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Trillium DIagnostics FETALtrol

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The laboratory determination of the level of fetal cells in maternal circulation remains an important support in the diagnosis and obstetrical management of women with suspected uterine trauma and in the proper dose administration of Rh Immune globulin (RhIg). The Kleihauer-Braun-Betke (KBB) acid elution method was first described in 1957 and is still considered by many to be the standard.

Limitations in its sensitivity and precision have prompted an increased utilization of flow cytometric methods for fetal cell detection in maternal blood samples. Both underestimation and overestimation of fetomaternal hemorrhage (FMH) result in undesirable costs ranging from ineffective anti-D prophylaxis and maternal immunization to unnecessarily higher dosing of RhIg and the related increased expense as well as the increased risks of adverse reactions and disease transmission, respectively. Therefore, it is necessary to reliably and confidently assess FMH.

Clinical and Laboratory Standards Institute (formerly NCCLS) recommends in document H52-A that, “Good laboratory practice requires that controls be run with every batch of patient samples or at least once per day of analysis. Ideal control materials contain the analyte of interest at concentrations that cover the analytical range of the assay or at least reflect the concentrations seen in patient samples. Controls are ideally stabilized whole blood materials that can be used to provide precision monitoring of the analytical method.” FETALtrol is an assayed, stabilized 3-level control set designed to validate and monitor the quality of procedures for the detection of FMH. FETALtrol is compatible as a control for both manual (KBB) and flow cytometric methods. 

Key Benefits

  • FETALtrol is CE marked as an IVD according to ISO13485:2003 and has been cleared by the FDA as a hematologic control (IVD) for fetal red cell detection.
  • Eliminates the need to acquire cord blood and prepare home brew controls, saving time precious to laboratory professionals and reducing exposure to untested potentially infectious material.
  • Assayed values at three levels serve as both a quality measure for the assay method, as well as a reference material for proper gating.
  • FETALtrol is a stabilized blood product that handles like patient blood samples.