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Evaluation of novel biomarkers for early pregnancy outcome prediction.

Biology of Reproduction 2023 November 28
OBJECTIVE: To assess performance and discriminatory capacity of commercially available enzyme-linked immunosorbent assays (ELISAs) of biomarkers for predicting first trimester pregnancy outcome in a multi-center cohort.

DESIGN: In a case-control study at three academic centers of women with pain and bleeding in early pregnancy, ELISAs of biomarkers were screened for assay performance. Performance was assessed via functional sensitivity, assay reportable range, recovery/linearity, and intra-assay precision (%CV). Top candidates were analyzed for discriminatory capacity for viability and location among 210 women with tubal ectopic pregnancy, viable intrauterine pregnancy or miscarriage. Assay discrimination was assessed by visual plots, area under the curve with 95% Confidence Intervals, and measures of central tendency with two-sample t-tests.

RESULTS: Of 25 biomarkers evaluated, 22 demonstrated good or acceptable assay performance. Transgelin-2, oviductal glycoprotein, and integrin-linked kinase were rejected due to poor performance. The best biomarkers for discrimination of pregnancy location were pregnancy-specific beta-1-glycoprotein 9 (PSG9), pregnancy-specific beta-1-glycoprotein 1 (PSG1), insulin-like growth factor binding protein 1 (IGFBP1), kisspeptin (KISS1), pregnancy-specific beta-1-glycoprotein 3 (PSG3), and beta parvin (PARVB). The best biomarkers for discrimination of pregnancy viability were PSG9, PSG3, EH domain-containing protein 3 (EHD3), KISS1, WAP four-disulfide core domain protein 2 (HE4), quiescin sulfhydryl oxidase 2 (QSOX2), and PSG1.

CONCLUSION: Performance of commercially available ELISAs was acceptable for a panel of novel biomarkers to predict early pregnancy outcome. Of these, six and seven candidates demonstrated good discriminatory capacity of pregnancy location and viability, respectively, when validated in a distinct external population. Four markers demonstrated good discrimination for both location and viability.

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