Valproic Acid

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Valproic Acid

Reagent | Valproic Acid

Valporic Acid Key Benefits

Applications available

For a wide variety of clinical chemistry analysers including the RX series

Strong correlation

The Valproic Acid assay showed a correlation coefficient of 0.99 against another commercially available method

Limited interference

From Bilirubin, Haemoglobin, Intralipid® and Triglycerides

Valproic Acid (Latex Enhanced Immunoturbidimetric) features

  • Latex Enhanced Immunoturbidimetric method
  • Liquid ready-to-use reagents
  • Stable to expiry date when stored at +2 to +8°C
  • Measuring range 8.64-150 µg/ml
  • Applications available

Ordering information

Cat NoSize
TD3414R1 2 x 12ml (L)
R2 2 x 5ml
EnquireKit Insert RequestMSDSBuy 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 Valproic Acid assay used for?

Valproic acid is a widely used anti-epileptic drug. It is used in the treatment of primary and secondary generalised seizures. Valproic acid has also become increasingly effective in the control of partial seizures. Measurements obtained by this device are used in the diagnosis and treatment of valproic acid overdose and in monitoring levels of valproic acid to ensure appropriate therapy. Within the therapeutic range most individuals will respond well to valproic acid treatment however, the side effects associated with toxicity of this drug can include tremors, gastrointestinal problems, dizziness and vision problems.

Therapeutic Drug Monitoring Panel

For more information or to view more reagents within the therapeutic drug monitoring panel, please click here


Phenobarbital

Reagent | Phenobarbital

Key Benefits

Exceptional correlation

The Phenobarbital assay showed a correlation of r=0.98 against another commercially available method

Applications available

For a wide variety of clinical chemistry analysers including the RX series

Wide measuring range

The Randox Phenobarbital assay has a wide measuring range of 2.55-87.7 µg/ml, capable of detecting levels beyond the therapeutic range of 15-30 µg/ml in infants and children under 5 and 15 – 40 µg/ml in adults

Randox Phenobarbital (Latex Enhanced Immunoturbidimetric)

  • LEI method
  • Liquid ready-to-use reagents
  • Stable to expiry when stored at 2-8⁰C
  • Measuring range of 2.55 – 87.7 μg/ml
  • Limited interference from Bilirubin, Haemoglobin, Intralipid® and Triglycerides
Cat NoSize
TD3408R1 2 x 17ml (L)
R2 2 x 6ml
EnquireKit Insert RequestMSDSBuy 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 Phenobarbital assay used for?

Phenobarbital is an anti-epileptic and sedative-hypnotic drug. The side effects associated with an incorrect phenobarbital prescription can include drowsiness, depression, headaches and dizziness.

Therapeutic Drug Monitoring Panel

For more information or to view more reagents within the therapeutic drug monitoring panel, please click here


Canine CRP Reagent

Key Benefits of the Canine CRP reagent

Calibrator included in the kit

A calibrator is included in the Randox Canine CRP kit making the Randox reagent extremely cost-effective

Wide measuring range

The Randox Canine CRP reagent can comfortably detect high levels of CRP in the blood of canines with a measuring range of 5 – 200 mg/l

Excellent stability

Stable until expiry date when stored at +2 to +8⁰C

Other features of the Randox Canine CRP reagent

  • Immunoturbidimetric method
  • Liquid ready-to-use reagents
  • Stable until expiry date when stored at +2 to +8⁰C
  • Measuring range 5 – 200 mg/l
  • Calibrator included in the kit
Cat NoSize
CP10389R1 2 x 18.1ml (C) (L)
R2 2 x 5ml
EnquireKit Insert RequestMSDSBuy Online
(L) Indicates liquid option
(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.

What is the Canine CRP assay used for?

What is Canine CRP?

C – reactive protein (CRP) is an acute phase protein produced by the liver in response to inflammation, infection and tissue injury.

Elevated concentration levels of CRP occur much earlier compared to other acute phase reactants, usually within 4 to 6 hours. This rapid response to trauma or infection is what distinguishes the features of CRP. In addition, CRP levels return to normal quickly at the end of an acute episode making CRP useful for both the detection of acute inflammation episodes as well as monitoring CRP treatment.  For more information on inflammatory episodes in canines, please click here [external link].

What is the Canine CRP assay used for?

As in humans, CRP is used as a marker of inflammatory activity, but with the Randox Canine CRP test, CRP can be tested in dogs as opposed to humans and uses the same high-quality materials as our human assay.  CRP in canines has been useful in determining the severity of the inflammation as CRP in healthy dogs is present in low concentrations (5 mg/dl) but can elevate to 600 mg/dl depending on the severity of the inflammation.  CRP can be useful in determining if a dog is pregnant as CRP levels increase to 80 mg/dl around four to five weeks after ovulation and return to normal five weeks later. Canine CRP is also useful as a treatment-independent marker such as treatment for inflammation using steroids or antibiotics.  Canine CRP is commonly used to diagnose viral and bacterial infections and infectious diseases including:

  • Pancreatitis
  • Neoplasia
  • Steroid-responsive meningitis arteritis
  • Valvular disease
  • Parvoviral enteritis
  • Nasal disease
  • Inflammatory bowel disease
  • Cystitis
  • Other possible uses for CRP testing are assessing tissue injury and as a marker for naturally occurring renal disease.

The Randox Canine CRP reagent is used as a marker of inflammatory activity for the in vitro determination of CRP in canines.

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    Veterinary Panel

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    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 NoSize
    IM38343 x 20ml (L)EnquireKit Insert RequestMSDSBuy Online
    IM8045R1 4 x 10.5ml (L)
    R2 4 x 4ml
    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.

    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

    For more information or to view more reagents within the specific proteins panel, please click here


    Lipoprotein(a) Assay

    Reagent | Lipoprotein(a) Assay

    Traceable 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) and provides an acceptable bias compared 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

    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

    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 NoSize
    LP2757R1 1 x 30ml (L)
    R2 1 x 15ml
    EnquireKit Insert RequestMSDSBuy Online
    LP3403R1 1 x 10ml (L)
    R2 1 x 6ml
    EnquireKit Insert RequestMSDSBuy Online
    LP8054R1 2 x 8.7ml (L)
    R2 2 x 5.8ml
    EnquireKit Insert RequestMSDSBuy 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.

    • Challenges
    • Clinical Significance
    • Frequency of Testing
    • WHO/IFCC
    • HEART UK
    • COVID-19

    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 that are standardised to the WHO/IFCC reference material, transferring values from mg/dl to nmol/l are more uniformed. The Denka Seiken Lp(a) assay is the most reliable commercially available Lp(a) assay, because 1:

    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.

    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 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


    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 NoSize
    CP3847R1 2 x 11ml (L)
    R2 2 x 11ml
    EnquireKit Insert RequestMSDSBuy Online
    CP3849R1 4 x 50ml (L)
    R2 4 x 50ml
    EnquireKit Insert RequestMSDSBuy Online
    CP8315R1 4 x 10ml (L)
    R2 4 x 10ml
    EnquireKit Insert RequestMSDSBuy 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.


    Featured Reagent – Lp(a)

    Featured Reagent | Lipoprotein(a)

    Back to Reagents Resource Hub >

     

    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 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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