RX series – Testing Capabilities for the Pharma Market
The RX series range of clinical chemistry analysers (fully automated and semi-automated), combined with its extensive and unique assay test menu, provides the Pharma Market with the essential tools to grow and develop new targeted therapeutic drugs and treatments that are specific to those at risk of certain diseases; thereby increasing the likelihood of clinical success.
The RX series encompasses many niche assays including HDL3, Bile Acids, sdLDL-C, Homocysteine, NEFA and Cystatin C, that provide accurate insights into the disease process during the early clinical trial phase. By identifying and evaluating certain biomarkers that indicate patients that are most likely to benefit from specific therapies, and incorporating them into early phase protocols, clinicians are able to move away from the traditional trial and error process. This saves the patient time and unnecessary side-effects from being treated with an ineffective drug whilst aiding the development of new treatments, including personalised medicine.
Certain diseases, including cardiovascular disease and diabetes are becoming more prominent and are constantly presenting new problems for the healthcare system. This highlights the urgent need for the development of more accurate and reliable testing solutions that will enable clinicians to make more informed clinical decisions that deliver the right drug to the right patient at the right time.
The RX series not only enables accurate clinical decision making and new growth opportunities but has a decisive impact on the continuum of care via early diagnosis, patient prognosis and treatment monitoring; thus driving excellence in patient care and healthcare worldwide.
Cystatin C is a small cysteine proteinase inhibitor that is produced at a constant rate by all nucleated cells. The small molecular weight of cystatin C allows it to be completely removed and broken down by the kidneys, levels therefore remain steady if the kidneys are working efficiently and the Glomerular Filtration Rate (GFR) is normal. Cystatin C is a useful marker of renal function in patients where creatinine measurements are not reliable.
This would include individuals who are obese, malnourished, have liver cirrhosis or reduced muscle mass. An additional benefit of cystatin C is the fact that unlike creatinine, cystatin C does not have a ‘blind area’ – up to 50% of renal function can be lost before significant creatinine elevation occurs. Cystatin C is extremely sensitive to very small changes in GFR and is therefore capable of detecting early stage kidney dysfunction.
Read more about our Cystatin C reagent here
Elevated levels of Lipoprotein (a) are considered to be both a casual risk factor and independent genetic marker of atherosclerotic disorders. The major challenge associated with Lp(a) measurement is the size variation of apo(a) within Lp(a). Dependent upon the size of apo(a) in the assay calibrator; many assays under or overestimate apo(a) size in the patient sample.
Numerous commercially available products suffer apo(a) size related bias, resulting in an over estimation of Lp(a) in samples with large apo(a) molecules and an under estimation in samples with small apo(a) molecules. The antibody used in the Randox method detects the complete apo(a) molecule providing accurate and consistent results.
Read more about our Lp(a) reagent here
Elevated levels of homocysteine can be associated with cardiovascular disease, alzheimer’s disease, diabetes, dementia and osteoporosis. Additionally elevated levels of homocysteine is a confirmed risk factor in some pregnancy complications including reduced fertility, preeclampsia and congenital development defects such as anencephaly; making homocysteine an essential addition to a laboratory’s testing panel.
Read more about our Homocysteine reagent here
Non-esterified fatty acids (NEFA) are molecules released from triglycerides by the action of the enzyme lipase and are transported in the blood bound to albumin. They contribute only a small proportion of the body’s fat, but provide a large part of its energy.
Measurement of NEFA is particularly important in diabetes where insulin deficiency results in the metabolism of fat. Levels are also frequently increased in obese patients.
Read more about our NEFA reagent here
The antioxidant defence system has many components. A deficiency in any of these components can cause a reduction in the overall antioxidant status of an individual.
Reduction in total antioxidant status (TAS) has been implicated in a number of disease states including heart disease, rheumatoid arthritis, diabetes and cancer. TAS analysis is also useful in relation to retinopathy and age-related conditions- these can be monitored to promote supplementation and disease prevention.
Read more about our TAS reagent here
Small-dense LDL Cholesterol (sdLDL-C) is a subtype of LDL cholesterol . All LDL transports triglycerides and cholesterol to the tissues but their atherogenicity varies according to size. Smaller particles such as sdLDL-C permeate the inner arterial wall more readily and are more susceptible to oxidation, making sdLDL-C particularly atherogenic. Research has shown individuals with a predominance of sdLDL-C have a three-fold increased risk of suffering from a heart attack, making sdLDL-C measurement extremely valuable.
Read more about our sdLDL-C reagent here
G6PDH is found in every cell in the body and it is used to break down carbohydrates and release their energy into the body. Depleted levels of G-6-PDH cause red blood cells to become particularly vulnerable to haemolysis. If red blood cell production is not subsequently increased to compensate for this breakdown, haemolytic anaemia can occur.
Read more about our G6PDH reagent here
Aldolase is an enzyme responsible for converting glucose into energy. In humans the approximate normal aldolase range is 1-7.6U/L, with elevated levels detected in the blood of individuals with skeletal muscle damage and liver disease. In skeletal muscle diseases, including muscular dystrophy, damaged cells lyse therefore releasing aldolase into the blood. Levels also rise in conditions such as injury and gangrene, however remain normal in situations where weakness is caused by a neurological disease e.g. multiple sclerosis.
Read more about our Aldolase reagent here
Testing for D-3 Hydroxybutyrate can aid in the diagnosis of ketosis which is particularly important. Ketosis occurs when carbohydrates are not available and the body uses fat for energy production.
Metabolism of fatty acids in the liver results in the production of ketone bodies, consisting of acetone, acetoacetate and D-3 Hydroxybutyrate. Levels of ketone bodies in the blood are elevated (ketosis) when synthesis exceeds breakdown. D-3 Hydroxybutyrate levels increase more than levels of acetone and acetoacetate making this the more sensitive marker of ketosis.
Read more about our D-3 Hydroxybutyrate reagent here
HDL comprises of several subclass particles, which differ in their sizes, densities and components. These HDL subclasses are considered to play different roles in the progression and regression of arteriosclerosis. HDL3 Cholesterol is a smaller and more dense subfraction of the HDL particle.
HDL is the scavenger of cholesterol within arterial walls and if HDL3 Cholesterol is in too low numbers the ability to remove this cholesterol is reduced. Therefore it is widely accepted that there is an inverse correlation between HDL3 Cholesterol and CVD risk. Standard tests for cholesterol, HDL, LDL and triglyceride levels only detect approximately 20% of all coronary artery disease patients. The other 80% can only be identified by differentiating subgroups, and carrying out more detailed lipid testing. Several clinical studies indicate that measuring these HDL subclasses better reflects primary and secondary CHD risk than measurement of total HDL, making it a significant independent biomarker for better risk profiling when used together with other risk markers.
Read more about our HDL2/3 reagent here
The microalbumin assay detects very low levels of albumin in urine. The detection of albumin in urine can be an indicator of kidney injury and can result in irreversible damage if left untreated. Low albumin concentrations in the urine (20-200 mg/day) are the earliest marker of renal damage and therefore enable preventative measures to be taken.
Microalbumin testing can identify individuals with diabetic nephropathy approximately 5-10 years earlier than proteinuria tests helping reduce the incidence of end stage renal disease.
Read more about our Microalbumin reagent here
Fructosamine is a mid-term indicator of diabetic control as it can provide information on a person’s average blood glucose levels over the preceding 14-21 days.
Due to the shorter time span of fructosamine, it is often used to evaluate the effectiveness of medication changes and to monitor the treatment of gestational diabetes. Fructosamine is also particularly useful in situations where HbA1c cannot be readily measured e.g. haemolytic anaemia, thalassemia or with genetic haemoglobin variants.
Read more about our Fructosamine reagent here
Bile Acids is a highly sensitive marker of liver function, enabling the early confirmation of liver disease. Bile acids is also the most accurate method for diagnosing obstetric cholestasis in pregnant women, a common liver condition affecting women during the second and third trimester of pregnancy. The condition restricts the flow of bile through the gallbladder resulting in a build-up of bile acids in the liver. As a consequence, bile acids leak into the bloodstream where they are detected at increased levels.
Read more about our Bile Acids reagent here
Consolidation of Routine & Specialised Testing on One Single Platform
With an extensive product portfolio covering over 100 disease markers within routine and niche testing, the RX series removes the need for a separate nephelometry system for specific proteins and allows laboratories to bring all testing in-house; thus providing real cost savings through consolidation and allowing laboratories to expand their testing capabilities.
Low Sample Volumes
Built with excellence in mind, the RX series range of analysers require a low sample volume to deliver consistent high quality reliable results. This proves beneficial when assessing the effectiveness of assays in pre-clinical trials where sample numbers and time spent analysing samples are of high importance. Combined with our high quality reagents, the RX series reduces the possibility of misdiagnosis, offering accurate, reliable and precise results each time, every time.
Robust Hardware & Intuitive Software
The RX series boasts many features including user-friendly Windows based software, an in-built inventory management system, generation of Levey-Jennings charts, calibration curves and QC statistics. With the additional benefit of multiple levels of password protection, the RX series ensures optimum performance, flexibility and excellent functionality.
Minimal Downtime
The RX series requires minimal servicing and maintenance while offering user-friendly Microsoft Windows software that enables users to easily navigate through the analyser software removing the cost of expensive engineer call outs. This combined with the low reagent and sample volumes and the ability to bring more tests in-house ensures minimal downtime and maximum output.
Versatility
The RX series offers a versatile range of routine and niche testing analysers that are applicable to a variety of laboratory settings including, clinical, hospital, university and educational institutes and food and wine laboratories. With a wide range of available throughputs, the RX series suits both small and larger laboratories and proves useful as a backup analyser where a high quantity of tests are conducted on a daily basis.
