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Applying the concept of uncertainty to the sFlt-1/PlGF cut-offs for diagnosis and prognosis of preeclampsia

  • Pacifique Lévy , Safouane Hamdi , Jean Guiboudenche , Marie Clothilde Haguet , Sophie Bailleul and Guillaume Lefèvre EMAIL logo
Published/Copyright: February 23, 2021
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Clinical Chemistry and Laboratory Medicine (CCLM)
From the journal Clinical Chemistry and Laboratory Medicine (CCLM) Volume 59 Issue 4

Abstract

Objectives

Placental growth factor (PlGF) and soluble fms-like tyrosine kinase-1 (sFlt-1) assays and the corresponding ratios (sFlt-1/PlGF) have been proposed to aid in the diagnosis by exclusion and/or prognosis of preeclampsia (PE). A method for evaluating ratio uncertainties (RUs), based on the theory of error propagation, was applied to the sFlt-1/PlGF ratio.

Methods

RUs were calculated using data derived from sFlt-1 and PlGF Internal Quality Control (IQC) results collected from four centers using Elecsys (Roche) or Kryptor (Thermo Fisher) sFlt-1 and PlGF assays. The corresponding ratio uncertainties were defined for each ratio value.

Results

The RUs increased linearly with the sFlt-1/PlGF ratio values. The Elecsys RUs were lower than the Kryptor RUs. Although RUs cannot eliminate differences in ratio values observed among various immunoassays, it can affect interpretation of the sFlt-1/PlGF ratio, especially when results are within the range of predefined PE diagnosis or prognosis cut-offs.

Conclusions

Since RUs are only a function of PlGF and sFlt-1 precision, they can be calculated for each assay from each laboratory to adjust the interpretation of sFlt-1/PlGF ratio results in the context of PE.

Keywords: internal quality control; placental growth factor; preeclampsia; soluble fms-like tyrosine kinase 1; uncertainty
Corresponding author: Guillaume Lefèvre, Hôpital Tenon, Hôpitaux Universitaires Est Parisien, – Biochimie et Hormonologie4 rue de la Chine Paris, 75020, France. Phone: 33 1 56 01 62 49, Fax: 33 1 56 01 10 17, E-mail:

  1. Research funding: None declared.

  2. Author contributions: All authors have accepted responsibility for the entire content of this manuscript and approved its submission.

  3. Competing interests: Authors state no conflict of interest.

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Supplementary Material

The online version of this article offers supplementary material (https://doi.org/10.1515/cclm-2020-0477).

Received: 2020-04-09
Accepted: 2020-10-18
Published Online: 2021-02-23
Published in Print: 2021-03-26

© 2020 Walter de Gruyter GmbH, Berlin/Boston

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https://doi.org/10.1515/cclm-2020-0477
Keywords for this article
internal quality control; placental growth factor; preeclampsia; soluble fms-like tyrosine kinase 1; uncertainty

Articles in the same Issue

  1. Frontmatter
  2. Editorials
  3. Perspectives in developments of mass spectrometry for improving diagnosis and monitoring of multiple myeloma and other plasma cell disorders
  4. Cytokine “storm”, cytokine “breeze”, or both in COVID-19?
  5. Review
  6. Clinical relevance of biological variation of cardiac troponins
  7. General Clinical Chemistry and Laboratory Medicine
  8. Development of novel methods for non-canonical myeloma protein analysis with an innovative adaptation of immunofixation electrophoresis, native top-down mass spectrometry, and middle-down de novo sequencing
  9. Falsely markedly elevated 25-hydroxyvitamin D in patients with monoclonal gammopathies
  10. Development of a pregnancy-specific reference material for thyroid biomarkers, vitamin D, and nutritional trace elements in serum
  11. Applying the concept of uncertainty to the sFlt-1/PlGF cut-offs for diagnosis and prognosis of preeclampsia
  12. Reducing sample rejection in Durban, South Africa
  13. Quality benchmarking of smartphone laboratory medicine applications: comparison of laboratory medicine specialists’ and non-laboratory medicine professionals’ evaluation
  14. Urine soluble CD163 (sCD163) as biomarker in glomerulonephritis: stability, reference interval and diagnostic performance
  15. Measurement of urine albumin by liquid chromatography-isotope dilution tandem mass spectrometry and its application to value assignment of external quality assessment samples and certification of reference materials
  16. Choice of faecal immunochemical test matters: comparison of OC-Sensor and HM-JACKarc, in the assessment of patients at high risk of colorectal cancer
  17. Reference Values and Biological Variations
  18. Reference values of trace elements in blood and/or plasma in adults living in Belgium
  19. Cancer Diagnostics
  20. Clinical performance of calcitonin and procalcitonin Elecsys® immunoassays in patients with medullary thyroid carcinoma
  21. Cardiovascular Diseases
  22. Analytical assessment of ortho clinical diagnostics high-sensitivity cardiac troponin I assay
  23. Evaluation of the 0 h/1 h high-sensitivity cardiac troponin T algorithm in diagnosis of non-ST-segment elevation myocardial infarction (NSTEMI) in Han population
  24. Diabetes
  25. Are hemoglobin A1c point-of-care analyzers fit for purpose? The story continues
  26. Infectious Diseases
  27. Diagnostic and prognostic role of presepsin in patients with cirrhosis and bacterial infection
  28. Hemocytometric characteristics of COVID-19 patients with and without cytokine storm syndrome on the sysmex XN-10 hematology analyzer
  29. Letters to the Editor
  30. Letter in reply to the letter to the editor of Geerts N and Schanhorst V with the title “Roche Troponin T hs-STAT meets all expert opinion analytical laboratory practice recommendations for the use of the differential diagnosis of acute coronary syndrome”
  31. Improving measurement uncertainty of plasma electrolytes: a complex but not impossible task
  32. Truncation limits of patient-based real-time quality control: a new model derived from between-subject biological variations
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  38. Diagnosis of vitamin B12 deficiency: combined indicator of B12-status should be interpreted with caution in the case of renal impairment
  39. Could the UKNEQAS program “Manual Differential Blood Count” be performed by the use of an automated digital morphology analyzer (Sysmex DI-60)? A feasibility study
  40. Low-dose oral methotrexate-induced crystalluria
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