Role of accredited biochemical reagents in aneuploidy and pre-eclampsia screening

Role of appropriate NT (nuchal translucency) measurement in aneuploidy screening is well established. Deviation of standard deviation and median NT from that expected, reduces the detection rates and hence continuous auditing of NT measurements is essential for quality assurance (Kagan et al. Ultrasound Obstet Gynecol 2009; 33: 657 – 664).

Similarly, it is important that laboratories analysing biochemical markers for aneuploidy and pre-eclampsia screening, also follow the same stringent criteria which was used during the research to develop the algorithm for screening test. It is necessary that when FMF algorithm (software) is used to calculate the risks, the laboratories should:

  • Use FMF accredited reagents (Delfia, Roche or Kryptor)
  • Ensure internal audits and controls
  • Submit their results for auditing to an external agency like UKNEQUAS for quality assurance.

Deviation from expected MoMs will reduce the detection rates for condition being screened and the efficacy of the test.

Everyone who is offering first trimester screening tests should understand the nuances of the tests being offered and ensure strict adherence to the quality of the tests being done. As an obstetrician, one should ensure NT is measured by FMF certified operator who uses the FMF risk calculation software and biochemical tests are done by laboratories fulfilling the above criteria.