Product Focus: Liquid Bilirubin Control

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Our Clinical Chemistry controls are suitable for a range of integrated analyser systems and methods. To cover all laboratory QC requirements, our flexible Clinical Chemistry Controls contain up to 100 analytes, delivering effective consolidation and cost savings. Available in a choice of assayed/unassayed, liquid/lyophilised and human/bovine formats, options are available to suit all laboratory sizes and budgets.

What is Bilirubin?

Bilirubin is an orange-yellow pigment, a waste product produced by the normal breakdown of haem, which is a component of haemoglobin. The detection of higher than normal levels of Bilirubin in the blood could be an indication that too many red blood cells are being destroyed or a sign of liver damage. Bilirubin tests are therefore carried out to screen for, detect and monitor liver disorders as well as haemolytic anaemia.

Bilirubin is also commonly tested to monitor jaundice in new-born babies. As many as 50% of new-born babies will present with Neonatal Jaundice with the majority of issues resolved within a few days. If Neonatal Jaundice persists for longer periods of time it could however be an indication of abnormal liver metabolism or haemolytic disease. If left untreated high Unconjugated Bilirubin levels could affect the development of brain cells in new-borns. It is therefore extremely important that Bilirubin levels do not get too high, once the concentration is 15 times higher than the normal limits, treatment is used to lower the levels. Treatment includes phototherapy.

Why are high levels of Bilirubin needed for paediatric testing?

Because high levels of Bilirubin are detected in Neonatal hyperbilirubinemia, a Quality Control with elevated levels of Bilirubin is required to ensure accurate test system performance.  In order to provide elevated levels of Bilirubin, the control material must be treated to inhibit oxidation of Bilirubin.  This process means that consolidation of multiple analytes is not an option and often results in dedicated Bilirubin controls.

Introducing the Acusera Liquid Bilirubin Quality Control

Providing a true third party solution for the measurement of Bilirubin, the new Acusera Liquid Bilirubin Control is designed to deliver an unbiased, independent assessment of analytical performance helping to ensure accurate and reliable patient testing for Direct and Total Bilirubin. Supplied liquid ready-to-use with a 30 day open vial stability the Acusera Liquid Bilirubin Control will reduce waste, whilst remaining easy and convenient to use. Two levels are available covering the required clinically relevant decision levels for paediatric testing. This will ensure that clinical chemistry instruments are performing reliably across the measuring range and at key decision levels.

Did you knowISO 15189:2012 states that the laboratory should choose concentrations of control materials wherever possible, especially at or near clinical decision levels, which ensure the validity of decisions made”. 

Features & Benefits

  • Liquid ready-to-use eliminating the need to reconstitute or thaw before use
  • Manufactured from 100% human serum ensuring commutability
  • Assayed, method specific target values provided, eliminating the need to assign values in-house
  • True third party control providing unbiased performance assessment
  • Clinically relevant concentrations
  • Stable to expiry at 2oC to 8oC
  • Open vial stability of 30 days at 2oC to 8oC, reducing waste and costs.

The table below provides an indication of the levels you can expect;

Level 1 (μmol/l)Level 2 (μmol/l)
Direct Bilirubin52.4111
Total Bilirubin104257

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