TABLE 1.

Optimization needs and clinical role for SARS-CoV-2 serologic testing^a

Optimization needs:  Standardize quantitative immunoassays to international standard  Identify clinically relevant antibody quantitative value(s)  Standardize immunoassay design to targeted immunoglobulin class and SARS-CoV-2 antigen   Current assays detect IgM, IgG, or total antibodies against NC, RBD, S1, trimeric S, etc.  Confirm immunoassay sensitivity to emerging SARS-CoV-2 VOCs exhibiting significant  mutations in the viral antigen used by the assay Current and possible future clinical role(s):  Support diagnosis of COVID-19 in select patients (Current; [60])  Identification of past infection to support the diagnosis of certain COVID-19 sequelae (Current; [60])   Use anti-NC immunoassays (except among individuals vaccinated with inactivated SARS-CoV-2)  Qualify high-titer COVID-19 convalescent plasma (Current/Future; [62])   Bridge therapy for immune evasive SARS-CoV-2 VOCs resistant to available monoclonal   antibody therapies   Use of anti-S immunoassays with established threshold for ‘high-titer’ CCP  Identify sufficient, postvaccination humoral immune response (Future)   Beneficial in select, immunocompromised patient populations that may benefit from additional   booster(s)

^aNC, nucleocapsid; RBD, receptor binding domain; S1, spike glycoprotein subunit 1; S, spike glycoprotein; VOC, variant of concern.