Spike protein antibody levels1/18/2024 Virological assessment of hospitalized patients with COVID-2019. Guo L, Ren L, Yang S, et al: Profiling early humoral response to diagnose novel coronavirus disease (COVID-19). Okba N, Muller MA, Li W, et al: Severe acute respiratory syndrome coronavirus 2-specific antibody responses in coronavirus disease 2019 patients. Zhang W, Du RH, Li B, et al: Molecular and serologic investigation of 2019-nCoV infected patients: implication of multiple shedding routes. Caution should be used in interpretation of results, and the laboratory should be alerted if the result does not correlate with the clinical presentation.ġ. The presence of antibodies to streptavidin or ruthenium rarely occur and may also interfere with this assay. In rare cases, some individuals can develop antibodies to mouse or other animal antibodies (often referred to as human antimouse antibodies or heterophile antibodies), which may cause interference in some immunoassays. Extremely high concentrations of biotin in patient serum due to heavy administration or supplementation of biotin may falsely depress Anti-SARS-CoV-2 antibody detection. Serum biotin concentrations up to 1200 ng/mL do not interfere with this assay. In rare cases, interference due to extremely high titers of antibodies to analyte-specific antibodies, streptavidin, or ruthenium can occur. It is not known at this time if the presence of antibodies to SARS-CoV-2 confers immunity to re-infection. If an acute infection is suspected, direct testing for SARS-CoV-2 virus is necessary.įalse-positive results for Roche Anti-SARS-CoV-2 IgG test may occur due to cross-reactivity from pre-existing antibodies or other possible causes. Negative results do not preclude SARS-CoV-2 infections. False-positive results for IgG antibodies may occur due to cross-reactivity from pre-existing antibodies or other possible causes.įor the manufacture of COVID-19 convalescent plasma using the Roche Diagnostics anti-SARS-CoV-2 spike electro-chemiluminescence immunoassays, per current US Food and Drug Administration Emergency Use Authorization guidelines, high-titer convalescent plasma is defined as plasma units with a semi-quantitative value of 132 U/mL and above (see appendix A: The sensitivity of Roche Elecsys Anti-SARS-CoV-2 test in early infection is unknown. Serologic results should not be used to diagnose recent SARS-CoV-2 infection. No minimum antibody level or threshold has been established to indicate long-term protective immunity against re-infection. Antibody levels greater than or equal to 0.80 U/mL are considered positive by this assay. These results suggest recent or prior SARS-CoV-2 infection or vaccination. Follow-up testing with a molecular test for SARS-CoV-2 is recommended in symptomatic patients.Īntibodies to the SARS-CoV-2 spike glycoprotein detected. This test does not rule out active or recent COVID-19 infection or vaccination. Negative results may occur in serum collected too soon following infection or vaccination, in immunosuppressed patients, or in patients with mild or asymptomatic infection. No antibodies to SARS-CoV-2 spike glycoprotein detected. Both vaccine and active infection can stimulate antibodies against this domain. This assay provides qualitative and semi-quantitative results for the presence of antibodies to the receptor binding domain on the SARS-CoV-2 spike glycoprotein.
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