoassay for COVID-19 disease. Methods: In this unmatched (1:1) case-control validation study, we used sera of 181 laboratory-confirmed SARS-CoV-2 cases and 176 negative controls collected before the emergence of SARS-CoV-2. Diagnostic accuracy of the immunoassay was assessed against a whole spike protein-based recombinant immunofluorescence assay (rIFA) by receiver operating characteristic (ROC) analyses. Discrepant cases between ELISA and rIFA were further tested by pseudo-neutralization assay. Results: COVID-19 patients were more likely to be male and older than controls, and 50.3% of them were hospitalized. ROC curve analyses indicated that IgG and IgA had a high diagnostic accuracy with AUCs of 0.992 (95% Confidence Interval [95%CI]: 0.986-0.996) and 0.977 (95%CI: 0.963-0.990), respectively. IgG assays outperformed IgA assays (p=0.008). Considering optimized cut-offs taking the 15% inter-assay im...
Comparative evaluation of six immunoassays for the detection of antibodies against SARS-CoV-2
medRxiv, 2020
Objectives: Serologic techniques can serve as a complement to diagnose SARS-CoV-2 infection. The objective of our study was to compare the diagnostic performance of six immunoassays to detect antibodies against SARS-CoV-2: three lateral flow immunoassays (LFAs), one ELISA and two chemiluminescence assays (CLIAs). Methods: We evaluated three LFAs (Alltest, One Step and SeroFlash), one ELISA (Dia.Pro) and two CLIAs (Elecsys and COV2T). To assess the specificity, 60 pre-pandemic sera were used. To evaluate the sensitivity, we used 80 serum samples from patients with positive PCR for SARS-CoV-2. Agreement between techniques was evaluated using the kappa score (k). Results: All immunoassays showed a specificity of 100% except for SeroFlash (96.7%). Overall sensitivity was 61.3%, 73.8%, 67.5%, 85.9%, 88.0% and 92.0% for Alltest, One Step, SeroFlash, Dia.Pro, Elecsys and COV2T, respectively. Sensitivity increased throughout the first two weeks from the onset of symptoms, reaching sensitivi...
The Journal of Applied Laboratory Medicine, 2021
Background Serological testing provides a record of prior infection with SARS-CoV-2, but assay performance requires independent assessment. Methods We evaluated 3 commercial (Roche Diagnostics pan-IG, and Epitope Diagnostics IgM and IgG) and 2 non-commercial (Simoa and Ragon/MGH IgG) immunoassays against 1083 unique samples that included 251 PCR-positive and 832 prepandemic samples. Results The Roche assay registered the highest specificity 99.6% (3/832 false positives), the Ragon/MGH assay 99.5% (4/832), the primary Simoa assay model 99.0% (8/832), and the Epitope IgG and IgM 99.0% (8/830) and 99.5% (4/830), respectively. Overall sensitivities for the Simoa, Roche pan-IG, Epitope IgG, Ragon/MGH IgG, and Epitope IgM were 92.0%, 82.9%, 82.5%, 64.5% and 47.0%, respectively. The Simoa immunoassay demonstrated the highest sensitivity among samples stratified by days postsymptom onset (PSO), <8 days PSO (57.69%) 8–14 days PSO (93.51%), 15–21 days PSO (100%), and > 21 days PSO (95.1...
2021
ObjectiveTo investigate the performance of a rapid point-of-care antibody test, the BioMedomics COVID-19 IgM/IgG Rapid Test, in comparison with a high-quality, validated, laboratory-based platform, the Roche Elecsys Anti-SARS-CoV-2 assay.MethodsSerological testing was conducted on 708 individuals. Concordance metrics were estimated. Logistic regression was used to assess associations with seropositivity.ResultsSARS-CoV-2 seroprevalence was 63.4% (449/708; 95% CI 59.8%-66.9%) using the BioMedomics assay and 71.9% (509/708; 95% CI 68.5%-75.1%) using the Elecsys assay. There were 62 discordant results between the two assays. One specimen was seropositive in the BioMedomics assay, but seronegative in the Elecsys assay, while 61 specimens were seropositive in the Elecsys assay, but seronegative in the BioMedomics assay. Positive, negative, and overall percent agreements between the two assays were 88.0% (95% CI 84.9%-90.6%), 99.5% (95% CI 97.2%-99.9%), and 91.2% (95% CI 88.9%-93.1%), res...
Diagnostic Microbiology and Infectious Disease, 2020
Introduction: SARS-CoV-2 seroconversion is important for epidemiological studies as well as contact tracing. Material and methods: The antibody response against SARS-CoV-2 was examined in 111 patients with a positive qRT-PCR. Seroconversion was assessed using the Elecsys from Roche, the Liaison S1/S2 IgG from Diasorin, the IgG and IgA from Euroimmun, as well as the VIDAS IgG and IgM. Specificity was estimated based on the measurement of SARS-CoV-2 antibodies in 96 residual samples collected during a non-pandemic period. Results: The highest overall sensitivity for detecting seroconversion was obtained using the Elecsys (81.1%), the Euroimmun with a combined detection of IgG/IgA (86.5%), and the VIDAS with a simultaneous measurement of IgG/IgM (78.4%).The Elecsys and the VIDAS IgG/IgM demonstrated a specificity as well as a positive predictive value of 100%. Conclusions: The Elecsys and the VIDAS methods with a combination of IgG/IgM measurement demonstrated a high sensitivity with no false positive results.
Frontiers in Public Health, 2021
The onset of the new SARS-CoV-2 coronavirus encouraged the development of new serologic tests that could be additional and complementary to real-time RT-PCR-based assays. In such a context, the study of performances of available tests is urgently needed, as their use has just been initiated for seroprevalence assessment. The aim of this study was to compare four chemiluminescence immunoassays and one immunochromatography test for SARS-Cov-2 antibodies for the evaluation of the degree of diffusion of SARS-CoV-2 infection in Salerno Province (Campania Region, Italy). A total of 3,185 specimens from citizens were tested for anti-SARS-CoV-2 antibodies as part of a screening program. Four automated immunoassays (Abbott and Liaison SARS-CoV-2 CLIA IgG and Roche and Siemens SARS-CoV-2 CLIA IgM/IgG/IgA assays) and one lateral flow immunoassay (LFIA Technogenetics IgG–IgM COVID-19) were used. Seroprevalence in the entire cohort was 2.41, 2.10, 1.82, and 1.85% according to the Liaison IgG, Ab...