Efficiency of CMV serodiagnosis during pregnancy in daily laboratory routine

• Published in: Journal of virological methods 2023-04, Vol.314, p.114685-114685, Article 114685
• Main Authors: Müller, Jens, Flindt, Juliane, Pollmann, Marc, Saschenbrecker, Sandra, Borchardt-Lohölter, Viola, Warnecke, Jens M.
• Format: Article
• Language: English
• Subjects: Antibodies, Viral; Antibody Affinity; Cytomegalovirus; Cytomegalovirus Infections - diagnosis; Female; glycoprotein B; Humans; Immunoglobulin G; Immunoglobulin M; Infant, Newborn; p52; Pregnancy; Pregnancy Complications, Infectious - diagnosis; Recombinant Proteins; Serologic Tests - methods; serology
• ISSN: 0166-0934; 1879-0984
• DOI: 10.1016/j.jviromet.2023.114685

Maternal acute primary cytomegalovirus (CMV) infection during the first trimester may cause severe long-term sequelae in newborns. For risk assessment, serological screening is routinely performed in pregnant women based on IgM, IgG and avidity tests using whole-virus antigen. A recent study evaluated the diagnostic value of recombinant protein-based ELISAs as second-line tests in pregnancy CMV screening, including anti-p52 IgM and anti-gB IgG as markers defining the early and late phase of infection, respectively. In the present study, these recombinant ELISAs were used as first-line screening tests in daily laboratory routine and compared to lysate-based assays with respect to [i] the number of conclusive results obtained with the initial sample and [ii] the underlying workload. 553 unselected routine serum samples from pregnant women were tested for anti-CMV IgM and IgG antibodies using lysate-based ELISAs and avidity testing. Anti-CMV IgM antibodies against recombinant p52 and anti-CMV IgG antibodies against recombinant glycoprotein B (gB) were also determined by ELISA. All assays were performed and interpreted according to the manufacturer’s instructions. For lysate-based IgM, IgG and avidity testing, 84.6 % of samples yielded conclusive results in a total of 1156 tests, while 15.4 % needed follow-up testing of a consecutive sample. Anti-p52 CMV IgM and anti-gB CMV IgG testing produced conclusive results for 92.8 % of samples in a total of 1026 tests, while 7.2 % samples required follow-up testing. The first-line use of ELISAs measuring anti-p52 CMV IgM and anti-gB CMV IgG antibodies to test for maternal CMV infection increases the number of conclusive results derived from an initial serum sample while requiring a considerably lower number of tests compared to the lysate-based approach. For day-to-day routines in a diagnostic laboratory, this high efficiency of the recombinant testing approach has significant practical relevance. •Screening for maternal CMV infection is important for risk assessment in newborns.•Routine testing is performed using immunoassays based on whole-virus antigens.•Alternatively, serodiagnosis is performed using assays with recombinant antigens.•Recombinant testing requires fewer test on consecutive samples.•The high efficiency of recombinant testing is important for diagnostic laboratories.