Acusera Internal Quality Control Analyte List

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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

A

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)

B

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

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

D-3-Hydroxybutyrate
D-dimer
Deoxypyridinoline
DHEA-Sulphate

 

DIFF-X
DIFF-Y
Digoxin
Dopamine

E

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

F

Factor II
Factor V
Factor VII
Factor VIII
Factor IX
Factor X
Factor XI
Factor XII
Ferritin
Fibrinogen
Folate
Fructosamine
FSC-X
FSH

 

G

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)

H

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

I

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)

K

Kappa Light Chain
Ketones

 

L

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)

M

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

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)

O

Oestradiol
Osmolality
Osteocalcin
Oxalate
Oxyhaemoglobin

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
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)

Q

Quinolones

R

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

S

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

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

U

Unconjugated Estriol
Urea
Uric Acid (Urate)
Urobilinogen

V

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

W

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

Z

Zinc


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.

Respondent Map - Westgard QC Survey

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

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


Diabetes – World Diabetes Day (14th Nov 2017)

World Diabetes Day

With World Diabetes Day on Tuesday 14th November 2017, we take a look at what diabetes is and why quality control is so important.

What is Diabetes?

Diabetes is a life-long condition which occurs when the glucose level in the blood is too high because it can’t enter the body’s cells to be used as fuel. There are two types of diabetes: type 1 and type 2. They are distinct conditions and must be treated and managed differently.

Type 1 Diabetes

Type one diabetes is an autoimmune condition in which the body attacks insulin-producing cells, this causes a lack of insulin, leading to an increased blood glucose level. Around 10% of people with diabetes has type 1.

Type 2 Diabetes

A mixture of genetic and environmental factors causes type 2 diabetes. The body doesn’t make enough insulin or the insulin it does create does not work correctly, leading to a glucose build up in the blood. It’s thought that up to 58% of type 2 diabetes can be prevented or delayed through healthy lifestyle choices.

Role of Quality Control

Quality control plays a crucial role in ensuring accurate and reliable diabetes monitoring. 70% of medical decisions are based on a laboratory test result and QC is vital in ensuring the results the laboratory report are both accurate and reliable.

Want to know what makes a good HbA1c control? Read on to find out.

Clinically Relevant Levels

In the diagnosis of diabetes, glycated haemoglobin (HbA1c) in blood provides an indication of average blood glucose levels in the previous three months. HbA1c is the recommended standard of care for type 2 diabetes monitoring. HbA1c is measured using the range below:

HbA1c – Clinically Relevant Levels
HbA1cmmol/mol%
NormalBelow 42 mmol/molBelow 6.0%
Prediabetes42 to 47 mmol/mol6.0% to 6.4%
Diabetes48 mmol/mol or over6.5% or over

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. 48 mmol/mol is the cut-off for diabetes diagnosis, it is crucial that this can be measured accurately because any inaccuracy could mean the difference between being diagnosed and treated and not.

In terms of accreditation, 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’.

Benefits of Third Party Controls

The importance of third party controls is evident. Third party controls can help identify instrument, reagent, and procedural errors. Unchecked these errors could lead to incorrect patient results, further leading to misdiagnosis.

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.

Again, in terms of accreditation, ISO 15189 states – “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.”

Many laboratories perform HbA1c testing on a dedicated machine and as a result, are not always using a third party control.

Controlling Waste

Wastage is a common issue when running HbA1c due to the pre-treatment step required for many HbA1c controls and poor stability of some controls on the market. Look out for controls with an extended open vial stability to help reduce waste and keep costs low.

How can Randox help?

To help you get your QC in check for World Diabetes Day, Randox Acusera HbA1c control contains both HbA1c and Total Haemoglobin, with a reconstituted stability of 4 weeks to reduce waste and reduce costs. To find out more about our HbA1c control visit the page using the button below or fill out the form above.

World Diabetes Day

References

Diabetes: The basics. (2017). Diabetes UK. Retrieved 3 November 2017, from https://www.diabetes.org.uk/diabetes-the-basics

Khan, H et al. (2016). Significance of HbA1c Test in Diagnosis and Prognosis of Diabetic Patients. Biomarker Insights, 95. http://dx.doi.org/10.4137/bmi.s38440


Get your teeth into a Randox commutable control this Halloween

Get your teeth into a Randox commutable control this Halloween

It is that time of year again – when people dress up, children trick-or-treat and many a scary story is told in households around the world. An age-old tradition celebrated globally by millions of people – it can only be Halloween.

Last year Randox QC brought you the truly scary story about a laboratory who chose not to use a third party control, but eventually “treated their laboratory to a true third party control”. This year, we have another scary story for you about a lab manager in Transylvania, Dr. Acula.

It was a normal, busy day in the lab for Dr. Acula. That was until it was time to change reagent batch, after changing batch of reagent Dr. Acula was shocked to find his QC results had shifted by over 20%.  This left Dr. Acula very frustrated, having to spend precious time troubleshooting and reassigning QC targets. After troubleshooting showed no apparent root cause, Dr. Acula searched the internet for an answer finally stumbling upon an educational guide from Randox Quality Control on commutability and its many benefits to the lab.

Grinning from ear-to-ear with excitement, Dr. Acula began to read the guide in the hope of finding a solution to his problem – and solutions he found. While reading the guide, Dr. Acula came across a quote from ISO 15189:2012.  It read that laboratories “must use quality control materials that react to the examining system in a manner as close as possible to the patient sample”.

Dr. Acula made a decision to look for a commutable control material that met all of his requirements and he didn’t have to search very far. Randox Quality Control were able to supply Dr. Acula and his laboratory with a QC material to meet all his needs – true third party, excellent stability, consistency and consolidation but most importantly of all commutable controls.  The fact all Randox immunoassay and immunology controls are manufactured from 100% human material appealed to Dr. Acula a lot.  After trialing the Randox control material alongside patient samples and comparing results between reagent batches, Dr. Acula was thrilled with the results.

Labs rely heavily on quality control to detect errors in their test system and to ultimately make critical decisions regarding the accuracy and reliability of patient test results, the use of a control that reacts to the test system in the same manner as a patient sample is therefore essential.

At Randox Quality Control we take quality seriously. All our QC products are manufactured to the highest possible standard ensuring controls of unrivalled quality time and time again. Designed to be commutable, the Acusera range will ensure accurate and reliable instrument performance while simultaneously helping laboratories meet ISO 15189:2012 requirements.

Just ask Dr. Acula, who likes our 100% human controls so much he has started to drink them himself!


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


World Heart Day – 29th September 2017

World Heart Day – 29th September – Introduction

This year (29th September 2017) join us as we help to raise awareness for World Heart Day! The theme for this year’s World Heart Day is to share the power – and you know what they say… “Knowledge is Power” so throughout this blog we will be providing vital knowledge as well as tips to having a healthy heart!

The heart is a muscular organ that pumps blood around the body and is indeed central to your circulatory system. The system consists of a network of blood vessels, including, veins, arteries and capillaries. These vessels transport blood – as well as carrying oxygen and other important nutrients – to every part of the body. Ensuring a healthy heart is therefore vital.

What is CVD?

When too much pressure is put on our hearts we start to run into some issues – the general term for conditions affecting the heart is Cardiovascular Disease – better known as CVD. The exact cause of CVD is far from clear, with many factors increasing your chances of developing CVD. These risk factors can include, but are not limited to, high blood pressure, smoking, high cholesterol, being overweight or in many cases, can be hereditary.

It is important to note that Cardiovascular Disease is accountable for nearly half of all non-communicable disease (NCD) deaths, therefore making it the number one killer across the globe! Scary thought considering there are a whopping 17.3 million CVD related deaths per year – including stroke and heart disease. Understanding CVD in today’s society is more important than ever before, we need to know the truth about CVD and be able to decipher the facts from the fiction. Below you can see a few examples of common misconceptions regarding CVD and also some that are indeed true.

Only older men can get heart disease/CVD

False

Cardiovascular Disease can develop before birth

True

Exercising won’t help if you’re genetically predisposed to CVD

False

Low and middle-income countries are the most susceptible to CVD

True

It is estimated that by 2030 the number of deaths, due to CVD, will rise to an enormous 23 million globally! However, by raising awareness of the critical numbers and facts we can all help prevent CVD by making small, simple lifestyle changes.

Tips for a Healthy Heart

Using our “art into heart” graphic below, we decided to outline some of our Randox QC top tips for staying healthy! Why not try some of them and feel the effects of having a happy, healthy heart!

This World Heart Day, join us and many more around the world, to raise awareness for this great cause and unite together to “Share the Power”.


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


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