Ultra-Low PSA Quality Control

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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.

The control has been optimised for use with Roche systems but is suitable for use across a variety of other 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)

Troponin T Quality Control

Therapeutic Drug Quality Control

Intended for use with the Roche system, this control is manufactured using only the highest quality material and offers an unrivalled 7-day thawed stability at +2ºC to +8ºC.

Features & Benefits

  • Liquid frozen for enhanced stability
  • Aqueous based material
  • Ultra low levels of Troponin T
  • Stable to expiry date at -18-24ºC storage
  • Thawed stability of 7 days at 2°C – 8°C
DescriptionSize AnalytesCat No
Troponin T Control6 x 3 ml1CQ10450

Analytes

  • Ultra low Troponin T

Ethanol Calibrator/Control Set

Therapeutic Drug Quality Control

Dedicated calibrator and control set designed for the calibration and quality control of the Randox Ethanol assay.

Features & Benefits

  • Liquid ready-to-use
  • Human urine
  • Stable to expiry date when capped and stored at 2oC – 8oC
  • Open vial stability of 28 days at 2oC – 8oC
DescriptionSizeAnalytesCat No
Ethanol Calibrator/Control Set4 x 10ml1DA2703

Analytes

Ethanol


Metabolic Syndrome Array II Quality Control

Therapeutic Drug Quality Control

A multi-analyte quality control with target values and ranges provided for 3 parameters associated with metabolic syndrome.

Features & Benefits

  • Lyophilised for enhanced stability
  • 100% human material
  • Stable to expiry date at 2oC – 8oC
  • Reconstituted stability of 72 hours at 2oC – 8oC and 7 days at -20°C
  • Assayed values available for Randox Biochip systems
DescriptionSizeAnalytesCat No
Metabolic Syndrome Array II Control3 x 3 x 1ml3EV3761
Metabolic Syndrome Array II Calibrator9 x 1 ml3EV3760

Analytes

  • Adiponectin
  • CRP
  • Cystatin C

Reconstituting Lyophilised Controls

What is Lyophilisation?

Lyophilisation or ‘freeze drying’ is the process by which water is removed from a product after it is frozen and placed under a vacuum, allowing the ice to change directly from solid to vapor without passing through a liquid phase. The process consists of three separate processes:

  1. Freezing
  2. Primary Drying (Sublimation)
  3. Secondary Drying (Desorption)

There are many benefits to using a lyophilised control including; improved product shelf-life and enhanced stability of volatile analytes. For example, many lyophilised controls have a shelf life of up to four years from the date of manufacture resulting in a reduction of costly new lot validation studies. Furthermore, lyophilised controls can be aliquoted and refrozen to extend the working stability of the product.

Reconstituting Lyophilised QC Material

The process of reconstitution involves adding a specified volume of distilled water to lyophilised QC material. The water should completely dissolve the lyophilised contents, giving a liquid solution, which is ready for analysis.

Reconstitution is a straightforward process, but requires a high level of precision. Small errors can have serious implications to the reconstituted material:

  • If too much water is pipetted during reconstitution, the material will be heavily diluted and results will be lower than expected
  • If too little water is pipetted during reconstitution, the material will not be sufficiently diluted, and results will be higher than expected
  • If the correct volume of water is pipetted, but a small amount of water gets stuck in the pipette tip due to poor pipetting technique, results will be higher than expected

If a lyophilised control has been reconstituted incorrectly the contents of the vial will be wasted. It is therefore vitally important that controls are reconstituted with care.

Materials and Methods Required

The list of requirements for an accurate and consistent reconstitution technique is not extensive, but each requirement is vital. Labs should have:

  • Calibrated volumetric pipettes
  • Sterile, appropriately sized pipette tips
  • Distilled water, or other reconstitution fluid as specified
  • Technician with good pipetting technique
  • Lyophilised QC stored according to manufacturer’s specifications

How to Reconstitute Lyophilised QC Material

Each different lyophilised control may require slightly different preparation, always refer to the instructions for use before reconstituting control material. The below guide provides a general overview of the reconstitution process, using the Randox Human Assayed Chemistry Premium Plus control (HN1530) as an example

  1. Place the vial of lyophilised QC on a flat surface, carefully remove the lid and the rubber stopper making sure not to spill any material
  2. Using a calibrated pipette and sterilised pipette tip, add exactly 5ml of distilled water directly into the QC vial, ensuring no water is left in the pipette tip, or on the rim/side of the vial
  3. Place the rubber stopper and lid firmly back onto the QC vial, and leave to stand for 30 minutes
  4. After 30 minutes, gently invert the QC vial 10-15 times to ensure the contents is completely dissolved, making sure to avoid the formation of foam. It is important that you DO NOT SHAKE the vial. Alternatively place the vial on a roller for 30 minutes to ensure the contents is thoroughly mixed
  5. Once satisfied all material has been completely dissolved, proceed to use the QC product in accordance with the ‘Control’ section of the individual analyser application
  6. Once finished, refrigerate any unused material. It is good practice to label the vial with the date of reconstitution to prevent the use of material outside of the recommended stability period
  7. Prior to reusing lyophilised material, mix the contents thoroughly by gentle inversion, as highlighted in Step 4

Additional Considerations

It is important to remember that there may be slightly different reconstitution requirements for different QC material. For this reason, it is vital that the instructions provided on the QC Kit Inserts are closely followed.

Reconstituting lyophilised QC can be time-consuming. Therefore, Randox Acusera offer convenient 5ml distilled water serum diluent to assist laboratories with reconstitution of lyophilised controls. These user-friendly pour over vials streamline the reconstitution process and eliminate the risk of pipetting errors.

If you have any further questions regarding lyophilised controls or would like to contact us, please do so by emailing us at acusera@randox.com or use the contact us button provided.


Product Focus: Randox HbA1c

This month’s product spotlight is our new Liquid HbA1c Control. Over the next few weeks, we will be taking a look at some of the QC solutions available from Randox for HbA1c.

Haemoglobin is an oxygen-transporting protein found inside Red Blood Cells (RBC). Glycated Haemoglobin is simply a haemoglobin with a glucose molecule attached. The higher the level of glucose in the blood the more glycated haemoglobin is formed. Red Blood Cells live for around 2-3 months, because of this the HbA1c test is used by clinicians to get an overall picture of average blood sugar levels for the last 2-3 months. For people with diabetes this is important as the higher the HbA1c, the greater the risk of developing diabetes-related complications. It is suggested that an individual’s HbA1c target should be under 48mmol/mol or below 6.5%. By lowering your HbA1c, you help reduce the risk of long-term health problems.

HbA1c is used to monitor patients with diabetes providing an indication of how well the condition is controlled. A measurement of less than 6% of HbA1c in the sample indicates good glucose control and a lower risk of diabetic complications for the majority of diabetics.

Week 1: HbA1C Quality Control

The Randox Acusera HbA1c control is designed for use in the quality control of both HbA1c and Total Haemoglobin assays. Assayed instrument and method specific target values and ranges are provided for all major systems and methods including HPLC. A reconstituted stability of 4 weeks keeps waste to a minimum and helps to reduce costs.

Main Features and Benefits:

Lyophilised for enhanced stability
100% human whole blood
Assayed target values provided for 2 parameters
Convenient bi-level pack containing two clinically significant levels of control
Stable to expiry date at 2°C – 8°C
Reconstituted stability of 4 weeks at 2°C – 8°C

Week 2: Liquid HbA1C Quality Control

The Randox Acusera Liquid HbA1C control is conveniently supplied in a liquid ready-to-use format and is ideally suited to both clinical laboratories and POCT helping to significantly reduce preparation time. With a stability of 30 days, waste and costs are also kept to a minimum.

Main Features and Benefits:

Liquid ready-to-use
Human based whole blood
Convenient bi-level pack covering clinically relevant decision levels
Stable to expiry date at  2°C – 8°C
Open vial stability of 30 days at  2°C – 8°C

Week 3: RIQAS HbA1C Programme

RIQAS is the largest international External Quality Assessment Scheme, with more than 40,000 participants in over 124 countries. World renowned for reducing the number of individual programmes required by even the most demanding laboratories, RIQAS covers 360 parameters across 32 flexible multi-parameter programmes.  Effective consolidation in this way will not only deliver real cost savings but free up storage space and ultimately reduce the time spent preparing multiple samples at each survey.

The RIQAS Glycated Haemoglobin (HbA1c) EQA programme is designed to monitor the performance of HbA1c and Total Haemoglobin assays.

Main Features and Benefits:

Accredited to ISO/IEC 17043 designed to meet ISO 15189 requirements
Lyophilised for enhanced stability
100% whole blood ensuring a matrix similar to the patient sample
Monthly reporting allowing identification of any system errors sooner
Submit results and view reports online via RIQAS.Net
Register up to five instruments at no extra cost


Product Focus: Calibrators

Calibrators

The importance of accurate instrument calibration in the laboratory is often overlooked. At Randox Quality Control we believe that accurate calibration is the foundation for producing reliable patient results. In fact, we believe that this should be your first step in ensuring accurate instrument performance and something you should consider carefully.

Effective instrument calibration will provide you with a baseline for your analysers from which accurate results can be produced. This baseline is then used to adjust readings to match the computed value and ensure accurate patient results are reported.

Calibrator features you should consider;

As well as frequent recalibration, according to the instructions provided by the instrument / reagent manufacturer, Randox Quality Control recommends;

  • Utilising a third party calibrator, such as those available from our Acusera range, which have independently assigned values and have not been optimized for use with any specific instrument or reagent system
  • Ensuring the calibrator you employ has the same matrix as a patient sample
  • Choosing a calibrator that is 100% commutable, ensuring it mimics the behaviour of a patient sample
  • multi-analyte calibrator with a long shelf life

Clinical Chemistry Calibration Serum

Third party calibrator covering 42 commonly used clinical chemistry tests. Method and instrument specific target values and ranges are provided for most chemistry analysers. Two clinically significant levels are available.

Features & Benefits

  • Lyophilised for enhanced stability
  • Human based serum
  • Instrument specific target values provided for 42 parameters
  • Stable to expiry date at 2°C – 8°C
  • Reconstituted stability of 7 days at 2°C – 8°C or 4 weeks at -20°C

Product Spotlight Archive

Don’t forget to visit our Product Spotlight Archive and see spotlights from different months