Featured Reagent – Lp(a)

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Featured Reagent – Lp(a)

Featured Reagent | Lipoprotein(a)

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Current Challenges

The biggest challenge that exists surrounding Lp(a) measurement is the heterogeneity of the apo(a) isoforms, resulting in the underestimation or overestimation of Lp(a) concentrations. In immunoassays, the variable numbers of repeated KIV-2 units in Lp(a) act as multiple epitopes. This is where standardisation across calibrators is vital. If the calibrants do have the same range of isoforms as test samples, those with higher numbers of the KIV-2 repeat, will represent with an overestimation in Lp(a) concentrations and those with smaller numbers of the KIV-2 repeat, will represent with an underestimation. The smaller isoforms are strongly associated with higher Lp(a) concentrations. Lack of standardisation of the calibrant would result in an underestimation of Lp(a) associated CVD risk. It is important to note that an Lp(a) immunoassay employing isoform insensitive antibodies does not exist 6.

Physiological Significance

Lipoprotein (a) [Lp(a)] is described as “the most complex and polymorphic of the lipoprotein particles”. Composed of a low-density lipoprotein (LDL) particle, an apolipoprotein(a) [apo(a)] particle which is covalently bonded to the apoB-100 via a disulphide bridge 1. Lp(a) is believed to have a chemical weight between 1.05 to 1.21 g/ml 2. Lp(a) behaves very differently to other apoB particles; LDL-C / sdLDL-C 3.

Apo(a) is the main component that distinguishes LDL from Lp(a) (Fig 2). Apo(a) is a large glycoprotein belonging to the plasminogen gene superfamily 1, 2. Comprised of five cysteine-rich domains called kringles, which are encoded by the LPA gene, located on the long (q) arm of chromosome 6 at positions 26 and 27 (6q26-27), and the plasminogen (PLG) gene, also located on the long (q) arm of chromosome 6 at position 26 (6q26) 2, 4, 5.

The PLG gene is believed to encode 5 kringles (types 1 to V) as well as an active protease domain. Conversely, kringles IV and V and an inactive protease domain are present in apo(a) 2. Apo(a) is described as polymorphic as the kringle type IV undergoes duplication, coding for 10 kringle IV types (K1 through K10).

The gold standard Lp(a) method is the Northwest Lipid Metabolism and Diabetes Research Laboratory (NLMDRKL) method which employs an isoform insensitive antibody and is meticulously calibrated with well characterised material, however, this test is not commercially available 6.

All kringles, except for K2, are present as single copies. K2 is present in multiple copies, ranging from 2 to >40, within the apo(a) proteins of distinct sizes (Fig 2). The number of K2 repeats determines the size of the apo(a) isoform, thus heterogeneously affecting the size of the apo(a) protein and the plasma levels of Lp(a). An inverse correlation between the size of the apo(a) isoform and plasma concentrations of Lp(a) has been identified 2.

Did you know?

Lp(a) should be measured utilising a method where the effect of the apo(a) isoform size has been minimised using calibrators that are certified against the WHO/IFCC reference material 5.

Benefits of Lp(a)

WHO/IFCC reference material – The Randox Lp(a) assay is calibrated in nmol/l and traceable to the WHO/IFCC reference material (IFCC SRM 2B) and provides an acceptable bias compared with the Northwest Lipid Metabolism Diabetes Research Laboratory (NLMDRKL) gold standard method.

Dedicated calibrator & control available – Five point calibrator with accuracy-based assigned target values (in nmol/l) is available, accurately reflecting the heterogeneity of the apo(a) isoforms. Dedicated Lp(a) control is available offering a complete testing package.

Excellent correlation – A correlation coefficient of r=0.995 was displayed when the Randox method was compared against other commercially available methods.

Precision Excellent precision – The Randox Lp(a) assay displayed a within run precision of <2.54%.

Liquid ready-to-use – The Randox Lp(a) assay is available in a liquid ready-to-use format for convenience and ease-of-use.

Applications available – Instrument-specific settings can be provided for a wide range of clinical chemistry analysers.

Clinical Significance

Lp(a) has been identified as a potent risk factor for calcific aortic valve stenosis. Understanding a patients Lp(a) levels could aid in informing the selection of the interval for valve surveillance as patients with elevated Lp(a) levels are likely to require earlier intervention 6.

Lp(a) measurement could be of value in those with a family history of premature CVD (<60 years), especially when a causative mutation for familial hypercholesterolemia (FH) hasn’t been identified.

In patients with heterozygous FH (HeFH), Lp(a) levels are higher compared to their non-affected siblings. Lp(a) has been identified as a strong risk factor of coronary heart disease (CHD) in patients with HeFH, independent of age, sex, smoking status, and LDL-C levels 6.

Lp(a) measurements aids in the re-classifying of those deemed at an intermediate CVD risk. Patients who over 10 years have >15% risk of a CV event should be receiving treatment, such as statin therapy irrespective of Lp(a) levels. The uptake of statin therapy in the UK as a primary prevention method for those deemed at an intermediate risk of CVD is poor 5. In the ‘Statin initiations and QRISK2 scoring in UK general practice: a THIN database study’ concluded that most patients deemed at a high risk of CVD were not initiated on statin therapy 7. Only 14% of patients with a 10-year CVD risk (10 – 19.9% risk) were initiated on statin therapy with one in six statin initiations were to low-risk patients 6, 8.

Fig 3: Lp(a) Infographic 7

  • WHO/IFCC Reference Material
  • HEART UK

The International Federation of Clinical Chemistry and Laboratory Medicine (IFCC), through its Working Group on Lp(a) and together with research institutions and several diagnostic companies recommends that laboratories use assays which do not suffer from apo(a) size-related bias. The IFCC SRM 2B was accepted by the WHO Expert Committee on Biological Standardisation as the First WHO/IFCC International Reference Reagent for Lp(a) to ensure conformity by diagnostic companies to the European Union’s Directive on In vitro Diagnostic Medical Devices for the metrological traceability of calibrator materials 9.

References

[1] Marcovina SM, Albers JJ. Lipoprotein (a) measurements for clinical application. Journal of Lipid Research 2019; 57(): 526-537.

[2] Nordestgaard BG, Chapman MJ, Ginsberg HN. Lipoprotein (a): EAS Recommendations for Screening, Desirable Levels and Management, 1st ed. Dorset: Sherborne Gibbs Limited; 2012.

[3] AMGEN Science. 10 Things to Know About Lipoprotein(a). https://www.amgenscience.com/features/10-things-to-know-about-lipoproteina/ (accessed 17 December 2019).

[4] Bermudez V, Rojas J, Salazar J, Bello L, Anez R, et al. Variations of Lipoprotein(a) Levels in the Metabolic Syndrome: A Report from the Maracaibo City Metabolic Syndrome Prevalence Study. Journal of Diabetes Research 2013; 2013(416451): 1-12. https://www.hindawi.com/journals/jdr/2013/416451/ (accessed 29 November 2019).

[5] Genetics Home Referencing. PLG gene. https://ghr.nlm.nih.gov/gene/PLG (accessed 29 November 2019).

[6] Cegla J, Dermot R, Neely G, France M, Ferns G, et al. HEART UK consensus statement on Lipoprotein(a): A call to action. Atherosclerosis 2019; 291(): 62-70.

[7] McGill University Health Centre. What is high lipoprotein(a), and should I be concerned?. https://medicalxpress.com/news/2017-02-high-lipoproteina.html (accessed 17 December 2019)

[8] Finnikin S, Ryan R, Marshall T. Statin initiations and QRISK2 scoring in UK general practice: a THIN database study. British Journal of General Practice 2017; 67(665): 881-887. https://bjgp.org/content/67/665/e881.long (accessed 3 December 2019).

[9] Dati F, Tate JR, Marcovina SM, Steinmetz A, et al. First WHO/IFCC International Reference Reagent for Lipoprotein(a) for Immunoassay–Lp(a) SRM 2B. Clinical Chemistry and Laboratory Medicine 2004; 42(6): 670-676.

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Randox develop a range of applications for a wide range of third-party analysers, including the ones listed below, so that laboratories worldwide can enjoy the benefits of freedom of choice from an independent manufacturer. For more information on the analysers below or any others that you don’t see listed, please email us.

Beckman Synchron CX4 / 5 / 7 / 9 / LX20 / DxC

Biolis 24i / Prestige 24i

Ortho Vistros 5600 / 5 / i FS / 4600

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Vitalab Flexor / Selectra E / Selectra II

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Siemens Atellica

Randox Acetaminophen Reagent

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We develop a range of applications for the Siemens Atellica analyser so that laboratories worldwide can enjoy the benefits of freedom of choice from an independent manufacturer, Randox Laboratories.

Randox Applications for Siemens Atellica

We have 31 reagents available for the Siemens Atellica, and are always developing more. If you don’t see the application you are looking for, please email us to request an application. All kits are produced to international standard and have ISO 13485 accreditation.

Aldoase
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Apolipoprotein C-II
Apolipoprotein C-III
Apolipoprotein E
Bile Acids
Cholesterol sdLDL
CK-MB
Creatinine
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Ferritin
G6PDH
GLDH
Glucose
Glutamate
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IgE
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Myoglobin
NEFA
Superoxide Dismutase (Ransod)
Syphilis
Total Antioxidant Status (TAS)
Urinary Protein
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Randox Acetaminophen Reagent

Applications for Mindray BS Series

We develop a range of applications for the Mindray BS Series (120 / 200 / 300 / 400) analysers so that laboratories worldwide can enjoy the benefits of freedom of choice from an independent manufacturer, Randox Laboratories.

Applications for Mindray BS Series

We have 74 reagents available for the Mindray BS Series (120 / 200 / 300 / 400), and are always developing more. If you don’t see the application you are looking for, please email us to request an application. All kits are produced to international standard and have ISO 13485 accreditation.

Albumin
Aldolase
Alkaline Phosphatase
ALT
Ammonia
Amylase
Apolipoprotein A-I
Apolipoprotein B
ASO
AST
ß2 Microglobulin
Bile Acids
Bilirubin
Calcium
Cholesterol Total
Cholesterol HDL
Cholesterol LDL
Cholesterol sdLDL
Cholinesterase (Butyryl)
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Ethanol
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Gamma GT
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Glucose
Glutathione Peroxidase (Ransel)
Glutathione Reductase
Haptoglobin
HbA1c
Homocysteine
IgA
IgE
IgG
IgM
Iron
L-Lactate
LD Lactate – Pyruvate
LD Pyruvate – Lactate
Lipase
Lipoprotein (a)
Malic Acid

Magnesium
Microalbumin
NEFA
Phosphorus
Potassium
Primary Amino Nitrogen
Rheumatoid Factor (RF)
Sodium
Superoxide Dismutase (Ransod)
Total Antioxidant Status (TAS)
Total Iron Binding
Capacity (TIBC)
Total Protein
Transferrin
Transthyretin (Prealbumin)
Triglycerides
Urea
Uric Acid
Urinary Protein
Zinc

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Thermo Konelab

Randox Acetaminophen Reagent

Applications for Thermo Konelab

We develop a range of applications for the Thermo Konelab (20i / 30i / 60i) analysers so that laboratories worldwide can enjoy the benefits of freedom of choice from an independent manufacturer, Randox Laboratories.

Randox applications available for Thermo Konelab

We have 86 reagents available for the Thermo Konelab (20i / 30i / 60i), and are always developing more. If you don’t see the application you are looking for, please email us to request an application. All kits are produced to international standard and have ISO 13485 accreditation.

Albumin
Aldolase
Alkaline Phosphatase
ALT
Ammonia
Amylase
Apolipoprotein A-I
Apolipoprotein A-II
Apolipoprotein B
Apolipoprotein C-II
Apolipoprotein C-III
Apolipoprotein E
ASO
AST
ß2 Microglobulin
Bile Acids
Bilirubin
Calcium
Carbamazepine
Cholesterol Total
Cholesterol HDL
Cholesterol LDL
Cholesterol sdLDL
Cholinesterase (Butyryl)
CK-MB
CK-NAC
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Complement C3
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Copper
Creatinine
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CRP Canine
CRP Full Range
CRP High Sensitivity
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Digoxin
Ethanol
Fructosamine (Glycated Protein)
G6PDH
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Glucose
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Homocysteine
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IgE
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LD Lactate – Pyruvate

Lipase
Lipoprotein (a)
Magnesium
Microalbumin
Myoglobin
NEFA
Phenobarbital
Phenytoin
Phosphorus
Potassium
Rheumatoid Factor (RF)
Sodium
Superoxide Dismutase (Ransod)
Total Antioxidant Status
Total Iron Binding
Capacity (TIBC)
Total Protein
Transferrin
Transthyretin (Prealbumin)
Triglycerides
Urea
Uric Acid
Urinary Protein
Valproic Acid
Zinc

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Siemens Dimension RxL/ Xpand

Randox Acetaminophen Reagent

Applications for Siemens Dimension RxL/Xpand

We develop a range of applications for the Siemens Dimension RxL/ Xpand analysers so that laboratories worldwide can enjoy the benefits of freedom of choice from an independent manufacturer, Randox Laboratories.

We have 31 reagents available for the Siemens Dimension RxL/ Xpand, and are always developing more. If you don’t see the application you are looking for, please contact us to request an application. All kits are produced to international standard and have ISO 13485 accreditation.

Randox applications available

Albumin
Aldolase
ALT
Amylase
Apolipoprotein A-I
Apolipoprotein B
ASO
Bile Acids
Ceruplasmin
Cholesterol sdLDL
CK-MB
Complement C3
Complement C4
Creatinine

CRP
CRP Canine
D-3 Hydroxybutyrate (Ranbut)
Fructosamine (Glycated Protein)
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Glucose
Glutathione Reductase
Glycerol
Haptoglobin
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NEFA
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Rheumatoid Factor (RF)
Superoxide Dismutase (Ransod)
Transthyretin (Prealbumin)
Total Protein
Transferrin
Uric Acid
Urinary Protein
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Hitachi 917/Modular P

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Applications for Hitachi 917 / Modular P

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Hitachi 917 / Modular P Applications

We have 90 reagents available for the Hitachi 917 and Modular P, and are always developing more. If you don’t see the application you are looking for, please email us to request an application. All kits are produced to international standard and have ISO 13485 accreditation.

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Ammonia
Amylase
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Apolipoprotein A-II
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Apolipoprotein C-III
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ASO
AST
ß2 Microglobulin
Bile Acids
Bilirubin
Calcium
Carbamazepine
Cholesterol Total
Cholesterol HDL
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Cholinesterase (Butyryl)
CK-MB
CK-NAC
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Complement C4

Copper
Creatinine
CRP
CRP Canine
CRP Full Range
CRP High Sensitivity
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Digoxin
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Ferritin
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Glutamate
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IgE
IgG
IgM
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L-Lactate
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Lipase
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Microalbumin
Myoglobin
NEFA
Phenobarbital
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(Ransod)
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Capacity (TIBC)
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Transferrin
Transthyretin (Prealbumin)
Triglycerides
Urea
Uric Acid
Urinary Protein
Valproic Acid
Zinc

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Hitachi 717/911/912

Applications for Hitachi 717 / 911 / 912 Analysers

Randox have developed a range of applications suitable for the Hitachi 717 /911 /912 analysers, so that laboratories worldwide can enjoy the benefits of freedom of choice from an independent manufacturer.

Hitachi 717 / 911 / 912 Applications

We have 83 reagents available for the Hitachi 717 / 911 / 912, and are always developing more. If you don’t see the application you are looking for, please email us to request an application. All kits are produced to international standard and have ISO 13485 accreditation.

Please note: The Hitachi 717 analyser does not have a barcode reading facility therefore Easy Read kits for this analyser will require the necessary ISA

Acetic Acid
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ALT
Ammonia
Amylase
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Apolipoprotein A-I
Apolipoprotein A-II
Apolipoprotein B
Apolipoprotein C-II
Apolipoprotein C-III
ASO
Apo E
AST
ß2 Microglobulin
Bile Acids
Bilirubin
Calcium
Carbamazepine
Cholesterol Total
Cholesterol HDL
Cholesterol LDL
Cholesterol sdLDL
Cholinesterase (Butyryl)
CK-MB
CK-NAC

CO2 Total
Complement C3
Complement C4
Creatinine
CRP
CRP Canine
CRP Full Range
CRP High Sensitivity
Cystatin C
D-3 Hydroxybutyrate (Ranbut)
Digoxin
Ethanol
Ferritin
Fructosamine (Glycated Protein)
G6PDH
Gamma GT
GLDH
Glucose
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Glutathione Reductase
Glycerol
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HbA1c
IgA
IgE
IgG
IgM

L-Lactate
LD Lactate – Pyruvate
Lipase
Lipoprotein(a)
Magnesium
Microalbumin
Myoglobin
NEFA
Phenobarbital
Phenytoin
Phosphorus
Potassium
Rheumatoid Factor (RF)
Sodium
Superoxide Dismutase (Ransod)
Total Antioxidant Status(TAS)
Total Iron Binding
Capacity (TIBC)
Total Protein
Transferrin
Transthyretin (Prealbumin)
Triglycerides
Urea
Uric Acid
Urinary Protein
Valproic Acid
Zinc

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Glutamine

Reagent | Glutamine

Key Benefits

Wide measuring range

The Randox Glutamine assay has a wide measuring range of 0.14 – 10 mmol/l

Limited interference

Glutamate at 10 mmol/l was found not to interfere with Glutamine concentrations of 0.5 mmol/l and 3.0 mmol/l

Excellent stability

Reconstituted stability of 7 days on board the analyser when stored at 10°C

Other features

  • Colorimetric method
  • Lyophilised reagents
  • Stable to expiry when stored at 2-8°C
  • Measuring range 0.14-10 mmol/l
  • For Biotechnology Industrial Use. Not for use in diagnostic procedures

Ordering information

Cat NoSize    
GM1373R1 4 x 16ml
R2 4 x 6.7ml
EnquireKit Insert RequestMSDSBuy Online

Instrument Specific Applications (ISA’s) are available for a wide range of biochemistry analysers.  Contact us to enquire about your specific analyser.

Clinical Chemistry Panel

For more information or to view more reagents within the clinical chemistry panel, please click here


Microalbumin Assay

Reagent | Microalbumin

Microalbumin: An Independent Predictor of Progressive Renal Disease

Benefits of the Randox Microalbumin Assay

Exceptional correlation

A correlation coefficient of r=0.99 was displayed when the Randox microalbumin assay was compared to commercially available methods.

Excellent precision

The Randox microalbumin assay displayed a precision of <4.8% CV.

Extensive measuring range

The Randox microalbumin assay has a measuring range of 4.06 – 396mg/l for the comfortable detection of clinically important results.

Liquid ready-to-use

The Randox microalbumin assay is available in a liquid ready-to-use format for convenience and ease-of-use.

Dedicated calibrator & controls available

Dedicated calibrator and controls available offering a complete testing package.

Applications available

Applications available detailing instrument-specific settings for the convenient use of the Randox microalbumin assay on a variety of clinical chemistry analsyers.

Ordering Information

Cat NoSize    
MA2426R1 1 x 60ml (C)
R2 1 x 7ml
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MA3828R1 6 x 20ml
R2 3 x 8ml
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MA8056R1 2 x 20ml
R2 2 x 6.6ml
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MA8325R1 1 x 20ml
R2 1 x 4.6ml
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MA4072R1 3 x 20ml
R2 3 x 7.5ml
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MA8388R1 1 x 20ml
R2 1 x 7.8ml
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MA8160R1 2 x 20ml
R2 2 x 9ml
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(C) Indicates calibrator included in kit

Instrument Specific Applications (ISA’s) are available for a wide range of biochemistry analysers.  Contact us to enquire about your specific analyser.

  • PHYSIOLOGICAL SIGNIFICANCE
  • Clinical Significance

Albumin is one of the major plasma proteins and is usually present in very low concentrations in urine. Damage to the glomerular basement membrane can alter its permeability meaning albumin and other proteins usually reabsorbed and recirculated in the blood enter the urine. Sustained elevations of urinary albumin concentrations are called microalbuminuria 1.

Microalbuminuria is strongly associated with poor glycaemic control, hypertension and other diabetic complications including ischaemic heart disease, diabetic retinopathy and neuropathy. Microalbumin is an early biomarker of diabetic nephropathy, the most common complication of type 2 diabetes mellitus (T2DM) 2. Microalbuminuria is an independent predictor of progressive renal disease and cardiovascular mortality. Due to the increasing prevalence of obesity, type 2 diabetes and metabolic syndrome in children, screening for microalbuminuria seems highly relevant in the paediatric population to detect and prevent cardiovascular disease 3.

Microalbumin Calibrator

Microalbumin Control

Human Urine EQA

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  • Rejestracja na naszej liście mailowej jest szybka i łatwa. Nie chcemy wysyłać e-maili zawierających spam lub wiadomości, które są automatycznie przekierowywane do kosza. W zawiązku z czym firma Randox deklaruje, że będzie wysyłac tylko informacje na temat nowych produktów,akutalizacji obecnych, trendów rynkowych, wydarzeń branżowych itp. Firma Randox Laboraotries obiecuje, że Państwa dane nie będą nigdzie przekazane, a przechowywanie owych danych będzie się odbywało z zachowaniem największego bezpieczeństwa. Prosimy o przeczytani naszje Polityki Prywatności.
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  • Rejestracja na naszej liście mailowej jest szybka i łatwa. Nie chcemy wysyłać e-maili zawierających spam lub wiadomości, które są automatycznie przekierowywane do kosza. W zawiązku z czym firma Randox deklaruje, że będzie wysyłac tylko informacje na temat nowych produktów,akutalizacji obecnych, trendów rynkowych, wydarzeń branżowych itp. Firma Randox Laboraotries obiecuje, że Państwa dane nie będą nigdzie przekazane, a przechowywanie owych danych będzie się odbywało z zachowaniem największego bezpieczeństwa. Prosimy o przeczytani naszje polityki prywatności.
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