Performance Evaluation of the Siemens SARS-CoV-2 Total Antibody and IgG Antibody Test

Florin, Lisa; Maelegheer, Karel; Vandewal, Wouter; Bernard, Dirk; Robbrecht, Johan

doi:10.1093/labmed/lmab027

Cited by 12 publications

(8 citation statements)

References 19 publications

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“…The PPV of Roche and Abbott was similar to the results of Park et al (2022) , who calculated the PPV using several exemplary COVID-19-prevalent populations. The PPV of Siemens was relatively lower than that of other CLIAs, with lower specificity compared to previous findings ( Florin et al, 2021 ; Yun et al, 2021 ; Park et al, 2022 ). As the CLIAs for the SARS-CoV-2 antibody are not routinely used in our laboratory work, the reagent evaluation for this study was performed only for a short period.…”

Section: Discussioncontrasting

confidence: 90%

Performance of Severe Acute Respiratory Syndrome Coronavirus 2 Serological Diagnostic Tests and Antibody Kinetics in Coronavirus Disease 2019 Patients

et al. 2022

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Serological testing is recommended to support the detection of undiagnosed coronavirus disease 2019 (COVID-19) cases. However, the performance of serological assays has not been sufficiently evaluated. Hence, the performance of six severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) binding antibody assays [three chemiluminescence (CLIAs) and three lateral flow immunoassays (LFIAs)] and a surrogate virus neutralization test (sVNT) was analyzed in a total of 988 serum samples comprising 389 COVID-19-positives and 599 COVID-19-negatives. The overall diagnostic sensitivities of CLIAs and LFIAs ranged from 54.2 to 56.6% and from 56.3 to 64.3%, respectively. The overall diagnostic specificities of CLIAs and LFIAs ranged from 98.2 to 99.8% and from 97.3 to 99.0%, respectively. In the symptomatic group (n = 321), the positivity rate increased by over 80% in all assays > 14 days after symptom onset. In the asymptomatic group (n = 68), the positivity rate increased by over 80% in all assays > 21 days after initial RT-PCR detection. In LFIAs, negatively interpreted trace bands accounted for the changes in test performance. Most false-positive results were weak or trace reactions and showed negative results in additional sVNT. For six binding antibody assays, the overall agreement percentages ranged from 91.0 to 97.8%. The median inhibition activity of sVNT was significantly higher in the symptomatic group than in the asymptomatic group (50.0% vs. 29.2%; p < 0.0001). The median times to seropositivity in the symptomatic group were 9.7 days for CLIA-IgG, 9.2 and 9.8 days for two CLIAs-Total (IgM + IgG), 7.7 days for LFIA-IgM, 9.2 days for LFIA-IgG, and 8.8 days for sVNT-IgG, respectively. There was a strong positive correlation between the quantitative results of the four binding antibody assays and sVNT with Spearman ρ-values ranging from 0.746 to 0.854. In particular, when using LFIAs, we recommend using more objective interpretable assays or establishing a band interpretation system for each laboratory, accompanied by observer training. We also anticipate that sVNT will play an essential role in SARS-CoV-2 antibody testing and become the practical routine neutralizing antibody assay.

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Section: Discussioncontrasting

confidence: 90%

Performance of Severe Acute Respiratory Syndrome Coronavirus 2 Serological Diagnostic Tests and Antibody Kinetics in Coronavirus Disease 2019 Patients

et al. 2022

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“…Both COV2T and COV2G antibody tests are directed against the spike 1 protein receptor binding domain (S1‐RBD). Sensitivity and specificity of COV2T of 93.2%–97.5% and 99.5%–100%, respectively, at >21 days after PCR positivity has been reported, 10,11 whereas a COV2G sensitivity of 92.2% and specificity of 100% between days 7 and 13 after PCR positivity was published 11 …”

Section: Methodsmentioning

confidence: 99%

“…A serological assay based on the chemiluminescent immunoassay by Atellica analyzer was used to determine the presence of total (S1-RBD). Sensitivity and specificity of COV2T of 93.2%-97.5% and 99.5%-100%, respectively, at >21 days after PCR positivity has been reported, 10,11 whereas a COV2G sensitivity of 92.2% and specificity of 100% between days 7 and 13 after PCR positivity was published. 11…”

Section: Quantification Of Antibodies To Sars-cov-2mentioning

confidence: 99%

Cellular and humoral immune response after mRNA-1273 SARS-CoV-2 vaccine in liver and heart transplant recipients

Herrera

Colmenero

Pascal

et al. 2021

American Journal of Transplantation

142

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Recently published studies have found an impaired immune response after SARS‐CoV‐2 vaccination in solid organ recipients. However, most of these studies have not assessed immune cellular responses in liver and heart transplant recipients. We prospectively studied heart and liver transplant recipients eligible for SARS‐CoV‐2 vaccination. Patients with past history of SARS‐CoV‐2 infection or SARS‐CoV‐2 detectable antibodies (IgM or IgG) were excluded. We assessed IgM/IgG antibodies and ELISpot against the S protein 4 weeks after receiving the second dose of the mRNA‐1273 (Moderna) vaccine. Side effects, troponin I, liver tests and anti‐HLA donor‐specific antibodies (DSA) were also assessed. A total of 58 liver and 46 heart recipients received two doses of mRNA‐1273 vaccine. Median time from transplantation to vaccination was 5.4 years (IQR 0.3–27). Sixty‐four percent of the patients developed SARS‐CoV‐2 IgM/IgG antibodies and 79% S‐ELISpot positivity. Ninety percent of recipients developed either humoral or cellular response (87% in heart recipients and 93% in liver recipients). Factors associated with vaccine unresponsiveness were hypogammaglobulinemia and vaccination during the first year after transplantation. Local and systemic side effects were mild or moderate, and none presented DSA or graft dysfunction after vaccination. Ninety percent of our patients did develop humoral or cellular responses to mRNA‐1273 vaccine. Factors associated with vaccine unresponsiveness were hypogammaglobulinemia and vaccination during the first year after transplantation, highlighting the need to further protect these patients.

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“…All participants received two doses of BNT162b2 mRNA COVID-19 vaccine (Comirnaty) 21 days apart and were assessed for the detection of receptor binding domain (RBD) IgG antibodies using Siemens SARS-CoV-2 IgG (COV2G) antibody tests( 9 ), at 4 time points: T0 – Baseline assessment at day 0 in the same morning before the first vaccine dose. T1 – 1st FU visit at day 21, i.e.…”

Section: Methodsmentioning

confidence: 99%

SARS-CoV-2 vaccine humoral response in adults with Down syndrome

Sali

Carfì

Paola

et al. 2022

Clinical Microbiology and Infection

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Performance Evaluation of the Siemens SARS-CoV-2 Total Antibody and IgG Antibody Test

Cited by 12 publications

References 19 publications

Performance of Severe Acute Respiratory Syndrome Coronavirus 2 Serological Diagnostic Tests and Antibody Kinetics in Coronavirus Disease 2019 Patients

Performance of Severe Acute Respiratory Syndrome Coronavirus 2 Serological Diagnostic Tests and Antibody Kinetics in Coronavirus Disease 2019 Patients

Cellular and humoral immune response after mRNA-1273 SARS-CoV-2 vaccine in liver and heart transplant recipients

SARS-CoV-2 vaccine humoral response in adults with Down syndrome

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