Key result
Architect rubella IgM, CMV IgM, and anti-HCV assays demonstrated cross-reactivity with sera reactive to other infectious antibodies, with CMV IgM showing suspicious cross-reactivity in up to 9.6% of samples.
Why the study?
Current infections are frequently diagnosed based on positive IgM results, but false positivity can occur, prompting an evaluation of cross-reactivity among infectious antibody assays.
Cross-Sectional (n=167)
Infectious antibody assays, particularly for CMV and rubella IgM, can exhibit significant cross-reactivity with other pre-existing antibodies, highlighting the need for careful clinical interpretation.
Clinicians should interpret Architect CMV/rubella IgM results cautiously; cross-sectional data leave open assay specificity questions for prospective validation.
Background: Current infections are frequently diagnosed based on positive immunoglobulin (Ig) M results, although false positivity can occur. We evaluated cross-reactivity among infectious antibody (Ab) assays. Methods: A total of 167 positive sera were collected for: rubella IgM and IgG, cytomegalovirus (CMV) IgM and IgG, Toxoplasma gondii (Toxo) IgG, human immunodeficiency virus (HIV) antigen (Ag)/Ab, hepatitis A virus (HAV) IgM and IgG, hepatitis C virus (HCV) Ab, herpes simplex virus (HSV) IgM and IgG, Epstein-Barr virus viral capsid Ag IgM, hepatitis B core (HBc) IgM, hepatitis B e Ab, and severe acute respiratory syndrome coronavirus 2 total Ab, Treponema pallidum IgM (each n=10) and Toxo IgM (n=7). All sera were tested with seven assays in duplicate: Architect rubella IgM, CMV IgM, Toxo IgM, HIV Ag/Ab, HAV IgM, anti-HCV (Abbott Laboratories, USA), and Elecsys HBc IgM (Roche Diagnostics GmbH, Germany). Additionally, sera showing repeatedly reactive were evaluated by following supplemental testing: Elecsys Toxo IgM, HIV Duo and HAV IgM, VIDAS rubella IgM and CMV IgM (bioMrieux SA, France); LIAISON XL CMV IgM (DiaSorin S.p.A., Italy); and HCV blot 3.0 (MP Diagnostics Inc., Philippines). Results: Except Elecsys HBc IgM, six assays showed reactive for several sera, including other infectious Abs. Upon supplemental testing, Architect rubella IgM, CMV IgM, and anti-HCV showed reactive or gray zone for two sera with HSV IgM (=0.903), eight to fifteen with various Abs (=0.607-0.814), and one with HAV IgG (=0.960), respectively. Conclusions: Architect rubella IgM, CMV IgM, and anti-HCV showed crossreactivity with reactive sera to other infectious Abs. Considering crossreactivity of Ab assays with other pre-existing infectious Abs, infectious Ab results should be carefully interpreted.
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Gong et al. (2022) conducted a cross-sectional in Infectious diseases (antibody assay cross-reactivity) (n=167). Disease-specific antibody assays vs. Supplemental testing was evaluated on Cross-reactivity with other infectious antibodies. Architect rubella IgM, CMV IgM, and anti-HCV assays demonstrated cross-reactivity with sera reactive to other infectious antibodies, with CMV IgM showing suspicious cross-reactivity in up to 9.6% of samples.
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