The Importance of Diagnostic Testing in SARS-CoV-2 Adverse Outcomes

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The Importance of Diagnostic Testing in SARS-CoV-2 Adverse Outcomes

SARS-CoV-2 (COVID-19), a highly contagious disease, primarily manifests as an acute respiratory illness, however, for those with health complications, including: autoimmune diseases, asthma, heart disease and diabetes, the risk of developing serious illness and adverse outcomes is much greater. It is estimated that 1 in 6 will experience adverse outcomes that could be life-threatening 1. The spread and devastation of COVID-19 highlights the vital role laboratory diagnostics plays in the diagnosis and management of suspected and affected patients. As the COVID pandemic continues, it is imperative that fast and accurate diagnostic testing strategies are implemented for effective risk stratification and monitoring of treatment and recovery.

In this article, we will review how Randox Reagents can aid in diagnosing and managing SARS-CoV-2 adverse outcomes.

 

Cytokine Storms

The immune system activates a pro-inflammatory response to enhance host immunity against viruses and decrease colonisation and infection, but only if the pro-inflammatory response is controlled. Uncontrolled pro-inflammatory responses can result in a cytokine storm 2. A cytokine storm is a serious complication associated with SARS-CoV-2, which can trigger life-threatening pneumonia, acute respiratory distress syndrome (ARDS) and multiple organ failure 3, 4. Cytokine storms occur in 5% of severe COVID-19 cases, with several inflammatory cytokines observed at high levels. Due to the elevation of several pro-inflammatory and anti-inflammatory cytokines, a multiplex immunoassay approach can offer several advantages over the widely utilised single ELISA tests. The simultaneous detection of multiple cytokines from a single patient sample will provide clinicians with a comprehensive overview of cytokine markers and complete patient profile, facilitating a personalised treatment plan to be implemented 5, 6.

Cytokine Storms Image

Inflammation

In COVID-19 patients, CRP testing has proved to perform well in discriminating disease severity and predicting adverse outcomes 7. Elevated CRP levels have been identified in 86% of patients admitted to hospital. CRP measurements are useful in diagnosis, prognosis and monitoring for clinical improvements or deterioration. Moreover, the acute phase reactant, ferritin, has been observed to increase in approximately 60% of COVID-19 patients. In the critically ill COVID-19 patients, extremely elevated ferritin concentrations were recorded, which could be attributed to a cytokine storm and secondary haemophagocytic lymphohistiocytosis (a hyper-inflammatory syndrome associated with multi-organ failure) 8.

Renal Function

Acute kidney injury (AKI) is a common complication in diabetic patients who test positive for COVID-19. Regardless, the National Institute for Health and Care Excellence (NICE) recommend AKI testing in all COVID-19 patients upon hospital admission and their condition monitored throughout their stay 9.

The most commonly utilised screening test for renal impairment is serum creatinine (SCr); however, it is important to consider the accuracy and reliability of the method. Two commercially available methods exist for SCr determination: Jaffe and enzymatic. Whilst the Jaffe method is less expensive, it is more susceptible to interferences which can lead to the misdiagnosis of patients, which isn’t ideal in the current pandemic 7. Moreover, the sensitivity of SCr, regardless of method, in the early detection of renal disease is poor, as SCr is insensitive to small changes in glomerular filtration rate (GFR). Up to 50% of renal function can potentially be lost before significant SCr levels become detectable 8, 9. In comparison, cystatin C (CysC) is a superior marker of renal function and is useful in the determination of the extent of renal damage, as well as distinguishing those with severe and mild COVID-19 10.

Hepatic Function

Liver Image

Abnormal liver function tests significantly increases a COVID-19 patients risk of developing severe disease and complications such as pneumonia 11. Bilirubin levels, 3 times the upper limit have been observed in COVID-19 patients 11, 12. Whilst the diazo method is commonly utilised in bilirubin testing, superior methods exist. The vanadate oxidation (VO) method offers several advantages particularly in haemolytic and lipemic samples. These advantages are particularly evident in neonatal and infant populations where haemolysis is extremely common. Moreover, the VO method offers a wider analytical measurement range for the comfortable detection of clinically important results 13.

Other liver function markers are known to be elevated in COVID-19 patients including both AST and ALT, with markers like albumin decreased.

The Importance of Lp(a) Testing

Lipoprotein(a) / Lp(a), a strong independent marker of cardiovascular disease risk has recently been identified as a key risk marker of cardiovascular complications in COVID-19 patients. Those with either baseline elevated or elevated levels of Lp(a) following COVID-19 infection may be at a significantly increased risk of developing thromboses. Consideration should be given to measurement of Lp(a) and prophylactic anticoagulation of infected patients to reduce the risk. Elevated Lp(a) levels may also cause acute destabilization of pre-existing but quiescent, atherosclerotic plaques, which could induce an acute myocardial infarction (AMI) or cerebrovascular accident (CVA) (stroke) 14.

The size heterogeneity of apo(a) isoforms represents the biggest challenge faced by laboratories in accurately measuring Lp(a).  The variable numbers of repeated KIV-2 units in act as multiple epitopes, and so standardisation across calibrators is vital. Unless the calibrants 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 15.

Lp(a) assays that are standardised to the WHO/IFCC (World Health Organization/International Federation of Clinical Chemistry) reference material, transferring values from mg/dl to nmol/l are more uniform. The assay considered the most reliable commercially available Lp(a) assay is so because: 15

1. The isoform size variations are reduced as a range of calibrators from separate pools of serum 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 are calibrated in nmol/l and traceable to WHO/IFCC reference material and give acceptable bias compared with the Northwest Lipid Metabolism and Diabetes Research Laboratory (NLMDRKL) gold standard method.

Want to know more?

Contact us or visit our COVID-19 disease management webpage.

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DEVELOPMENT OF A BIOCHIP ARRAY FOR THE SIMULTANEOUS DETECTION OF CANCER BIOMARKERS ON THE RANDOM ACCESS, FULLY AUTOMATED EVIDENCE EVOLUTION ANALYSER

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DEVELOPMENT OF NEW BIOCHIP ARRAYS FOR THE DETERMINATION OF BIOMARKERS RELATED TO ACUTE KIDNEY INJURY APPLIED TO THE EVIDENCE INVESTIGATOR ANALYSER

DEVELOPMENT OF A NEW BIOCHIP BASED IMMUNOASSAY FOR THE DETECTION OF PARATHYROID HORMONE APPLIED TO THE EVIDENCE EVOLUTION ANALYSER

DEVELOPMENT OF A HIGHLY MULTIPLEXED MOLECULAR ASSAY FOR DETECTION OF INFECTION IN CF AIRWAYS

Repeatability and within-laboratory precision were assessed (n=80): Assay Repeatability Within-laboratory precision CV (%) CV (%) VCAM-1 4.5 6.8 ICAM-1 5.6 8.8 ESEL 12.8 16.6 PSEL 3.5 4.7 LSEL 5.7 8.2 17.096, 097.105RDRT DEVELOPMENT OF A BIOCHIP ARRAY FOR THE DETECTION OF ADHESION MOLECULES ON THE NEW RANDOM ACCESS FULLY AUTOMATED EVIDENCE EVOLUTION ANALYSER

DEVELOPMENT OF A NEW BIOCHIP BASED IMMUNOASSAY UNAFFECTED BY DHEA-S INTERFERENCE FOR THE ACCURATE MEASUREMENT OF SERUM PROGESTERONE

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CLINICAL EVALUATION OF A RAPID FULLY-AUTOMATED MULTIPLEX BIOCHIP ARRAY FOR STROKE DIAGNOSIS

DEVELOPMENT OF A NEW BIOCHIP ARRAY APPLIED TO THE NEW RANDOM ACCESS FULLY AUTOMATED EVIDENCE EVOLUTION ANALYSER FOR THE SIMULTANEOUS MEASUREMENT OF TSH, FREE T4 AND FREE T3

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GENETIC DIAGNOSIS OF MONOGENIC OR POLYGENIC FAMILIAL HYPERCHOLESTEROLEMIA IN NORTHERN IRELAND: EVALUATION OF THE RANDOX FH ARRAYS IN COMBINATION WITH THE RANDOX 6SNP POLYGENIC HYPERCHOLESTEROLEMIA ARRAY

DEVELOPMENT OF A BIOCHIP ARRAY FOR THE SIMULTANEOUS MEASUREMENT OF DISTINCT FATTY ACID-BINDING PROTEINS (FABPs)

DEVELOPMENT OF A NEW ENZYME-LINKED IMMUNOSORBENT ASSAY KIT TO DETECT NGAL IN HUMAN SERUM AND ITS APPLICATION TO CHRONIC KIDNEY DISEASE

SCREENING AND SELECTION OF ANTIBODIES FOR THE DETECTION OF MIP-1 ALPHA AND ITS APPLICATION TO THE STUDY OF CHRONIC KIDNEY DISEASE

DEVELOPMENT OF A 4-PLEX BIOCHIP ARRAY FOR THE EARLY DETECTION OF CHRONIC KIDNEY DISEASE

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APPLICATION OF THE NEW RANDOM ACCESS, FULLY AUTOMATED BIOCHIP ANALYSER EVIDENCE EVOLUTION TO SIMULTANEOUSLY MEASURE ANALYTES RELATED TO ENDOCRINE FUNCTION

SARS-CoV-2 Vascular & Multi-System Dysfunction


Featured Reagent – Microalbumin

Featured Reagent | Microalbumin

What is Microalbumin?

Albumin is the most common protein found in the blood and is produced in the liver, it helps your body maintain fluid balance. To prevent fluid from leaking out of the blood vessels a proper balance of albumin is needed. Albumin also carries vital nutrients and hormones, and provides your body with the proteins it needs to maintain growth and repair tissues.

A urine microalbumin test is a test to detect very small levels of albumin in the urine. This test can detect early signs of kidney damage. Microalbumin tests are recommended for people with an increased risk of kidney disease, such as those with type 1 diabetes, type 2 diabetes or high blood pressure.

Healthy kidneys filter waste from your blood and hang on to the healthy components, including proteins such as albumin. Kidney damage can cause proteins to leak through your kidneys and exit your body in your urine. Albumin is one of the first proteins to leak when kidneys become damaged.

Features of Microalbumin

Immunoturbidimetric method
Liquid ready-to-use reagents
Stable to expiry at 2-8°C
Measuring range 5.11-234 mg/l

Applications available for a wide number of clinical chemistry analysers. Please contact us at reagents@randox.com for more information.

Did you know?

The Randox Microalbumin test can identify individuals with diabetic nephropathy approximately 5-10 years earlier than proteinuria tests.

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Featured Reagent – Complement C4

Featured Reagent | Complement C4

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What is Complement C4?

The complement system is one of the major mechanisms of innate immunology consisting of more than 30 plasma and membrane-associated  serum proteins which evokes cytolytic immune responses to pathogens, including viruses, bacteria and anything that is classified as foreign to the body.

Complement c4 works alongside Complement c3 to accurately diagnose and monitor autoimmune disorders. Low levels of complement c4 levels are associated with the risk of developing disorders such as rheumatoid arthritis and Systematic Lupus Erythematosus (SLE), due to the cell-bound levels of processed complement activation products. On the other hand, higher levels of complement c4 are highlighted in patients with autoimmune haemolytic anaemia.

Key Features

Liquid ready-to-use reagents – for convenience and ease of use
Exceptional correlation with standard methods – Our assay showed a correlation coefficient of r=0.98 when compared against other commercially available methods
Wide measuring range – 2.90 – 152 mg/dl comfortably detecting levels outside the healthy range of 7 – 49 mg/dl
Immunoturbidimetric method
Excellent stability – Stable to expiry when stored at +2°C – + 8°C

Applications available for a wide number of clinical chemistry analysers. Please contact us at reagents@randox.com for more information.

Did you know?

Approximately 1 in 250 people may end up developing Systemic Lupus Erythematosus (SLE) at some point with 90% of SLE patients being female.

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Featured Reagent – Acetaminophen

Featured Reagent | Acetaminophen

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What is Acetaminophen?

Acetaminophen, commonly known as paracetamol, is a frequently used pain-relieving drug whose consumption is not normally associated with any adverse effects at therapeutic levels. However, long-term treatment and prolonged use of acetaminophen can cause liver and kidney damage. If it is left untreated or in the event of an overdose, hepatic failure can occur, which can be fatal. Possible side effects of acetaminophen include anaemia, thrombocytopenia (reduced number of platelets in the blood) and allergic reactions.

As part of our therapeutic drug monitoring panel, the acetaminophen test can therefore be used to determine if an overdose has taken place, to assess the risk of kidney and liver damage to the patient and to evaluate the type of treatment the patient will require.

Key Features of Randox Acetaminophen

Colorimetric method
Wide measuring range – 4.89-652 mg/l, comfortably detecting levels outside the therapeutic range of acetaminophen of 10-30 mg/l.
Liquid ready-to-use reagent – for convenience and ease of use
Excellent stability – Stable on board the analyser for seven days at approximately 10°C
Limited interference – from Bilirubin, Haemolysis, Intralipid® and Triglycerides
Liquid ready-to-use and calibrator included in the kit

Applications available for a wide number of clinical chemistry analysers. Please contact us at reagents@randox.com for more information.

Did you know?

In the United Kingdom, approximately 28% of all deaths by acute liver failure are due to an overdose of acetaminophen.

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Featured Reagent – Complement C3

Featured Reagent | Complement C3

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What is Complement C3?

Complement C3 is a complex biological system which works in conjunction with antibodies and other factors to protect the body from invasion by pathogens. When activated by either the classical or alternative pathway Complement acts on biological membranes and may cause cell death. Complement C3 and complement C4 levels are important in determining inherited or acquired deficiencies.

Complement testing can be used to help diagnose the cause of recurrent microbial infections, unexplained swellings or inflammation. In addition, low levels of complement C3 can be found in patients diagnosed with Systemic Lupus Erythematosus (SLE), a form of lupus, which is a chronic autoimmune disease that triggers inflammation in different organs and tissues of the body and can cause widespread inflammation and tissue damage in the affected organs. Periodic tests should be carried out to help monitor known long term diseases that affect the complement system.

Did you know?

There are approximately 80 different autoimmune diseases, with around 5-10% of the world’s population affected by one.

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Featured Reagent – Cystatin C

Featured Reagent | Cystatin C

Kidney Disease

Kidney disease is a huge global health crisis, increasing healthcare costs, mortality and morbidity rates.  The global prevalence of chronic kidney disease (CKD) has continued to rise during a short lifespan.  In 2016, 1 in 10, equivalent to 10 percent of the global population were identified with having CKD with the highest prevalence’s reported in Europe, the Middle East, East Asia and Latin America, estimated at 12 per cent and the lowest in South Asia, estimated at 7 percent1.

The early risk assessment of renal function is vital.  In 1990, CKD was ranked the 27th leading cause of death in the Global Burden of Disease study2, rising to 18th 3 in 2010, 13th in 20132 and 12th by 2015.  From 2005-2015, the overall CKD mortality rate has risen by 31.7 percent, accounting for 1.1 million deaths globally in 20154.

Inadequacies of Traditional CKD Biomarkers

The most commonly used screening test for renal impairment is creatinine.  When testing for CKD using creatinine, certain factors must be taken into consideration, including: age, gender, ethnicity, and muscle mass.  As such, black men and black women will present with higher creatinine levels compared to white men and white women respectively5.

Serum creatinine is not an adequate screening test for renal impairment in the elderly (65 years of age and over) due to their decreased muscle mass.  As such, patients are misdiagnosed, thus, patients with severe renal failure are receiving suboptimal care6.

The main disadvantage of using creatinine to screen for renal impairment is that up to 50 percent of renal function can be lost before significant creatinine levels become detectable as creatinine is insensitive to small changes in the glomerular filtration rate (GFR).  Consequently, treatment is not provided at the appropriate time which can be fatal, thus, an earlier and more sensitive biomarker for renal function is vital7.

Biological Significance

Cystatin C is a small (13 kDa) cysteine proteinase inhibitor, produced by all nucleated cells at a constant rate.  Cystatin C travels through the bloodstream to the kidneys where it is freely filtered by the glomerular membrane, resorbed and fully catabolised by the proximal renal tubes.  Consequently, cystatin C is the ideal biomarker of GFR function8.

Clinical Significance of Cystatin C

The National Institute for Health and Care Excellence (NICE) (2014) guidelines recommend cystatin C testing due to its higher specificity for significant disease outcomes than those based on creatinine. As such, eGFR cystatin C measurements will significantly reduce the number of misdiagnosed patients, thus reducing the overall CKD burden9.

In 2017, a systematic literature search found 3,500 investigations into cystatin C as a marker of GFR. The study concluded that eGFRcystatinc was a significantly more superior than eGFRcreatinine10.

Benefits of Cystatin C

The Randox cystatin C assay utilises the latex enhanced immunoturbidimetric method offering numerous key features:

A niche product from Randox meaning that Randox are one of the only manufacturers to provide the cystatin C test in an automated biochemistry format

An automated assay which removes the inconvenience and time consumption associated with traditional ELISA testing

Applications are available detailing instrument-specific settings for the convenient use of the Randox cystatin C assay on a wide range of biochemistry analysers

Liquid ready-to-use reagents for convenience and ease-of-use

Latex enhanced immunoturbidimetric method delivering high performance

Extensive measuring range for the detection of clinically important results

Complementary controls and calibrators available offering a complete testing package

Limited interference from Bilirubin, Haemoglobin, Intralipid® and Triglycerides

Cystatin C does not suffer from a ‘blind area’ like creatinine due to cystatin C’s sensitivity to small changes in GFR enabling the early detection renal impairment

An exceptional correlation coefficient of r=1.00 when compared against standard methods

References

[1] Bello, AK, et al. Global Kidney Health Atlas: A report by the Internal Society of Nephrology on the current state of organization and structures for kidney care across the globe. Brussels : Internal Society of Nephrology, 2017.

[2] Bikbov, Boris. Chronic kidney disease: impact on the global burden of mortality and morbidity. The Lancet. [Online] 2015. http://www.thelancet.com/campaigns/kidney/updates/chronic-kidney-disease-impact-on-global-burden-of-mortality-and-morbidity.

[3] National Kidney Foundation. Global Facts: About Kidney Disease. National Kidney Foundation. [Online] National Kidney Foundation, 2015. https://www.kidney.org/kidneydisease/global-facts-about-kidney-disease#_ENREF_1.

[4] Neuen, Brendon Lange, et al. Chronic kidney disease and the global NCDs agenda. s.l. : BMJ Global Health, 2017.

[5] Lascano, Martin E and Poggio, Emilio D. Kidney Function Assessment by Creatinine-Based Estimation Equations. Cleveland Clinic. [Online] August 2010. [Cited: May 16, 2018.] http://www.clevelandclinicmeded.com/medicalpubs/diseasemanagement/nephrology/kidney-function/.

[6] Swedko, Peter J, et al. Serum Creatinine Is an Inadequate Screening Test for Renal Failure in Elderly Patients. Research Gate. [Online] February 2003. [Cited: May 6, 2018.] https://www.researchgate.net/publication/8243393_Serum_Creatinine_Is_an_Inadequate_Screening_Test_for_Renal_Failure_in_Elderly_Patients.

[7] Mishra, Umashankar. New technique developed to detect chronic kidney disease. Business Line. [Online] May 07, 2018. [Cited: May 17, 2018.] https://www.thehindubusinessline.com/news/science/new-technique-to-detect-chronic-kidney-disease/article23803316.ece.

[8] Chew, Janice SC, et al. Cystatin C-A Paradigm of Evidence Based Laboratory Medicine. NCBI. [Online] May 29, 2008. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2533150/.

[9] National Institute for Health and Care Excellence. Chronic kidney disease in adults: assessment and management: 2 Implementation: getting started. NICE. [Online] January 2015. [Cited: April 19, 2018.] https://www.nice.org.uk/guidance/cg182/chapter/implementation-getting-started.

[10] Grubb, Anders. Cystatin C is Indispensable for Evaluation of Kidney Disease. NCBI. [Online] December 28, 2017. [Cited: April 19, 2018.] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5746836/.

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Apolipoprotein E (ApoE) Assay

Reagent | Apolipoprotein E (ApoE)

A Genetic Risk Factor for CVD & Alzheimer’s Disease

Benefits of the Randox ApoE Assay

Correlation

Exception correlation

A correlation coefficient of r=1.00 was displayed when the Randox apoE assay was compared to commercially available methods.

Precision

Excellent precision

The Randox apoE assay displayed a precision of <2.79% CV.

Measuring range

Extensive measuring range

The Randox apoE assay has a measuring range of 1.04 – 12.3mg/dl for the comfortable detection of clinically important results.

Liquid ready-to-use

Liquid ready-to-use

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

Calibrator & Controls

Dedicated calibrator and controls available

Randox offer dedicated apolipoprotein calibrator and controls for a complete testing package.

Applications available

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

  • Ordering Information
  • PHYSIOLOGICAL SIGNIFICANCE
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  • NEUROLOGICAL DISEASES
Cat NoSize    
LP3864R1 2 x 11ml
R2 2 x 5ml
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.

The apolipoproteinE (APOE) gene provides instructions for the production of the apolipoprotein E (apoE) protein. The apoE protein binds with lipid forming lipoproteins which are responsible for the transportation of cholesterol and other lipids through the bloodstream 1.

Apolipoprotein E (apoE) is a multifunctional glycoprotein with central roles in lipid metabolism, neurobiology, and neurodegenerative diseases. ApoE has three major isoforms (apoE2, apoE3, and apoE4) all of which have different effects on lipid and neuronal homeostasis (fig 1). The key function of apoE is to mediate the binding of lipoproteins or lipid complexes in the plasma or interstitial fluids to specific cell-surface receptors. These receptors internalise apoE-containing lipoprotein particles and so apoE participates in the distribution or redistribution of lipids among various tissues and bodily cells 2. The e3 allele is the most of the three and may be considered an ancestral allele. The e4 allele is more common in those of Northern European ancestry and lower in those of Asian ancestry 3.

Fig. 1. ApoE isoforms and their properties 2

Both apoE2 and apoE4 alleles are associated with cardiovascular disease (CVD).

As apoE2 binds defectively to LDL receptors, apoE2 homozygosity can precipitate type III hyperlipoproteinemia, however, only occurs when another condition, including: diabetes, oestrogen deficiency, hypothyroidism, or obesity, leads to the overproduction of VLDL or fewer LDL receptors, overwhelming the limited ability of apoE2 to mediate the clearance of triglyceride-rich and cholesterol-rich β-VLDL. Other dominant and recessive mutations in apoE that affect residues in or around the receptor binding region also causes type III hyperlipoproteinemia 3.

ApoE3 increases LDL levels in plasma and the risk of atherosclerosis. The lipoprotein-binding preference of apoE4 to large (30-80nm), triglyceride-rick VLDL, is associated with elevated levels of LDL. The enrichment of VLDL with apoE4 accelerates their clearance from the plasma by receptor-mediated endocytosis in the liver and consequently, LDL receptors are downregulated, and LDL levels rise 3.

ApoE4 is the major genetic risk factor, or causative gene, for Alzheimer’s disease (AD) and other neurological disorders, including poor clinical outcomes following traumatic brain injury, stroke, frontotemporal dementia, Down syndrome, certain patients with Parkinson’s disease, and Lewy body disease 3.

Apo E4 drastically affects AD with 65-80% of all AD patients carrying at least one apoE4 allele. ApoE4 increases the risk of developing AS 4-fold (one allele) and 14-fold (two allele). Carrying one e4 allele is not uncommon with approximately 25% of people worldwide having at least one E4 allele. Fig. 2 illustrates the apoE-mediated pathogenic pathways leading to AD, with amyloid β playing a key role 3.

Fig. 2. ApoE-mediated pathogenic pathways leading to Alzheimer’s Disease 4

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IgE Assay

Reagent | Immunoglobulin (IgE)

A Marker of Allergic Diseases

Our Benefits

Correlation

Exceptional correlation

A correlation coefficient of r=1.00 was displayed when the Randox methodology was compared against commercially available methods.

Precision

Excellent precision

The Randox IgE assay displayed a precision < 4.0% CV.

Measuring range

Excellent measuring range

The Randox IgE assay has a measuring range of 19.6 – 1007IU/ml for the comfortable detection of clinically important results.

Liquid ready-to-use

Liquid ready-to-use

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

Calibrator & Controls

Calibrator and controls available

Dedicated IgE calibrator and specific protein controls available for a complete testing package.

Applications available

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

  • Ordering Information
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  • Clinical Significance
Cat NoSize    
IE7308R1 1 x 8ml
R2 1 x 5ml
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.

Immunoglobulin E (IgE) is one of five classes of immunoglobulins (IgA, IgD, IgE, IgG and IgM). IgE was the last immunoglobulin to be discovered. However, since it’s discovery, vast amounts of research have been aimed at characterising its physiological and clinical significance’s. Whilst IgEs chemical structure is unique compared to the rest of the immunoglobulin family (lacks a ‘hinge’ region in the centre of the molecule and gets replaced by the C-epsilon2 domain), it has an array of physiological functions. For immunoglobulin E to fulfil its function, the Fc portion of the antibody must bind to a given cellular receptor located on certain cell types, such as eosinophil or mast cells. Whilst many an array of cellular receptors have been identified, the main ones are Fc-epsilon-RI, Fc-epsilon-II and CD23. Fc-epsilon-RI is the high affinity receptor located on basophils, dendritic cells, eosinophils, mast cells and macrophages and is responsible for immediate hypersensitivity reactions, enhanced cytokine production, parasitic immunity, and antigen presentation 1.

It is believed that immunoglobulin E evolved as a defence mechanism against parasitic infestation. The major sites of parasitic invasion are the gut, respiratory tract and skin, the typical allergic response sites. IgE antibodies play a key role in the early recognition of foreign material or a general potentiation of the immune system response through improved antigen presentation. An allergy triggered by IgE could be beneficial to the host as the typical allergic reactions include: sneezing, coughing, inflammation, bronchoconstriction and vomiting, to expel allergenic proteins from the body. Different allergens stimulate the production of corresponding allergen-specific immunoglobulin E antibodies 2. The antigen-dependent activation of tissue mast cells that have specific immunoglobulin E bound to their surface is the central event in acute allergic reactions. IgE specific allergens include: allergic or atopic asthma, atopic dermatitis (eczema), food allergies such as peanut and shellfish, allergic rhinitis (hay fever), house dust mite, latex allergy, dog or cat allergies 2, 3.

IgE Calibrator

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Immunoassay EQA

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Apolipoprotein C-II (Apo C-II) Assay

Reagent | Apolipoprotein C-II (Apo C-II)

In Association with Hypertriglyceridemia

Benefits of the Randox Apo C-II Assay

Superior method

The immunoturbidimetric method limits interference from Bilirubin, Haemoglobin, Intralipid® and Triglycerides, producing more accurate results.

Exceptional correlation

A correlation coefficient of r=1.00 was displayed when the Randox apo C-II assay was compared to commercially available methods.

Excellent measuring range

The Randox apo C-II assay has a measuring range of 1.48 – 9.70mg/dl for the comfortable detection of clinically important results.

Liquid ready-to-use

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

Dedicated calibrator and controls available

Randox offer dedicated apolipoprotein calibrator and controls for a complete testing package.

Applications available

Applications available detailing instrument-specific settings for the convenient use of the Randox apo C-II assay on a variety of clinical chemistry analysers.

  • Ordering Information
  • PHYSIOLOGICAL SIGNIFICANCE
  • Clinical Significance
Cat NoSize    
LP3866R1 2 x 11ml
R2 2 x 5ml
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.

Apo C – II is a 79-amino acid protein synthesised in the liver and is the co-factor for lipid transport in the bloodstream 1. Apo C – II is a surface constituent of lipoproteins and the C – terminal helix activates lipoprotein lipase (LPL) 2. The active peptide of apo C – II corresponds to residues 44 – 79 and has been identified to reverse the symptoms of genetic apo C – II deficiency. Moreover, LPL is also a key enzyme in the regulation of triglyceride levels 3.

Both an excess and deficiency of apo C – II is associated with hypertriglyceridemia and reduced LPL activity. Elevated levels of apo C-II is associated with excess triglyceride – rich particles and altercations in the distribution of HDL particles, increasing the risk of CVD 4. Whilst extremely rare, a deficiency in apo C-II results in excess fasting hypertriglyceridemia and chylomicronemia. Hypertriglyceridemia can cause eruptive xanthomas, pancreatitis, hepatosplenomegaly and lipemia retinalis. Biologically and clinically, apo C – II deficiency closely mimics LPL deficiency. Synonyms for apo C-II deficiency include: C – II an apolipoproteinemia and hyperlipoproteinemia type Ib 5.

Apolipoprotein Calibrator

Apolipoprotein Control

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