FETALtrol
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.
For More information on FETALtrol and FMH detection see FMH
REFERENCES.
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For information on Fetal Hemoglobin Quantitation Kits and /or
reagents currently available from the following vendors use the
links below:
CALTAG
Laboratories
Chemicon
IQ Products
SureTech Laboratories
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