Abstract
Background: Patients with hematological malignancies (HM), including multiple myeloma (MM), frequently suffer from immune deficiency-associated infectious complications because of both the disease and the treatment. Alarming results from China and the UK confirm the vulnerability of HM patients to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection-driven coronavirus disease 2019 (COVID-19). Given that the immunoassay interference from the endogenous monoclonal immunoglobulin (M paraprotein) and treatment antibodies continually challenges the MM management, it is critical to evaluate the SARS-CoV-2 serology tests for suspected interference/cross-reactivity. Methods: We compared the degree of interference in three SARS-CoV-2 serology assay platforms in HM patients with and without COVID-19 and on various therapeutic monoclonal antibody (t-mAb) treatments. Further, we confirmed the cross-reactivity in pooled samples from normal and COVID-19 + samples spiked with respective antibodies in vitro. Results: None of the 93 HM patient samples with or without t-MAbs showed cross-reactivity on any of the three serology platforms tested. Conclusions: The tested three serologic assays for SARS-CoV-2 are specific and do not have cross-reactivity with M-components or t-MAbs indicating that they can be used safely in oncology practice and in research exploring the immunologic response to COVID-19 in patients with HM.
Highlights
The impact of COVID-19 infection on patients with cancer remains to be elucidated
A recent study has shown that the combination of rapid serology testing along with nucleic acid testing significantly improves the diagnostic accuracy of COVID-19 infection
Patients were on therapeutic monoclonal antibody (t-mAb) treatments. (b) Flowchart to assess the patients were on therapeutic monoclonal antibody (t-mAb) treatments. (b) Flowchart to assess the degree of interference in three SARS-CoV-2 serology assays due to different therapeutic monoclonal degree of interference in three SARS-CoV-2 serology assays due to different therapeutic monoclonal antibodies in normal and COVID-19 + samples by supplementing/spiking with respective antibodies antibodies in normal and COVID-19 + samples by supplementing/spiking with respective antibodies in vitro
Summary
The impact of COVID-19 infection on patients with cancer remains to be elucidated. Initial reports have shown more severe disease and higher case-fatality rates for patients with cancer [1]. A timely and accurate diagnosis of SARS-CoV-2 infection is critical in patients with MM and other hematologic malignancies. A recent study has shown that the combination of rapid serology testing (immunoassay) along with nucleic acid testing significantly improves the diagnostic accuracy of COVID-19 infection. Numerous constituents present in the biological samples can alter the accuracy of analyte quantification, erroneously elevating or lowering the signal or results This continuous challenge of immunoassay interference can cause the misinterpretation of a patient’s results by the laboratory and major delays in intended therapy for the underlying malignancy. The interference of therapeutic monoclonal antibodies (t-MAb) present in the sera of patients, with HM, on diagnostic tests has been reported [11]. The potential cross-reactivity of M-proteins and t-MAbs on SARS-CoV-2 serology tests has not been studied. The investigation of suspected interference in SARS-CoV-2 serology testing will be crucial to prevent any inconsistencies that may occur between clinical and laboratory findings for proper clinical management of this population
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