Acusera Infectious Disease Serology Controls

Randox Quality Control are pleased to announce the launch of our new Infectious Disease Serology Internal Quality Controls. Our portfolio includes Lyme Disease, ToRCH, EBV, HIV, HAV, HTLV, CMV, VZV and much more.

All samples are provided in a user-friendly, liquid ready-to-use format. This significantly reduces preparation time and the risk of pipetting errors.

There is approximately 1 million people in the USA living with HIV and around 15% of them are unaware they are infected (CDC, March 2019). Furthermore, the Centers for Disease Control and Prevention (CDC) estimate that around 39,000 new HIV infections are reported per year.

The impact of not only HIV but all infectious diseases is getting much greater. Therefore, laboratories now play a much more important role in providing accurate test results. This is a key component in controlling the spread of infections.

Reporting a false positive result has its own obvious implications, however, what about the consequences of reporting a false negative. This can be just as devastating to a person in terms of the treatment they will receive and even personal lifestyle changes for the patient in question.

Randox Stroke Biochip

The Randox Stroke Biochip is a rapid and highly sensitive blood test that will complement and enhance existing CT scanning technology to facilitate accurate classification of stroke patients and improve patient care pathways.

Using Randox revolutionary patented Biochips, the Randox Stroke Biochip provides a unique solution for simultaneous detection of multiple stroke biomarkers from a single sample, facilitating fast and accurate classification of stroke patients in an emergency setting.

Benefits of the Randox Stroke Biochip

> Multiplex biochip for rapid stroke classification in under 30 minutes from a single plasma sample

> Complements and enhances existing CT scanning ensuring fast and accurate diagnosis

> Fast and accurate diagnostic classification between ischaemic and haemorrhagic stroke

> Simple 2 step process from sample entry to results

> Ensures better outcomes guaranteeing timely therapeutic intervention

Lipoprotein(a) [Lp(a)]

 Lipoprotein(a) [Lp(a)] is described as “the most complex and polymorphic of the lipoprotein particles” ¹. The biggest challenge that exists surrounding Lp(a) measurement is the heterogeneity of the apo(a) isoforms. Standardisation across calibrators is vital as the repeated KIV-2 units in Lp(a) act as multiple epitopes. A lack of standardisation could result in the underestimation of Lp(a) associated CVD risk ².

Lp(a) assays that are standardised to the WHO/IFCC reference material, transferring values from mg/dl to nmol/l are more uniformed. The Denka Seiken Lp(a) assay is the most reliable commercially available Lp(a) assay, because ²:

1. The isoform size variations are reduced as a range of calibrators from separate pools of serum were used which covered a range of Lp(a) concentrations.
2. The isoform size and concentrations are inversely correlated better matching calibrants with test samples.
3. Methods based on the Denka Lp(a) assay, calibrated in nmol/l and traceable to the WHO/IFCC reference material produced an acceptable bias compared with the Northwest Lipid Metabolism and Diabetes Research Laboratory (NLMDRKL) gold standard method.

 

HEART UK advocate the widespread clinical utility of Lp(a) to refine the CVD risk assessment. In doing so, HEART UK developed ten statements on Lp(a) (Table 1) utilising the 2016 ACC/AHA Clinical Guideline Recommendation Classification System, to assess the strength of the recommendation and aid in guiding the phrasing of the recommendation ².

Key Features of the Randox Lp(a) Assay

• 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 Lp(a) kit is standardised to the WHO/IFCC reference material (IFCC SRM 2B) and is closest in terms of agreement to the ELISA reference method.
• Five-point calibrator with accuracy-based assigned target values, and control are available, accurately reflecting the heterogeneity of the apo(a) isoforms present in the general population and offering a complete testing package.
• Measuring units are available in nmol/l which is more uniformed and recommended by HEART UK.
• Immunoturbidimetric method is highly sensitive and specific for the detection of Lp(a) in serum and plasma.
• Excellent correlation co-efficient of r=0.995 when compared against other commercially available methods.
• Excellent within run precision of <2.54%.
• Liquid ready-to-use format for convenience and ease-of-use.
• Applications available detailing instrument-specific settings for the convenient use of the Randox Lp(a) assay on a wide range of clinical chemistry analysers.

 

References

1. Marcovina SM, Albers JJ. Lipoprotein (a) measurements for clinical application . Journal of Lipid Research 2019; 57(): 526-537.
2. Cegla J, Dermot R, Neely G, France M, Ferns G, et al. HEART UK consensus statement on Lipoprotein(a): A call to action. Atherosclerosis 2019; 291(): 62-70.

H-FABP in CSA-AKI Testing

Cardiac surgery-associated acute kidney injury (CSA-AKI) is a well-recognised postoperative complication of cardiac surgery and is the second most common cause of AKI in the ICU, occurring in up to 30% of patients. Higher pre-operative values of H-FABP were associated with a higher risk of developing AKI. Following adjustments of certain patient characteristics, the association of pre-operative H-FABP with the development of AKI remained significant. In fact, the researchers observed that a 1 unit increase in log H-FABP was associated with a 3-fold increase in the odds of developing AKI.

Meet CLIA requirements with accuracy and ease

Acusera Linearity Sets are designed to challenge a larger section of an instruments reportable range and test if a system’s calibration is still valid. Our linearity materials cover a wide range of testing including, CRP, RF, Lipids, Therapeutic Drugs, Esoterics and more. Designed with user convenience in mind, all our linearity sets are supplied in a liquid format, while also presented in varying levels. Our unique combination of analytes enables laboratories to reduce the number of individual products required while ultimately reducing costs and time.

Complimentary, cloud-based data reduction software is supplied with all linearity sets, providing a graphical representation of results for at-a-glance performance assessment.  Access to instantly updated peer group data and automatically generated statistics also helps to speed up data review.

The new Evidence+

The fully automated Evidence+ analyzer is set to truly revolutionize laboratories worldwide. Continuing to provide high standards of quality, efficiency and reliability, the fully automated batch immunoanalyzer simultaneously detects multiple drugs and drug metabolites from a single sample.

The Evidence+ analyzer enables both efficient and cost-effective testing whilst providing accurate and reliable results to larger high throughput laboratories.

Randox Biosciences is part of Randox Laboratories and is dedicated to advancing scientific discovery, drug development and diagnostics. We provide a variety of services and products to numerous industries including clinical laboratories, biopharma and academic research institutes.

Our revolutionary multiplex Biochip Array Technology includes multiplex protein immunoassays and multiplex nucleic acid arrays, and is delivered via the award winning Evidence range of analysers. Biochip Array Technology is a multi-analyte testing platform facilitating the simultaneous quantitative or qualitative detection of a wide range of analytes from a single sample. Biochip provides a unique platform for assessment in a rapid, accurate and easy to use format.

Vivalytic

Vivalytic the newest offering from Randox Biosciences brings innovation to the Molecular Diagnostic industry providing tests for respiratory, genitourinary and hospital acquired infections. The Vivalytic platform is capable of both Hi-Plex and Lo-Plex testing. Nucleic acid extraction, PCR amplification followed by a suite of detection methods are combined in a truly revolutionary, fully automated platform. Manual preparation, cold chain reagents and the use of multiple devices are no longer required making Vivalytic  a unique space-saving, hygienic solution for Molecular Diagnostic testing.

RIQAS – The World’s Largest International PT scheme

With over 45,000 laboratory participants in more than 133 countries, the Randox International Quality Assessment Scheme (RIQAS) is truly the largest international PT provider in the world. Our comprehensive product offering currently covers over 360 parameters across 33 flexible programmes. Each RIQAS programme contains a unique combination of parameters meaning laboratories can significantly reduce the number of individual programmes required whilst increasing efficiency and reducing costs. Further benefits to a laboratory include accreditation to ISO 17043:2010, frequent reporting, reduced parameter options and access to comprehensive yet user-friendly reports.

QCMD is a world leading External Quality Assessment (EQA) / Proficiency Testing (PT) scheme, dedicated to improving the quality of molecular diagnostic assays used in the detection of infectious diseases.

With an extensive database of over 2000 participants in over 100 countries, QCMD is one of the largest providers of molecular EQA in the field of molecular diagnostics.

Molecular Infectious Disease Controls

Qnostics is a leading manufacturer of Third Party Quality Control solutions for Molecular Infectious Disease testing. Supplying microbiology/virology laboratories, molecular diagnostic assay manufacturers, EQA providers, pharmaceutical and CRO organisations for over a decade.

Designed to meet the demand of today’s molecular diagnostics laboratory and laboratories carrying out Nucleic Acid Testing (NAT), the Qnostics Molecular Infectious Disease range comprises hundreds of characterised viral, bacterial and fungal targets covering a wide range of Transplant Associated Diseases, Respiratory Infections, Blood Borne Viruses, Sexually Transmitted Infections, Gastrointestinal Diseases and Central Nervous System Diseases.

Randox Reagents are internationally recognised as being of the highest quality, offering reliable and rapid results. Our product portfolio consists of 117 clinical chemistry assays, covering a range of testing panels, including: antioxidants, diabetes, cardiology and lipids, specific proteins, therapeutic drug monitoring and veterinary testing.

Randox are continuously striving to improve diagnostic solutions worldwide.  As a result, Randox have produced 29 niche and superior performance assays, including: 5^th Generation Bile Acids, Adiponectin, Aldolase, Copper, Cystatin C, D-3-Hydroxybutyrate, G6PDH, H-FABP, Lipoprotein (a), NEFA, HDL Cholesterol, sdLDL Cholesterol, Total Antioxidant Status and Zinc.

Evidence series immunoassay analysers guarantee cost-effective, highly accurate and flexible testing solutions. Having been developed to work with patented Biochip Array Technology, this precision multiplex testing platform allows for the simultaneous quantitative or qualitative detection of a wide range of analytes from a single sample.

This multiplex system delivers an unrivalled increase in patient information, offering a more in-depth diagnostic profile with each patient sample. This further analysis places the focus on the diagnosis, and on improving patient outcomes.

Renowned for quality and reliability, the RX series leads the way with the world’s most extensive dedicated clinical chemistry test menu comprising routine chemistries, specific proteins, lipids, therapeutic drugs, antioxidants, veterinary and diabetes testing. Guaranteeing real cost savings through consolidation of routine and specialised tests onto a single platform, the RX series of analysers delivers excellence in patient care, offering unrivalled precision, accuracy and reliability.

RX misano

The RX misano semi-automated analyser has been developed with the user in mind by incorporating a responsive touch-screen display. The sleek ergonomic design boasts intuitive user-friendly software allowing for test menu personalisation and ease of use. The RX misano is capable of high standard, precise results at a competitive price per test.

RX monaco

The RX monaco is a fully automated solution for low to mid volume clinical chemistry testing offering the ultimate in convenience, performance and confidence. At optimal configuration, the RX monaco performs 170 tests per hour providing cost effective, high quality testing.

RX daytona +

The RX daytona+ is a fully automated, benchtop, clinical chemistry analyser capable of performing high quality testing, with a combined throughput of 450 tests per hour, for accurate results you can trust. The most versatile analyser in its class, the RX daytona+ combines robust hardware and intuitive software with the world leading RX series test menu for unrivalled performance with direct HbA1c testing capabilities.

RX imola

The RX imola is a cost-effective system that delivers consistent high-quality results. Capable of handling the workload of a medium to high throughout laboratory and a combined throughput of 560 tests per hour, the RX imola provides rapid, comprehensive testing on a small footprint analyser with direct HbA1c testing capabilities. The RX imola is a fully automated system with random access and STAT sampling functionality, boosting productivity and saving time when it matters most

RX modena

Capable of performing up to 1,200 tests per hour, with direct HbA1c testing capabilities, the RX modena consolidates all your assay requirements onto one intuitive platform. The RX modena boasts icon based, interactive touch-screen technology adding a modern flair to your laboratory.

Randox Toxicology offer the most comprehensive Drugs of Abuse (DoA) test menu across multiple forensic matrices. Our level of expertise in toxicology research and development allows us to adapt quickly to ever changing market influences and develop assays for current and novel drug trends. Excellent assay precision and performance eliminates false reporting, therefore reducing unnecessary confirmatory tests and time lost in the laboratory as a result. Our Biochip Arrays offer CVs typically less than 10%, producing an accurate drug profile to ensure confidence in results.