Identifying and Reducing Pre-analytical Errors in the Medical Laboratory

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Identifying and Reducing Pre-analytical Errors in the Medical Laboratory

 

Medical laboratory professionals must comply with stringent and robust standards in all aspects of their daily activities. The set of standards to which a laboratory must comply will differ depending on the scientific discipline of the laboratory, however, ISO 15189:2022 – Medical Laboratories – Requirements for quality and competence, applies to all medical laboratories. This recent version of the standard introduces increased focus on risk stratification and mitigation for patients and laboratory stakeholders, placing more emphasis on quality control to improve the accuracy and validity of the results obtained.

In a clinical chemistry laboratory, as in others, internal quality control is of upmost importance. Internal quality control (IQC) is the process used to ensure that all results produced are accurate, reliable, and reproducible. To achieve this, a laboratory must carry out checks on the pre-analytical, analytical, and post-analytical phases of testing.

The pre-analytical phase of laboratory testing includes collection, handling, transportation, storage, and preparation of samples. Even when the highest level of care is taken to ensure that all aspects of the pre-analytical phase are suitable and correct, errors can occur, exhibiting the need for clear and efficient quality control processes.

As part of our Acusera quality control range, Randox has developed the Serum Indices quality control to aid in the detection of the common pre-analytical error’s haemolysis, icterus and lipemia, collectively known as HIL. HIL interference can have disastrous effects on the quantification of many analytes, and it is therefore vital to determine levels of interference to improve laboratory efficiency and reduce the frequency of erroneous results. Figure 1 shows a graph of wavelengths at which each of these interferents may affect assays and the table below describes these forms of interference:

 

Interference Description
Haemolysis The degradation of red blood cells causes interference between 340-440nm and 540-580nm. Red blood cells experience membrane disruption due to tangential stress which results in degradation of cellular integrity and the release of interfering cellular components such as haemoglobin, K+ ions  and aspartate aminotransferase. Haemolytic interference may be evident in assays such iron, lipase, albumin, and creatine kinase.
Icterus Interference as a result of high bilirubin concentrations, affecting assays measured between 400-550nm. The high bilirubin levels result in a yellowish pigmentation of the sample, caused by hepatic necrosis, sepsis, or several other conditions.  Most prevalent in neonatal departments, icteric interference can cause inaccuracies in assays for phosphate, creatinine, cholesterol, triglycerides, and uric acid.
Lipemia Interference caused by an aggregation of lipoproteins which affects the turbidity of samples. Lipemic interference can be cause by several mechanisms, the most common being the light scattering effect caused by aggregations of chylomicrons or other large forms of LDL. The larger the LDL molecule, the larger the lipemic effect.  Lipemic interference is evident in assays measured between 300-700nm, however, interference increases as wavelength decreases.

Classical determination of HIL interference took the form of a visual assessment. A sample was examined for tell-tale signs of one or more of these types of interference. However, these methods are subject to operator interpretation and lack harmonisation and uniformity across the industry.  These signs are detailed in the table below and illustrated in figure 2.

Interference Visual indicator
Haemolysis Red discoloration of serum samples which is directly proportional to the concentration of haemoglobin and other interfering erythrocyte components.
Icterus Yellow pigmentation of serum samples increases proportionally to the concentration of conjugated and unconjugated bilirubin.
Lipemia Increased sample turbidity proportional to lipid concentration.

Modern clinical chemistry analysers have onboard HIL detection capabilities which offer objective, semi-qualitative or qualitative analysis of these forms of interference in a more precise and consistent manner. Automation of HIL detection improves laboratory throughput along with test turnaround times and enhances the reportability of the results.

Errors at any stage of the analytical process will result in retesting of the sample. Errors in the pre-analytical phase can have repercussions such as increased cost of repeated sample collection and testing, poor test turnaround times, and more seriously, delayed or incorrect diagnosis causing an exacerbation in the condition of the patient. To add to the adverse outcomes on patients, repeated testing places additional stress on laboratory resources and staff which ultimately affects every aspect of a laboratory’s daily activities.

We hope that by using the Acusera Serum Indices quality control and EQA scheme we can help to improve the accuracy of laboratory testing around the world and remove some of the excessive strain placed on laboratories and the professionals who continually strive for the highest levels of quality in all their work.

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Ultra-Low PSA Quality Control

Therapeutic Drug Quality Control

The Acusera ultra-low PSA control delivers a true third party solution for use in monitoring the performance of in vitro diagnostic assays used in the quantitative determination of low levels of PSA.

This control is suitable for use across a variety of platforms.

Name Unit Target Analyser
Ultra-Low PSA ng/ml 0.055 * Roche Cobas e801

* Example of values for Roche Cobas e801. Other systems may vary dependent on laboratory assignment. Typical values displayed, please see control IFU for lot specific values.

Features & Benefits

  • Impressive 30-day stability at +2°C to +8°C minimising waste
  • Liquid ready-to-use control ensuring minimal sample preparation
  • True third-party control providing an unbiased assessment of performance
  • Manufactured using human based material providing a matrix similar to the patient sample
  • 1 year shelf life from date of manufacture ensuring continuity of lot supply
  • Target values for specific instruments are available

This control is for Research Use Only (RUO)

DescriptionSizeAnalytesCat No
Ultra-Low PSA Control6 x 1ml1TU10523

Analyte

  • Total PSA

BNP Quality Control

Therapeutic Drug Quality Control

The new Acusera BNP Control is designed for use with in vitro diagnostics assays for the quantitative determination of BNP in human serum and plasma. The BNP control delivers an unbiased independent assessment of analytical performance, helping to ensure accurate and reliable patient testing for BNP.

With a 30 day open-vial stability, the BNP control will reduce waste, whilst remaining easy and convenient to use.

This tri-level control is optimised for use on Beckman, Abbott and Siemens analysers however, it can be used across other platforms.  Our control will provide accurate and reliable results that your laboratory can trust.

Features & Benefits

  • 30-day stability at +2°C to +8°C minimising waste.
  • Liquid ready-to-use control ensuring no preparation of material is required and therefore eliminates manual error.
  • True third-party control providing an unbiased assessment of performance.
  • Manufactured using human serum providing a matrix similar to the patient sample.
  • Optimised for use with Abbott, Beckman and Siemens. Also suitable for use with other platforms.
DescriptionPack SizeAnalytesCat. NumberContact Us
BNP Controls (Beckman)3 x 1 x 1 ml1CQ10520
BNP Controls (Abbott)3 x 1 x 1 ml1CQ10521
BNP Controls (Siemens)3 x 1 x 1 ml1CQ10522

Analyte

  • Brain Natriuretic Peptide (BNP)

Anti-Müllerian Hormone (AMH) Quality Control

Therapeutic Drug Quality Control

The Randox Acusera AMH control is designed for use as a third-party control for the quantitative determination of Anti-Müllerian Hormone (AMH). An AMH test is often used to check a woman’s ability to produce eggs that can be fertilized for pregnancy. Thus, helping women to make informed decisions about their health.

Available in a liquid frozen format, this control should be treated in the same manner as a patient sample.

 

Features & Benefits

  • 30-day stability at +2°C to +8°C
  • Liquid Frozen format for convenience and reduced handling errors
  • True third-party control providing an unbiased assessment of performance
  • Manufactured using human serum, ensuring commutable sample matrix
  • Assayed target values provided eliminating the need to assign values in-house
  • Control available at recommended cut-off values for AMH

 

DescriptionPack SizeCat. NumberTypical Values
Beckman DXL / Roche ng/ml
AMH Control 13 x 2mlAMH105090.5
AMH Control 23 x 2mlAMH105141.0
AMH Control 33 x 2mlAMH105156.0
AMH Control 43 x 2mlAMH1051616.0

Analyte

  • Anti-Müllerian Hormone (AMH)

Serum Indices Quality Control

Therapeutic Drug Quality Control

The Randox Acusera Serum Indices control is designed to be used to monitor an IVD instrument’s response in the detection of haemolyzed, icteric and lipemic (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 (+, ++ & +++)

Features & Benefits

  • Lyophilised for enhanced stability
  • Manufactured using human serum, ensuring commutable sample matrix
  • 2-year shelf life from date of manufacture
  • True third party control providing unbiased assessment of performance
  • Reconstituted stability of 14 days at 2°C – 8°C
  • 4 separate levels available including -, +, ++ & +++
DescriptionSizeAnalytesCat No
Serum Indices Control4 x 5 ml3SI10448

Analytes

  • Haemolysis (H)
  • Icterus (I)
  • Lipemia (L)

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