How can we interpret SARS-CoV-2 antibody test results?

Føns, Sofie; Krogfelt, Karen A.

doi:10.1093/femspd/ftaa069

Cited by 17 publications

(14 citation statements)

References 44 publications

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“…The role of antibody testing and the need for continuous evaluation of available tests has been discussed early during the pandemic [ 1 , 2 ] and is still an open issue [ 3 ]. To date, the comparative studies of various types of assays measuring levels of anti-SARS-CoV-2 antibodies have mainly relied on test results from COVID-19 patients and recovered patients [ 4 , 5 , 6 , 7 , 8 , 9 , 10 , 11 , 12 , 13 , 14 , 15 ].…”

Section: Introductionmentioning

confidence: 99%

Usefulness of IVD Kits for the Assessment of SARS-CoV-2 Antibodies to Evaluate the Humoral Response to Vaccination

Łukaszuk

Kiewisz

Rozanska³

et al. 2021

Vaccines

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Background: The introduction of the vaccination against SARS-CoV-2 infection creates the need for precise tools for the quality control of vaccination procedures, detection of poor humoral response, and estimation of the achieved protection against the disease. Thus, the study aimed to compare the results of the anti-SARS-CoV-2 tests to evaluate the application of the WHO standard unitage (the binding antibody units; BAU/mL) for a measurement of response to the vaccination. Methods: Patients undergoing vaccination against SARS-CoV-2 with Pfizer/BioNTech BNT162b2 (BNT162b2) (n = 79), referred for SARS-CoV-2 antibody measurement prior to vaccination and 21 days after dose 1, and 8, 14, and 30 days after dose 2 were included. The sera were tested with three assays: Elecsys SARS-CoV-2 S (Roche), LIAISON® SARS-CoV-2 TrimericS IgG (DiaSorin), and SARS-CoV-2 IgG II Quant (Abbott). Results: The three assays showed varying correlations at different time points in the study. The overall agreement for all samples was moderate to high (ρ = 0.663–0.902). We observed the most uniform agreement for the day of dose 2 (ρ = 0.775–0.825), while it was least consistent for day 8 (ρ = −0.131–0.693) and 14 (ρ = −0.247–0.603) after dose 2. The dynamics of changes of the SARS-CoV-2 antibody levels in patients without history of prior SARS-CoV-2 infection appears homogenous based on the Roche results, more heterogenous when considering the DiaSorin results, and in between for the Abbott results. Conclusions: The results highlight the need for further work on the international standard of measurement of SARS-CoV-2 Ig, especially in the era of vaccination. The serological assays can be useful to detect IgG/IgM antibodies to assess the response to the vaccination. However, they cannot be used interchangeably. In terms of the evaluation of the immune response to the BNT162b2 vaccine, Roche and Abbott kits appear to be more useful.

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Section: Introductionmentioning

confidence: 99%

Usefulness of IVD Kits for the Assessment of SARS-CoV-2 Antibodies to Evaluate the Humoral Response to Vaccination

Łukaszuk

Kiewisz

Rozanska³

et al. 2021

Vaccines

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“…The pentameric structure of IgM, along with a lower affinity for viral proteins compared with IgG, increases the likelihood of the detection of FPs [ 20 ]. Additionally, due to the time course of IgM seroconversion, the PIO time will greatly impact analyte levels in donor serum [ 21 , 22 ]. While our assays did display lowest specificity for IgM (90.5%) as well as a lower cross-reactivity specificity (85.7%) compared with other analytes, this level of specificity still compares well to similar assays [ 21 ].…”

Section: Resultsmentioning

confidence: 99%

Validation of High-Throughput, Semiquantitative Solid-Phase Sarscoronavirus-2 Serology Assays in Serum and Dried Blood Spot Matrices

et al. 2021

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Aim: Serological assays for the detection of anti-SARS coronavirus-2 (SARS-CoV-2) antibodies are essential to the response to the global pandemic. A ligand binding-based serological assay was validated for the semiquantitative detection of IgG, IgM, IgA and neutralizing antibodies (nAb) against SARS-CoV-2 in serum. Results: The assay demonstrated high levels of diagnostic specificity and sensitivity (85–99% for all analytes). Serum IgG, IgM, IgA and nAb correlated positively (R2 = 0.937, R2 = 0.839, R2 = 0.939 and R2 = 0.501, p < 0.001, respectively) with those measured in dried blood spot samples collected using the hemaPEN® microsampling device (Trajan Scientific and Medical, Victoria, Australia). In vitro SARS-CoV-2 pseudotype neutralization correlated positively with the solid phase nAb signals in convalescent donors (R2 = 0.458, p < 0.05). Conclusion: The assay is applicable in efficacy studies, infection monitoring and postmarketing surveillance following vaccine rollout.

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“…Several types of assays have been developed in a short period of time in response to the COVID-19 outbreak, each with its own set of uncertainties in terms of clinical sensitivity and specificity, such as sample collection and handling, technological challenges, unknown systematic error margins, and dependencies on patient health conditions [ 85 ]. According to the most recent literature, a single assay result will not reflect a representative quantitative measure, whereas merging different test results can help minimize biases and provide more conclusive therapeutic thresholds [ 86 , 87 ].…”

Section: Discussionmentioning

confidence: 99%

Convalescent Plasma Transfusion for the Treatment of COVID-19 in Adults: A Global Perspective

Kanj

Al-Omari

2021

Viruses

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More than one year into the novel coronavirus disease 2019 (COVID-19) pandemic, healthcare systems across the world continue to be overwhelmed with soaring daily cases. The treatment spectrum primarily includes ventilation support augmented with repurposed drugs and/or convalescent plasma transfusion (CPT) from recovered COVID-19 patients. Despite vaccine variants being recently developed and administered in several countries, challenges in global supply chain logistics limit their timely availability to the wider world population, particularly in developing countries. Given the measured success of conventional CPT in treating several infections over the past decade, recent studies have reported its effectiveness in decreasing the duration and severity of COVID-19 symptoms. In this review, we conduct a literature search of published studies investigating the use of CPT to treat COVID-19 patients from January 2020 to January 2021. The literature search identified 181 records of which 39 were included in this review. A random-effects model was used to aggregate data across studies, and mortality rates of 17 vs. 32% were estimated for the CPT and control patient groups, respectively, with an odds ratio (OR) of 0.49. The findings indicate that CPT shows potential in reducing the severity and duration of COVID-19 symptoms. However, early intervention (preferably within 3 days), recruitment of donors, and plasma potency introduce major challenges for its scaled-up implementation. Given the low number of existing randomized clinical trials (RCTs, four with a total of 319 patients), unanticipated risks to CPT recipients are highlighted and discussed. Nevertheless, CPT remains a promising COVID-19 therapeutic option that merits internationally coordinated RCTs to achieve a scientific risk–benefit consensus.

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How can we interpret SARS-CoV-2 antibody test results?

Cited by 17 publications

References 44 publications

Usefulness of IVD Kits for the Assessment of SARS-CoV-2 Antibodies to Evaluate the Humoral Response to Vaccination

Usefulness of IVD Kits for the Assessment of SARS-CoV-2 Antibodies to Evaluate the Humoral Response to Vaccination

Validation of High-Throughput, Semiquantitative Solid-Phase Sarscoronavirus-2 Serology Assays in Serum and Dried Blood Spot Matrices

Convalescent Plasma Transfusion for the Treatment of COVID-19 in Adults: A Global Perspective

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