DIAGNOSTICS
Generally, if a sample is deemed to be subject to one or more of these types of interference, the laboratory should reject the result and dispose of the sample correctly. However, in some cases, cut-off values can be defined
concentration. In this case laboratories may wish to have a different procedure for handling these results than those which show haemolytic interference at low analyte concentration.
Verification and quality control of HIL indices C56-A states that laboratories should consider verification and quality control of expected performance to assess the following implications:3 n HIL parameters, like all spectrophotometric measurements, are subject to drift and failure.
n Failure to maintain consistent measurements may lead to changes in effective criteria for acceptance/ rejection of specimens.
n Inter-analyser variability can result in inconsistent acceptance/rejection criteria.
To account for these implications, Randox Laboratories has introduced the Serum indices Control and Serum Indices EQA.
Randox Serum Indices control The Randox Acusera Serum Indices (SI) control is designed to be used to monitor an IVD instrument’s response in the detection of haemolysed, icteric and lipaemic (HIL) samples. This control can be utilised in laboratory interference testing to assist in improving error detection of pre-analytical errors affecting clinical chemistry testing. This control provides a full range of clinically relevant testing levels, including a negative (-) and three positives (+, ++ and +++) An existing product supplies only one level for each form of interference and a negative control, covering only a fraction of the range covered by the four-level Randox Control. This competitor product is supplied in a liquid frozen format, increasing delivery costs. The Randox
Haemolysis. Left: without haemolysis - red blood cell (RBC) suspension (0.5% sheep RBCs in saline), seems red and opaque. Middle: without haemolysis – RBCs sedimented spontaneously for 60 min. Note that the supernatant is not coloured. Right: haemolysis – RBC suspension treated with the haemolysin of S. pyogenes at 37°C for 30 minutes, become transparent by haemolysis.
SI control is supplied lyophilised for enhanced shelf life.
RIQAS EQA
The RIQAS Serum Indices EQA programme is designed for the pre- analytical assessment of haemolytic, icteric and lipaemic (HIL) interferences. Available in a bi-monthly format with the option to report either quantitative or semi-quantitative results for the HIL parameters, this programme also provides an assessment on how these interferences impact on up to 25 routine chemistry parameters. This provides invaluable information on whether a correct judgement is being made to report results. n Lyophilised for enhanced stability n Human-based serum ensuring commutable sample matrix
n Bi-monthly reporting n HIL parameters include the option of quantitative or semi-quantitative reporting
n Interpretation of chemistry parameter results
n Submit results and view reports online via
RIQAS.net.
References 1 Farrell CJ, Carter AC. Serum indices:
managing assay interference. Ann Clin Biochem. 2016;53 (Pt 5):527-538. doi:10.1177/0004563216643557
2 Lippi G, Cervellin G, Mattiuzzi C. Critical review and meta-analysis of spurious hemolysis in blood samples collected
WWW.PATHOLOGYINPRACTICE.COM JUNE 2023
from intravenous catheters. Biochem Med (Zagreb). 2013;23(2):193-200. doi:10.11613/bm.2013.022
3 CLSI. Hemolysis, Icterus and Lipaemia/ Turbidity Indices as Indicators of Interference in Clinical Laboratory Analysis; Approved Guideline. Vol 32. CLSI Document C56-A. Clinical and Laboratory Standards Institute; 2012.
4 Tian G, Wu Y, Jin X, et al. The incidence rate and influence factors of hemolysis, lipaemia, icterus in fasting serum biochemistry specimens. PLoS One. 2022;17(1):e0262748. Published 2022 Jan 19. doi:10.1371/journal.pone.0262748
5 Nikolac N. Lipaemia: causes, interference mechanisms, detection and management. Biochem Med (Zagreb). 2014;24(1):57-67. Published 2014 Feb 15. doi:10.11613/ BM.2014.008
Jason Armstrong BSc is a Scientific Content Creator at Randox Laboratories. After achieving his degree in Biochemistry and beginning his career in an R&D laboratory, he made the switch to pursue his passion in scientific communications. Jason has a background in the research and development of immunology, clinical chemistry and food diagnostic assays giving him an insight into the workings of a laboratory and what is required of an efficient and successful medical laboratory.
+44 28 94422413
www.randox.com
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