Elecsys Anti-SARS-CoV-2

Elecsys Anti-SARS-CoV-2 is an immunoassay that detects total antibodies to SARS-CoV-2 in human serum and plasma samples collected 15 or more days after symptom onset. It uses electrochemiluminescence on the cobas e 601 analyzer to identify individuals with adaptive immune response to SARS-CoV-2, indicating recent or prior infection.

The candidate uses electrochemiluminescence (ECLIA) detection on the cobas e 601 analyzer, while the predicate VITROS assay uses chemiluminescent detection on VITROS systems. Both are double-antigen sandwich immunoassays intended for qualitative detection of total anti-SARS-CoV-2 antibodies in serum and plasma samples collected ≥15 days post-symptom onset, with the same intended clinical use.

CLSI EP05-A3 for precision and reproducibility studies; CLSI EP37 for drug interference testing. The analytical cutoff was established using the First International Standard for anti-SARS-CoV-2 immunoglobulin (human) code 20/136.

Substantial equivalence is based on comparable analytical and clinical performance despite different detection chemistry. Both assays demonstrate similar precision (CV <6%), equivalent matrix compatibility (serum and multiple plasma types), and comparable clinical sensitivity (PPA 98.82% in traditional study; 96.49% in real-world data) and specificity (NPA 99.81%). The predicate assay was included in the composite comparator method for clinical evaluation, and both detect total anti-SARS-CoV-2 antibodies with identical intended use and patient population criteria.