SARS-CoV-2 immunochromatographic IgM/IgG rapid test in pregnancy: A false friend?
M Fabre, S Ruiz-Martinez, M E Monserrat Cantera, A Cortizo Garrido, Z Beunza Fabra, M Peran, R Benito, P Mateo, C Paules, D Oros
Author Information
M Fabre: Aragon Institute of Health Research (IIS Aragon) Biochemistry Department, Hospital Clínico Universitario Lozano Blesa, Zaragoza, Spain. ORCID
S Ruiz-Martinez: Aragon Institute of Health Research (IIS Aragon), Obstetrics Department, Hospital Clínico Universitario Lozano Blesa, Zaragoza, Spain.
M E Monserrat Cantera: Aragon Institute of Health Research (IIS Aragon), Obstetrics Department, Hospital Clínico Universitario Lozano Blesa, Zaragoza, Spain.
A Cortizo Garrido: Aragon Institute of Health Research (IIS Aragon), Obstetrics Department, Hospital Clínico Universitario Lozano Blesa, Zaragoza, Spain.
Z Beunza Fabra: Aragon Institute of Health Research (IIS Aragon), Obstetrics Department, Hospital Clínico Universitario Lozano Blesa, Zaragoza, Spain.
M Peran: Aragon Institute of Health Research (IIS Aragon) Biochemistry Department, Hospital Clínico Universitario Lozano Blesa, Zaragoza, Spain.
R Benito: Microbiology Department, Hospital Clínico Universitario Lozano Blesa, Zaragoza, Spain. Universidad de Zaragoza. IIS Aragón. CIBERehd.
P Mateo: Aragon Institute of Health Research (IIS Aragon), Obstetrics Department, Hospital Clínico Universitario Lozano Blesa, Zaragoza, Spain.
C Paules: Aragon Institute of Health Research (IIS Aragon), Obstetrics Department, Hospital Clínico Universitario Lozano Blesa, Zaragoza, Spain.
D Oros: Aragon Institute of Health Research (IIS Aragon), Obstetrics Department, Hospital Clínico Universitario Lozano Blesa, Zaragoza, Spain.
BACKGROUND: An increasing body of evidence has revealed that SARS-CoV-2infection in pregnant women could increase the risk of adverse maternal and fetal outcomes. Careful monitoring of pregnancies with COVID-19 and measures to prevent neonatal infection are warranted. Therefore, rapid antibody tests have been suggested as an efficient screening tool during pregnancy. CASES: We analysed the clinical performance during pregnancy of a rapid, lateral-flow immunochromatographic assay for qualitative detection of SARS-CoV-2 IgG/IgM antibodies. We performed a universal screening including 169 patients during their last trimester of pregnancy. We present a series of 14 patients with positive SARS-CoV-2 immunochromatographic assay rapid test result. Immunochromatographic assay results were always confirmed by chemiluminescent microparticle immunoassays for quantitative detection of SARS-CoV-2 IgG and IgM+IgA antibodies as the gold standard. We observed a positive predictive value of 50% and a false positive rate of 50% in pregnant women, involving a significantly lower diagnostic performance than reported in non-pregnant patients. DISCUSSION: Our data suggest that although immunochromatographic assay rapid tests may be a fast and profitable screening tool for SARS-CoV-2infection, they may have a high false positive rate and low positive predictive value in pregnant women. Therefore, immunochromatographic assay for qualitative detection of SARS-CoV-2 IgG/IgM antibodies must be verified by other test in pregnant patients.
