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Module CC-31 · Version 1.0

Preeclampsia Testing and Emerging Biomarkers

Use routine laboratory evidence and a bounded, assay-specific angiogenic biomarker result to support evaluation of suspected preeclampsia without turning a risk assay into a diagnosis.

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Who this module is for

Advanced medical laboratory scientists and clinical laboratory professionals who support obstetric testing and critical-result communication.

Learning objectives

  • Recognize routine laboratory domains used to assess maternal organ involvement.
  • Explain sFlt-1, PlGF, and ratio concepts at a pathway level.
  • State the assay-specific intended use, gestational range, cutoff, and limitation for the Elecsys sFlt-1/PlGF ratio.

How completion works

Mark every required section done and answer every knowledge check in those sections correctly. The final save completes the module automatically.

Sources

10 sources

  1. 1. American College of Obstetricians and Gynecologists. Gestational Hypertension and Preeclampsia. ACOG Practice Bulletin No. 222. Obstet Gynecol. 2020;135(6):e237-e260.

    Source note · professional society guidance

  2. 2. US FDA. 510(k) Premarket Notification K241453, Elecsys sFlt-1 immunoassay / Elecsys PlGF immunoassay, cleared February 7, 2025. Decision summary.

    Source note · federal regulation

  3. 3. US FDA. De Novo classification request DEN220027, B·R·A·H·M·S sFlt-1/PlGF KRYPTOR, decision May 18, 2023.

    Source note · federal regulation

  4. 4. Roche Diagnostics. Roche Elecsys sFlt-1/PlGF ratio for preeclampsia receives FDA 510(k) clearance. News release, February 13, 2025.

    Source note · manufacturer labeling

  5. 5. Zeisler H, Llurba E, Chantraine F, et al. Predictive Value of the sFlt-1:PlGF Ratio in Women with Suspected Preeclampsia. N Engl J Med. 2016;374(1):13-22.

    Source note · peer-reviewed literature

  6. 6. Levine RJ, Maynard SE, Qian C, et al. Circulating Angiogenic Factors and the Risk of Preeclampsia. N Engl J Med. 2004;350(7):672-683.

    Source note · peer-reviewed literature

  7. 7. Clinical Laboratory Improvement Amendments, 42 CFR Part 493, Subparts H, K, and M.

    Source note · federal regulation

  8. 8. College of American Pathologists. All Common Checklist, COM.30000 Critical Result Notification (Phase II). CAP Accreditation Program, 12.09.2025 edition.

    Source note · accreditation standard

  9. 9. College of American Pathologists. All Common Checklist, COM.30100 Critical Result Read-Back (Phase I). CAP Accreditation Program, 12.09.2025 edition.

    Source note · accreditation standard

  10. 10. Clinical and Laboratory Standards Institute. PRE05-Ed1, Processes for the Collection of Urine Specimens, 1st ed. 2024.

    Source note · consensus standard