Protected: The Benefits of True Third Party Controls -New Test
Protected: The Benefits of True Third Party Controls -New Test
Product Spotlight: RIQAS CO-Oximetry EQA
RIQAS CO-Oximetry EQA
The RIQAS CO-Oximetry EQA Programme is a comprehensive programme suitable for monitoring the performance of 7 CO-Oximetry parameters. All samples are supplied in a liquid ready-to-use format ideal for both clinical and point-of-care testing (POCT).
Background
CO-Oximetry is a methodology that measures the levels of the oxygen-carrying protein haemoglobin, which is the chief component of red blood cells. CO-Oximetry is a useful tool in that it helps determine the levels of various forms of haemoglobin.
Key Benefits & Features
- Liquid ready-to-use
- Monthly reporting
- Submit results and view reports online via RIQAS.Net
- Suitable for POCT
Liquid ready-to-use
The liquid stable formulation requires no preparation making the samples extremely easy and convenient to use.
Consolidation
Covering 7 CO-Oximetry parameters, the RIQAS CO-Oximetry programme offers a streamlined approach to your EQA, allowing you to test your whole CO-Oximetry menu.
RIQAS
RIQAS is the largest international External Quality Assessment (EQA)/ Proficiency Testing (PT) scheme, there are currently more than 45,000 participants in 133 countries. World renowned for reducing the number of individual programmes required by even the most demanding laboratories.
Analytes
- Carboxyhaemoglobin (COHb / HbCO)
- Methaemoglobin (MetHb)
- Oxygen Content (O₂CT)
- Oxygen Saturation (sO₂ / Vol O₂)
- Oxyhaemoglobin (O₂Hb / HbO₂)
- Total Haemoglobin (tHb)
- Reduced / Deoxyhaemoglobin (RHb / HHb)
Related Products
RIQAS Blood Gas EQA
Suitable for monitoring the performance of 10 blood gas parameters.
- Accredited to ISO/IEC 17043
- Liquid ready-to-use
- Aqueous material
- Monthly reporting
- Submit results and view reports online via RIQAS.Net
- Suitable for POCT
Download some of our related brochures below and broaden your understanding.
References
Chatburn, R. (2014). To co-ox or not to co-ox. Acutecaretesting.org. Retrieved 19 February 2018, from https://acutecaretesting.org/en/articles/to-coox-or-not-to-coox
The Benefits of True Third Party Controls
In the clinical laboratory, Quality Control (QC) refers to the process of detecting analytical errors to ensure both the reliability and accuracy of patient test results. Poor performance can result in misdiagnosis, delayed/inappropriate treatment, increased costs and may even be potentially life threatening for the patient. Third party controls offer a better solution to ensure optimum performance and accuracy, read on to learn how.
1. Dependent / First Party Controls
Dependent controls refer to any control material that has been produced by the instrument or reagent manufacturer for use on a specific test system. Such controls are often manufactured from the same raw materials as the calibrator, making them less sensitive to subtle changes in performance.
As dependent controls are generally optimised for use with the manufacturer’s test system, these controls can mask weaknesses, and therefore, are increasingly considered less effective than independent controls.
2. Semi-Dependent Controls
Semi-dependent control material, although produced independently of the instrument or reagent, is often supplied or recommended by the instrument/reagent manufacturer. It is this manufacturing relationship between the two that requires close scrutiny when considering if these controls are fit-for-purpose.
Although the control material is not produced by the instrument manufacturer, it is produced according to their exact specifications and therefore, optimised to work with a specific platform.
3. Independent / Third Party Controls
Independent or third party quality control material has not been designed or optimised for use with any instrument, kit or method. This complete independence enables the quality control material to closely mirror the performance of patient samples, and in doing so, provide an unbiased, independent assessment of analytical performance across multiple platforms.
Third party controls have been designed to deliver an independent, unbiased assessment of performance with any instrument or method helping you gain accreditation. Below are some of the key benefits of third party controls:
- Values assigned using a large number of independent laboratories ensuring statistically valid targets.
- Highly consolidated controls allow for space, time, and ultimately, cost savings.
- Boosted shelf life ensures continuity of supply and reduced costs
- Reduced preparation times by removing the need for multiple instrument controls
Regulatory Requirements
Third party controls are growing in popularity across the globe. More and more laboratories are beginning to use third party controls as part of their daily QC strategy. The benefits of such controls are widely accepted and recommended by both key opinion leaders and regulatory bodies in the field of Quality Control.
“Use of independent third party control materials should be
considered, either instead of, or in addition to, any control
materials supplied by the reagent or instrument manufacturer”
ISO 15189:2012 Section 5.6.2.2
ISO 15189:2012 Medical Laboratories – Requirements for Quality and Competence
The benefit of running third party controls in your laboratory cannot be underestimated. The following case studies highlight their many benefits and how they have helped laboratories across the world to provide more accurate and reliable test results.
Case Study One: Identifying Lot-to-Lot Variability with Third Party Controls
A laboratory in the UK contacted Randox Technical Services, reporting higher than expected QC results for
Thyroglobulin. When using a third party control (Acusera Immunoassay Premium Plus) the results were four
times higher on their main analyser compared to other systems. However, when they ran the instrument
manufacturer’s control alongside the third party control it did not show the same problem.
After reviewing EQA data, the Technical Services team confirmed there was a significant difference in results
compared to other instruments, and set about helping the laboratory troubleshoot. After an exhaustive
review of procedures and processes, the customer contacted the instrument manufacturer, who advised of a
positive bias with several batches of reagent, including the batch the laboratory was using.
Conclusion: By using a third party control the laboratory was able to detect a shift in results after changing
reagent batch that the instrument manufacturer’s control did not.
Case Study Two: Overcoming Instrument Errors with Third Party Controls
A laboratory using the Acusera Assayed Chemistry Premium Plus control contacted Randox Technical Services
after observing a consistent negative bias for ALT which was not replicated by the instrument control. They
had previously contacted their instrument manufacturer who advised that the problem was with the control
and not the reagent or instrument.
Randox investigated the problem and demonstrated that patient results were also wrongly reported low. This
later led the instrument manufacturer to recommend a wash stage to eliminate any interference.
Conclusion: The use of a third party control in this instance enabled the identification of a procedural error
with the instrument that the recommended control did not.
Explore the benefits of Randox Acusera third party controls below.
Our extensive range of assayed quality controls are supplied with highly accurate target values for a wide range of instruments and methods. Our unique value assignment process utilises thousands of independent laboratories globally ensuring target values won’t change throughout the shelf life of the control and eliminates the need to spend time and money performing value assignment in-house.
Accuracy coupled with unrivalled traceability to International Reference Laboratories, provides a product of unsurpassed accuracy and reliability.
We take quality seriously, that’s why all QC products are manufactured to the highest possible standard delivering control products of unrivalled quality. Our superior manufacturing processes ensure stability claims and analyte levels won’t differ significantly from lot to lot. You can therefore be sure of receiving the same standard of product time and time again.
Regular shifts in QC results when a reagent batch is changed can be both costly and frustrating for many labs, resulting in a frequent need to reassign target values. Designed to be commutable, the Acusera range of Internal Quality Controls will react to the test system in a manner as close as possible to the patient sample helping you to meet ISO 15189:2012 requirements while ultimately ensuring accurate & reliable instrument performance. Furthermore our lyophilized controls contain no added preservatives or stabilisers ensuring a sample matrix that closely matches the patient sample.
ISO 15189:2012 states, “The laboratory shall use quality control materials that react to the examining system in a manner as close as possible to patient samples”.
All controls for use with immunoassay/immunology based methods are manufactured using only 100% human components demonstrating our commitment to quality and eliminating costly QC shifts when reagent batch is changed.
Working stability and product shelf life are important considerations for any lab when choosing which internal quality control material is best suited to their needs. Labs often spend up to one month validating new material, a process which can be minimised by opting for a control with an extended shelf life. At Randox our lyophilised controls have a shelf life of up to four years and our liquid controls a shelf life of up to two years from the date of manufacture ensuring continuity of lot supply and ultimately reducing the need for expensive new lot validation studies.
Each of our third party controls will have its own reconstituted or open vial stability, some of the analytes will have limitations, however we pride ourselves on not misleading customers with false claims. The extended open vial and reconstituted stabilities will help laboratories to minimise waste and reduce costs.
Randox is a leading provider of multi-analyte, third party controls designed to allow any lab to carry out highly accurate QC using fewer controls. In an industry where budgets and resources are increasingly under pressure, highly consolidated controls will ensure high levels of throughput without compromising on accuracy. Uniquely comprising up to 100 analytes in a single control product, costs, preparation time and storage space are dramatically reduced without sacrificing on quality.
The presence of analytes at key decision levels in all Acusera controls will not only ensure accurate test system performance across the clinical range, but will further aid consolidation and maximise laboratory efficiency by eliminating the need to purchase additional high or low level controls, which are often expensive.
Available in multiple levels, the Acusera range of third party controls are designed to challenge laboratory instruments throughout the patient reportable range. The presence of analytes at clinically relevant decision levels not only helps to ensure accurate instrument performance but maximizes laboratory efficiency by eliminating the need to purchase additional low/high concentration controls at extra expense.
Randox also employs easy to use colour-coded packaging to help distinguish between different levels and reduce costly mix-ups.
ISO 15189:2012 states, “The laboratory should choose concentrations of control materials wherever possible, especially at or near clinical decision values, which ensure the validity of decisions made”.
Randox Acusera is a world leading manufacturer of true third party controls providing a cost effective, high quality solution for any lab – regardless of their size or budget. Designed to provide an unbiased, independent assessment of performance, our internal quality controls have not been manufactured in line with, or optimised for use with any particular reagent, method or instrument helping you to easily meet ISO 15189:2012 recommendations.
ISO 15189:2012 states that the “use of independent third party control material should be considered, either instead of, or in addition to, any control materials supplied by the reagent or instrument manufacturer.”
Traceability refers to the property of a measured result or calibrator value to be related or traced back to a reference measurement procedure or reference material through a series of measurements with known uncertainties.
The European parliament and council directive 98/79 EC require values assigned to both calibrators and control materials on in vitro diagnostic medical devices to be traceable to a recognised reference material or reference measurement procedure of higher order, e.g. SI units.
Guidelines have been set for diagnostic manufacturers to follow when assigning calibrator values and establishing traceability. These guidelines were set by the European standards EN/ISO 17511 and also EN/ISO 18153. The Randox traceability pathway has been established with reference to standards ISO 17511 and ISO 18153. The pathway has been followed to establish traceability for Randox calibrators allowing all patient results to be traced right back to the source.
With an extensive range of assayed/unassayed, liquid/lyophilised and single/multi-analyte controls, the Acusera portfolio has a solution to suit all laboratory preferences.
Custom Controls
Randox is a market leader in the manufacture of customised quality controls designed to meet the individual and unique requirements of even the most specialised laboratories.
Acusera Third Party Controls
Download Third Party Benefits Brochure
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Product Spotlight: Liquid Urinalysis Control
Liquid Urinalysis Quality Control
The Randox Acusera Urinalysis Quality Control is 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.
Background
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 urinary tract infections, or they can be much more serious, for example, prostate or testicular cancer.
Urinalysis is used as a screening or diagnostic tool because it can detect kidney and metabolic disorders. Often, substances such as glucose or protein will appear in the urine before a patient is aware that they have a problem. In some conditions, urinalysis also provides an easy and economical test to track patient progress, for example, if you want to know if a condition is improving.
Key Benefits & Features
- 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°C – 8°C
- Open vial stability of 30 days at 2°C – 25°C (20 immersions for UC5033/5034)
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. The Randox Liquid Urinalysis Control combines multiple analytes into a single control reduces cost, preparation time, and required storage space without sacrificing quality. Analytes at key decision levels will ensure test system performance across the clinical range. It can also be used in monitoring the performance of both automated and manual methods of urine test strip analysis.
Liquid Stable
Samples are conveniently supplied ready-to-use requiring no preparation as such they can save valuable laboratory time. The Acusera Liquid Urinalysis Control can be used for POCT as well as laboratory based testing.
True third party quality control
The Acusera Liquid Urinalysis Quality 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
- Bilirubin
- Blood
- Creatinine
- Glucose
- hCG
- Ketones
- Leukocytes
- Nitrate
- pH
- Protein
- Specific Gravity
- Urobilinogen
Complete QC solution
The combining of the Acusera Liquid Urinalysis Quality Control, RIQAS Urinalysis EQA programme, and our Acusera 24•7 software will provide a complete QC solution for laboratories of all sizes.
Download some of our related brochures below and broaden your understanding.
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;
- Lyophilised (freeze dried)
- Liquid frozen
- 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.
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
17-OH-progesterone
17β Clostebol
1-25-(OH₂)-Vitamin D
25-OH-Vitamin D
α-1-Acid Glycoprotein
α-1-Antitrypsin
α-1-Globulin (Electrophoresis)
α-2-Globulin (Electrophoresis)
α-2-Macroglobulin
α-Fetoprotein (AFP)
α-HBDH
ACE (Angiotensin Converting Enzyme)
Acetaminophen
Acid Phosphatase (Non-Prostatic)
Acid Phosphatase (Prostatic)
Acid Phosphatase (Total)
ACTH
Activated Partial Thromboplastin Time (APTT)
AHD
Albumin
Albumin (Electrophoresis)
Aldolase
Aldosterone
Alkaline Phosphatase (ALP)
ALT (GPT)
AMH
Amikacin
Ammonia
AMOZ
Amylase
Amylase (Pancreatic)
Androstenedione
Anti-HAV
Anti-HBc
Anti-HBe
Anti-HBs
Anti-HCV
Anti-HIV 1 / 2
Anti-HTLV 1 / 2
Anti-SARS-CoV-2
Anti-SARS-CoV-2 Spike
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)
β-Globulin (Electrophoresis)
β-2-Microglobulin
BASO-X
BASO-Y
Basophils (BASO)
Basophils % (% BASO)
Bicarbonate
Bile Acids
Bilirubin (Direct)
Bilirubin (Total)
Blood
Bone Alkaline Phosphatase (B-ALP)
Borrelia burgdorferi IgG
Borrelia burgdorferi IgM
Brain Natriuretic Peptide (BNP)
C-Peptide
C-Telopeptide
CA 15-3
CA 19-9
CA 72-4
CA 125
Caffeine
Calcitonin
Calcium
Carbamazepine
CEA
Ceftiofur
Ceruloplasmin
Chloramphenicol
Chloride
Cholesterol (HDL)
Cholesterol (LDL)
Cholesterol (Total)
Cholinesterase
CK-MB
CK (Total)
Complement C3
Complement C4
Copper
Cortisol
CRP
Creatinine
Cyclosporine
Cytomegalovirus (CMV) IgG
Cytomegalovirus (CMV) IgM
CYFRA 21
Cystatin C
D-3-Hydroxybutyrate
D-dimer
Deoxypyridinoline
DHEA-Sulphate
DIFF-X
DIFF-Y
Digoxin
Dopamine
E-Selectin (E-SEL)
Eosinophils (EOS)
% Eosinophils (% EOS)
Epidermal Growth Factor (EGF)
Epinephrine
Epstein Barr Virus (EBV) EBNA IgG
Epstein Barr Virus (EBV) IgM
Epstein Barr Virus (EBV) VCA IgG
Estriol
Ethanol
Ethinylestradiol
Ethosuximide
Factor II
Factor V
Factor VII
Factor VIII
Factor IX
Factor X
Factor XI
Factor XII
Ferritin
Fibrinogen
Folate
Fructosamine
FSC-X
FSH
G-6-PDH
γ-Globulin (Electrophoresis)
γGT
Gastrin
Gentamicin
Gestagens (Generic)
GLDH
Glucose
Glutamate
Glutathione Peroxidase (Ransel)
Glutathione Reductase
Glycerol
GM-CSF
Growth Hormone (GH)
Haematocrit (HCT)
Haemoglobin (HGB)
Haemoglobin (Total)
Haemolysis (H)
Haemopioetic Progenitor Cell (HPC)
Haptoglobin
HAV IgM
HbA1c
HBc IgM
HBeAg
HBsAg
hCG
Free β-hCG
Total β-hCG
HDL-3
Helicobacter pylori IgG
Herpes Simplex Virus 1 (HSV-1) IgG
Herpes Simplex Virus 1 (HSV-1) IgM
Herpes Simplex Virus 2 (HSV-2) IgG
Herpes Simplex Virus 2 (HSV-2) IgM
HIV-1 P24Ag
Homocysteine
Icterus (I)
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
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)
Kappa Light Chain
Ketones
L-Selectin (L-SEL)
Lactate
Lactate Dehydrogenase (LDH)
Lambda Light Chain
Lambda Light Chain (Free)
LAP
Leptin
Leukocytes
Lipase
Lipemia (L)
Lipoprotein (a)
Lithium
Luteinising Hormone (LH)
Lymphocytes (LYMPH)
% Lymphocytes (% LYMPH)
Magnesium
Matrix Metalloproteinase-9 (MMP-9)
Measles IgG
Mean Corpuscular Haemoglobin (MCH)
Mean Corpuscular Haemoglobin Concentration (MCHC)
Mean Corpuscular Volume (MCV)
Mean Platelet Volume (MPV)
Metanephrine
Methandriol
Methotrexate
Methyltestosterone
Microalbumin
Macrophage Inflammatory Protein-1a (MIP-1a)
Monocytes (MONO)
Monocytes % (% MONO)
Monocyte Chemoattractant Protein-1 (MCP-1)
Mumps IgG
Myoglobin
Methyltestosterone
MDMA
Microalbumin
Macrophage Inflammatory Protein-1α (MIP-1α)
Monocytes (MONO)
Monocytes % (% MONO)
Monocyte Chemoattractant Protein-1 (MCP-1)
Morphine (Opiates)
Myoglobin
N-MID Osteocalcin (OC)
N-Telopeptide
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)
Oestradiol
Osmolality
Osteocalcin
Oxalate
Oxyhaemoglobin
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
Procollagen Type 1 N-Terminal Propeptide (P1NP)
Progesterone
Prolactin
Protein C
Protein S
Protein (Total)
Prothrombin Time (PT)
Pyridinium Crosslinks
Pyridinoline
PSA (Total)
PSA (Free)
PTH (Parathyroid Hormone)
PTH (Intact)
Quinolones
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)
Rubella IgG
Rubella IgM
Salicylate
Semicarbazine (SEM)
Sex Hormone Binding Globulin (SHBG)
sLDL
Sodium
Soluble IL-2 Receptor α (sIL-2Rα)
Soluble IL-6 Receptor (sIL-6R)
Soluble Transferrin Receptor (sTfR)
Soluble Tumour Necrosis Factor Receptor 1 (sTNFR I)
Soluble Tumour Necrosis Factor Receptor 11 (sTNFR I1)
Specific Gravity
Streptomycin
Superoxide Dismutase (Ransod)
T Uptake
T3 (Free)
T4 (Free)
T3 (Total)
T4 (Total)
Testosterone
Testosterone (Free)
Tetracyclines (Generic)
Theophylline
Thiamphenicol
Thrombin Time (TT)
Thyroglobulin
Tobramycin
Total Antioxidant Status (TAS)
Toxoplasma gondii IgG
Toxoplasma gondii IgM
Transferrin
Treponema pallidum (Syphilis) IgG
Triglycerides
Trimethoprim
Troponin I
Troponin T
TSH
Tumour Necrosis Factor α (TNFα)
Tylosin
Unconjugated Estriol
Urea
Uric Acid (Urate)
Urobilinogen
Valproic acid
Vancomycin
Vanillylmandelic Acid (VMA)
Varicella Zoster Virus (VZV) IgG
Vascular Cell Adhesion Molecule-1 (VCAM-1)
Vascular Endothelial Growth Factor (VEGF)
Vitamin B₁₂
White Blood Cells (WBC)
White Blood Cells Differential (WBC-D)
Zinc
Product Spotlight: Maternal Screening
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
Related Products:
Download some of our related brochures below and broaden your understanding.
Product Spotlight: Liquid CSF Control
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: PTH Control
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 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
