Positive COVID19-PCR patients as negative controls for COVID19 antibody tests

Nasr Alrabadi; Razan Haddad; Ibrahim Al-Faouri; Nail Obeidat; Mohammad Al-Ghazo; Khalid El-Salem; Ziad Elnasser; Nizar Mhaidat

doi:10.1016/j.amsu.2021.102320

Positive COVID19-PCR patients as negative controls for COVID19 antibody tests

Ann Med Surg (Lond). 2021 May:65:102320. doi: 10.1016/j.amsu.2021.102320. Epub 2021 Apr 19.

Authors

Nasr Alrabadi¹, Razan Haddad², Ibrahim Al-Faouri³, Nail Obeidat⁴, Mohammad Al-Ghazo⁵, Khalid El-Salem⁶, Ziad Elnasser⁷, Nizar Mhaidat⁸

Affiliations

¹ Department of Pharmacology, Faculty of Medicine, Jordan University of Science and Technology, Irbid, 22110, Jordan.
² Department of Pharmaceutical Technology, Faculty of Pharmacy, Jordan University of Science and Technology, Irbid, 22110, Jordan.
³ Department of Community and Mental Health Nursing, Faculty of Nursing, Jordan University of Science and Technology, Irbid, 22110, Jordan.
⁴ Department of Obstetrics and Gynecology, Faculty of Medicine, Jordan University of Science and Technology, Irbid, 22110, Jordan.
⁵ Department of Surgery and Urology, Faculty of Medicine, Jordan University of Science and Technology, Irbid, 22110, Jordan.
⁶ Department of Neuroscience, Faculty of Medicine, Jordan University of Science and Technology, Irbid, 22110, Jordan.
⁷ Department of Pathology and Microbiology, Faculty of Medicine, Jordan University of Science and Technology, Irbid, 22110, Jordan.
⁸ Department of Clinical Pharmacy, Faculty of Pharmacy, Jordan University of Science and Technology, Irbid, 22110, Jordan.

Abstract

COVID-19 serological antibody tests are recently needed for a relatively quick, affordable, and valuable assessment of the immunity toward COVID-19 infection. Furthermore, they can help with evaluating the sufficiency of the vaccination process and its longevity. There are limitations in the current approach of choosing the positive and negative control samples for the validation of those tests. Herein, we are proposing the use of blood samples from positive COVID-19 patients, at the beginning of the disease course, as negative control blood samples for the antibody tests. For more precision, both the negative and the positive control samples can be obtained from the same patients where the accuracy of the test will depend on its ability to detect the seroconversion, from negative to positive antibodies detection, within the same patient. Furthermore, when the validation of the test is accompanied by detecting/sequencing the viral genome in those COVID-19 patients, this can also aid in determining the accuracy of the test in detecting the immune response to specific viral variants. The latter notion is needed for the proper management of the COVID-19 crisis, new vaccines' manufacturing, and evaluating the vaccines' efficiencies. Finally, this approach could be requested/formulated by the regulatory agencies as part of the tests' validation and can be "in-house" obtained by health facilities before its clinical use.

Keywords: Antibody; COVID-19; Immunity; Negative control; Positive control; Seroconversion.