IgM
Reagent | IgM (Immunoturbidimetric)
Key Benefits
Excellent precision
The IgM assay showed a precision of less than 3.5% CV
Exceptional correlation
The assay showed a correlation of r=0.98 against another commercially available method
Completely automated protocols
Available for a wide range of analysers
| Cat No | Size | ||||
|---|---|---|---|---|---|
| IM3834 | 3 x 20ml (L) | Enquire | Kit Insert Request | MSDS | Buy Online |
| IM8045 | R1 4 x 10.5ml (L) R2 4 x 4ml | Enquire | Kit Insert Request | MSDS | Buy Online |
Instrument Specific Applications (ISA’s) are available for a wide range of biochemistry analysers. Contact us to enquire about your specific analyser.
What is IgM assay used for?
IgM measurement has the following uses: to establish diagnosis and monitor therapy in Waldenström’s macroglobulinemia and plasma cell myeloma, to detect intra-uterine infection by measuring levels in new born babies, diagnosis of primary biliary cirrhosis, viral hepatitis, rheumatoid arthritis and parasitic infections.
Sample containing human IgM is suitably diluted and then reacted with specific antiserum to form a precipitate, which is measured turbidimetrically at 340 nm. By constructing a standard curve from the absorbances of standards, the IgM concentration of a sample can be determined.
Specific Proteins Panel
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Lipoprotein(a) Assay
Powered by BiozTraceable to the WHO/IFCC Reference Material
Benefits of the Randox Lp(a) Assay
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), providing minimal bias. Measuring Lp(a) in nmol/L accurately reflects particle concentration and avoids size-related bias present in traditional mass-based methods, ensuring consistency with the Northwest Lipid Metabolism Diabetes Research Laboratory (NLMDRKL) gold standard method.
Dedicated Five-Point Calibrator 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 and Precision
The Randox Lp(a) assay demonstrates excellent performance, evidenced by a correlation coefficient of r=0.995 when compared with other commercially available methods and a within-run precision of less than 2.54%.
510(K) Cleared
Randox’s Lp(a) assay has received FDA 510(k) clearance, signifying its safety and effectiveness and ensuring healthcare professionals can trust its accurate and reliable cardiovascular risk assessments.
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
Applications are available detailing instrument-specific settings for the convenient use of the Randox Lp(a) assay on a wide range of clinical chemistry analysers.
Ordering information
| Cat No | Size | ||||
|---|---|---|---|---|---|
| LP2757 | R1 1 x 30ml (L) R2 1 x 15ml | Enquire | Kit Insert Request | MSDS | Buy Online |
| LP3403 | R1 1 x 10ml (L) R2 1 x 6ml | Enquire | Kit Insert Request | MSDS | Buy Online |
| (L) Indicates liquid option | |||||
Instrument Specific Applications (ISA’s) are available for a wide range of biochemistry analysers. Contact us to enquire about your specific analyser.
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. Unless 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 1.
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 1.
Lp(a) assays standardized to the WHO/IFCC reference material and transferring values from mg/dL to nmol/L are more uniform. The European Atherosclerosis Society (EAS) recommends using nmol/L for measuring Lp(a) because it provides a more accurate reflection of particle concentration and reduces bias caused by isoform size variations. . This method helps laboratories with legacy systems transition more easily while maintaining comparability.
The Denka Seiken Lp(a) assay is the most reliable commercially available Lp(a) assay because:
1. The isoform size variations are reduced as a range of calibrators from separate pools of serum were used which covered a range of Lp(a) concentrations.
2. The isoform size and concentrations are inversely correlated better matching calibrants with test samples.
3. Methods based on the Denka Lp(a) assay, calibrated in nmol/l and traceable to WHO/IFCC reference material gave acceptable bias compared with the NLMDRL gold standard method.
Thirty percent of mortality associated with cardiovascular disease (CVD) occurs in individuals without elevated conventional risk factors. This statistic underscores the clinical need to expand the range of diagnostic tools available for assessing an individual’s risk of developing CVD. One such tool is the measurement of lipoprotein(a) [Lp(a)], which can be particularly valuable in individuals 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 1.
Understanding a FH patients Lp(a) levels can aid the physician in identifying the patient’s risk of a cardiovascular event and in the evaluation of treatment methods. However, Lp(a) is not a predictor of CHD in HeFH patients on currently available cholesterol-lowering treatment but may be when lower LDL-C levels are achieved. On this basis, it is recommended that Lp(a) levels are measured in all genetic dyslipidaemias 1.
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 1.
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 1. 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 2. 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 1, 2.
Lp(a) is believed to remain relatively stable over a lifespan as Lp(a) is predominantly genetically determined. Lp(a) testing is believed to more cost effective in comparison to genetic testing at this time. A single Lp(a) test is believed to be enough to improve the accuracy of cardiovascular risk assessment, however, qualification levels that are close to the action thresholds should be considered on a case-by-case basis. Repeat testing can be initiated if a secondary cause is suspected or therapeutic measures to lower Lp(a) levels have been instigated 1. The once-only recommendation for Lp(a) testing is consistent with the recently published European Guidelines 3, however HEART UK 1, recommend that Lp(a) are measured in specific cohorts as opposed to all adults. Currently, Lp(a) screening is not currently advocated by the HEART UK consensus panel. The European guideline aims to identify those at a very high risk (Lp(a) levels >430nmol/l), however, HEART UK argues that the risk conferred by Lp(a) occurs at a much lower threshold. Consequently, the HEART UK approach is to measure Lp(a) in specific populations and manage Lp(a) associated risk in those with levels >90nmol/l 1.
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 4.
Lp(a) has been identified to play a role in COVID-19. Those with either baseline elevated Lp(a) or those whose Lp(a) levels increased following infection from COVID-19, or both, may be at a significantly increased risk of developing thromboses. Elevate Lp(a) levels may cause acute destabilisation of pre-existing but quiescent, atherosclerotic plaques, which could induce an acute myocardial infarction and stroke 5.
Related products
Lp(a) Calibrator
Lp(a) Control
Lipid EQA Scheme
Reagents Resource Hub
Publications
References
Full Range CRP
Reagent | CRP Full Range
Key Benefits
Limited Interference
From Conjugate and Free Bilirubin, Haemoglobin, Intralipid and Triglycerides
Excellent stability
Stable to expiry when stored at 2-8⁰C
Methodology
Latex enhanced Immunoturbidimetric method
Ordering Information
| Cat No | Size | ||||
|---|---|---|---|---|---|
| CP3847 | R1 2 x 11ml (L) R2 2 x 11ml | Enquire | Kit Insert Request | MSDS | Buy Online |
| CP3849 | R1 4 x 50ml (L) R2 4 x 50ml | Enquire | Kit Insert Request | MSDS | Buy Online |
| CP8315 | R1 4 x 10ml (L) R2 4 x 10ml | Enquire | Kit Insert Request | MSDS | Buy Online |
| (L) Indicates liquid option | |||||
Instrument Specific Applications (ISA’s) are available for a wide range of biochemistry analysers. Contact us to enquire about your specific analyser.
What is the Full Range CRP assay used for?
The extended reporting capability of the Randox Full Range CRP assay enables labs to improve efficiency, save time and costs by using a single method for both low and elevated CRP concentrations. Full Range CRP is particularly useful for the early detection of bacterial infections in new-born babies, where initial values are very low and can rise rapidly with the onset of infection.
A complete clinical history is required for accurate interpretation of CRP levels. CRP levels within the normal range may be affected by a number of different factors and should always be compared to previous values.
Protected: Cardiology & Lipid Testing Panel
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.
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
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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Other Instruments
Applications available for third-party analysers
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
Pentra 400
Siemens Dimension RXL / Xpand
Vitalab Flexor / Selectra E / Selectra II
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Siemens Atellica
Applications for Siemens Atellica
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 18 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.
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Mindray BS
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)
CK-MB
CK-NAC
CO2
Total
Complement C3
Complement C4
Copper
Creatinine
CRP
CRP Canine
Cystatin C
D-3 Hydroxybutyrate (Ranbut)
Ethanol
Ferritin
Fructosamine
G6PDH
Gamma GT
GLDH
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
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 85 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.
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Siemens Dimension RxL/ Xpand
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 44 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
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