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Phenytoin

Reagent | Phenytoin

Key Benefits

Exceptional correlation

The Phenytoin assay showed a correlation of r=0.99 against another commercially available method

Wide measuring range

The Randox Phenytoin assay has a wide measuring range of 2.9-44.5 µg/ml, capable of detecting levels beyond the therapeutic range of 10-20 µg/ml

Excellent precision

The Phenytoin assay has a precision of less than 5% CV

Randox Phenytoin (Latex Enhanced Immunoturbidimetric)

  • LEI method
  • Liquid ready-to-use reagents
  • Stable to expiry when stored at 2-8⁰C
  • Measuring range 2.9-44.5 µg/ml
Cat NoSize    
TD3409R1 2 x 17ml
R2 2 x 6ml
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Instrument Specific Applications (ISA’s) are available for a wide range of biochemistry analysers.  Contact us to enquire about your specific analyser.

What is Phenytoin assay used for?

Phenytoin is an anti-epileptic drug used for the control of generalised seizures; however incorrect doses can prove toxic. The effects of incorrect phenytoin treatment can include insomnia, nausea, confusion and fatigue.

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
R2 2 x 6ml
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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


Digoxin

Reagent | Digoxin

Key benefits of the Randox Digoxin (Latex Enhanced Immunoturbidimetric)

Exceptional correlation

A correlation coefficient of r=0.99 was found when measured against another commercially available method

Wide measuring range

The Randox Digoxin assay has a wide measuring range of 0.371 – 5.46 ng/ml which will comfortably detect levels outside of the healthy range of 0.5 – 2.0 ng/ml

Excellent stability

Stable to expiry when stored at 2-8⁰C

Liquid ready-to-use reagents

Liquid format is more convenient for labs and can also help reduce the risk of errors occurring

Limited interference

Limited interference from Bilirubin, Intralipid® and Triglycerides

Ordering Information

Cat NoSize    
TD3410R1 2 x 8ml
R2 2 x 6ml
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Instrument Specific Applications (ISA’s) are available for a wide range of biochemistry analysers.  Contact us to enquire about your specific analyser.

What is Digoxin used for?

The digoxin test system is intended to measure digoxin, a cardiovascular drug that is used to treat heart conditions such as arrhythmias and heart failure, in human serum. Measurements obtained by this device are used in the diagnosis and treatment of digoxin overdose and in monitoring levels of digoxin to ensure appropriate therapy. Digoxin toxicity can be associated with a number of health problems such as changes in heart rate and rhythm, gastrointestinal problems and fatigue.

Therapeutic Drug Monitoring Panel

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


Carbamazepine Reagent

Reagent | Carbamazepine 

Key Benefits of the Carbamazepine reagent

Latex Enhanced Immunoturbidimetric method

The Randox Carbamazepine latex enhanced immunoturbidimetric (LEI) method is  a more stable and sensitive method  compared to other available methods

Multi-analyte controls and calibrators available

Randox offers multi-analyte Acusera controls and calibrators for the carbamazepine assay as opposed to only single analyte calibrators and controls, proving to  be more cost effective as separate products do not need to be ordered. Some controls and calibrators include: therapeutic drug control, precision chemistry premium plus, liquid assayed chemistry premium, therapeutic drug calibrator.

Wide measuring range

The healthy range for carbamazepine detectable in serum is 4 – 12 µg/ml. The Randox assay can comfortably detect levels outside of the healthy range measuring between 1.02 – 19.0 µg/ml.

Other features of the Carbamazepine reagent

  • Latex Enhanced Immunoturbidimetric method
  • Liquid ready-to-use reagents
  • Stable until expiry date when stored at +2 to +8⁰C
  • Measuring range 1.02 – 19.0 µg/ml
  • Limited interference from Bilirubin, Haemoglobin, Intralipid® and Triglycerides
Cat NoSize    
TD3416R1 2 x 12ml
R2 2 x 5ml
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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 Carbamazepine assay used for?

What is Carbamazepine?

Carbamazepine is an anticonvulsant drug that is administered in oral form for the treatment of epilepsy, bipolar disorder, and trigeminal neuralgia (a specific seizure caused as a result of epilepsy). For more information on the pathology of trigeminal neuralgia, please click here [external link].  It has also been used as a mood stabiliser and for treatment of neuropathic pain syndrome. Carbamazepine reduces abnormal electrical signals between nerve cells through blocking the sodium currents throughout the brain and the body. The side effects of toxicity as a result of an incorrect dosage can include breathing difficulties, hallucinations, seizures, blurred vision, vomiting, slurred speech, and drowsiness. In 2014, the American Association of Poison Control Centres reported 3734 toxic exposures.

What is the Carbamazepine assay used for?

The Randox Carbamazepine assay is used in the diagnosis and treatment of carbamazepine overdose and toxicity. The assay can also be used to monitor treatment to ensure the patient is taking the therapeutic levels.

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 0.8 – 220 mg/dl

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 0.8 – 220 mg/dl
  • Calibrator included in the kit
Cat NoSize    
CP10389R1 2 x 18.1ml (C)
R2 2 x 5ml
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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.

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.

Veterinary Panel

For more information or to visit more reagents within the veterinary panel, please click here

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Transthyretin (Prealbumin)

Reagent | Transthyretin (Prealbumin)

Key Benefits

Excellent precision

The Transthyretin assay has a precision of less than 4% CV

Applications available

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

Exceptional correlation

The Transthyretin assay showed a correlation coefficient of 0.98 against another commercially available method

Randox Transthyretin (Prealbumin) (Immunoturbidimetric)

  • Immunoturbidimetric method
  • Liquid ready-to-use reagents
  • Stable on board the analyser for 28 days at 10°C
  • Measuring range 2.3-65 mg/dl
  • Applications available
Cat NoSize    
PA3843R1 6 x 20ml
R2 3 x 11ml
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 Transthyretin (Prealbumin) assay used for?

Transthyretin is a negative acute phase reactant and serum levels fall in inflammation, malignancy, cirrhosis of the liver and protein-wasting diseases of the gut or kidneys, owing to decreased synthesis. Elevated levels have been reported in Hodgkinson’s disease.

Transthyretin is a specific clinical indicator of nutritional risk in the management of diseases such as HIV/AIDS, Renal disease, Diabetes, Pneumonia and Cancer. Nutritional assessment using Transthyretin has also been effective in surgical cases, pre-surgical screening, fractures, and wound healing.

Specific Proteins Panel

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


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 20mlEnquireKit Insert RequestMSDSBuy Online
IM8045R1 4 x 8.7ml
R2 4 x 3.9ml
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
R2 1 x 15ml
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LP3403R1 1 x 10ml
R2 1 x 6ml
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LP8054R1 2 x 8.7ml
R2 2 x 5.8ml
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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

Wide measuring range

The Randox Full Range CRP assay has a wide measuring range of 0.3 – 161 mg/l which will comfortably detect levels outside of the healthy range

Excellent stability

Stable to expiry when stored at 2-8⁰C

Methodology

Latex enhanced Immunoturbidimetric method

Ordering Information

Cat NoSize    
CP3847R1 2 x 11ml
R2 2 x 11ml
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CP3849R1 4 x 50ml
R2 4 x 50ml
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CP8028R1 2 x 13ml
R2 2 x 13ml
EnquireKit Insert RequestMSDSBuy Online
CP8315R1 4 x 10ml
R2 4 x 10ml
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 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.


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