Dataset Information

Longitudinal characterization of the IgM and IgG humoral response in symptomatic COVID-19 patients using the Abbott Architect.

ABSTRACT: Background: Antibody testing has recently emerged as an option to assist with determining exposure to SARS-CoV-2, the causative agent of COVID-19. Elucidation of the kinetics and duration of the humoral response is important for clinical management and interpreting results from serological surveys.

Objectives: Here we evaluated the clinical performance of Abbott SARS-CoV-2 IgM and IgG assays, as well as the longitudinal dynamics of the antibody response in symptomatic COVID-19 patients.

Study design and results: The diagnostic specificity was 100 % for IgM and 99.67 % for IgG using 300 pre-COVID-19 serum specimens. Using 1349 sequential serum samples collected up to 168 days post symptom onset from 427 PCR-confirmed individuals, clinical test sensitivity of the SARS-CoV-2 IgM assay was 24.6 % at ?7 days, 75.3 % at 8-14 days, 95.0 % at 15-21 days, and 96.0 % at 4-5 weeks (peak test sensitivity). The median duration of time for IgM seroconversion was 10 days. IgM levels declined steadily 4-5 weeks after symptom onset, and the positive rate dropped to 30.8 % at >3 months. The diagnostic sensitivity for the SARS-CoV-2 IgG assay post symptom onset was 23.2 % at ?7 days, 69.5 % at 8-14 days, 93.6 % at 15-21 days, and 99.6 % at 4-5 weeks (peak test sensitivity). The median duration of time for IgG seroconversion was 11.5 days. During the convalescent phase of the infection, a decline in the IgG level was observed in patients who were followed for >100 days. Despite that decline, 92.3 % of the patient cohort remained IgG positive 3-6 months following symptom onset.

Conclusions: This study demonstrates the Abbott IgM assay against SARS-CoV-2 is detected slightly earlier compared to IgG, with both tests exhibiting excellent overall sensitivity and specificity. In symptomatic patients who test negative by PCR for a SARS-CoV-2 infection, assessing IgM and IgG antibodies can aid in supporting a diagnosis of COVID-19.

SUBMITTER: Maine GN

PROVIDER: S-EPMC7590643 | biostudies-literature | 2020 Dec

REPOSITORIES: biostudies-literature

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Longitudinal characterization of the IgM and IgG humoral response in symptomatic COVID-19 patients using the Abbott Architect.

Maine Gabriel N GN Lao Kriselle Maris KM Krishnan Subhashree Mallika SM Afolayan-Oloye Olabisi O Fatemi Seyedalireza S Kumar Sandeep S VanHorn Lindsay L Hurand Ashley A Sykes Elizabeth E Sun Qian Q

Journal of clinical virology : the official publication of the Pan American Society for Clinical Virology 20201027

<h4>Background</h4>Antibody testing has recently emerged as an option to assist with determining exposure to SARS-CoV-2, the causative agent of COVID-19. Elucidation of the kinetics and duration of the humoral response is important for clinical management and interpreting results from serological surveys.<h4>Objectives</h4>Here we evaluated the clinical performance of Abbott SARS-CoV-2 IgM and IgG assays, as well as the longitudinal dynamics of the antibody response in symptomatic COVID-19 patie ...[more]

PMID: 33161369

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Project description:Critical evaluation of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) serologic assays is needed to guide clinical decision-making and ensure that these assays provide optimal benefit to patients and the public. Here, three commercially available assays with widespread distribution capabilities are compared. A total of 667 specimens, 103 from patients with confirmed SARS-CoV-2 infections and 564 collected prior to the emergence of SARS-CoV-2, were analyzed in parallel using the Roche Elecsys SARS-CoV-2 total antibody and Abbott Alinity SARS-CoV-2 IgG assays; a subset of 55 samples from patients with confirmed SARS-CoV-2 infections was additionally evaluated using the Abbott Architect SARS-CoV-2 IgM assay. Qualitative agreement between the Abbott IgG and Roche total antibody assays was 98.7% (658/667), with Cohen's kappa value of 0.919 (95% confidence interval [CI], 0.867 to 0.972). Qualitative agreements with the Abbott IgM assay were 92.7% (51/55, Abbott IgG) and 85.5% (47/55, Roche total antibody). Diagnostic specificities determined using pre-COVID-19 samples for the Abbott IgG and Roche total antibody assays were 99.65% (95% CI, 98.72 to 99.90%) and 100.00% (95% CI, 99.32 to 100.00%), respectively, spanning claims made by each manufacturer. Diagnostic sensitivities increased for all three assays with increasing time since the onset of symptoms. Among 51 patients with confirmed SARS-CoV-2 infections, 23 (45.1%), 24 (47.1%), and 22 (43.1%) were reactive by the Abbott IgG, Roche total antibody, and Abbott IgM assays, respectively, with sampling times 0 to 56 days post-positive PCR (median/mean, 2/6.2 days). Combining IgG and IgM screening identified 4/55 additional samples with detectable antibodies that would not have been observed using the assays independently. Notably, one immunocompromised patient with confirmed SARS-CoV-2 infection showed no detectable antibodies using any of the three assays 43 days after onset of symptoms.

Dataset Information

Longitudinal characterization of the IgM and IgG humoral response in symptomatic COVID-19 patients using the Abbott Architect.

Publications

Longitudinal characterization of the IgM and IgG humoral response in symptomatic COVID-19 patients using the Abbott Architect.

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