QC Shelf Life – Why is it Important?

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QC Shelf Life – Why is it Important?

An important consideration when choosing your Quality Control material that is often overlooked is the shelf life of the control. With every new lot of control extensive validation studies must be performed. Regulatory bodies such as CLIA require new lot numbers to be evaluated before routine use in the laboratory. For example, CLIA has instructed that any new control lot to be run alongside patient samples will need to be verified alongside the old lot of control. The process is designed to give laboratory professionals confidence in the new material and ensure it is fit for purpose before implementing it in the lab.

As part of the validation process laboratories are required to assay both the old and new lots side by side. The current lot is then used to help verify if the new lot will be acceptable to run within the lab. Such validation studies can be very costly for a lab as well as being extremely time consuming – with some studies taking up to a month to complete! By choosing a control with a longer shelf life laboratories can aim to use the same lot of control for a longer time period. Ultimately this means fewer lot changes and minimal inconvenience for the lab. With a shelf life of 2 years for liquid controls and up to 4 years for lyophilised, coupled with unrivalled stability claims, employing Randox Quality Control in your laboratory will ensure that expensive lot changes will be a thing of the past. Our comprehensive control offering is guaranteed to increase efficiency and reduce costs in any laboratory without compromising on quality.

Contact us today to find out more information on our Acusera range of Quality Controls.


Liquid Controls vs Lyophilised Controls

Results of our Liquid vs Lyophilised Poll

Having conducted a recent poll on our Social Media platforms (Facebook, LinkedIn & Twitter) asking our customers what format they preferred their quality control material in – liquid or lyophilised – we saw a large preference for liquid controls.

What does this poll result really tell us?

That most people prefer Liquid controls? Yes.

Lyophilised controls are not as popular amongst our social following? Yes.

However, it also tells us that even though most people chose a liquid format there was still almost a quarter of people who prefer to use lyophilised controls. Liquid and lyophilised controls both have their advantages and disadvantages, this blog is designed to help you decide which is the best fit for your lab.

Liquid Controls

Firstly, it is important to note that there are two distinct types of liquid control available on the market;Liquid ready-to-use and Liquid for ease-of-use, better known as Liquid Frozen. Both types of liquid controls reduce the potential for reconstitution errors and prevent contamination from poor quality water.

Liquid frozen controls must be thawed in a refrigerator before use, making them a little less convenient than the liquid ready-to-use alternative. They require no reconstitution so associated errors are removed. Due to the frozen nature of these controls, they are often shipped on dry ice to prevent thawing in transit, as such transportation costs can be significant.

Liquid ready-to-use controls are arguably the most favoured of the three formats and it is easy to understand why. The controls are simple to use, they require no preparation and there is no need to thaw before use.– With zero preparation required, these controls can be removed from the packaging and used right away! What’s more, they can be conveniently stored at 2-8oC minimising expensive shipping costs.

Another major benefit of using a liquid ready-to-use control is the fact that they are ideal for POCT (Point of Care Testing). The ability to use these controls on the spot is extremely beneficial to POC providers.

Lyophilised Controls

Lastly, the choice of 22% of respondents – lyophilised. This is freeze dried material which requires the laboratory professional to reconstitute the sample using sterilised water and mixing before use. Although this format is not as easy to use as either liquid control it does come with benefits. The enhanced stability of this control sees a shelf life of almost double the two years that is normal with a liquid control, however, the potential for reconstitution errors and the fact it is not as simple to use lead to the majority of people opting for a more convenient liquid control.

Randox Quality Control Range

With Randox QC there are a vast array of controls available in liquid ready-to-use and liquid frozen formats. Areas we have liquid frozen formats available in, include; Clinical Chemistry and Immunoassay.

Liquid ready-to-use controls can be found in the following; Liquid Cardiac, Blood Gas, Liquid Urine, Urinalysis, Specific Protein, Ammonia Ethanol, Haematology, Liquid HbA1c and Liquid Tumour Markers.

Lyophilised controls available with Randox QC can be found within; Chemistry, Immunoassay, Cardiac, Coagulation, HbA1c, Lipids and Therapeutic Drug Monitoring.

To register an interest in any of our controls simply contact us at acusera@Randox.com and let us know how we can help and support you or alternatively click here – where you will be redirected to our contact page.


Evidence Immunoassay Control

Therapeutic Drug Quality Control

Multi-analyte immunoassay control designed for use in the routine monitoring of the Randox Fertility, Thyroid and Tumour Marker Arrays.

Features & Benefits

  • Lyophilised for enhanced stability
  • Assayed values available for Randox Biochip systems
  • 100% human serum
  • Stable to expiry date at 2oC – 8oC
  • Reconstituted stability of 7 days at 2oC – 8oC or 4 weeks at -20oC
DescriptionSizeAnalytesCat No
Evidence Immunoassay Control 4 x 3 x 5ml14EV3570

Analytes

  • CEA
  • Estradiol
  • FSH
  • Free T4
  • Free T3
  • Leutinising Hormone
  • Prolactin
  • Progesterone
  • PSA (Total)
  • PSA (Free)
  • Testosterone
  • Total T4
  • Total T3
  • TSH

Cardiac Array Quality Control

Therapeutic Drug Quality Control

Multi-analyte cardiac control designed for use in the routine monitoring of accuracy and precision on clinical chemistry and immunoassay systems. This is the only control of its type to include the novel marker heart type fatty acid binding protein (H-FAP). Three levels of control are supplied spanning the complete clinical range.

Features & Benefits

  • Lyophilised for enhanced stability
  • Assayed values available for Randox Biochip systems
  • 100% human serum
  • Stable to expiry at 2oC – 8oC
  • Reconstituted stability of 16 hours at 2oC – 8oC or 7 weeks at -80oC
DescriptionSizeAnalytesCat No
Cardiac Array Control3 x 3 x 1ml4 EV3691

Analytes

  • Heart-type acid binding protein (H-FABP)
  • Myoglobin (MYO)
  • Troponin I (cTnI)
  • Creatine-Kinase Muscle Brain (CK-MB)

Not for sale in the USA


CYFRA 21-1 External Quality Assessment

The RIQAS CYFRA 21-1 EQA programme is designed to cover the analysis of CYFRA 21-1 in clinical laboratories when monitoring the response to treatment of cancers such as non-small cell lung carcinoma, cervical, breast and bladder cancer.

  • Lyophilised samples
  • Monthly reporting
  • Testing covers the full range of clinically relevant decision levels
  • Submit results and view reports online via RIQAS.net
  • 12 month subscription

Not accredited to ISO/IEC 17043

Cat NoKit SizeFrequencyCycle StartParameters
RQ917512 x 1mlMonthlyMarch1

Parameter

  • CYFRA 21-1 (Cytokeratin 19)

Please note, product availability may vary country to country.


Anti-TSH Receptor External Quality Assessment

The RIQAS Anti-TSH Receptor EQA programme is designed to cover the analysis of Anti-TSH Receptor in clinical laboratories when thyroid dysfunction is suspected.

  • Lyophilised samples
  • Monthly reporting
  • Testing covers the full range of clinically relevant decision levels
  • Submit results and view reports online via RIQAS.net
  • 12 month subscription

Not accredited to ISO/IEC 17043

Cat NoKit SizeFrequencyCycle StartParameters
RQ917412 x 1mlMonthlyMarch1

Parameter

  • Anti-TSH Receptor (TRAb)

Please note, product availability may vary country to country.


Immunosuppressant External Quality Assessment

The RIQAS Immunosuppressant EQA programme has been designed to cover the analysis of Immunosuppressants in clinical laboratories. Immunosuppressants are primarily used after transplant operations to prevent the host body from rejecting donor organs.

  • Lyophilised samples
  • Monthly reporting
  • Testing covers the full range of clinically relevant decision levels
  • Submit results and view reports online via RIQAS.net
  • 12 month subscription
  • LC/MS reference values provided enabling participants to compare results to an accurately assigned value

Not accredited to ISO/IEC 17043

Cat NoKit SizeFrequencyCycle StartParameters
RQ915912 x 2mlMonthlyMarch4

Parameters

  • Cyclosporin
  • Everolimus
  • Sirolimus
  • Tacrolimus

Please note, product availability may vary country to country.


Lipid Control Calibrators

Therapeutic Drug Quality Control

Apolipoprotein Calibrator

Multi-analyte, apolipoprotein calibrator with values provided for Apolipoprotein A-1 and Apolipoprotein B.

Features & Benefits

  • Lyophilised for enhanced stability
  • 100% human serum
  • Stable to expiry date at 2°C – 8°C
  • Reconstituted stability of up to 7 days at 2°C – 8°C
DescriptionSizeAnalytesCat No
Apolipoprotein Calibrator3 x 1ml2LP3023

Analytes

  • Apo A-1
  • Apo B

Apolipoprotein Calibrator 2

Multi-analyte calibrator covering four specialised apolipoprotein assays. A reconstituted stability of up to 28 days helps to keep waste and costs to a minimum.

Features & Benefits

  • Lyophilised for enhanced stability
  • 100% human serum
  • Stable to expiry date at 2°C – 8°C
  • Reconstituted stability of up to 8 hours at 2°C – 8°C and one month at -20°C when frozen once
DescriptionSizeAnalytesCat No
Apolipoprotein Calibrator 23 x 1ml4LP5047

Analytes

  • Apolipoprotein A-II
  • Apolipoprotein C-III
  • Apolipoprotein C-II
  • Apolipoprotein E

Lipoprotein (a) Calibrator

Dedicated Lipoprotein (a) calibrator specifically designed for use with the Randox Lipoprotein (a) assay.

Features & Benefits

  • Lyophilised for enhanced stability
  • 100% human serum
  • Stable to expiry date at 2°C – 8°C
  • Reconstituted stability of up to 14 days at 2°C – 8°C
DescriptionSizeAnalytesCat No
Lipoprotein (a) Calibrator5 x 1ml1LP3404

Analytes

  • Lipoprotein (a)

Direct HDL/LDL Cholesterol Calibrator

Dedicated HDL and LDL cholesterol calibrator specifically designed for use with direct methods of measurement.

Features & Benefits

  • Lyophilised for enhanced stability
  • 100% human serum
  • Stable to expiry date at 2°C – 8°C
  • Reconstituted stability of up to 5 days at 2°C – 8°C and 1 month at -20°C
DescriptionSizeAnalytesCat No
HDL/LDL Cholesterol Calibrator3 x 1ml2CH2673

Analytes

  • HDL Cholesterol
  • LDL Cholesterol

sdLDL Cholesterol Calibrator

Dedicated sdLDL Cholesterol calibrator designed for use with the Randox sdLDL Cholesterol assay.

Features & Benefits

  • Lyophilised for enhanced stability
  • 100% human serum
  • Stable to expiry date at 2°C – 8°C
  • Reconstituted stability of up to 5 days at 2°C – 8°C
DescriptionSizeAnalytesCat No
sdLDL Cholesterol Calibrator3 x 1ml1CH5050

Analytes

  • sdLDL Cholesterol

Therapeutic Drugs Control Calibrator

Therapeutic Drug Quality Control

Therapeutic Drug Calibrator

Multi-analyte calibrator set covering 5 different therapeutic drugs. Six levels are available with a reconstituted stability of 4 weeks helping to keep waste to a minimum.

Features & Benefits

  • Lyophilised for enhanced stability
  • 100% human serum
  • Stable to expiry date at 2°C – 8°C
  • Reconstituted stability of 4 weeks at 2°C – 8°C or 8 weeks at -20°C
DescriptionSizeAnalytesCat No
Therapeutic Drug Calibrator Series6 x 3ml5TD3417

Analytes

  • Carbamazepine
  • Digoxin
  • Phenobarbital
  • Phenytoin

 

  • Valproic Acid

Diabetes Control Calibrator

Therapeutic Drug Quality Control

Fructosamine Calibrator

Dedicated Fructosamine calibrator specifically designed for use with the Randox Fructosamine assay.

Features & Benefits

  • Lyophilised for enhanced stability
  • Human based serum
  • Stable to expiry date at 2°C – 8°C
  • Reconstituted stability of 4 weeks at 2°C – 8°C
DescriptionSizeAnalytesCat No
Fructosamine Calibrator3 x 1ml1FR2993

Analytes

  • Fructosamine

HbA1c Calibrator

A human based whole blood calibrator designed for use in the routine calibration of the HbA1c assay.

Features & Benefits

  • Liquid ready-to-use
  • 100% human whole blood
  • Treated in the same manner as a patient sample
  • Once opened stable to expiry date at 2°C – 8°C
DescriptionSizeAnalytesCat No
HbA1c Calibrator Series5 x 2ml
1 x 8ml
1HA3444

Analytes

  • HbA1c

HbA1c II Calibrator

A human whole blood calibrator designed for use in the routine calibration of the HbA1c II assay.

Features & Benefits

  • Supplied in a lyophilised format
  • 100% human whole blood
  • Treated in the same manner as a patient sample
  • Once opened the calibrator is stable for 14 days at +2°C to +8°C
DescriptionSizeAnalytesCat No
HbA1c II Calibrator Series5 x 0.5mL1HA8124

Analytes

  • HbA1c II