Liquid ready-to-use controls & their benefits

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Liquid ready-to-use controls & their benefits

Randox Quality Control is a world leading manufacturer of third party quality controls. With an extensive product portfolio – including the largest range of liquid ready-to-use controls, Randox QC will meet your laboratory requirements and deliver trustworthy results repeatedly.

What control formats are available for your laboratory?

There are three distinct formats available for use in the laboratory with each format having benefits and drawbacks. When choosing a Quality Control material it is important you choose the most convenient solution for your laboratory requirements. The three formats are;

  1. Lyophilised (freeze dried)
  2. Liquid frozen
  3. Liquid stable (ready-to-use)

What format is best?

There are several possible answers to this question, simply because, every laboratory is different. What works for one laboratory may not work for another and for this reason there is no one format that works best for all laboratories.

What we can say however, is that there are varying levels of convenience across the different formats. The most convenient, and arguably, the most favoured of the three formats is liquid ready-to-use. It is not difficult to understand why this format is widely regarded as the preferred choice of control in laboratories – they are simple to use, require no preparation and can be conveniently stored and shipped at 2-8oC.

Why should you consider a liquid ready-to-use control?

There are many benefits to using a liquid ready-to-use control over both liquid frozen and lyophilised controls. One of the main benefits of a liquid stable control material is that it eliminates any potential reconstitution/pipetting errors often associated with lyophilised controls.  They also eliminate the additional time taken to thaw liquid frozen controls and can significantly reduce shipping/delivery costs as they do not need to be shipped on dry ice.

Another major benefit of running a liquid ready-to-use control is the fact they are also suitable for use in Point-of-Care-Testing (POCT). With growing popularity amongst laboratory professionals and more people expecting rapid results, POCT is on the rise. Due to their easy to use nature, liquid ready-to-use controls are extremely beneficial to POCT providers.

One further benefit to using a liquid ready-to-use control is the longer open vial stability when compared to both lyophilised and liquid frozen controls. With many lyophilised and liquid frozen controls, the open vial stability can vary and generally is around 7 days when fully thawed or reconstituted in comparison to 28 days with a liquid ready-to-use control.

Randox Quality Control – Liquid Ready-to-Use Control Portfolio

The Randox QC portfolio – better known as Acusera – is convenient, hassle-free and cost effective. Our liquid ready-to-use control range includes; Liquid Cardiac, Blood Gas, Liquid Urine, Urinalysis, Specific Protein, Ammonia Ethanol, Haematology, Liquid HbA1c, Liquid CSF & Liquid Tumour Markers.

For further information on Randox Quality Control or our range of liquid ready-to-use controls please email us at acusera@randox.com.

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Randox QC Liquid ready-to-use controls


Acusera Internal Quality Control Analyte List

Quality Control is our passion; we believe in producing high quality material that can help streamline procedures, whilst saving time and money for laboratories of all sizes and budgets. With an extensive product offering comprising third party controls and calibrators, interlaboratory data management, external quality assessment, and calibration verification, you can count on Randox to deliver trustworthy results time and time again. Just ask one of our 60,000 users worldwide.

Our Acusera Internal Quality Control A – Z analyte list highlights how comprehensive our Acusera product portfolio is. Search through the list to see if we have the analyte you require.

Acusera Parameter List

#

5-HIAA
7-amino flunitrazepam
11 dhTXB₂
17-OH-progesterone
17β Clostebol
1-25-(OH₂)-Vitamin D
25-OH-Vitamin D

A

α-1-Acid Glycoprotein
α-1-Antitrypsin
α-1-Globulin (Electrophoresis)
α-2-Globulin (Electrophoresis)
α-2-Macroglobulin
α-Fetoprotein (AFP)
α-HBDH
Acetaminophen
Acid Phosphatase (Non-Prostatic)
Acid Phosphatase (Prostatic)
Acid Phosphatase (Total)
ACTH
Activated Partial Thromboplastin Time (APTT)
Adiponectin
AHD
Albumin
Albumin (Electrophoresis)
Aldolase
Aldosterone
Alkaline Phosphatase (ALP)
ALT (GPT)
Amikacin
Ammonia
AMOZ
Amphetamine
Amylase
Amylase (Pancreatic)
Androstenedione

Anti-Streptolysin (ASO)
Anti-Thyroglobulin (Anti-TG)
Anti-Thyroperoxidase (Anti-TPO)
Anti-Thrombin III (AT III)
AOZ
Apolipoprotein A-I
Apolipoprotein A-II
Apolipoprotein B
Apolipoprotein C-II
Apolipoprotein C-III
Apolipoprotein E
AST (GOT)

B

β-Globulin (Electrophoresis)
β-2-Microglobulin
β-Agonists (Clenbuterol)
Barbiturates
BASO-X
BASO-Y
Basophils (BASO)
Basophils % (% BASO)
Bath Salts 1
Bath Salts 2
Benzodiazepines 1 + 2
Benzoylecgonine (Cocaine)
Benzylpiperazines
Bicarbonate
Bile Acids
Bilirubin (Direct)
Bilirubin (Total)
Blood
BNP
Boldenone
Brain Derived Neurotropic Factor (BDNF)
Buprenorphine

C

C-Peptide
CA 15-3
CA 19-9
CA 27-29
CA 72-4
CA 125
Caffeine
Calcitonin
Calcium
Cannabinoids
Carbamazepine
CEA
Ceftiofur
Ceruloplasmin
Chloral Hydrate Metabolite
Chloramphenicol
Chloride
Cholesterol (HDL)
Cholesterol (LDL)
Cholesterol (Total)
Cholinesterase
CK-MB
CK (Total)
Complement C3
Complement C4
Copper
Corticosteroids
Cortisol
CRP
Creatinine
Cyclosporine
CYFRA 21
Cystatin C

D

D-3-Hydroxybutyrate
D-dimer
Dextromethorphan
DHEA-Sulphate

DIFF-X
DIFF-Y
Digoxin
Dopamine

E

E-Selectin (E-SEL)
EDDP
Eosinophils (EOS)
% Eosinophils (% EOS)
Epidermal Growth Factor (EGF)
Epinephrine
Escitalopram
Estriol
Ethanol
Ethinylestradiol
Ethosuximide
Ethyl Glucuronide

F

Factor II
Factor V
Factor VII
Factor VIII
Factor IX
Factor X
Factor XI
Factor XII
Fatty Acid Binding Protein (FABP)
Fentanyl
Ferritin
Fibrinogen
Fluoxetine
Folate
Fructosamine
FSC-X
FSH

G

G-6-PDH
γ-Globulin (Electrophoresis)
γGT
Gastrin
Gentamicin
Gestagens (Generic)
GLDH
Glial Fibrillary Acidic Protein (GFAP)
Glucose
Glutamate
Glutamine
Glutathione Peroxidase (Ransel)
Glutathione Reductase
Glycerol
GM-CSF
Growth Hormone (GH)

H

H-FABP
Haematocrit (HCT)
Haemoglobin (HGB)
Haemoglobin A2 (HbA2)
Haemoglobin F (HbF)
Haemoglobin S (HbS)
Haemoglobin (Total)
Haemopioetic Progenitor Cell (HPC)
Haloperidol
Haptoglobin
HbA1c
hCG
Free β-hCG
Total β-hCG
Homocysteine
hsCRP

I

Ibuprofen

IMIDC
IMIRF
Immature Granulocytes (IG)
% Immature Granulocytes (% IG)
Immature Myeloid Information (IMI)
Immature Platelet Fraction (IPF)
Immunoglobulin A (IgA)
High Sensitivity Immunoglobulin A (hsIgA)
Immunoglobulin E (IgE)
Immunoglobulin G (IgG)
High Sensitivity Immunoglobulin G (hsIgG)
Immunoglobulin M (IgM)
High Sensitivity Immunoglobulin M (hsIgM)
Inhibin A
Insulin
Insulin Like Growth Factor-1 (IGF-I)
Intercellular Adhesion Molecule-I (ICAM-I)
Interferon-γ (IFN-γ)
Interleukin-Ia (IL-la)
Interleukin-1β (IL-1β)
Interleukin-2 (IL-2)
Interleukin-4 (IL-4)
Interleukin-5 (IL-5)
Interleukin-6 (IL-6)
Interleukin-8 (IL-8)
Interleukin-10 (IL-10)
Interleukin-15 (IL-15)
Iron
Iron (TIBC)
Iron (UIBC)

K

Kappa Light Chain
Kappa Light Chain (Free)
Ketamine Metabolite
Ketones

L

L-Selectin (L-SEL)
Lactate
Lactate Dehydrogenase (LDH)
Lambda Light Chain
Lambda Light Chain (Free)
LAP
Leptin
Leukocytes
Lipase
Lipoprotein (a)
Lithium
Luteinising Hormone (LH)
Lymphocytes (LYMPH)
% Lymphocytes (% LYMPH)
Lysergic Acid Diethylamide (LSD)

M

Magnesium
Matrix Metalloproteinase-9 (MMP-9)
Mean Corpuscular Haemoglobin (MCH)
Mean Corpuscular Haemoglobin
Concentration (MCHC)
Mean Corpuscular Volume (MCV)
Mean Platelet Volume (MPV)
Meprobamate
Meperidine
Mescaline
Metanephrine
Methadone
Methandriol
Methamphetamine
Methaqualone
Methotrexate
Methylphenidate

Methyltestosterone
MDMA
Microalbumin
Macrophage Inflammatory Protein-1α (MIP-1α)
Monocytes (MONO)
Monocytes % (% MONO)
Monocyte Chemoattractant Protein-1 (MCP-1)
Morphine (Opiates)
Myoglobin

N

Nandrolone
NEFA
Neuron-Specific Enolase (NSE)
Neutrophils (NEUT)
Neutrophils % (% NEUT)
Neutrophil Gelatinase-associated Lipocalin (NGAL)
Nitrite
Norepinephrine
Normetanephrine
NT-proBNP
Nucleated Red Blood Cells (NRBC)
Nucleated Red Blood Cells % (% NRBC)
Nucleated Red Blood Cells X (NRBC-X)
Nucleated Red Blood Cells Y (NRBC-Y)

O

Oestradiol
Opiates
Osmolality
Osteocalcin
Oxalate
Oxazepam
Oxycodone (I+II)

P

P-Selectin (P-SEL)
Paracetamol
PAPP-A
pCO₂
pH
Phencyclidine
Phenobarbital
Phenylpiperazines
Phenytoin
Phosphate (Inorganic)
Plasminogen
Plasminogen Activator Inhibitor
Platelet Distribution Width (PDW)
Platelet Large Cell Ratio (P-LCR)
Plateletcrit (PCT)
Platelet (PLT)
Platelet Optical Count (PLT-O)
pO₂
Potassium
Prealbumin
Primidone
Procalcitonin
Progesterone
Prolactin
Propoxyphene
Protein C
Protein S
Protein (Total)
Prothrombin Time (PT)
PSA (Total)
PSA (Free)
PTH (Intact)

Q

Quinolones (Generic)

R

Ractopamine
Red Blood Cells (RBC)
Red Blood Cells Optical Count (RBC-O)
Red Blood Cell X (RBC-X)
Red Blood Cell Y (RBC-Y)
Red Blood Cell Distribution Width CV
(RDW-CV)
Red Blood Cell Distribution Width SD (RDW-SD)
Renin
Resistin
Retinol Binding Protein (RBP)
Rheumatoid Factor (RF)

S

Salicylate
Salicyluric Acid
Salvinorin
Secobarbital
Semicarbazine (SEM)
Sertraline
Sex Hormone Binding Globulin (SHBG)
sLDL
Sodium
Soluble IL-2 Receptor α (sIL-2Rα)
Soluble IL-6 Receptor (sIL-6R)
Soluble Tumour Necrosis Factor Receptor 1 (sTNFR I)
Soluble Tumour Necrosis Factor Receptor 11 (sTNFR I1)
Specific Gravity
Stanozolol
Stilbenes
Streptomycin
Superoxide Dismutase (Ransod)
Synthetic Cannabinoids (1 to 4)

T

T Uptake
T3 (Free)
T4 (Free)
T3 (Total)
T4 (Total)
Testosterone
Testosterone (Free)
Tetracyclines (Generic)
Theophylline
Thiamphenicol
Thrombin Time (TT)
Thrombomodulin (TM)
Thyroglobulin
Tobramycin
Total Antioxidant Status (TAS)
Tramadol
Transferrin
Trazadone
Trenbolone
Tricyclic Antidepressants
Triglycerides
Trimethoprim
Troponin I
Troponin T
TSH
Tumour Necrosis Factor α (TNFα)
Tylosin

U

Unconjugated Estriol
Urea
Uric Acid (Urate)
Urobilinogen

V

Valproic acid
Vancomycin
Vanillylmandelic Acid (VMA)
Vascular Cell Adhesion Molecule-1 (VCAM-1)
Vascular Endothelial Growth Factor (VEGF)
Vitamin B₁₂

W

White Blood Cells (WBC)
White Blood Cells Differential (WBC-D)

Z

Zaleplon
Zeronal
Zinc
Zolpidem
Zopiclone


Product Spotlight: Maternal Screening

Product Spotlight: Maternal Screening Control

Maternal Screening Control

Background

A maternal serum screening test (MSS) is a blood test offered to pregnant women that helps determine the risk of Down’s syndrome and other chromosomal conditions, further testing can be offered if the patient is found to be high risk. It can be performed at 10 weeks (combined first trimester screening test), and 14-20 weeks (second trimester maternal serum screening test).

MSS is generally offered to all pregnant women, but the decision to have the test is a personal decision.

Quality Control is an important part of any diagnostic test but is of particular importance in screening methods, when a disorder must be detected without the presence of symptoms. In such screening methods, errors can present as false negative or false positive results both of which can have devastating consequences.  In the case of maternal screening a false positive result could mean additional and often invasive procedures which can carry risk of harm to the unborn child. The accuracy and reliability of the laboratory test results are extremely important in minimising both false positive and false negative results.

Product Overview

The Randox Acusera Maternal Screening quality control is the only commercially available control which covers all six analytes used during first and second trimester screening of Down’s syndrome and Spina Bifida.

Instrument specific target values and ranges are provided for AFP, Inhibin A, PAPP-A, β hCG, Total hCG and Unconjugated Estriol. The inclusion of PAPP-A and Inhibin A eliminates the need to purchase additional controls at extra expense.

Key Benefits & Features

  • Lyophilised for enhanced stability
  • 100% human serum
  • Assayed target values provided for 6 parameters
  • Suitable for double, triple and quad screens
  • Unconjugated Estriol present at clinically significant levels
  • Reconstituted stability of 7 days at 2°C – 8°C
  • Stable to expiry date at 2°C – 8°C

Consolidation

As a leading provider of multi-analyte, third party controls, Randox helps busy laboratories significantly reduce the number of controls needed to cover their test menu. Combining multiple analytes into a single control reduces cost, preparation time, and required storage space without sacrificing quality.

Analytes at key decision levels will not only ensure test system performance across the clinical range but will further aid consolidation and maximise laboratory efficiency by eliminating the need to purchase additional and often expensive low or high level controls.

First and second trimester

As the only control on the market to cover all first and second trimester analytes, you can be sure that your lab is covering all bases.

True third party control

The Acusera Maternal Screening Control is a true third party control designed to provide an unbiased assessment of performance with a range of instruments and methods, helping your laboratory meet the ISO 15189 requirements.

“the use of third party control materials should be considered,
either instead of, or in addition to, any control materials
supplied by the reagent or instrument manufacturer”.

Analytes

  • AFP
  • PAPP-A
  • Free Beta hCG
  • Total hCG
  • Inhibin A
  • Unconjugated Oestriol

Download some of our related brochures below and broaden your understanding.

Product Spotlight Archive

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


Product Spotlight: Liquid CSF Control

Liqiuid CSF Control - Product Spotlight

Liquid CSF Control

Cerebral Spinal Fluid (CSF) is produced by the body to protect, provide nutrients, and remove waste from the Central Nervous System (CNS). The CNS consists of the brain, spinal cord, and a complex neuron network. It is responsible for sending information to and receiving information from all parts of the body, co-ordinating organ function and responding to changes in the immediate external environment.

When testing CSF, it is removed from the subarachnoid space via lumbar puncture or spinal tap. The analysis of CSF includes tests such as; clinical chemistry, haematology, immunology and microbiology. These are used to diagnose serious bacterial, fungal, and viral infections, such as meningitis, a cerebral bleed, cancer involving the CNS and inflammatory conditions of the CNS.

Product Overview

Providing a true third party solution for the measurement of Cerebrospinal Fluid (CSF), the Acusera Liquid CSF Control is designed to deliver an unbiased, independent assessment of analytical performance helping to ensure accurate and reliable patient testing of 14 analytes.

Key Features & Benefits

  • Liquid ready-to-use samples requiring no preparation
  • Human based material
  • Assayed target values available
  • True third party control providing unbiased performance assessment
  • Shelf life of 2 years from date of manufacture
  • Open vial stability of 30 days at 2ºC to 8ºC
Unrivalled Stability

Our Liquid CSF Control boasts a remarkable 30-day open vial stability reducing waste, while remaining easy and convenient to use.

A True Third Party Control

The Acusera CSF Control is a true third party control designed to provide an unbiased assessment of performance with a range of instruments and methods, helping your laboratory meet the ISO 15189 requirements.

“the use of third party control materials should be considered,
either instead of, or in addition to, any control materials
supplied by the reagent or instrument manufacturer”.

Analytes

  • Albumin (electrophoresis)
  • Alpha – 1- globulin (electrophoresis)
  • Alpha – 2- globulin (electrophoresis)
  • Beta- globulin (electrophoresis)
  • Chloride
  • Gamma – globulin (electrophoresis)
  • Glucose
  • hsIgA
  • hsIgG
  • hsIgM
  • Lactate
  • Microalbumin
  • Protein (Total)
  • Sodium

Download some of our related brochures below and broaden your understanding.

Product Spotlight Archive

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


Product Spotlight: PTH Control

Liquid CSF Control Image

PTH Control

PTH is a notoriously unstable analyte and many competitors make reduced stability claims in their Immunoassay controls. Randox’s Liquid PTH Control provides laboratories with a dedicated product with an extended, 30-day, open vial stability to reduce waste and costs.

Parathyroid Hormone, better known as PTH, is produced by the Parathyroid glands to help the body maintain steady
volumes of calcium in the blood stream. PTH is part of a ‘feedback loop’ which also includes; calcium, vitamin
D, phosphate and magnesium. Interruptions to this loop can result in higher or lower levels of calcium or
PTH, leading to Hypercalcaemia or Hypocalcaemia. The Parathyroid Glands are responsible for the secretion of PTH in response to low calcium concentrations in the blood.

Product Overview

Released in 2016, Randox’s Liquid PTH Control provides a true third party solution for the measurement of Intact PTH, delivering an unbiased, independent assessment of analytical performance.

Key Features & Benefits

  • Liquid for ease-of-use
  • Human based serum
  • Assayed target values available for many immunoassay platforms
  • Stable to expiry date at -20°C to 70°C
  • Open vial stability of 30 days at 2°C to 8°C
Unrivalled Stability

Our Liquid PTH Control boasts a remarkable 30-day open vial stability! Many competitors fail to make stability claims in their immunoassay controls. Our PTH control includes target values and ranges, eliminating the need for extra validation work.

A True Third Party Control

The Acusera PTH Control is a true third party control designed to provide an unbiased assessment of performance with a range of instruments and methods, helping your laboratory meet the ISO 15189 requirements.

“the use of third party control materials should be considered,
either instead of, or in addition to, any control materials
supplied by the reagent or instrument manufacturer”.

Liquid Frozen

Available in three levels Acusera PTH Control is supplied in liquid frozen format, ensuring ease-of-use with no need to reconstitute. Coupled with it’shuman based matrix, it’s perfect for any laboratories conducting PTH testing.

Analytes

Intact PTH (Parathyroid Hormone)

Download some of our related brochures below and broaden your understanding.

Product Spotlight Archive

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


Product Focus: Urology

Did you know?”

The month of September is Urology Awareness Month in 2017.

Focus On - Urology

This month our Randox QC Product Spotlight focuses on urology and our extensive range of urine chemistry controls and EQA programmes.

During the month of September, there is a particular focus placed on helping to raise awareness for Urology and the effects that urological diseases can have on a person’s life.

It is estimated that 1 in 2 people will be affected by a urological condition at some point in their lifetime. Conditions and diseases related to kidneys, bladder and prostate, among others, are commonplace and can be devastating for millions of men, women and children across the globe.

Urological conditions can be common, such as a urinary tract infections, or they can be much more serious, for example, prostate or testicular cancer.

Throughout September the aim is to make people more aware of these urological conditions and reduce the stigma attached by encouraging people to be more open when talking about their conditions.

So where do Randox Quality Control fit into this?

It is accepted that over 70% of medical decisions are based on laboratory test results with Quality Control playing an often behind the scenes but vital role in ensuring both accuracy and reliability.

Our range of Urine Chemistry and Urinalysis quality controls are designed primarily to ensure accurate test system performance however offer the laboratory additional benefits that will help them to meet regulatory requirements whilst also reducing costs and time.  Manufactured from 100% human urine each control will react to the test system in the same manner as a patient sample reducing inconvenient shifts in QC results when reagent batch is changed.  As true third party controls you can be sure of unbiased performance assessment with any instrument or method.

Introducing Acusera Urine Controls

With a choice of liquid or lyophilised and assayed or unassayed controls there is a cost effective option to suit any laboratory. Read on to find out more information on the range – each week of Urology month we will add additional products so make sure you come back every week to find out more!

Week One (1) - Acusera Assayed Urine Control

The Randox Acusera Assayed Urine Quality Control is designed for use in the routine monitoring of urine chemistry tests. Assayed, method specific target values and ranges are provided for 24 analytes including kidney function parameters, catecholamines and urinary proteins.

 

Features & Benefits

  • Lyophilised for enhanced stability
  • 100% human urine
  • Assayed target values provided for 24 parameters
  • Stable to expiry date at 2 – 8℃
  • Reconstituted stability of 5 days at 2 – 8℃ or 14 days at -20℃

Week Two (2) - Acusera Liquid Urine Control

The Randox Acusera Liquid Urine quality control is designed to be both convenient and easy to use. The liquid ready-to-use format eliminates issues with pipetting and allows convenient storage at 2 – 8℃. Assayed instrument and method specific target values and ranges are provided for 18 commonly tested urine chemistry parameters.

Features & Benefits

  • Liquid ready-to-use
  • 100% Human Urine
  • Assayed target values provided for 18 parameters
  • Stable to expiry date at 2oC – 8oC
  • Open vial stability of 30 days at 2oC – 8oC

Week Three (3) - Acusera Unassayed Urine Control

The Randox Acusera Unassayed Urine Quality Control is designed for use in the routine monitoring of 12 common urine chemistry parameters.

Features & Benefits

  • Lyophilised for enhanced stability
  • 100% human urine
  • Approximate target values available
  • Stable to expiry date at 2 – 8℃
  • Reconstituted stability of 5 days at 2 – 8℃or 14 days at -20℃

Week Four (4) - Acusera Liquid Urinalysis Control

The Randox Acusera Urinalysis quality control is specifically designed for use with both manual and automated method of urine test strip analysis. The control is available in convenient 12ml vials with assayed ranges provided for 13 parameters covering the chemical examination of urine strips.

Features & Benefits

  • Liquid ready-to-use
  • 100% human urine
  • Assayed ranges provided for 13 parameters
  • Suitable for use in POC testing
  • Stable to expiry date at 2 – 8℃
  • Open vial stability of 30 days at 2oC – 25oC (20 immersions for UC5033/5034)

Introducing RIQAS Urine Programmes

It is important to note that Randox QC don’t just supply top quality Urine Controls, we also have a number of RIQAS EQA programmes that go hand-in-hand perfectly. RIQAS is the largest, international EQA scheme in the world with over 45,000 laboratory participants spanning 133 countries, as such peer groups are maximised ensuring data for a wide range of instruments.

Week One (1) - RIQAS Human Urine Programme

The RIQAS Human Urine EQA programme is designed to monitor the performance of 25 routine chemistry assays in urine.

  • Accredited to ISO/IEC 17043
  • Lyophilised for enhanced stability
  • 100% human urine
  • Bi-weekly reporting
  • 24 x 10ml samples provided
  • Submit results and view reports online via RIQAS.Net
  • Register up to five instruments at no extra cost

Week Two (2) - RIQAS Urinalysis Programme

The RIQAS Urinalysis EQA programme is designed to monitor the performance of urine dipstick test using both manual and automated methods. All samples are supplied in a liquid ready-to-use format ideal for both clinical and point-of-care testing (POCT).

  • Liquid ready-to-use
  • 100% human urine
  • Bi-monthly reporting
  • Submit results and view reports online via RIQAS.Net
  • Suitable for POCT

The RIQAS Urine Toxicology EQA programme is designed to monitor the performance of 20 drugs of abuse tests in urine. Suitable for both qualitative and semi-quantitative methods of analysis.

  • Liquid ready-to-use
  • 100% human urine
  • Monthly reporting
  • Submit results and view reports online via RIQAS.Net
  • Suitable for use with both quantitative and screening methods
  • Report results for drug group or individual metabolite

Product Spotlight Archive

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


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

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What is Measurement of Uncertainty?

Measurement Uncertainty (MU) relates to the margin of doubt that exists for the result of any measurement, as well as how significant the doubt is. For example, a piece of string may measure 20 cm plus or minus 1 cm, at the 95% confidence level. As a result, this could be written: 20 cm ±1 cm, with a confidence of 95%. Therefore, we are 95% sure that the piece of string is between 19 cm and 21 cm long.

Standards such as ISO 15189 require that the laboratory must determine uncertainty for each test. However, they have not specified how this should be done.

How do we calculate Measurement Uncertainty using QC data?

Employing your QC data to calculate uncertainty makes several assumptions; your test system is under control, the patient samples are treated in the same manner as your controls and gross outliers have been removed. If you choose to use your QC data to calculate this you should ensure that you use a commutable control with a matrix similar to that of a patient sample, with analytes present at clinically relevant levels

To calculate MU, labs must look at the intra-assay precision and inter-assay precision of their test.

Intra-assay precision: Sometimes known as ‘within run’ precision, is where 20 or more replicates of the same sample are run at the same time, under the same conditions (calculated from a single experiment). Intra-assay precision helps to assess systematic uncertainties

Inter-assay precision: Sometimes known as ‘between run’ precision, is where 20 or more replicates are run at different times – e.g. 1 replicate every day for 20 days (can be calculated from routine IQC data). Inter-assay precision can help identify random uncertainties within the test system.

*The Australian Association of Clinical Biochemists (AACB) recommends that at least 6 months’ worth of QC data are used when calculating the inter-assay precision1.

Once the data is collected, you must calculate the standard error of the mean (SEM) of the intra-assay precision (A) and the SD of the inter-assay precision (B) in order to measure the uncertainty (u). Once A and B have been calculated, they need to be squared, added together and the square root of the sum found:

As uncertainty is calculated as SD and 1SD is equal to 68% confidence on a standard Gaussian curve, we can conclude that if we multiply using a coverage factor of 2, we can attain 2SD confidence of 95%. This is known as the Expanded Uncertainty (U):

What is the Advantage of Measurement Uncertainty for a lab?

Labs need to carry out MU as it is a requirement of ISO 15189. It states: “The laboratory shall determine measurement uncertainty for each measurement procedure, in the examination phases used to report measured quantity values on patients’ samples. The laboratory shall define the performance requirements for the measurement uncertainty of each measurement procedure and regularly review estimates of measurement uncertainty”.

MU also helps determine whether the difference between two results is negligible due to uncertainty or significant due to a genuine change in condition of the patient; giving labs a greater confidence in reported results.

How can Randox help?

Our new Acusera 24.7 Live Online software provides automatic calculation of MU, saving valuable time and helping labs meet ISO 15189 requirements with ease.

Contact marketing@randox.com to find out how your lab can benefit from Acusera 24.7 Live Online


Take steps to prevent incorrect patient results by making one simple change

According to the NHS Litigation Authority; in 2015 within the UK alone, £193,680,744.30 was spent on ‘wrong diagnosis’ or ‘failed/delayed diagnosis’ causing huge financial strain and impact on labs.

With approximately 75% of clinical decisions and diagnosis based on laboratory test results. The only way to guarantee a high degree of accuracy is to implement a good Quality Control plan. The importance of this is recognised globally, several bodies exist internationally including ISO (International organisation for standardisation) who have developed a set of guidelines and quality systems to ensure the reliability of laboratory test results.

So what can you do to improve accuracy and reliability?

Choose a third party QC

ISO 151589:2012 Section 5.6.2.2 states that “the use of third party control materials should be considered, either instead of, or in addition to, any control materials supplied by the reagent or instrument manufacturer”.

First Party Controls are those manufactured by the instrument/reagent manufacturer. These controls are optimised specifically for use with the manufacturers test system and therefore will mask a multitude of weaknesses. First Party Controls tend to result in perceived accuracy and a biased assessment of performance.

Third Party Controls on the other hand are designed to be completely independent  and are not optimised for use with a specific test or system. Leading manufacturers of third party controls will assign target values based on data collected from thousands of independent laboratories, ensuring the availability of statistically robust multi-method, multi-analyser data. Therefore laboratories using Third Party Controls can be assured of unbiased error detection across multiple platforms.

Randox Acusera is a world leading manufacturer of true third party controls providing a cost effective, high quality solution for any laboratory-regardless of size or budget.

Look out for QC samples with clinically relevant concentrations

ISO 15189:2012 states that ‘The laboratory should choose concentrations of control materials wherever possible, especially at or near clinical decision values, which ensure the validity of decisions made’.

It is important to assess the full clinical range of an assay i.e. the range between the lowest and highest results which can be reliably reported. In order to make sure a laboratory instrument is performing accurately across the full clinical range and in particular at the medical decision level, QC materials that cover low, normal and elevated concentrations should be used.

Due to the superior manufacturing process used by Randox, QC target values consistently cover the MDL of tests. By ensuring the controls in use cover clinical decision levels laboratories can be confident of the reliability and accuracy of the patient results they release.

Opt for a commutable control material

A good QC material has many essential properties but above all, controls must perform consistently and reflect the performance of patient samples – if a control meets these requirements then we can say it is commutable. Having a commutable control would aid in the prevention of incorrect patient results because they replicate the performance of a patient sample and react to the test system in a similar manner. Use of a commutable control will also reduce costly shifts in QC target values when reagent batch is changed.

At Randox we take quality seriously, that’s why all QC products are manufactured to the highest possible standard, delivering controls of unrivalled quality. Designed to be commutable, the Acusera range will ensure accurate and reliable instrument performance while simultaneously helping laboratories to meet ISO 15189:2012 requirements. A good QC process will include the use of Third Party Controls, Clinically Relevant Concentrations and controls which can be described as commutable. By employing Quality Control’s that encompass these traits, a laboratory professional can be certain that they have taken the necessary steps to decrease incorrect results and therefore potential misdiagnosis.


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