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
Meeting ISO 15189:2012 Requirements for Multiple Instruments
Approximately 70% of clinical decisions are based on laboratory test results. Poor laboratory quality can result in unreliable test results ultimately leading to misdiagnosis, inappropriate treatment and may even impact the overall quality of life for the patient. Having multiple instruments can often add to the difficulties faced in labs. The importance of quality medical services is recognised globally with several bodies existing internationally including ISO (International Organisation for Standardisation) who have developed a set of guidelines and quality systems to ensure reliable test results – ISO 15189:2012.
About ISO 15189:2012
ISO 15189:2012 was designed to outline the “requirements for competence and quality that are particular to medical laboratories”. Laboratory competence and quality are critical in patient diagnosis and care to ensure they meet the need of the clinicians & patients. Gaining accreditation to ISO 15189:2012 will assure clinicians employing your services that they will be benefitting from accurate results which have been measured against a consistent standard. You could benefit too from cost savings and enhanced end-user satisfaction.
Gaining Accreditation
ISO 15189:2012 divides the quality requirements of the laboratory into two distinct areas; Internal Quality Control (IQC) and External Quality Assessment (EQA). By combining both you can comprehensively review and monitor the overall performance of your laboratory, including personnel, equipment, and procedures.
A particular requirement of ISO 15189:2012 is:
“Laboratories accredited according to ISO 15189 that have two or more analysers for examinations, should have a defined mechanism for comparison of results across analysers”
How Randox can help labs with multiple instruments?
Randox offers solutions in both IQC and EQA to help your lab meet the ISO 15189 requirements.
RIQAS
Our international EQA scheme is the largest in the world with 45,000 participants in 133 countries.
Multi-Instrument Reports
All RIQAS participants can register up to five separate instruments per programme at no extra cost. Individual reports for each instrument plus a unique multi-instrument report are provided. The multi-instrument report plots the performance of each individual instrument on a single, colour coded Levey-Jennings chart, ensuring instant identification of any differences in instrument performance. Additional sample packs may be ordered as required.
The multi-instrument report includes many of the same statistical features found in the main RIQAS report including; CV%, SDI, RMSDI, %DEV, RM%DEV, Target Score, and RM Target Score.
Acusera 24.7 Live Online
Our stress free QC analysis software is designed to assist in the management of daily QC activities.
Support for multiple instruments
Acusera 24.7 Live Online allows laboratories to conveniently combine multiple instruments as well as analytes and QC lots on a single Levey-Jennings chart, allowing comparative performance assessment and immediate visualisation of any ongoing or emerging trends.
Helping you get accredited
Randox helps you get accredited by offering products from the full spectrum of Quality Control, meaning you never have to look elsewhere. Not all manufactures can offer these features.
To find out more about how we can help you meet ISO 15189 requirements, contact us using the form below.
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.
Mythbusting: ‘Using IQC and EQA From the Same Provider Leads to QC Bias’
Some laboratory professionals believe that using Internal Quality Control (IQC) and External Quality Assurance (EQA, also known as Proficiency Testing) material from the same provider can lead to increased levels of qc bias, or that their test system will not be appropriately challenged. It is important to address these concerns, because some labs may in fact be hindering their own performance by using IQC and EQA material from different sources.
It is important to first understand how IQC and EQA work together to help form a complete Laboratory Quality Management System.
IQC and EQA in Laboratory Quality Management
IQC is a means of monitoring test system precision on a daily basis. IQC effectively evaluates test system performance over time, so that any sudden or gradual shifts in performance can be detected. However, while IQC is an effective performance monitor, it cannot detect more intricate problems like calibration errors or wide acceptable limits provided by some QC manufacturers.
EQA is essential for challenging test system accuracy, and is carried out less frequently than IQC testing. EQA samples are tested ‘blind’ and the results are returned to the scheme organiser. As EQA testing compares an individual lab’s performance to other labs using the same method and instrument, it is a very effective tool for identification of potential issues.
Is there any disadvantage to using IQC and EQA material from the same provider?
The answer to this question depends primarily on the source material of the IQC and EQA. If an IQC provider manufactures their material using artificial additives or components of animal origin, then it will not be suitable to use EQA material from the same provider. Westgard (2011) maintains that using non-commutable IQC or EQA material can lead to results becoming compromised due to matrix effects – something which would not happen using commutable controls.
For example, with Immunoassay testing, non-human components of IQC material interact with antibodies in the reagent in a different way to fully human patient samples – ultimately giving unpredictable shifts, and not adhering to the ISO 15189 requirement to: “use quality control materials that react to the examining system in a manner as close as possible to patient samples”.
However, if the IQC and EQA material is manufactured using a source material which is similar in composition to patient samples (100% human), this commutable control will adequately mimic patient sample performance; meaning labs can use EQA and IQC material from the same provider with confidence that the integrity of their results is maintained.
Conclusion
ISO 15189 also states: “Use of independent third party control materials should be considered…”. In this instance, ‘Independent’ does not mean from a separate provider. It means that the QC material should not be optimized for use on one specific instrument (i.e. not dependent on a single instrument/method type).
No regulatory body states a requirement to use different providers for IQC and EQA material. Indeed, using IQC from one provider and EQA from another provider could increase the risk of labs using non-commutable material.
Labs should use commutable IQC and EQA material for a true assessment of their test system. Randox QC and RIQAS EQA are specifically designed with commutability in mind, giving labs a control which reflects patient sample performance and ensures excellent performance.
How can we help?
To learn how Randox can offer a complete solution for your laboratory, follow the links below or submit a question using the form above.
References
Westgard, S. (2011). Is QC Quality Compromised?. Available: https://www.westgard.com/qc-quality-compromised.htm. Last accessed 31st October 2017.
Got a question?
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
7-amino flunitrazepam
11 dhTXB₂
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
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)
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-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-3-Hydroxybutyrate
D-dimer
Dextromethorphan
DHEA-Sulphate
DIFF-X
DIFF-Y
Digoxin
Dopamine
E-Selectin (E-SEL)
EDDP
Eosinophils (EOS)
% Eosinophils (% EOS)
Epidermal Growth Factor (EGF)
Epinephrine
Escitalopram
Estriol
Ethanol
Ethinylestradiol
Ethosuximide
Ethyl Glucuronide
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-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-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
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)
Kappa Light Chain
Kappa Light Chain (Free)
Ketamine Metabolite
Ketones
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)
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
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)
Oestradiol
Opiates
Osmolality
Osteocalcin
Oxalate
Oxazepam
Oxycodone (I+II)
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)
Quinolones (Generic)
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)
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 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
Unconjugated Estriol
Urea
Uric Acid (Urate)
Urobilinogen
Valproic acid
Vancomycin
Vanillylmandelic Acid (VMA)
Vascular Cell Adhesion Molecule-1 (VCAM-1)
Vascular Endothelial Growth Factor (VEGF)
Vitamin B₁₂
White Blood Cells (WBC)
White Blood Cells Differential (WBC-D)
Zaleplon
Zeronal
Zinc
Zolpidem
Zopiclone
Westgard’s Great Global QC Survey 2017
In a QC survey conducted this year, Sten Westgard reached out to more than 45,000 laboratory professionals to gain a comprehensive view of the world’s Quality Control practices. It was one of the largest surveys that have been conducted and shared publicly.
Read on as we take a summarised look at our favourite bits.
Setting control Limits
Most labs are using their actual performance to set their mean and SD, however, a large percentage of labs still use manufacturer’s ranges, peer group ranges, and other non-individual sources for SD. These ranges can typically be set wider than they would if the ranges were based on their actual mean and SD. This can result in labs releasing incorrect patient results.
Laboratories were asked if they used 2 SD control limits on all tests and it was found that a majority use 2 SD. The strict use of 2 SD can generate a high level of false rejections (9% for two controls and higher for three). This causes a high level of out-of-control events; the use of QC multi-rules is recommended.
The types of Controls used by labs
More than 60% of labs were found to be using manufacturer controls, the drawbacks of which are well known. The latest ISO standards strongly encourage the use of independent / third-party controls. Westgard speculates that this will become a mandatory requirement in the next version of ISO 15189.
Frequency of QC
The first question about frequency asked how often labs ran QC during a run. Respondents reported how often they schedule QC in their labs. Around half only run QC at the beginning of a run with labs running it throughout the day coming in close second. A small proportion of labs reported running QC at both the beginning and the end of a run.
The final, least popular option involves spacing out QC based on test volume, the most scientific method determining how many patient samples can be run between controls without raising the risk of unacceptable results.
The next question asked about the overall frequency of QC. Most labs are meeting the once-a-day minimum standard for CLIA regulations.
“QC frequency remains primarily based on the rotational speed of the earth, not driven by needs of the clinician and patient.” – Sten Westgard
QC Frequency Influences
Regulator and accreditation requirements lead the way in influencing the frequency of QC with manufacturer recommendations, and professional judgement following close behind. Only a quarter of labs use the volume of testing to guide their QC frequency and one in six look to EP23 or IQCP for guidance.
Managing QC
Most labs are using on-board instrument informatics to support their QC charting, followed by LIS charting programs, and peer group software.
Of significance is the number of labs using Excel spreadsheets as their primary QC tool as well as standalone QC programs or even manual graph paper. This could be due to varying technological capabilities where some locations may not have access to, or the funds to afford, informatics.
A combined third of labs are out-of-control every day. In some labs this could be the result of running such a high volume of controls that false rejections are inevitable. However, rationalising in this way can lead to ‘alert fatigue’, where users begin to ignore alert flags and stop troubleshooting.
More than a quarter of labs have an out-of-control flag every few days while another roughly one in six have just one per week. A small number of labs report having few QC flags.
Managing QC Costs
Finally, laboratories were asked about the steps they take to manage QC costs. 60% claimed that they take no steps to manage costs. One in six reduced QC frequency, one in eight switched to cheaper controls, while, worryingly, almost one in ten changed their QC rules or widened limits.
Conclusion
Westgard’s Global QC Survey suggests there exists many inefficient implementations of Quality Control, with plenty of room for improvement. The current state of QC is, like many aspects of healthcare, unsustainable. Labs must adopt better approaches or risk their continuing feasibility, or worse, their patient’s results.
How Randox Can Help
Westgard highlights particular issues with labs mismanaging costs, still using manufacturer controls, and setting control limits – this is where Randox comes in.
Acusera Third Party Controls offer the highest quality solution for any lab – regardless of 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 recommendations. Unrivaled consolidation allows for significant cost savings.
Acusera 24•7 Live Online allows you to automatically apply multi-rules and generate charts to help with setting accurate control limits, helping you get your quality control under control.
Reference: Westgard, S (2017), The 2017 Great Global QC Survey Results
To learn more about how Randox Quality Control can help you improve your QC visit the pages below or fill out the contact form and someone will be in touch.
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.
Randox showcases future-proofing diagnostic technology at MEDICA 2017
Randox Laboratories, the world-leading medical diagnostics manufacturer, is showcasing advancements in laboratory technology at the 2017 MEDICA – World Conference for Medicine conference, being held November 13-16 in Dusseldorf, Germany.
Unveiling its state-of-the-art interactive exhibition stand, Randox will host a series of demonstrations of its innovative analysers including the Evidence Evolution and Rx modena, and a number of exciting advances in laboratory medicine, involving increasing the test menu available to clinicians and improving the connectivity of laboratories across the world to improve overall quality.
“Through our advancements in laboratory innovation, we’re driving an industry-wide evolution” said Randox CEO, Dr Peter FitzGerald.
“Our products are leading the way in innovation and enabling laboratories to transform the way they operate. We will be hosting demonstrations of a wide range of our fully-automated analysers, which are packed with cutting-edge technology and intuitive software. The goal is to provide future-proof diagnostic technology that will create the most efficient and effective laboratories.”
Paving the way is Randox’s patented Biochip Array Technology (BAT). This multi-analyte testing platform is the product of a £250 million research and development project. The ceramic tile measuring 9×9 mm can currently run up to 49 assays simultaneously,100 assays in the near future. This innovation allows the simultaneous quantitative or qualitative detection from a wide range of analytes from a single sample. It is suitable for use in a wide range of laboratories including clinical, research, hospital, veterinary and forensic and clinical toxicology.
To enhance the benefits of BAT, Randox introduced the Evidence Evolution to its stable of immunoassay analyser platforms. The Evidence Evolution is the world’s first fully automated random-access biochip testing platform, capable of delivering 2640 results in one hour, with the first delivered in just 37 minutes.
Joining the Evolution in Hall 3 stand A08 is the RX modena. This highly reliable, precise, fully automated clinical chemistry analyser can run 1200 tests per hour including ISE. When combined with its unrivalled RX series test menu, it offers a winning combination for all large, multi-disciplinary laboratories.
“We develop more new tests than any other diagnostics manufacturer, and one of the products that we’re showcasing at this year’s MEDICA is Adiponectin,” added Susan Hammond, Global Sales Manager at Randox.
“This novel biomarker is a powerful new weapon in the fight against some of the biggest health issues faced throughout the world including diabetes, cancers and cardiovascular disease. As it’s World Diabetes Day on Tuesday 14th November, it’s a great opportunity to draw attention to this array which labs can run as part of their routine testing panel.”
MEDICA attendees will also be among the first to experience the advancements delivered by the latest update for Randox’s Acusera 24.7. This online interlaboratory data management and peer reporting package is now smarter, faster and more powerful than ever before.
Acusera 24.7 is designed to help laboratories efficiently review QC data from all their lab instruments on one central platform, thereby allowing quick and easy identification of QC failures and emerging trends. Unique access to peer group data updated instantly in real-time from our global network of laboratory participants will speed up troubleshooting and help pinpoint the root cause of any QC failures by easily identifying if an issue is isolated or widespread.
The Randox team will be on hand throughout MEDICA 2017 at stand #3A08. To make an appointment in advance, contact them through the Randox MEDICA webpage.
Click here for more information on Randox, or to get in touch, phone the Randox PR Team on 028 9442 2413, or email randoxpr@randox.com
Acusera 24.7 Packages Explained
Packages for Customisation
Acusera 24.7 now boasts even more customisation with the introduction of three distinct packages; Platinum, Gold & Silver.
The Acusera 24.7 software is an interlaboratory data management and peer group reporting package complementing the Acusera range of true third party quality controls. Designed to assist in the management of daily QC activities by providing access to an impressive range of features, including interactive charts and real-time peer group data, Acusera 24.7 Live Online will improve error detection, reduce false rejections, ensure accurate patient results, and help you meet regulatory requirements, such as ISO 15189.
The introduction of the new Acusera 24.7 packages ensures a solution to suit laboratories of all sizes and budgets. All three membership packages give our users access to the world-renowned Acusera 24.7 global peer group, but users now have the flexibility to choose whether they require access to additional features to help revolutionise their QC strategy.
Package Benefits
| FEATURE | PLATINUM | GOLD | SILVER |
|---|---|---|---|
| Access to real-time peer group data | ✔ | ✔ | ✔ |
| FEATURE | PLATINUM | GOLD | SILVER |
|---|---|---|---|
| Multiple levels of user access | ✔ | ✔ | ❌ |
| Unlimited number of registered users | ✔ | ❌ | ❌ |
| FEATURE | PLATINUM | GOLD | SILVER |
|---|---|---|---|
| Custom Multi-Rules | ✔ | ❌ | ❌ |
| Ability to use other manufacturer controls or custom controls | ✔ | ❌ | ❌ |
| FEATURE | PLATINUM | GOLD | SILVER |
|---|---|---|---|
| Data import via Acusera 24•7 Connect | ✔ | ✔ | ✔ |
| Manual data entry by panel | ✔ | ✔ | ❌ |
| Semi automated data entry via EDI | ✔ | ✔ | ✔ |
| Recording of instrument events | ✔ | ❌ | ❌ |
| FEATURE | PLATINUM | GOLD | SIGNIFICANCE |
|---|---|---|---|
| Automatic calculation of Mean, SD and %CV | ✔ | ✔ | ✔ |
| Result History | ✔ | ✔ | ✔ |
| Automatic calculation of %Bias and Total Error | ✔ | ✔ | ❌ |
| Automatic calculation of Inter-Precision, Sigma Scores, Uncertainty of Measurement and Expanded Uncertainty | ✔ | ❌ | ❌ |
| FEATURE | PLATINUM | GOLD | SILVER |
|---|---|---|---|
| Statistical Analysis Report | ✔ | ✔ | ✔ |
| Peer Group Statistics Report | ✔ | ✔ | ✔ |
| Exception Report | ✔ | ✔ | ❌ |
| Statistical Metrics Report | ✔ | ❌ | ❌ |
| Uncertainty of Measurement Report | ✔ | ❌ | ❌ |
| FEATURE | PLATINUM | GOLD | SILVER |
|---|---|---|---|
| Levey-Jennings Chart | ✔ | ✔ | ✔ |
| Histogram Chart | ✔ | ✔ | ✔ |
| Performance Summary Chart | ✔ | ✔ | ✔ |
| Multi-Levey Jennings/Histogram Charts | ✔ | ✔ | ❌ |
| FEATURE | PLATINUM | GOLD | SILVER |
|---|---|---|---|
| Dashboard | ✔ | ✔ | ❌ |
| Audit Trail | ✔ | ❌ | ❌ |
| Advisor Tool | ✔ | ❌ | ❌ |
| Data Review | ✔ | ✔ | ✔ |
Learn More About Acusera 24.7 Packages
To learn more about Acusera 24.7 you can visit the webpage, download the brochure or contact us using the form below.