CARDIOLOGY & LIPID TESTING

COMPLETE CARDIOLOGY AND LIPID TESTING FROM RANDOX

CARDIOLOGY & LIPID TESTING
Complete Cardiology and Lipid Testing from Randox
01 BENEFITS
02 INTRODUCTION
03 RISK ASSESSMENT AND MONITORING
03 HDL CHOLESTEROL
05 LDL CHOLESTEROL
07 CHOLESTEROL
07 TRIGLYCERIDES
08 sLDL CHOLESTEROL
09 LIPOPROTEIN (a)
11 APOLIPOPROTEIN A-I
11 APOLIPOPROTEIN B KEY
11 APOLIPOPROTEIN A-II
12 APOLIPOPROTEIN C-II NP
12 APOLIPOPROTEIN C-III NICHE PRODUCT
12 APOLIPOPROTEIN E When you see this
symbol you will know
13 HDL3-C that Randox have one
of the only automated
14 sPLA2-IIA biochemistry assays
available on the market
15 HOMOCYSTEINE
15 HIGH-SENSITIVITY CRP
UF
16 ADIPONECTIN
UNIQUE FEATURE
17 DIAGNOSIS OF MI
When you see this
17 HEART-TYPE FATTY ACID BINDING PROTEIN symbol you will know
that this feature is unique
19 CK-MB to the Randox product
19 MYOGLOBIN
19 THERAPY MONITORING
19 DIGOXIN
20 TxBCARDIO™
21 DIAGNOSTIC BIOCHIP PRODUCTS
22 RESEARCH BIOCHIP PRODUCTS
23 ORDERING INFORMATION
25 REFERENCES
26 PORTFOLIO OF REAGENTS
27 GLOBAL DIAGNOSTIC SOLUTIONS PROVIDER
28 CONTACT US
BENEFITS 01

BENEFITS OF RANDOX REAGENTS

Randox offers an extensive range of third party diagnostic A wide range of formats and methods are available providing
reagents which are internationally recognised as being of the greater flexibility and choice for any laboratory size.
highest quality; producing accurate and precise results.
In addition to flexible pack sizes and a comprehensive list of
We have the largest test menu of 118 assays, covering analyser applications, we can also provide dedicated reagent
over 100 disease markers including specific proteins, lipids, packs (Randox Easy Read and Easy Fit regents) for a wide
therapeutic drug monitoring, drugs of abuse, antioxidants, range of chemistry analysers providing you with freedom
coagulation, diabetes and veterinary testing. of choice from an independent manufacturer.

REDUCE COSTS EXPAND ROUTINE TESTING

We can help create cost-savings for your With speciality assays for 195 of the most common
laboratory through excellent reagent stability; by clinical chemistry analysers; assays which usually
eliminating the need for costly re-runs through require dedicated equipment (or was previously only
the excellent quality of products; and by offering available as an ELISA) can now be run on automated
a range of kit sizes (including smaller kit sizes for biochemistry analysers, allowing your laboratory
niche tests to reduce waste). to expand its routine test menu. E.g. TxBCardio™,
cystatin C, adiponectin, and many more.

REDUCE THE RISK OF ERRORS AND HAVE BRING TESTING IN-HOUSE

CONFIDENCE IN PATIENT RESULTS With smaller kit sizes and excellent reagent stability
Our traceability of material and extremely tight (most are stable for 28 days on-board the analyser),
manufacturing tolerances ensure uniformity across you don’t have to worry about reagent wastage,
reagent batches reducing lot-to-lot variability and allowing testing to be brought in-house.
our assays are validated against gold-standard
methods; giving you the confidence that you are
sending out the correct patient results.

REDUCE LABOUR EXPAND YOUR TEST MENU WITHOUT

EXPANDING YOUR LAB
Reduce your time spent on running tests through
liquid ready-to-use reagents, automated methods There is no need to buy any extra equipment in
(compared to the traditional laborious ELISA order to expand your test menu. Our reagents
methods used for some tests such as cystatin C can be programmed onto the majority of the most
or adiponectin); and our easy-fit options. common biochemistry analysers.
 INTRODUCTION 02

INTRODUCTION TO RANDOX CARDIOLOGY

AND LIPID TESTING

The need for more extensive lipid profiling is on the increase, to truly
identify the risk of cardiovascular diseases, both in primary and secondary
risk categories; and as such provide the necessary tools to prevent and
reduce the risks. Randox offer a comprehensive cardiology product profile
which includes high performance reagents for the detection of conventional
risk factors, as well as emerging biomarkers associated with further risk.

LIPOPROTEIN SUBFRACTIONS
“BELOW THE AGE
OF 70, CVDs ARE
RESPONSIBLE FOR
39% OF ALL NCD “
DEATHS.
- World Heart Federation, 2017

VLDL
Density

LDL

HDL

Diameter

Small Dense Large Small Dense Large Buoyant

HDL HDL LDL LDL

Please note this is a visual representation and is not drawn to scale.

 HDL CHOLESTEROL 03

HDL CHOLESTEROL
Key Features of Randox HDL Cholesterol Clinical Significance

• UF Superior direct clearance methodology - ensuring truly High-density lipoproteins (HDL) are one of the major classes of plasma
accurate results even with abnormal samples lipoproteins. HDL is often referred to as ‘good cholesterol’ since it
• Liquid ready-to-use reagents - for convenience and ease of use transports cholesterol from the tissues to the liver for removal from the
• Extensive measuring range - of 0.189 - 3.73mmol/l for body. High levels of HDL can lower risk of developing heart disease.
measurement of clinically important results
• Applications available for an extensive range of biochemistry Performance in discrepant patient samples
analysers - which detail instrument-specific settings for the
convenient use of Randox HDL Cholesterol assays on a Fig.1 below compares the performance of the Randox direct
variety of systems clearance method and two other direct masking methods with the
ultracentrifugation reference method in two abnormal samples.
UF Benefits of the Randox Direct Clearance Method The Randox direct clearance method compares well with the
ultracentrifugation method; however the two other commercially
Although many direct methods of HDL measurement perform available direct masking methods seriously underestimate the
well with normal samples, they show reduced specificity and often concentration of HDL.
underestimate the concentration of HDL cholesterol in samples
containing abnormal lipoproteins e.g. samples from patients with
elevated triglycerides or liver damage. The Randox direct clearance
method offers superior performance to these methods and works
by completely removing all non-HDL components resulting in a high
degree of accuracy fugationand
Ultracentrifugation
Ultracentri specificity with abnormal samples
Ultracentrifugation
Direct Direct
method Direct
method method
Fig.1 Randox Direct Clearance Method vs Direct Masking Methods.1

2525 25 40 40 40
35 35 35 Ultracentrifugation
2020 20
30 30 30
25 25 25 Direct Method
1515 15
mg/dL
mg/dL

mg/dL

mg/dL

mg/dL

mg/dL

20 20 20
1010 10 15 15 15
10 10 10
55 5
5 5 5
00 0 0 0 0
RANDOXRANDOX
MethodRANDOX
1 Method Method
2 Method
1 RANDOX
Method
1 Method
Method
2 1 Method2 2 RANDOX
RANDOX
MethodMethod
1 Method
1 Method
2 2

SAMPLE 1SAMPLE
SAMPLE
1 SAMPLE
1 2 SAMPLE
SAMPLE
2 2

All ordering information can be found on Page 24-25

 HDL CHOLESTEROL 04

Fig. 2 Specificity of Randox Direct Clearance

60 Assay for HDL Cholesterol
LDL
Specificity of the Randox direct clearance HDL assay
50 was verified against gel filtration. Fig. 2 shows just how
specific the Randox direct clearance method is for
HDL Cholesterol. Our kit was found to only react
40
with the HDL fractions separated by gel filtration.
mg/dL

30
HDL
20
VLDL

10

0 Total Cholesterol Reagent

-10 Randox HDL Cholesterol Reagent

1 3 5 7 9 11 13 15 17 19 21 23 25 27 29

Frac no.

“
THE DIAGRAM ABOVE
SHOWS HOW SPECIFIC
THE RANDOX DIRECT
CLEARANCE METHOD IS “

All ordering information can be found on Page 24-25

LDL CHOLESTEROL 05

LDL CHOLESTEROL
Key Features of Randox LDL Cholesterol Excellent precision - Our LDL assay retains its precision even at
high levels of triglycerides.

• Superior direct clearance methodology - ensuring truly

Minimal interference - Our advanced reagent formulation enables
accurate results are delivered
rapid clearance of turbidity resulting in minimal interference from
• Liquid ready-to-use reagents - convenience and ease-of-use
patient samples.
• Extensive measuring range - of 0.189 – 22.2mmol/l for
measurement of clinically important results
Does not suffer from inaccuracy of the Friedewald Equation -
•
UF Applications available for an extensive range of biochemistry
which is only accurate if triglyceride levels are <400mg/dl,
analysers which detail instrument-specific settings for the
chylomicrons are not present and the sample does not contain
convenient use of Randox LDL Cholesterol assays on a variety
beta-VLDL.
of systems

Clinical Significance
UF Benefits of the Randox Direct Clearance Method

LDL Cholesterol, often referred to as ‘bad cholesterol’, transports

Requires no sample pre-treatment - The detergents and buffering
cholesterol to the tissues and is linked to the development of
systems used by most commercially available direct clearance
atherosclerotic lesions. Accurate measurement of LDL cholesterol
LDL assays produce varying results, leading to differences in assay
is therefore of vital importance in therapies which focus on lipid
performance. The Randox direct LDL cholesterol assay requires no
reduction to prevent or reduce the progress of atherosclerosis and
sample pre-treatment and displays excellent correlation to both the
to avoid plaque rupturing.
ultracentrifugation and precipitation methods.

Fig.3 Mis-estimation of LDL by Calculation Method with Increasing Triglycerides TG>400 mg/dl

80 TG<400 mg/dl
100
% of samples misestimated by more than 10%

70
UC- Ultracentrifugation
60

50

40
50
30

20

10

0
0-50 51-100 101-150 151-200 201-300 301-400 401-600 601-800 0
Triglyceride concentration (mg/dl) UC RANDOX Friedewald

TG <400mg/dl TG >400mg/dl
This shows the mis-estimation of LDL cholesterol by the Friedewald equation with increasing triglycerides and how the Randox direct clearance method
UC = Ultracentrifugation
offers better performance.

All ordering information can be found on Page 24-25

 LDL CHOLESTEROL 06
% of samples misestimated by more than 10%

Fig. 4 Specificity of Randox

50 Direct Clearance Assay for LDL
Cholesterol

40 Specificity of the Randox direct

LDL clearance LDL assay was verified
against gel filtration. Fig. 4 shows just
how specific the Randox direct clearance
30
method is for LDL Cholesterol. Our kit
mg/dL

was found to only react with the LDL

fractions separated by gel filtration.
20
HDL

VLDL
10
Randox LDL Cholesterol

Total Cholesterol
0
1 3 5 7 9 11 13 15 17 19 21 23 25 27

Frac No.

“
THE FRIEDEWALD
FORMULA HAS
BEEN REPORTED TO
MISCLASSIFY UP TO
50% OF PATIENTS2 “

All ordering information can be found on Page 24-25

TOTAL CHOLESTEROL & TRIGLYCERIDES 07

Triglycerides: Cholesterol:
recommended recommended
levels below levels below
1.7 mmol/l 5.0 mmol/l

CHOLESTEROL (TOTAL) TRIGLYCERIDES

Key Features of Randox Cholesterol Key Features of Randox Triglycerides

• Wide range of kits available - ensuring laboratories of all sizes • Wide range of kit sizes and formats available - offering choice
can find a product to suit their needs and minimal reagent waste
• Liquid ready-to-use reagents - for convenience and ease-of-use • Liquid and lyophilised formats available - for greater choice
• Standards included in manual kits - for user convenience (these • Standards included in manual kits - for user convenience (these
are for manual and semi-automated use only) are for manual and semi-automated use only)
• Extensive measuring range - of 0.865-16.6 mmol/l for • Extensive measuring range - of 0.134-12.7 mmol/l for
measurement of clinically important results measurement of clinically important results
• Applications available for an extensive range of biochemistry • Applications available for an extensive range of biochemistry
analysers - which detail instrument-specific settings for the analysers - which detail instrument-specific settings for the
convenient use of Randox Cholesterol assays on a variety of systems convenient use of Randox Triglyceride assays on a variety of systems
• CHOD-PAP method • GPO-PAP method

Clinical Significance Clinical Significance

Total Cholesterol measures all lipoprotein sub-classes to assess a High triglyceride levels increase the atherogenicity of HDL and LDL
patient’s overall cholesterol level. High levels of cholesterol in the cholesterol. A triglyceride concentration of less than 1.7 mmol/l
blood are associated with atherosclerosis and an increased risk of is desirable. Levels higher than this are not only associated with
heart disease. As such Total Cholesterol testing plays a vital role in an increased risk of heart disease but also type 2 diabetes, kidney
preventative health care. Both the American National Cholesterol disease, hypothyroidism and pancreatitis.
Education Programme (NCEP) and the European Society of
Cardiologists (ESC) recommend levels below 5 mmol/l.

All ordering information can be found on Page 24-25

sLDL CHOLESTEROL 08

NP SMALL-DENSE LDL Fig. 5 Correlation of Ultracentrifugation and Seiken Methods5

(sLDL) CHOLESTEROL
Key Features of Randox sLDL Cholesterol 100 y = 0.95x - 0.38
R = 0.910
Until recently, the primary methods of assessing a patient’s sLDL were
80
based on techniques such as ultracentrifugation and electrophoresis

sd LDL-C “SEIKEN“(mg/dl)
both of which are extremely laborious and time-consuming. 3 sLDL
can now be assessed in the routine biochemistry laboratory using the 60
Randox immunoturbidimetric assay.

• Randox sLDL utilises the “Denka Seiken” method - which 40

produces results in ten minutes. There are two main reaction
steps based on the presence of surfactants and enzymes that 20
selectively react with a certain group of lipoproteins
• The Randox automated sLDL assay correlates extremely well
with the gold standard method - ultracentrifugation shown in Fig. 5
• Applications are available for a wide range of automated 20 40 60 80 100
biochemistry analysers - which detail instrument-specific settings Ultracentrifugation (mg/dL)

for the convenient use of Randox sLDL on a variety of systems

64 SAMPLES FROM HEALTHY PEOPLE, CAD & DIABETIC PATIENTS
• Liquid ready-to-use reagents - for convenience and ease-of-use

Clinical Significance Fig. 6 Types of patients where sLDL should be requested

Small-dense LDL is a subtype of LDL cholesterol. There are two

main types of LDL which vary in size through genetic determination
ABDOMINAL OBESITY
and dietary lipid intake, ranging from small and dense to large and
buoyant LDL. All LDLs transport triglycerides and cholesterol to PATIENTS ON STATIN THERAPY
the tissues but their atherogenesis varies according to size. Smaller
particles such as sLDL more readily permeate the inner arterial wall CVD RISK EQUIVALENT
and are more susceptible to oxidation.

PREDIABETES OR METABOLIC SYNDROME

Research has shown individuals with a predominance of sLDL have a
3-fold increased risk of myocardial infarction (MI).4 Elevated levels
of sLDL are caused by sedentary lifestyle, a diet high in saturated fat, HYPERTENSION
insulin resistance, pre-diabetes and genetic disposition. Measurement
of sLDL allows the clinician to get a more comprehensive picture of HIGH TRIGLYCERIDES
lipid risk factors and tailor treatment accordingly.

TYPE 2 DIABETES

LOW HDL-C

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Lp(a) 09

LIPOPROTEIN (a) (Lp(a)) Criteria to overcome challenges of Lp(a) measurement

Traditional challenges of Lp(a) measurement IFCC -

The International Federation of Clinical Chemistry (IFCC) Working
The widespread use of Lp(a) as an independent risk factor for Group on Lp(a) recommends that laboratories use assays which
cardiovascular disease risk has, until recently, been impeded by the do not suffer from apo(a) size-related bias, in order to minimise the
lack of internationally accepted standardisation and the fact that potential of risk misclassification of patients for coronary heart disease.
many commercial Lp(a) methods suffer from apo(a) size related
bias, potentially leading to patient misclassification. Lipoprotein(a) Foundation -
The Lp(a) Foundation has referenced Marcovina and Albers (2016)6
The size heterogeneity of apo(a) affects to varying degrees the as their recommendation for the best Lp(a) test. This study comes
results of many commercially available Lp(a) kits. This may result in to the following conclusions:
an underestimation of Lp(a) in samples containing apo(a) molecules • Robust assays based on the Denka method are available, which
smaller than that used in the assay’s calibrator and conversely may are reported in nanomoles per litre (nmol/L) and are
overestimate the concentration in samples containing larger traceable to WHO/IFCC reference material
apo(a) particles. • Five point calibrators with accuracy assigned target values
will minimise the sensitivity to apo (a) size
• Upon request, manufacturers should provide the certificate
of evaluation of the calibrator and reagent lots with the
relative expiration dates

“ Randox Lp(a)

•
UF The Randox Lp(a) assay is one of the only methodologies on
the market that detects the non-variable part of the Lp(a)
molecule and therefore suffers minimal size related bias -
providing more accurate and consistent results. The Randox
A FAMILY Lp(a) kit is standardised to the WHO/ IFCC reference material
HISTORY OF SRM 2B and is closest in terms of agreement to the ELISA
PREMATURE reference method.
CVD IS A RISK •
UF Five calibrators with accuracy-based assigned target values
are provided - which accurately reflect the heterogeneity of
FACTOR FOR
isoforms present in the general population
ELEVATED Lp(a)8 • Measuring units available in nmol/L upon request
• Highly sensitive and specific - method for Lp(a) detection in
serum and plasma
• Applications are available for a wide range of biochemistry
analysers - which detail instrument-specific settings for the
convenient use of Randox Lp(a) on a variety of systems
• Liquid ready-to-use reagents - for convenience and ease-of-use

All ordering information can be found on Page 24-25

Lp(a) 10

Clinical Significance

The size of the apo(a) protein is genetically determined and varies

widely hence, levels of Lp(a) can vary up to 1000-fold between
individuals.7 Recent years have seen major scientific advances in the
understanding of Lp(a) and its causal role in premature CVD.

Elevated Lp(a) levels associate robustly and specifically with

increased CVD risk.

Additional Risks
• Along with other tests, Lp(a) can provide additional information Repeat measurement is only necessary if treatment for high Lp(a)
on a patient’s risk factor of developing cardiovascular disease levels is initiated in order to evaluate therapeutic response.
• It is particularly useful for determining the risk of cardiovascular
disease (CVD) in specific populations due to ethnic variations EAS Consensus Panel
• The predictive value of Lp(a) is independent of LDL, non-HDL The evidence clearly supports Lp(a) as a priority for reducing
and the presence of other CVD risk factors cardiovascular risk, beyond that associated with LDL cholesterol.
• Lp(a) levels, like elevated LDL, is causally related to premature Clinicians should consider screening statin-treated patients with
development of atherosclerosis and CVD recurrent heart disease, in addition to those considered at
moderate to high risk of heart disease.
Guidelines for Clinical Significance

European Guidelines for Management of Dyslipidaemia

Lp(a) should be measured in individuals considered at high
risk of CVD or with a strong family history of premature CVD.
The guidelines recommended aiming for Lp(a) ~<50mg/dl as
a treatment priority, after maximal therapeutic management
of LDL cholesterol.

European Atherosclerotic Society8

The European Atherosclerotic Society suggest that Lp(a) should be
measured once in all subjects at intermediate or high risk of CVD/
CHD who present with:

I. Premature CVD
II. Family hypercholesterolaemia
III. A family history of premature CVD and/or elevated Lp(a)
IV. Recurrent CVD despite statin treatment
V. ≥ 3% 10-year risk of fatal CVD according to the
European guidelines
VI. ≥ 10% 10-year risk of fatal and/or non-fatal CHD
according to the US guidelines

All ordering information can be found on Page 24-25

APOLIPOPROTEINS 11

APOLIPOPROTEIN A-I APOLIPOPROTEIN A-II

Key Features of Randox Apolipoprotein A-I Key Features of Randox Apolipoprotein A-II

• Liquid ready-to-use reagents - for convenience and ease-of-use • Liquid ready-to-use reagents - for convenience and ease-of-use
• Wide measuring range - of 6.50-233 mg/dl for measurement • Wide measuring range - of 6.75-61.1 mg/dl for measurement
of clinically important results of clinically important results
• Limited interference - from Bilirubin, Haemoglobin, Intralipid® • Limited interference - from Bilirubin, Haemoglobin, Intralipid®
and Triglycerides, producing more accurate results and Triglycerides, producing more accurate results
• Applications available for an extensive range of biochemistry • Applications available for an extensive range of biochemistry
analysers - which detail instrument-specific settings for the analysers - which detail instrument specific settings for the
convenient use of Randox Apolipoprotein A-I assays on a convenient use of Randox Apolipoprotein A-II on a variety
variety of systems of systems

Clinical Significance Clinical Significance

Apolipoprotein A-I is one of the main protein forms found in High Apolipoprotein A-II is a major constituent of High Density
Density Lipoproteins (HDL). The chief role of Apolipoprotein A-I Lipoprotein (HDL) particles and plays an important role in the
is in the activation of lecithin cholesterol acyl transferase (LCAT) processes of reverse cholesterol transport and lipid metabolism.
and the capture and removal of free cholesterol from extra Increased production of Apolipoprotein A-II promotes
hepatic tissues- this process is called reverse cholesterol transport. atherosclerosis by decreasing the proportion of anti-atherogenic
Apolipoprotein A-I may therefore be described as non-atherogenic, HDL containing Apolipoprotein A-I.
showing an inverse relationship to cardiovascular risk.

Studies have shown that there is an inverse relationship between APOLIPOPROTEIN B

Apolipoprotein A-I and coronary artery disease (CAD), whereas
Apolipoprotein B has a direct relationship with CAD. Patients with Key Features of Randox Apolipoprotein B
CAD generally display reduced levels of Apolipoprotein A-I and
increased levels of Apolipoprotein B. • Liquid ready-to-use reagents - for convenience and ease of use
• Extensive measuring range - of 11.2-184mg/dl for measurement
of clinically important results
• Limited interference - from Bilirubin, Haemoglobin, Intralipid®
and Triglycerides, producing more accurate results
• Applications available for an extensive range of biochemistry
analysers - which detail instrument-specific settings for the
convenient use of Randox Apolipoprotein B assays on a variety
of systems

Clinical Significance

Apolipoprotein B is the main form of protein found in Low Density

Lipoproteins (LDL). Apolipoprotein B shows atherogenic signs and is
therefore useful in the evaluation of coronary risk. Elevated levels of
Increased Apo A-1 decreased CVD Apolipoprotein B indicate increased cardiovascular risk even when
Levels = risk total and LDL cholesterol levels are shown to be within the normal
range, making this an important risk marker.

Apolipoprotein B is often tested alongside Apolipoprotein A-I

to determine the Apolipoprotein B/Apolipoprotein A-I ratio
which can be used as an alternative to the Total Cholesterol
/HDL Cholesterol ratio when determining cardiovascular risk.

All ordering information can be found on Page 24-25

APOLIPOPROTEINS 12

Apo C-II Apo C-III Apo E

All associated with

CARDIOVASCULAR DISEASE RISK

NP APOLIPOPROTEIN C-II Clinical Significance

Key Features of Randox Apolipoprotein C-II

Apolipoprotein C-III modulates the uptake of triglyceride-rich
lipoproteins by the LDL receptor related protein through inhibition
• Liquid ready-to-use reagents - for convenience and ease-of-use
of lipoprotein lipase. Elevated levels of Apolipoprotein C-III are
• Excellent sensitivity - of 1.48 mg/dl, ensuring depleted levels of
associated with both primary and secondary hypertriglyceridemia.
Apo C-II are detected
• Limited interference - from Bilirubin, Haemoglobin, Intralipid®
Genetically determined Apolipoprotein C-III deficiency has shown
and Triglycerides, producing more accurate results
to increase the rate of triglyceride clearance from the plasma by up
• Applications available for an extensive range of biochemistry
to 7-fold. Apolipoprotein C-III levels have been reported higher in
analysers - which detail instrument-specific settings for the
many conditions including type 2 diabetes, hyperbilirubinemia, kidney
convenient use of Randox Apolipoprotein C-II on a variety
deficiency and decreased thyroid function. Factors that can influence
of systems
Apolipoprotein C-III levels include gender, age, menopause and
genetic polymorphisms in the Apolipoprotein C-III gene.
Clinical Significance

Apolipoprotein C-II deficiency can lead to hypertriglyceridemia in NP APOLIPOPROTEIN E

patients; therefore measuring Apolipoprotein C-II can be used as
an aid in assessing cardiovascular disease risk. Apolipoprotein C-II Key Features of Randox Apolipoprotein E
deficient patients present with chylomicronemia, xanthomas, and
recurrent pancreatitis. • Liquid ready-to-use reagents - for convenience and ease-of-use
• Extensive measuring range - of 1.04-12.3mg/dl for
measurement of clinically important results
NP APOLIPOPROTEIN C-III • Limited interference - from Bilirubin, Haemoglobin, Intralipid®
and Triglycerides, producing more accurate results
Key Features of Randox Apolipoprotein C-III
• Applications available for an extensive range of biochemistry
analysers - detailing instrument-specific settings for the convenient
• Liquid ready-to-use reagents - offering optimum convenience
use of Randox Apolipoprotein E on a variety of systems
and ease-of-use
• Excellent linearity - of 21.7mg/dl. The approximate normal
Clinical Significance
upper limit for Apo C-III is 9.5 mg/dl, therefore the Randox
assay will comfortably detect elevated, potentially harmful levels of
Apolipoprotein E is an amino acid which has many functions
Apo C-III
including transport of triglycerides to the liver tissue and distribution
• Limited interference - from Bilirubin, Haemoglobin, Intralipid®
of cholesterol between cells.
and Triglycerides, producing more accurate results
• Applications available for an extensive range of biochemistry
A deficiency in Apo E gives rise to high serum cholesterol and
analysers - which detail instrument-specific settings for the
triglyceride levels and as a result, leads to premature atherosclerosis.
convenient use of Randox Apolipoprotein C-III on a variety
A number of factors can affect Apo E concentrations including the
of systems
genetic polymorphism, oral contraceptive intake, puberty, BMI and age.

All ordering information can be found on Page 24-25

HDL3 CHOLESTEROL 13

High decreased
NP HDL3 CHOLESTEROL HDL3-C = CVD risk
NEW!
What is HDL3 Cholesterol?

HDL comprises of several subclass particles, which differ in their sizes, In secondary prevention, increased risk for long-term hard clinical events is
densities and components. These HDL subclasses are considered to associated with low HDL3-C, but not HDL2-C or HDL-C, highlighting the
play different roles in the progression and regression of arteriosclerosis. potential value of subclassifying HDL-C.
HDL3-C is a smaller and more dense subfraction of the HDL particle.
3. Smaller, denser HDL3-C levels are primarily responsible for the
Standard tests for cholesterol, HDL, LDL and triglyceride levels only inverse association between HDL-C and incident CHD in this diverse
detect approximately 20% of all CAD patients. The other 80% can group of primary prevention subjects. (Joshi et. al, 2016)11
only be identified by differentiating subgroups, and carrying out more
detailed lipid testing. We aimed to clarify the associations of HDL-C subclasses with incident
CHD in two large primary prevention cohorts.
Clinical Significance
We measured cholesterol at baseline from the two major HDL subfractions
HDL is the scavenger of cholesterol within arterial walls and if HDL3 (HDL2 and HDL3) in 4114 African American participants from the Jackson
is in too low numbers the ability to remove this cholesterol is reduced. Heart Study and 818 predominantly Caucasian participants from the
Therefore it is widely accepted that there is an inverse correlation Framingham Offspring Cohort Study.
between HDL3-C and CVD risk, as demonstrated in a number of
recent key publications: Smaller, denser HDL3-C levels are primarily responsible for the inverse
association between HDL-C and incident CHD in this diverse group of
1. HDL3 subclass may be primarily responsible for the inverse primary prevention subjects.
association of HDL-C and CV disease. (Albers et. al, 2016)9

The aims of this secondary analysis were to examine the levels of Randox HDL3 Cholesterol
cholesterol in HDL subclasses (HDL2-C and HDL3-C), sdLDL-C, and
LDL-TG at baseline, as well as the relationship between these levels and CV • Liquid ready-to-use reagents - for convenience and ease-of-use
outcomes. Analyses were performed on 3094 study participants who were • Applications available for an extensive range of biochemistry
already on statin therapy prior to enrollment in the trial. analysers – which detail instrument-specific settings for the
convenient use of Randox HDL3-C on a variety of systems
The results of this secondary analysis of the AIM-HIGH Study indicate that • A 2 step procedure - based on patented technology from
levels of HDL3-C, but not other lipoprotein fractions, are predictive of CV Denka Seiken
events, suggesting that the HDL3 subclass may be primarily responsible for • Open vial stability of 28 days - when stored at +2 to +8°C
the inverse association of HDL-C and CV disease. • HDL3-C controls and calibrators available - offering the
complete testing package
2. In secondary prevention, increased risk for long-term hard • Measuring range of 4 - 60mg/dl - for the measurement of
clinical events is associated with low HDL3-C, but not HDL2-C or clinically important results
HDL-C, highlighting the potential value of subclassifying HDL-C. • Demonstrates a strong correlation with the conventional
(Martin et. al, 2015)10 Ultracentrifugation Method
• Allows for quantification of HDL2-C - by the subtraction of
We collaboratively analysed data from two, complementary prospective HDL3-C from total HDL-C
cohorts: the TRIUMPH study of 2465 AMI patients, and the IHCS study of • Measures total HDL3-C
2414 patients who underwent coronary angiography.

All ordering information can be found on Page 24-25

sPLA2-IIA 14

COMING
NP sPLA2-IIA SOON FROM • Individuals with sPLA2 levels in the highest quartile had a 58%
higher risk of cardiovascular death, MI or stroke, independent
RANDOX
of established risk factors12
What is sPLA2-IIA?
• sPLA2 activity but not LpPla2 activity was related to
atherosclerosis and increased risk of all-cause mortality in a
sPLA2 is a family of pro-inflammatory enzymes linked to the
sample of elderly subjects and predicted mortality or recurrent
formation and destabilization of atherosclerotic plaques. The
MI in a sample of post-MI patients13
sPLA2 protein expression increases with atherosclerotic lesions
• sPLA2 independently predicts death during a 16 week period
development. IIA is the dominant isoform within sPLA2 activity.
after acute coronary syndrome14
• Elevated concentrations of sPLA2–IIA mass and activity showed
Clinical Significance
a statistically significant increased risk for secondary CVD
events independent of a variety of potential confounders
sPLA2-IIA is a cardiovascular biomarker, which aids in prediction
including markers of inflammation, renal function, and
of coronary risk and in the prognosis of patients across different
haemodynamic stress, and even if considered simultaneously15
cardiac risk groups. It is a strong predictor of adverse outcomes,
including CVD, myocardial infarction, stroke and heart failure.
Randox sPLA2-IIA

Conclusions from key publications: • Liquid ready-to-use reagents – for convenience and
ease-of-use
• sPLA2 provides independent prognostic information beyond • Immunoturbidimetric method
established risk markers in patients with stable CAD12 • Complementary value-assigned controls and calibrators
• Strong association observed between increasing sPLA2 and risk available – offering a complete testing package
of heart failure, such that subjects in the highest quartile had • Applications available for an extensive range of biochemistry
nearly a 3-fold higher incidence of heart failure during follow up12 analysers – which detail instrument-specific settings for the
convenient use of Randox sPLA2-IIA on a variety of systems

Across 8 publications covering more than 13,200 patients, the significance of sPLA2 is
demonstrated within secondary and primary prevention:

Secondary prevention
sPLA₂ activity
3738 stable CHD patients PEACE study 12
2587 UA or AMI patients MIRACL study 14
1206 CHD patients KAROLA study 15
1036 Acute Coronary Events patients FAST-MI study 16,17
446 Acute CAD patients GRACE study 18
419 Emergency patients DIMU-Bichat study 19

Primary prevention

2797 asymptomatic patients EPIC-Norfolk study 20,21

1016 elderly patients PIVUS study 13

0 1 2 3 4 5

Relative Risk of Cardiovascular Events

(adjusted odd ratio, first quartile/tertile vs last quartile/tertile)
Adjusted for traditional risk factors, treatments and
biomarkers when available

To register for updates about sPLA2-IIA, please contact reagents@randox.com

 HSCRP & HOMOCYSTEINE 15

HOMOCYSTEINE HIGH SENSITIVITY CRP

Key Features of Randox Homocysteine Key Features of Randox High Sensitivity CRP

•
UF Two part, liquid ready-to-use reagent kit - for • Liquid ready-to-use reagents - for optimum convenience and
optimum convenience ease-of-use
UF Limited interference - from Bilirubin, Haemoglobin, Intralipid® • Latex Enhanced Immunoturbidimetric methodology -
and Triglycerides, producing more accurate results delivering high performance
• Calibrator is included in the kit - for greater convenience • Wide measuring range - of 0.477-10mg/l for measurement of
• Wide measuring range - of 1.7 - 47.9 μmol/L. The normal clinically important results
range for homocysteine is approximately 5-20μmol/L therefore • Limited interference - from Bilirubin, Haemoglobin, Intralipid®
the Randox assay can detect abnormal levels of homocysteine and Triglycerides, producing more accurate results
within a sample • Applications available for an extensive range of automated
• Excellent stability - of 28 days on-board the analyser at biochemistry analysers - which detail instrument-specific
+10°C, minimising reagent waste settings for the convenient use of Randox High Sensitivity CRP
• Applications available for an extensive range of automated assays on a variety of systems
biochemistry analysers - detailing instrument-specific settings
for the convenient use of Randox Homocysteine on a variety Clinical Significance
of systems
Risk Assessment - High Sensitivity CRP (hsCRP) in addition to
Clinical Significance lipid evaluation and risk scoring systems helps in the assessment
of cardiovascular disease (CVD) risk. Approximately half of all
Hyperhomocysteinemia, elevated levels of homocysteine, can be heart attacks occur in patients who have a normal lipid profile
associated with an increased risk of CVD. Patients with chronic and are classified as low risk based on traditional methods of
renal disease experience an excess morbidity and mortality due to risk estimation - the measurement of hsCRP can help clinicians to
arteriosclerotic CVD. Elevated concentration of homocysteine is a identify these individuals earlier. Healthy individuals with CRP levels
frequently observed finding in the blood of these patients. higher than 3mg/l are 2 to 4 times more likely to have a heart attack
or stroke. It can also be used to evaluate the risk of a recurrent
cardiac event.
Fig. 7 2006 AHA /
CDC Guidelines: Prognosis - In high risk groups there have been indications that CRP
hsCRP Levels vs
could be used as a prognostic tool.
Heart Attack Risk

Guidelines - The American Heart Association (AHA) and Centre

for Disease Control and Prevention (CDC) recommend the use
of hsCRP as a more sensitive marker of CVD risk compared to
traditional CRP assays, and suggest the risk guidelines, shown in Fig. 7.

Low Risk Average Risk High Risk

<1mg/L 1 – 3 mg/L >3mg/L

All ordering information can be found on Page 24-25

ADIPONECTIN 16

NP ADIPONECTIN
Key Features of Randox Adiponectin Key references

• Automated assay - removes the inconvenience and time • Adiponectin levels are an independent predictor of CHD in
consumption associated with traditional ELISA based testing caucasian men initally free of CHD. Raising plasma adiponectin
• Liquid ready-to-use reagents - for convenience and level is highly protective of future CHD events in men22
ease-of-use • Low plasma adiponectin concentrations are associated with MI
• Latex Enhanced Immunoturbidimetric method - delivering in individuals below the age of 60, and this remains significant
high performance after adjustment for history of hypertension HDL cholesterol,
• Extensive measuring range - for measurement of clinically smoking and BMI23
important results • Low levels of adiponectin are associated with an increased
• Complementary controls and calibrators available - offering a risk of new-onset hypertension in men and postmenopausal
complete testing package women24
• Applications available for an extensive range of biochemistry • In children, serum levels of adiponectin are inversely related
analysers – which detail instrument-specific settings for the to hypertension. Low values of adiponectin in both obese and
convenient use of Randox Adiponectin on a variety of systems normal weight children are associated with a higher probability
of hypertension25
Clinical Significance

Adiponectin is solely secreted by adipocytes and is a protein

hormone with anti-inflammatory and insulin-sensitising properties.
It plays an important role in a number of metabolic processes such
as glucose regulation and fatty acid oxidation.
ADIPONECTIN
Adiponectin levels are inversely correlated with abdominal
visceral fat (AVF) levels, which have proven to be a strong
predictor of several pathologies including metabolic
syndrome, type 2 diabetes, cancer and cardiovascular disease.
It is widely recognised that people who are overweight are at
higher risk of developing these diseases. Body mass index
(BMI) (weight kg / height m2) is the common method
Glucose output
of determining which patients are classed as overweight or Fat accumulation Inflammation
obese, however it has limitations in measuring athletes Inflammation Endothelial adhesion
and varies in reliability based on age, sex, and race. Foam cell formation
Glucose uptake
As such adiponectin levels are a much more reliable Fat accumulation
indicator of at-risk patients. Energy expenditure

Protection from Insulin-resistance, T2DM, CAD

Fig. 8 (Menzaghi et al 2007) Proposed

salutary effects of adiponectin26

All ordering information can be found on Page 24-25

H-FABP 17

NP HEART- TYPE FATTY ACID

BINDING PROTEIN (H-FABP)
Key Features of Randox H-FABP H-FABP: The Protein

• The only CE-marked automated biochemistry assay available - • Heart-type Fatty Acid Binding Protein (H-FABP) is an unbound,
on the market for the routine assessment of Heart-type Fatty low molecular weight protein, located in the cytoplasm of
Acid Binding Protein cardiac myocytes.27
• Results are returned rapidly - typically within 14 minutes • The molecular weight is only 15kDa smaller than Myoglobin
• Liquid ready-to-use reagents - for convenience and ease-of-use (18kDa), Troponin I (22kDa), Troponin T (37kDa) and CK-MB
• Applications available for an extensive range of biochemistry (86kDa).
analysers - which detail instrument-specific settings for the • The function of H-FABP is in the intracellular uptake of long
convenient use of Randox H-FABP on a variety of systems chain fatty acids in the myocardium.

EARLY RELEASE OF PROTEIN AFTER MI

Ischemia Necrosis

Endothelial
Cell

Endothelial
Cell

Cardiac Myocyte Cardiac Myocyte

H-FABP
Troponin

All ordering information can be found on Page 24-25

 H-FABP 18

Prognostic Value in ACS Diagnostic Value in ACS

• Elevated H-FABP is a significant predictor of death or MI up to • Using the combination approach consistently improved the
1 year.31 NPV, negative likelihood ratio, and the risk ratio.31
• H-FABP provides additional prognostic information, • Measurement of plasma h-FABP and hs-TropT together on
independent of Troponin T, ECG and clinical examination.28 admission appears to be more precise predictor of ACS rather
than either hs-Trop T or h-FABP alone. 32
H-FABP and Troponin - the optimum biomarker strategy

• In the early hours after chest pain onset (CPO), H-FABP

offered superior diagnostic sensitivity for AMI than Troponin.29
• The optimal combination of biomarkers across all timepoints
was Troponin I and H-FABP. 29
• Even based on samples taken immediately after hospital
admission (<24h after CPO), the combination of H-FABP &
Troponin I was superior to the triple marker strategy across
the measures of sensitivity, specificity, PPV & NPV.30

Release Kinetics H-FABP in reinfarction

CK-MB cTnT H-FABP CK-MB cTnT H-FABP

cTnI Myo cTnI Myo

800
700
Concentration (µg/l)
Concentration (µg/l)

600
500
400
300
200
100
0
0 6 12 18 24 30 36 42 50
Time after symptom onset Times (Hours after onset of symptoms)

• H-FABP is highly specific to the heart – approximately 15-20 • Furthermore, the rapid return to baseline within 24 hours, offers
times more specific than Myoglobin.33 significant potential utility in patients with suspected reinfarction,
2h 24h 4d 14d
• The normal serum/plasma value is also much lower, compared instead of CK-MB.37
to Myoglobin.34
• Due to the low molecular weight & cytoplasmic location
of H-FABP, it is released extremely quickly after an ischemic
episode – detectable as early as 30 minutes afterwards.35,36

All ordering information can be found on Page 24-25

MYOGLOBIN,CK-MB & DIGOXIN 19

CK-MB MYOGLOBIN
Key Features of Randox CK-MB Key Features of Randox Myoglobin

• Wide range of kits sizes and formats available - offering • Latex Enhanced Immunoturbidimetric methodology - delivers
choice and minimal reagent waste high performance
• Liquid and lyophilised options available - to satisfy individual • Liquid ready-to-use reagents - for convenience and ease-of-use
user requirements • Wide measuring range of 20.1 - 725 ng/ml - with normal
• Randox Easy Fit reagents available - these reagents fit on to a levels of myoglobin being < 85 ng/ml
wide range of analysers, including Hitachi 717, Abbott Architect • Applications available for an extensive range of biochemistry
and Beckman Coulter AU Series machines; and are used in analysers - which detail instrument-specific settings for the
conjunction with validated analyser applications to ensure ease convenient use of Randox Myoglobin on a variety of systems
of programming
• Randox Easy Read reagents available for Hitachi analysers -
these reagents are packaged in dedicated bottles and are
barcoded for use, removing the need for any additional steps
to be completed
• Applications available for an extensive range of biochemistry
analysers - which detail instrument-specific settings for the
convenient use of Randox CK-MB on a variety of systems

DIGOXIN
Key Features of Randox Digoxin Clinical Significance

• Latex Enhanced Immunoturbidimetric methodology - delivers Digoxin is a drug commonly used to treat patients with heart failure
high performance and arrhythmias. It increases the strength of the heart’s contraction.
• Liquid ready-to-use reagents - for convenience and ease-of-use A stronger heartbeat means that the heart will circulate more blood
• Excellent stability - of 21 days on-board the analyser at +2 to and helps to reduce the symptoms of heart failure. Digoxin can also
+8°C, minimising reagent waste regulate, and slow the heart rate, and is therefore useful in certain
• Applications available - for an extensive range of heart rhythm disorders.
biochemistry analysers which detail instrument-specific
settings for the convenient use of Randox Digoxin on a As these conditions are generally chronic, monitoring Digoxin levels is
variety of systems useful in managing the patient’s condition.

All ordering information can be found on Page 24-25

 TXBCARDIO 20

up to

30%
of patients on low dose
aspirin therapy are
affected by aspirin
“resistance”

NP TxBCARDIOTM
Key Features of Randox TxBCardioTM Clinical Significance

• Highly accurate method for the evaluation of aspirin therapy Aspirin is the foundation of antiplatelet therapy and is widely prescribed in
effectiveness - the primary target of aspirin therapy is TxA2 the primary and secondary prevention of cardiovascular disease. However,
however this has a very short half-life making accurate not all patients receiving aspirin therapy respond in the same way with many
measurement difficult. When TxA2 degrades it is converted suffering from a lack of aspirin effect, also known as aspirin resistance.
into a number of metabolites, the most abundant of which
is 11dhTxB2. Randox TxBCardio™ specifically measures Clinical research has shown that patients who have a sub-optimum response
11dhTxB2 offering a highly accurate method for TxA2 to their aspirin therapy are over three times more likely to die from a
production analysis in patients heart attack or stroke than those who respond positively to such therapy.
• Automated latex-enhanced immunoturbidimetric assay - Up to 30% of patients on low dose aspirin therapy are affected by aspirin
facilitating aspirin therapy testing on automated biochemistry “resistance”.
analysers and eliminating the need for dedicated equipment
• Rapid analysis with an assay time of as little as ten minutes - The identification of these patients can be significantly improved through the
for more efficient results use of Randox TxBCardio™. Results generated by the Randox TxBCardio™
• Liquid ready-to-use reagents - for convenience and ease-of-use assay can be used to enable timely intervention by clinicians with patients
• Applications available for an extensive range of biochemistry deemed to be at increased risk. Patient management can then be altered
analysers - which detail instrument-specific settings for the via improved patient compliance, increased aspirin dosage levels and/or
convenient use of Randox TxBCardio™ on a variety of combination therapies with other drugs.
systems
Aspirin effect correlates to low urinary 11dhTxB2 Lack of Aspirin effect correlates to high urinary 11dhTxB2

TxB 2

TxB 2 TxB 2 TxB 2

TxB 2 TxB 2
TxA 2 TxA 2
TxA 2 TxA 2
TxA 2 TxA 2

TxB 2 TxB 2
TxB 2
Platelets Liver Platelets Liver

LOW HIGH
11dhTxB2 11dhTxB2 11dhTxB2

11dhTxB2

11dhTxB2 11dhTxB2 11dhTxB2

TxA2 TxA2
Urinary II-dehydro Urinary II-dehydro
thromboxane B2 thromboxane B2
Kidney Kidney
TxB2 TxB2
11dhTxB2 11dhTxB2

11dhTxB2 11dhTxB2
11dhTxB2

11dhTxB2 11dhTxB2 11dhTxB2

11dhTxB2

11dhTxB2

11dhTxB2 11dhTxB2 11dhTxB2

11dhTxB2

Urine Urine

All ordering information can be found on Page 24-25

DIAGNOSTIC BIOCHIP PRODUCTS 21

RANDOX MULTIPLEX FAMILIAL

BIOCHIP ARRAY TECHNOLOGY HYPER CHOLESTEROLAEMIA
Randox offer diagnostic and research solutions utilising our
(FH) ARRAYS I & II
innovative Biochip Array Technology (BAT). BAT enables multi-analyte
testing of biological samples to provide a complete patient profile Key Features
from a single sample for rapid and accurate diagnosis.
•  apid turnaround time of ~3 hours from extracted genomic
R
The biochip acts as a solid phase reaction vessel, where biochips are DNA to result
pre-fabricated with discrete test regions (DTR’s); a different antibody/ • Samples can be assessed in low batches (3 biochips) with only
oligonucleotide is immobilised at each spatially distinct DTR. Up to 20ng of genomic DNA required per array
49 individual DTR’s can be arrayed on to a single biochip with one • Ideal protocol for rapid, cost effective cascade testing in family
biochip per sample used to generate multiple results simultaneously. members of FH index patient

The biochip detection is based on a chemiluminescent signal emitting Patient

light, without heat, as a result of a chemical reaction. The light emitted
is detected and quantified using a CCD camera. •  apid mutational test to diagnose FH, the most commonly
R
inherited lipid disease 
Biochip Array Technology operates via the Evidence series of analysers • Mutational status can be determined rapidly from a single test,
designed to deliver efficient high-quality testing and significant time with a reduced need for confirmatory testing with NGS
and cost savings. • Genetic analysis for FH mutations gives a definitive diagnosis
compared to lipid profiling

Laboratory
REMOVABLE
STRIP OF
• CE - marked IVD product.
3 WELLS
• The array tests for 40 specific FH-causing mutations with
~78% coverage in the UK and Ireland, providing a targeted,
cost-effective assay for FH testing. Rapid turnaround time
allows results to be reported same day, compared to lengthy
SINGLE NGS screening which can take several weeks
UP TO 49
REACTION DISCRETE • The array consists of 2 mutation panels, allowing for single
WELL TEST REGIONS panel testing in cases of cascade screening of known mutations
for further laboratory cost savings

All ordering information can be found on Page 24-25

RESEARCH BIOCHIP PRODUCTS 22

CARDIAC RISK CARDIAC PROTEIN ARRAY

PREDICTION ARRAY The Cardiac Array simultaneously detects up to four cardiac
markers from a single patient sample, providing highly accurate
Key features
quantitative results. Suitable for use within both a clinical and
research setting.
• Same day genotyping of 20 GWAS - identified SNPs.
• 36 patient samples can be processed per kit
Acute coronary syndrome (ACS) refers to a range of acute
• Easy to interpret results using the Randox Evidence Investigator
myocardial states, ranging from unstable angina pectoris to acute
dedicated software
myocardial infarction (AMI) with or without ST-segment elevation.
Diagnosis and risk stratification (from low risk to high risk) are
Patient
closely linked in ACS.

• Enhanced CHD risk assessment allows for early intervention

Biochemical markers in serum are used as analytical tools for the
therapeutic treatment and/or lifestyle changes to improve
diagnosis in conjunction with physical examination, clinical history,
cardiovascular health and reduce the risk of CHD
electrocardiogram and imaging investigations. The Randox Cardiac
• Genetic profiling identifies those patients predisposed to
Array enables the simultaneous determination of four cardiac
statin-induced myopathy, allowing clinicians to make more
markers (including late and early markers) from a single sample
informed decisions when prescribing lipid lowering therapies
thus increasing the test result output to facilitate early detection ,
diagnosis and therapeutic monitoring. Corresponding tri-level QC
Laboratory
material available.

• Developed with key opinion leaders in cardiovascular genetics

Cardiac Array
to identify SNPs associated with CHD risk
• Uniquely combines SNP genotyping and patient questionnaire
• Creatine-Kinase Muscle Brain (CK-MB)
data with an algorithim to generate an easy to interpret cardiac
• Heart-Type Fatty Acid Binding Protein (H-FABP)
risk score
• Myoglobin (MYO)

“
• Troponin I (cTnI)

Key benefits of Randox Cardiac Array

• Multiplex testing from a single sample

SIMULTANEOUS • Suitable for human serum samples
• Small sample volume
GENOTYPING
OF 20 SNPS FOR Available on Evidence Investigator analyser
ENHANCED CHD
RISK ASSESSMENT “ • Increased analytical information
• Improved risk stratification of patients with suspected ACS

All ordering information can be found on Page 24-25

ORDERING INFORMATION 23

DESCRIPTION METHOD SIZE CAT. NO.

BR3807

Adiponectin S L.E.I. R1 4 x 65ml, R2 4 x 33.5ml AO2799

Adiponectin S L.E.I. R1 2 x 15.8ml, R2 2 x 8.4ml AO2999
Apolipoprotein A-I S Immunoturbidimetric R1 4 x 40ml, R2 4 x 17ml (S) LP2116
Apolipoprotein A-I S Immunoturbidimetric R1 4 x 60ml, R2 4 x 36ml LP2989
Apolipoprotein A-I S Immunoturbidimetric R1 4 x 30ml, R2 4 x 12ml LP3838
Apolipoprotein A-I S Immunoturbidimetric R1 2 x 10ml, R2 2 x 4.9ml LP8007
Apolipoprotein A-II S Immunoturbidimetric R1 2 x 11ml, R2 2 x 5ml LP3867
Apolipoprotein B S Immunoturbidimetric R1 4 x 50ml, R2 4 x 9ml (S) LP2117
Apolipoprotein B S Immunoturbidimetric R1 4 x 60ml, R2 4 x 15ml (S) LP2990
Apolipoprotein B S Immunoturbidimetric R1 4 x 20ml, R2 4 x 6ml LP3839
Apolipoprotein B S Immunoturbidimetric R1 2 x 10ml, R2 2 x 4ml LP8008
Apolipoprotein C-II S Immunoturbidimetric R1 2 x 11ml, R2 2 x 5ml LP3866
Apolipoprotein C-III S Immunoturbidimetric R1 2 x 11ml, R2 2 x 5ml LP3865
Apolipoprotein E S Immunoturbidimetric R1 2 x 11ml, R2 2 x 5ml LP3864
Cardiac Array Biochip 54 biochip kit EV3692 (Investigator kit)
Cardiac Array Biochip 180 biochip kit EV3688 (Evidence Kit)
Cardiac Risk Predication Array Biochip 72 biochip kit EV3836A&B
CK-MB Immunoinhibition (UV) 19 x 2.5ml CK1296
CK-MB Immunoinhibition (UV) 5 x 20ml CK1553
CK-MB Immunoinhibition (UV) R1 4 x 20ml, R2 4 x 6ml CK3813
CK-MB S Immunoinhibition (UV) R1 4 x 20ml, R2 4 x 6ml CK4043
CK-MB Immunoinhibition (UV) R1 6 x 20ml, R2 3 x 10ml CK7946
CK-MB Immunoinhibition (UV) R1 4 x 20ml, R2 4 x 6ml CK8026
CK-MB Immunoinhibition (UV) R1 6 x 21ml, R2 2 x 15ml CK9717
FH Arrays I & II Biochip 54 biochip kit EV3836A&B
Digoxin S L.E.I. R1 2 x 8ml, R2 2 x 6ml TD3410
HDL Cholesterol S Direct Clearance R1 3 x 2.5L, R2 1 x 2.5L CH1383
HDL Cholesterol S Direct Clearance R1 6 x 30ml, R2 3 x 20ml CH2652
HDL Cholesterol S Direct Clearance R1 6 x 78ml, R2 3 x 52ml CH2655
HDL Cholesterol S Direct Clearance R1 3 x 51ml, R2 3 x 20ml CH3811
HDL Cholesterol S Direct Clearance R1 4 x 38.2ml, R2 4 x 15.2ml CH8033
HDL Cholesterol S Direct Clearance R1 4 x 20ml, R2 4 x 9ml CH8311
HDL Cholesterol Precipitant S Phosphotungstic Acid 4 x 80ml CH203*
HDL3 Cholesterol S Immunoturbidimetric R1 1 x 20ml, R2 1 x 7.5ml CH10165
HDL3 Cholesterol S Immunoturbidimetric R1 4 x 38.2ml, R2 4 x 18.2ml CH10163

To place an order contact reagents@randox.com

ORDERING INFORMATION 24

DESCRIPTION METHOD SIZE CAT. NO.

BR3807

H-FABP S Immunoturbidimetric R1 1 x 19 ml, R2 1 x 7ml FB4025

High Sensitivity CRP S L.E.I. R1 2 x 11ml, R2 2 x 11ml CP3885
High Sensitivity CRP S L.E.I. R1 2 x 13ml, R2 2 x 13ml CP8029
Homocysteine S Enzymatic R1 2 x 21.7ml, R2 2 x 4.6ml (S) HY4036
LDL Cholesterol S Direct Clearance R1 6 x 78ml, R2 3 x 52ml CH2656
LDL Cholesterol S Direct Clearance R1 6 x 30ml, R2 3 x 20ml CH2657
LDL Cholesterol S Direct Clearance R1 3 x 51ml, R2 3 x 20ml CH3841
LDL Cholesterol S Direct Clearance R1 4 x 19.2ml, R2 4 x 8.2ml CH8032
LDL Cholesterol S Direct Clearance R1 4 x 20ml, R2 4 x 9ml CH8312
LDL Cholesterol S Direct Clearance R1 6 x 20ml, R2 2 x 20ml CH9702
Lipoprotein(a) S Immunoturbidimetric R1 1 x 30 ml, R2 1 x 15 ml LP2757
Lipoprotein(a) S Immunoturbidimetric R1 1 x 10 ml, R2 1 x 6 ml LP3403
Lipoprotein(a) S Immunoturbidimetric R1 1 x 10ml, R2 1 x 6.5ml LP8324
Myoglobin S L.E.I. R1 1 x 9.5ml, R2 1 x 4.5ml MY2127
sLDL Cholesterol S Clearance R1 1 x 19.8 ml, R2 1 x 8.6 ml 562616
Total Cholesterol S CHOD-PAP 6 x 30ml (S) CH200
Total Cholesterol S CHOD-PAP 6 x 100ml (S) CH201
Total Cholesterol S CHOD-PAP 8 x 250ml (S) CH202
Total Cholesterol S CHOD-PAP 9 x 51ml CH3810
Total Cholesterol S CHOD-PAP 9 x 50ml CH7945
Total Cholesterol S CHOD-PAP 12 x 66ml CH9715
Total Cholesterol S CHOD-PAP 4 x 68ml CH8019
Total Cholesterol S CHOD-PAP 4 x 20ml CH8310
Triglycerides GPO-PAP 6 x 15ml (S) TR210
Triglycerides GPO-PAP 5 x 100ml (S) TR212
Triglycerides GPO-PAP 10 x 50ml (S) TR213
Triglycerides GPO-PAP 4 x 100T (S) TR1697
Triglycerides GPO-PAP 6 x 51ml TR3823
Triglycerides GPO-PAP 6 x 50ml TR7971
Triglycerides GPO-PAP 4 x 58ml TR8067
Triglycerides S GPO-PAP 8 x 20ml TR8147
Triglycerides S GPO-PAP 4 x 20ml TR8332
Triglycerides S GPO-PAP 12 x 66ml TR9728
Triglycerides GPO-PAP 4 x 58ml TR9780
TxBCardio S L.E.I. R1 1 x 9ml, R2 1 x 4.7ml TBX2759

Precipitant for use with CH200, CH201 and CH202

*
 Indicates liquid option available

(S) Indicates standard included in kit

Not all products are available for diagnostic use in USA. Please contact your local representative for further information.
Please note: All product performance information was achieved using the Randox RX series of clinical analysers. Results may vary depending on the analyser used.
REFERENCES 25

1. Izawa, S., Okada, M., Matsui, H. and Horita,Y. A new direct method for measuring HDL cholesterol which does not produce any biased values. Journal of Medical and Pharmaceutical Science. Vol. 37, p. 1385–1388 (1997).
2. Cohen et al (1997) Canadian Journal of Cardiology 13B No. 0762**
3. Hirano, T. Ito, Y. and Yoshino, G. Measurement of small dense low density lipoprotein particles. J Atherosclerosis Thromb. Vol. 12, no. 2, p. 67-72 (2005).
4. Austin, M.A., Breslow, J. L., Hennekens, C.H., Buring, J.E.,Willett,W. C. and Krauss, R.M. LDL subclass patterns and risk of MI. JAMA. Vol. 260, no. 13, p. 1917-21 (1988).
5. Teng Leary, E., Ph.D. AACC Presentation by Pacific Biometrics. AACC Annual Scientific Meeting & Clinical Lab Expo; 2006 Jul 23-27; Chicago, IL.
6. Marcovina, S.M. and Albers, J.J. Lipoprotein (a) measurements for clinical application. Lipid Res. Vol. 57, p. 526-37 (2016).
7. Kamstrup P.R.,Tybjaerg-Hansen A., Steffensen R., Nordestgaard B.G. Genetically elevated lipoprotein (a) and increased risk of myocardial infarction. JAMA.Vol. 301, p. 2331-2339 (2009).
8. Nordestgaard, B. G., Chapman, M. J., Ray, K., Bore´n, J., Andreotti, F., Watts, G. F., Ginsberg, H., Amarenco, P., Catapano, A., Descamps, O. S., Fisher, E., Kovanen, P.T., Kuivenhoven, J. A., Lesnik, P., Masana, L., Reiner, Z.,Taskinen, M. R.,Tokgo¨
zoglu, L., and Tybjærg-Hansen, A., for the European Atherosclerosis Society Consensus Panel. Lipoprotein(a) as a cardiovascular risk factor: current status. European Heart Journal. Vol. 23, p. 2844-2853 (2010).
9. Albers, J. J., Slee, A., Fleg, J. L., O’Brien, K. D., Marcovina S. M. Relationship of baseline HDL subclasses, small dense LDL and LDL triglyceride to cardiovascular events in the AIM-HIGH clinical trial. Atherosclerosis.Vol. 251, p. 454 – 459, (2016).
10. Martin, S. S., Khokhar, A. A., May, H.T, Kulkarni, K. R., Blaha, M. J, Joshi, P. H.,Toth, P. P, Muhlestein, J. B., Anderson, J. L., Knight, S., Li,Y., Spertus, J. A., and Jones, S. R., on behalf of the Lipoprotein Investigators Collaborative (LIC). HDL
cholesterol subclasses, myocardial infarction, and mortality in secondary prevention: the lipoprotein investigators collaborative. European Heart Journal.Vol. 36, p. 22–30 (2015).
11. Joshi, P. H.,Toth, P. P., Lirette, S.T., Griswold, M. E., Massaro, J. M., Martin, S. S, Blaha, M. J., Kulkarni, K. R., Khokhar, A. A., Correa, A., D’Agustino Sr, R. B., and Jones, S. R. on behalf of the Lipoprotein Investigators Collaborative (LIC) Study
Group. Association of high-density lipoprotein subclasses and incident coronary heart disease:The Jackson Heart and Framingham Offspring Cohort Studies. Eur J Prev Cardiol.Vol. 23, no. 1, p. 41 – 49 (2016).
12. Martin SS, Khokhar AA, May HT, Kulkarni KR, Blaha MJ, Joshi PH,Toth PP, Muhlestein JB, Anderson JL, Knight S, Li Y, Spertus JA, Jones SR, Lipoprotein Investigators Collaborative (LIC). HDL cholesterol subclasses, myocardial
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13. O’Donoghue, M. L., Mallat, Z., Morrow, D. A., Benessiano, J., Sloan, S., Omland,T., Solomon, S. D., Braunwald, E.,Tedgui, A., and Sabatine, M. S. (2011). Prognostic Utility of Secretory Phospholipase A2 in Patients with Stable Coronary
Artery Disease. Clinical Chemistry. 57 (9), p. 1311-1317.
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Atherosclerotic Plaques and Future All-Cause Mortality. European Heart Journal. 33 (23), p. 2946-2954.
15. Ryu, S. K., Mallat, Z., Benessiano, J.,Tedgui, A., Olsson, A. G., Bao, W., Schwartz, G. G. and Tsimikas, S. (2012). Phospholipase A2 Enzymes, High-Dose Atorvastatin, and Prediction of Ischemic Events After Acute Coronary Syndromes.
Circulation. 125 (6), p. 757-766.
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Coronary Heart Disease. European Heart Journal. 30 (22), p. 2742-2748.
17. Simon T et al, European Society of Cardiology Meeting, 2008, P1317
18. Simon T et al, European Society of Cardiology Meeting, 2009, P5109
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Circulating Secretory Phospholipase A2 Activity Predicts Recurrent Events in Patients With Severe Acute Coronary Syndromes. J Am Coll Cardiol. 46(7):1249-1257.
20. Benessiano J et al, JE of the SFC Meeting, 2010, A0229-P256
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events in healthy men and women: the EPIC-Norfolk study. Arterioscler Thromb Vasc Biol. 27(5), p. 1177-83.
22. Tsimikas, S., Mallat, Z., MD,Talmud, P. J., Kastelein, J. J. P., Wareham, N. J., Sandhu, M. S., Miller, E. R., Benessiano, J.,Tedgui, A., Witztum, J. L., Khaw, K.T. and Boekholdt, S. M. (2010). Oxidation-Specific Biomarkers, Lipoprotein(a), and Risk of
Fatal and Nonfatal Coronary Events. JACC. 56:12, p. 946-955.
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Framingham Offspring Study. Atherosclerosis. Vol. 217, p. 543-548 (2011).
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2, p. 194-205 (2010).
25. Jung, D. H., Kim, J.Y., Kim, J. K., Koh, S. B., Park, J. K. and Ahn, S.V. Relative contribution of obesity and serum adiponectin to the development of hypertension. Diabetes Res. Clin. Practise. Vol. 103, no. 1, p. 51-6 (2014).
26. Brambilla, P., Antolini, L., Street, M. E., Giussani, M., Galbiati, S.,Valsecchi, M. G., Stella, A., Zucotti, G.V., Bernasconi, S. and Genovesi, S. Adiponectin and hypertension in normal-weight and obese children. Am. J. Hypertens.Vol. 26, no. 2,
p. 257-64 (2013).
27. Menzaghi, C.,Trischitta,V. and Doria, A. Genetic Influences of Adiponectin on Insulin Resistance,Type 2 Diabetes, and Cardiovascular Disease. Perspectives in Diabetes, vol. 56, p. 1198-1209 (2007).
28. Glatz, J.F.C., van Bilsen, M., Paulussen, R.J.A.,Veerkamp, J., van der Vusse, G.J. and Reneman, R.S.. Release of fatty acid-binding protein from isolated rat heart subjected to ischemia and reperfusion or the calcium paradox. Biochim
Biophys Acta. Vol. 961, p. 148-52 (1988).
29. McCann, C.J., Glover, B.M., Menown, I.B., Moore, M.J., McEneny, J., Owens, C.G., Smith, B., Sharpe, P.C.,Young, I.S. and Adgey, J.A. Prognostic value of a multimarker approach for patients presenting to hospital with acute chest pain.
Am J Cardiol.Vol. 103, no. 1, p. 22-8 (2009).
30. McMahon, C.G., Lamont, J.V., Curtin, E., McConnell, R.I., Crockard, M., Kurth, M.J., Crean, P. and Fitzgerald, S.P. Diagnostic accuracy of heart-type fatty acid-binding protein for the early diagnosis of acute myocardial infarction. Am J
Emerg Med.Vol. 30, no. 2, p. 267-74 (2012).
31. Body, R., McDowell, G., Carley, S., Wibberley, C., Ferguson, J. and Mackway-Jones, K. A FABP-ulous ‘rule out’ strategy? Heart fatty acid binding protein and troponin for rapid exclusion of acute myocardial infarction. Resuscitation.
Vol. 82, no. 8, p. 1041-6 (2011).
32. McCann, C.J., Glover, B.M., Menown, I.B., Moore, M.J., McEneny, J., Owens, C.G., Smith, B., Sharpe, P.C.,Young, I.S. and Adgey, J.A. Novel biomarkers in early diagnosis of acute myocardial infarction compared with cardiac troponin T.
Eur Heart J.Vol. 29, no. 23, p. 2843-50 (2008).
33. Reddy, L.L., Shah, S.A., Dherai, A.J., Ponde, C.K. and Ashavaid,T.F.Troponin T and heart type fatty acid binding protein (h-Fabp) as biomarkers in patients presenting with chest pain. Indian J Clin Biochem.Vol. 31, no. 1, p. 87-92 (2016).
34. Data on file.
35. Ghani, F., Wu, A., Graff, L., Petry, C., Armstrong, G., Prigent, F. and Brown, M. Role of heart-type fatty acid-binding protein in early detection of acute myocardial infarction. Clin Chem. Vol. 46, p. 718-719 (2000).
36. Pelsers, M.M., Hermens, W.T. and Glatz, J.F. Fatty acid-binding proteins as plasma markers of tissue injury. Clin. Chem. Acta.Vol. 352, no. 1-2, p. 15-35 (2005).
37. Kleine, A.H., Glatz, J.F., van Nieuwenhoven, F.A. and van der Vasse, G.J. Release of heart type fatty acid binding protein into plasma after acute myocardial infarction in man. Mol Cell Biochem. Vol. 116, p. 155-162 (1992).
38. Data on file.
 26

A-Z PORTFOLIO OF REAGENTS

Acetaminophen (Paracetamol) CK-NAC Iron
Acid Phosphatase CO2 Total Iron/UIBC
Activated Partial Thromboplastin Time Cocaine Metabolite L-Lactate
(APTT) Complement C3 Lactate Dehydrogenase
Adiponectin Complement C4 Leucine Arylamidase (LAP)
Albumin Copper Lipase
Aldolase Creatinine Lipoprotein (a)
Alkaline Phosphatase CRP Lithium
Alpha-1-Acid Glycoprotein CRP (Canine) Magnesium
Alpha-1-Antitrypsin CRP (Full Range) Methadone
Alanine Aminotransferase (ALT) CRP (High Sensitivity) Methamphetamine
Ammonia Cystatin C Microalbumin
Amylase Digoxin Myoglobin
Amylase (Pancreatic) Ecstasy NEFA (Non-Esterified Fatty Acids)
Anti-Streptolysin O (ASO) EDDP Opiates
Antithrombin III Ethanol Phenobarbital
Apolipoprotein A-I Fibrinogen Phenytoin
Apolipoprotein A-II Ferritin Phosphorus
Apolipoprotein B Fructosamine Potassium
Apolipoprotein C-II G-6-PDH Pregnancy Test
Apolipoprotein C-III Gamma GT Prothrombin Time (PT)
Apolipoprotein E Gentamicin Rheumatoid Factor (RF)
Aspartate Aminotransferase (AST) GLDH Salicylate
Barbiturates Glucose Sodium
Benzodiazepines Glutamate sPLA2-11A
ß2 Microglobulin Glutamine Superoxide Dismutase (Ransod)
Bile Acids Glutathione Peroxidase (Ransel) Syphilis
Bilirubin (Total/Direct) Glutathione Reductase Thrombin Time
Calcium Glycerol Total Iron Binding Capacity (TIBC)
Cannabinoids Haemoglobin Total Antioxidant Status (TAS)
Carbamazepine Haptoglobin Total Protein
Ceruloplasmin HbA1c Transferrin
Chloride Heart-type Fatty Acid Binding Protein Transthyretin (Prealbumin)
Cholesterol (Total) (H-FABP) Triglycerides
Cholesterol (HDL) Homocysteine TxBCardio™
Cholesterol (HDL3) D-3-Hydroxybutyrate (Ranbut) Urea
Cholesterol (LDL) IgA Uric Acid
Cholesterol (sLDL) IgE Urinary Protein
Cholinesterase IgG Valproic Acid
CK-MB IgM Zinc
 27

RANDOX : A GLOBAL DIAGNOSTIC SOLUTIONS PROVIDER

Randox has been supplying laboratories worldwide with revolutionary diagnostic solutions for over 30 years. Our
experience and expertise allow us to create a leading product portfolio of high quality diagnostic tools which offer reliable
and rapid diagnosis. We believe that by providing laboratories with the right tools, we can improve health care worldwide.

RX series of Clinical Analysers

The RX series combines robust hardware and intuitive software with the world leading RX series test menu, including
routine chemistries, specific proteins, lipids, therapeutic drugs, drugs of abuse, antioxidants and diabetes testing.
Renowned for quality and reliability, the RX series boasts one of the most extensive dedicated clinical chemistry
test menus on the market guaranteeing real cost savings through consolidation of routine and specialised
tests onto a single platform. This extensive dedicated test menu of high quality reagents guarantees
excellence in patient care reducing costly test re-runs or misdiagnosis and offers unrivalled precision
and accuracy for results you can trust.

ACUSERA
Randox is a world leading manufacturer of multi-analyte, true third party controls.
Thousands of laboratories rely on us to accurately assess test system performance and
ultimately empower them with the confidence required to release patient test results.
With more than 390 analytes available across the Acusera range we can uniquely
reduce the number of individual controls required while simultaneously reducing
costs, time and storage space. A choice of formats are available, including liquid
or lyophilised, ensuring flexibility and suitability for laboratories of all sizes
and budgets. Some of our principle products include Clinical Chemistry,
Immunoassay, Urine, Immunology/Proteins, Cardiac Markers and Therapeutic
Drugs among others. As a primary manufacturer, Randox are also able
to offer the unique service of custom made controls.

RIQAS
Boasting over 45,000 participants and more than 360 parameters across
33 comprehensive & flexible EQA programmes, RIQAS is the largest
international EQA scheme. Designed to cover all areas of clinical testing, each
of our multi-analyte programmes benefit from a wide range of concentrations,
frequent reporting, rapid feedback and informative yet user-friendly reports.

Biochip Array Technology

Biochip Array Technology (BAT) is an innovative assay technology for multi-
analyte screening of biological samples in a rapid, accurate and easy to use format.
BAT offers highly specific tests, coupled to highly sensitive chemiluminescent
detection, providing quantitative results in easy to interpret reports. Randox BAT assays
offer diagnostic, prognostic and predictive solutions across a variety of disease areas including
sexually transmitted infection, cardiovascular disease (CVD), familial hypercholesterolemia (FH),
colorectal cancer and respiratory infection.
 28

CONTACT US FOR MORE INFORMATION ON ANY OF OUR PRODUCTS AND SERVICES:

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 LT147 DEC17

R E A G E N T S

Information correct at time of print. Randox Laboratories Ltd is a subsidiary of Randox Holdings Limited a company registered within Northern Ireland with company number N.I. 614690. VAT Registered Number: GB 151
6827 08. Product availability may vary from country to country. Please contact your local Randox representative for information. Products may be for Research Use Only and not for use in diagnostic procedures in the USA.