Monday, 28 November 2011

FETALtrol: Assayed whole blood controls for confident foetal cell detection in maternal circulation


Laboratory determination of the level of foetal 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).

FETALtrol is an assayed, stabilized 3-level control set designed to validate and monitor the quality of procedures for the detection of Foeto-maternal haemorrhaging. It is compatible as a control for both manual (KBB) and flow cytometric methods.

“Good laboratory practice requires that controls be run with every batch of patient samples or at least once per day of analysis....Controls are ideally stabilized whole blood materials that can be used to provide precision monitoring of the analytical method.”

Clinical and Laboratory Standards Institute (formerly NCCLS) recommendations from document H52-A.

Key Benefits of FETALtrol:

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

Complimentary sample kits available - limited number. Email: sarah@caltagmedsystems.co.uk to request a kit.

Product Code: FH102 - FETALtrol Sample Kit Pack Size: 25; Complimentary, conditions apply*

Product Code: IQP-370 FT – FETALtrol Pack Size: 50 test kit; £205

Download FETALtrol product information sheet

FETALtrol Production Schedule available on request, please email office@caltagmedsystems.co.uk

*One complimentary kit per department. Limited stock available.

FETALtrol is an in vitro diagnostic reagent composed of D-antigen (Rho) negative human adult erythrocytes, supplemented with D-antigen (Rho) positive human cord blood erythrocytes.

Level 1 (N) - Normal or Negative

Level 2 (L) - Low Positive

Level 3 (H) - High Positive

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