Meeting ISO 15189:2012 Requirements for Multiple Instruments

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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.

Meet ISO 15189 Requirements for Multiple Instruments

Product Spotlight: Liquid Urinalysis Control

Product Spotlight - Jan - Liquid Urinalysis Quality 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.

Product Spotlight Archive

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


RIQAS Instrument Group Report

All RIQAS participants are entitled to register up to five separate instruments per programme at no extra cost.

Individual reports for each instrument are supplied as normal in addition to a complimentary instrument group report allowing the performance of each instrument to be uniquely compared and assessed easily.

RIQAS EQA Reports

The multi-instrument group report displays the %Deviation for the last 10 samples along with the RM%Dev across all registered laboratory instruments. The %Dev for each instrument is plotted on a user-friendly, colour coded chart for instant identification of poor performing instruments.

As an ISO requirement, the Multi-Instrument Report is an extremely useful and beneficial tool for laboratories – “Laboratories with two or more analysers for examinations, should have a defined mechanism for comparison of results across analysers” – ISO 15189:2012.

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RIQAS Inter-Laboratory Group Report

A unique group reporting facility is available allowing laboratory groups or chains to effectively monitor the performance of satellite sites.

All laboratories within a group will receive their RIQAS sample packs, analyse the samples, return results to RIQAS and receive their individual RIQAS reports as normal. In addition to this a separate group report will be sent to the group manager or supervisor allowing relative performance of all laboratories within the group to be assessed.

RIQAS EQA Reports

For each laboratory in the group, the interlaboratory group report displays the %Dev for the last 10 samples along with the RM%Dev. The %Dev for each laboratory is plotted on a user-friendly, colour coded chart for instant identification of poor performing labs.

inter-laboratory group report

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RIQAS End-of-Cycle Report

RIQAS End-of-Cycle reports are sent to all participants who receive the standard report. Therefore, participants who are enrolled in RIQAS Urinalysis, RIQAS Urine Toxicology and RIQAS Serology programmes will not receive an End-of-Cycle report.

The RIQAS End-of-Cycle report provides laboratories with a complete summary of their External Quality Assessment performance. Performance is also compared to that of the previous cycle providing an indication of progress and improvement over time. Data is presented in both written and graphical format allowing a visual assessment of overall performance.

The RIQAS End-of-Cycle report is split into 3 sub-sections. These sub-sections are designed to allow performance assessment at a glance.

RIQAS EQA Reports

RIQAS End-of-Cycle Report Features

The Parameter Cycle Summary section provides an overview of the results returned for each sample in the cycle. The text section summarises the laboratory’s result compared to the Mean for Comparison. Laboratory performance for the current cycle is also compared to that of the previous cycle. A variety of charts including Levey-Jennings, Target Score, % Deviation by sample and % Deviation by concentration are also presented allowing a visual assessment of laboratory performance over the cycle.

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The text section provides a summary of the laboratory’s results and statistics including Mean for Comparison, SDPA, %CV, Uncertainty, SDI, Target Score and % Deviation. An additional table comparing performance for the current cycle to the previous cycle is also provided.

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The laboratory’s performance is summarised in various charts including Levey-Jennings, Target Score, % Deviation by sample and % Deviation by Concentration.

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The absolute SDI summary report compares current performance for all parameters to the previous cycle and indicates whether performance is better or worse. Performance is compared to other RIQAS participants in your country and worldwide.

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A certificate of performance is provided listing all parameters, for which the laboratory achieved an acceptable level of performance (Average Absolute SDI <2). Although the End-of-Cycle Report is issued for all registered parameters, the certificate of performance will only be available for parameters where results for at least 50% of samples in the cycle have been returned.

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RIQAS Standard Report

There are a variety of RIQAS reports designed to enable quick and easy identification of any trends or test system issues. The standard quantitative report is provided in a user-friendly, one page per parameter format allowing a visual, at-a-glance assessment of performance. The standard quantitative report is split into several easy to interpret subsections each designed to save valuable laboratory time.

You can explore each of the report sections using the table below. Don’t forget, to enlarge the image, simply click on it.

RIQAS EQA Reports

RIQAS Reports Features

Performance data is presented in a simple one page format for each analyte. Each one page report comprises seven sub-reports providing a statistical and graphical representation of laboratory performance.

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The text section provides a statistical breakdown of results by all methods, your method and instrument group. The Mean, CV% and Uncertainty or Measurement is presented for each comparison group.

Your laboratory’s result is compared to the Mean for Comparison (usually the instrument group Mean). Also included are the RIQAS performance indicators; SDI, Target Score and %Deviation.

Acceptable performance criteria:

  • SDI <2
  • Target Score >50
  • %Deviation

The defined acceptable limits default to the RIQAS TDPA values but may be based on CLIA, biological variation or country specific limits.

Performance goals based on Biological Variation are also stated within the text section for information purposes.

 

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The histogram chart provides an overview of how your laboratory’s result compares to the all method group, your method group and your instrument group. Your result is represented by a black triangle; the closer to the centre the better.

The chart is intended to provide a quick visualisation of performance compared to other method groups and can be used to identify any potential bias.

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The Levey-Jennings chart plots the last 20 SDI’s and is extremely useful for monitoring EQA performance over time, allowing quick and easy identification of any trends or bias. The chart is colour coded making interpretation simple and easy; results that fall in the white area are excellent and those in the red area unacceptable.

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The Target Score (TS) chart is a unique chart which displays your laboratory’s last 20 target scores delivering an instant, visual indication of performance. The TS chart is conveniently colour coded for even easier performance assessment, a TS >50 is acceptable. The TS is a numerical index relating your %Deviation from the mean to a Target Deviation for Performance Assessment (TDPA).

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The %Deviation by sample chart displays the %Deviation for the last 20 EQA samples enabling identification of trends and shifts in performance. Similar to the other charts on the RIQAS report, the %Deviation by sample chart is shaded to indicate the limit of acceptable performance. A black dot within the white section of the chart will represent results with a %Deviation within your acceptable limits of performance; a black dot within the red section of the chart will represent results with a %Deviation outside your acceptable limits of performance. %Deviations are not influenced by the performance of your peers, as seen with the standard deviation index (SDI) and therefore is a better indicator of individual performance.

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The %Deviation by concentration chart enables easy detection of possible concentration related biases. Unlike the other charts provided on the report, the %Deviation by concentration chart displays the concentration range of the previous 20 samples along the bottom of the chart.

Using this scale along with the percentage deviation, you are provided with a rapid assessment of your %Deviation in relation to the concentration of the:

• Current sample (represented by a square)
• Your 19 previous results (represented by circles)

This chart provides an easy interpretation of potential positive or negative biases at high or low concentrations, or whether a particular sample is a random outlier.

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The Multi Method Stat Section provides you with an easy way of assessing the performance of the other methods used to analyse the parameter. This is useful when your laboratory plans to change the analytical method used for the parameter.

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Located at the back of the standard quantitative report, our quick reference summary page details the performance for each registered parameter in the programme.

Within the performance column, RIQAS provides an effortless method of assessing the performance of each parameter within the sample distribution. When a red triangle appears next to the parameter, this indicates that all performance indicators (SDI, TS and %DEV) have exceeded the performance criteria.

The performance indicator limits for each parameter are exceeded when your result produces:
• An SDI greater than +/- 2 standard deviations.
• A Target Score less than 50 (only when Target Scoring is available)
• A %Deviation greater than your set acceptable limits of performance.

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A summary CSV file is available on request to all participating laboratories. The report provides a summary of all statistics, acceptable limits and performance indicators as a .csv file for each sample in the cycle.

A retrospective statistics summary is also available, four weeks after the final submission date for parameters where a result was not submitted on time.


RIQAS Parameters List

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, 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.

RIQAS Parameter List

#

1-25-(OH)₂-Vitamin D
17-OH-Progesterone
25-OH-Vitamin D
5-HIAA

A

α-1-Acid Glycoprotein
α-1-Antitryspin
α-I-Globulin (Electrophoresis)
α-2-Globulin (Electrophoresis)
α-2-Macroglobulin
ACE (Angiotensin Converting Enzyme)
Acid Phosphatase (Prostatic)
Acid Phosphatase (Total)
ACR
ACTH
AFP
Albumin
Albumin (Electrophoresis)
Aldosterone
Alkaline Phosphatase
ALT (ALAT)
Aluminium
Amikacin
Ammonia
Amylase (Pancreatic)
Amylase (Total)
Androstenedione
Anti Streptolysin O (ASO)
Anti-CMV
Anti-CMV IgG

Anti-CMV IgM
Anti-EBNA IgG
Anti-EBV VCA IgG
Anti-EBV VCA IgM
Anti-HBc
Anti-HCV
Anti-HIV-1
Anti-HIV-1 & 2 Combined
Anti-HIV-2
Anti-HSV- 1 & 2 IgG Combined
Anti-HSV- 1 & 2 IgM Combined
Anti-HSV1 IgG
Anti-HSV1 IgM
Anti-HSV2 IgG
Anti-HSV2 IgM
Anti-HTLV-1 & 2 Combined
Anti-HTLV-I
Anti-HTLV-II
Anti-Rubella IgG
Anti-Rubella IgM
Anti-TG
Antithrombin III
Anti-Toxoplasma IgG
Anti-Toxoplasma IgM
Anti-TPO
Anti-TSH Receptor (TRAb)
Apolipoprotein AI
Apolipoprotein B
aPTT
AST (ASAT)

B

β-2-Microglobulin
β-Globulin (Electrophoresis)
Benzoylecgonine
Bicarbonate
Bile Acids
Bilirubin (Direct)
Bilirubin (Total)
Blood
BNP
Buprenorphine

C

CA15-3
CA19-9
CA125
Cadmium
Caffeine
Calcitonin
Calcium
Calcium (Ionised)
Cannabinoids (THC)
Carbamazepine
CEA
Ceruloplasmin
Chloride
Cholesterol (Total)
Cholinesterase
Chromium
CK, Total
CK-MB (Activity)
CK-MB (Mass)

Cobalt
Complement C₃
Complement C₄
Conductivity
Copper
Cortisol
Cotinine
C-Peptide
C-Reactive Protein (CRP)
Creatinine
Cyclosporine
CYFRA 21-1 (Cytokeratin 19)

D

D-3-Hydroxybutyrate
d-Amphetamine
D-Dimer
DHEA Unconjugated
DHEA-Sulphate
Digoxin
d-Methamphetamine
Dopamine

E

EDDP
Epinephrine
ESR
Estriol Total
Ethanol
Ethosuximide
Everolimus

F

Factor II
Factor IX
Factor V
Factor VII
Factor VIII
Factor X
Factor XI
Factor XII
Ferritin
Fibrinogen
Folate
Free Morphine
free β-hCG
Fructosamine
FSH

G

γ-GT
γ-Globulin (Electrophoresis)
Galactose
Gastrin
Gentamicin
Growth Hormone (GH)
GLDH
Glucose

H

Haematocrit (HCT)
Haemoglobin (Hb)
Haptoglobin
HbA1c
HBsAG
HBDH
hCG

HDL-Cholesterol
Homocysteine
hsCRP

I

IgA
IgE
IGF-1
IgG
IgM
Inhibin A
Insulin
Iodine
Iron

K

Kappa Light Chain (Free)
Kappa Light Chain (Total)
Ketones

L

Lactate
Lambda Light Chain (Free)
Lambda Light Chain (Total)
LD (LDH)
LDL-Cholesterol
Lead
Leukocytes
Leutinising Hormone (LH)
Lipase
Lipoprotein (a)
Lithium
Lorazepam
LSD

M

Magnesium
Manganese
MDMA
Mean Cell Haemoglobin (MCH)
Mean Cell Haemoglobin Concentration (MCHC)
Mean Cell Volume (MCV)
Mean Platelet Volume (MPV)
Metanephrine
Methadone
Methotrexate
Molybdenum
Myoglobin

N

NEFA
Nickel
Nitrite
Norepinephrine
Normetanephrine
Norpropoxyphene
Nortriptyline
NT proBNP

O

Oestradiol
Osmolality
Osteocalcin
Oxalate
Oxazepam

P

PAPP-A

Paracetamol (Acetaminophen)
pCO₂
pH
Phencyclidine
Phenobarbital
Phenytoin
Phosphate (Inorganic)
Plasma Renin Activity
Plasminogen
Plateletcrit (PCT)
Platelets (PLT)
pO₂
Potassium
Prealbumin (Transthyretin)
Primidone
Procalcitonin
Progesterone
Prolactin
Protein (Total)
Protein C
Protein S
PSA (Free)
PSA (Total)
PT (Including INR)
PTH

R

Red Blood Bell Count (RBC)
Red Cell Distribution Width (RDW)
Renin (Direct Concentration)
Retinol Binding Protein
Rheumatoid Factor

S

Salicylic Acid
Secobarbital
Selenium
SHBG
Sirolimus
Sodium
Specific Gravity
Syphilis

T

T₃ (Free)
T₃ (Total)
T₄ (Free)
T₄ (Total)
Tacrolimus
Testosterone (Free)
Testosterone (Total)
Thallium
Theophylline
Thyroglobulin
TIBC
Tobramycin
Total hCG

Total White Blood Cell Count (WBC)
Transferrin
Triglycerides
Troponin I
Troponin T
TSH
TT

U

UIBC
Unconjugated Oestriol
Urea
Uric Acid
Urobilinogen

V

Valproic Acid
Vancomycin
Vitamin B₁₂
VMA

Z

Zinc


Acusera Internal Quality Control Analyte List

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

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

Acusera Parameter List

#

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

A

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

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

B

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

C

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

D

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

DIFF-X
DIFF-Y
Digoxin
Dopamine

E

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

F

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

G

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

H

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

I

Ibuprofen

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

K

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

L

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

M

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

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

N

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

O

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

P

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

Q

Quinolones (Generic)

R

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

S

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

T

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

U

Unconjugated Estriol
Urea
Uric Acid (Urate)
Urobilinogen

V

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

W

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

Z

Zaleplon
Zeronal
Zinc
Zolpidem
Zopiclone


Product Spotlight: Maternal Screening

Product Spotlight: Maternal Screening Control

Maternal Screening Control

Background

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

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

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

Product Overview

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

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

Key Benefits & Features

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

Consolidation

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

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

First and second trimester

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

True third party control

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

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

Analytes

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

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

Product Spotlight Archive

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


Product Spotlight: Liquid CSF Control

Liqiuid CSF Control - Product Spotlight

Liquid CSF Control

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

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

Product Overview

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

Key Features & Benefits

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

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

A True Third Party Control

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

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

Analytes

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

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

Product Spotlight Archive

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


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