Randox Clinical Laboratory Services

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Randox Clinical Laboratory Services

Randox Clinical Laboratory Services

Randox Clinical Laboratory Services (RCLS) specialises in offering esoteric biomarker testing utilising the expertise and knowledge Randox has built over 40 years producing high quality IVD diagnostics. RCLS strives to provide a clinical laboratory service to meet the time sensitive, bespoke requirements of research and clinical trial projects globally.

By utilising Randox Clinical Laboratory Services you can save your laboratory time and money. Our multiplex panels offer a cost effective, labour saving and time reducing solution for your sample testing. As a result, we provide your laboratory with the best solution for your sample testing.

Clinical laboratories traditionally perform diagnostic testing from a variety of patient samples (whole blood, serum, plasma, saliva, sputum, CSF, swab collections) to determine their health status.

In addition to Diagnostics, Randox Laboratories also perform Biomarker analysis from selected patient cohorts in support of pharma research, aiming at discovering a biological signal related to an NDE’s activity (targeted Biomarker approach) or a novel druggable target (proteomic analysis).  Randox Biosciences offer multiple technical solutions to address the above, mostly based on the Randox proprietary Biochip Array Technology.

  • Labs located at RCLS Science Park, Liverpool, Warrington & Dunstable
  • ISO17025 and ISO15189 accredited
  • LA Laboratory will open in Q2 2022 to run CLIA waved tests, with plans to be fully CAP certified by 2024
  • GCP certified for testing in clinical trials
  • Can be used for post approval sample analysis
  • Labs coming to LA, Glasgow, Cardiff, London & Dublin in 2022/2023

Sample & Data Management

 

– LIMS system (Labware) utilised and connected throughout the lab.

– Customer and project specific folders on an internal secure server

– Ability to transfer data securely through secure email/drop box

Capabilties

 

Randox Biosciences provide the building blocks of diagnostic development which includes antibodies, corresponding conjugates and proteins. Our immunoassay product offering provides diagnostic solutions covering a variety of disease areas including thyroid, reproduction, cardiovascular and renal.

Biochip Technology from Randox is an innovative assay technology which utilises multiplex testing methodology in a rapid, accurate and easy-to-use format, catering both molecular and immunoassay testing. The technology works by combining a panel of related assays in a single biochip with a single set of reagents, controls and calibrators. Only one single undivided sample is used. The results are read by a CCD-camera and custom image-processing software.

Custom Assay Development

 

Serving the diagnostic, pharmaceutical, contract research and biotech industries, Randox Biosciences dedicates custom unit develops and manufactures custom assay solutions. This also includes full customised quality control sera and calibrators. A selection of over 320 pre-qualified biomarkers is available for a custom panel design. However, any specific biomarker of interest will be considered for integration into an existing or desired panel, for technical feasibility (concentration range compatibility, potential interferences/cross-reactivities). The number of the required novel biomarkers will help make the feasibility study as a pertinent and complete as possible.

Companion Diagnostics (CDx) are part of the services that Randox Biosciences supply to pharmaceutical companies. With a long-recognized expertise in the development of esoteric assays, and more than 500 IVD products available globally, Randox is a partner of choice to support your CDx needs.

Full Assay Menu

  • Clinical
  • Molecular
AKI Array
Lipocalin (NGAL)ClusterinCystatin CKIM-1
ADHESION MOLECULES ARRAY
E-selectinP-selectinL-selectinICAM-1
VCAM-1
ANAEMIA ARRAY
FerritinFolateVitamin B12
ALZHEIMERS RISK ARRAY
Pan ApoEApoE4
CEREBRAL ARRAY II
sTNFRINGALNSED-dimer
CKD ARRAY I
EGFFABP1D-DimerIL-8
MIP-1 αsTNFRIsTNFRII
CKD ARRAY II
CYTOKINE ARRAY I
IL-1αIL-1βIL-2IL-4
IL-6IL-8IL-10IFNγ
EGFMCP-1TNFαVEGF
CYTOKINE ARRAY IV
MMP-9sIL-2RαsIL-6RsTNFRI
sTNFRII
CYTOKINE ARRAY V
IL-3IL-7IL-12p70IL-13
IL-23
FERTILITY ARRAY
Follicle Stimulating Hormone (FSH)Luteinising Hormone(LH)Prolactin Hormone (PRL)Progesterone (PROG)
Estradiol (EST)
GASTROPANEL ARRAY
Pepsinogen I (PGI)Pepsinogen II (PGII)Gastrin 17 (G17)
HELICOBACTER PYLORI ASSAY
Helicobacter Pylori (HP)
METABOLIC SYNDROME I ARRAY
FerritinIL-6InsulinLeptin
Plasminogen Activator Inhibitor-1 (PAI-1)ResistinTumour Necrosis Factor α (TNFα)
METABOLIC SYNDROME II ARRAY
AdiponectinC-reactive Protein (CRP)Cystatin C
PTH ASSAY
Parathyroid Hormone (PTH)
SHGB ASSAY
Sex Hormone-Binding Globulin (SHBG)
STROKE ARRAY
Soluble Tumour Necrosis FactorReceptor 1 (sTNFR1)Glial fibrillary acidic protein (GFAP)IL-6
Fatty acid binding protein 3 (FABP3)D-DimerParkinson Disease Protein 7 (PARK7)Nucleoside Diphosphate Kinase A
(NDKA)
Glutathione S-transferase, Pi (GSTP1)
TESTOSTERONE ASSAY
Testosterone
THYROID TOTAL ARRAY
Total thyroxine (TT4)Total tri-iodothyronine (TT3)Thyroid stimulating hormone (TSH)
THYROID FREE ARRAY
Free thyroxine (FT4)Free tri-iodothyronine (FT3)Thyroid stimulating hormone (TSH)
THYROID AUTO ANTIBODY ARRAY
Anti-thyroglobulin (TgAb)Anti-thyroid peroxidase Antibody (TPOAb)
THYROID TBG ASSAY
Thyroxine Binding Globulin (TBG)
TISSUE DAMAGE ARRAY
Liver Fatty Acid Binding
Protein-1 - FABP1
Heart-Type Fatty Acid-Binding
Protein - FABP3
Adipose Fatty Acid Binding
Protein - FABP4
Epidermal Fatty Acid Binding
Protein - FABP5
Ileal Fatty Acid Binding Protein - FABP6Brain Fatty Acid Binding
Protein - FABP7
Testis Fatty Acid Binding
Protein - FABP9
TUMOR PSA ARRAY
Free Prostate Specific Antigen (fPSA)Total Prostate Specific Antigen (tPSA)Carcinoembryonic Antigen (CEA)
VITAMIN D ASSAY
Vitamin D
CARDIAC RISK PREDICTION
TargetSNPTargetSNP
MIA3*rs17465637LPA*rs3798220
9p21rs10757274LPA*rs10455872
DAB2IPrs7025486MRAS*rs9818870
CXCL12rs1746048LPL*rs328
ACErs4341LPLrs1801177
NOS3rs1799983SORT1*+rs646776+
APOA5rs662799PCSK9rs11591147
SMAD3rs17228212APOE*rs429358
APOB*rs1042031APOE*rs7412
CETPrs708272
CHRONIC LUNG DISEASE (CLD) ARRAY
Viral
AdenovirusMetapneumovirusRespiratory syncytial virus ARespiratory syncytial virus B
Rhinovirus A/B/CInfluenza virus AInfluenza virus B
Bacterial
Achromobacter xylosoxidansBordetella pertussisBurkholderia cepacia complex (21spp)Burkholderia cenocepacia
Chlamydia pneumoniaeHaemophilus influenzaMoraxella catarrhalisMycoplasma pneumoniae
Non-tuberculous mycobacterium (15 spp)Mycobacterium avium complex (4 spp)Pandoraea species (5 spp)Prevotella species (16 spp)
Pseudomonas aeruginosaStaphylococcus aureusStenotrophomonas maltophiliaStreptococcus pneumoniae (21 spp)
Streptococcus species (19 spp)Veillonella species (3 spp)
Fungal
Aspergillus fumigatusCandida albicansExophialia dermatitidisScedosporium species (7 spp)
Antibiotic Resistance Markers
mecA (incl MRSA)
FAMILIAL HYPERCHOLESTEROLEMIA
LDLR 38 mutationsAPOB 1 mutationPCSK9 1 mutation
APOBPCSK9
MutationProteinMutationProtein
c.10580G>Ap.(Arg3527Gln)c.1120G>Tp.(Asp374Tyr)
LDR
MutationProteinMutationProtein
c.2292delAp.(Ile764Metfs*2)c.1187-10G>Ap.(=)
c.1444G>Ap.(Asp482Asn)c.1048C>Tp.(Arg350*)
c.551G>Ap.(Cys184Tyr)c.118delAp.(Ile40Serfs*166)
c.1845+11C>Gp.(=)c.1168A>Tp.(Lys390*)
c.693C>Ap.(Cys231*)c.232C>Tp.(Arg78Cys)
c.933delAp.(Glu312Serfs*58)c.1587-1G>Ap.(=)
c.301G>Ap.(Glu101Lys)c.1706-10G>Ap.(=)
c.313+1G>Ap.(=)c.1796T>Cp.(Leu599Ser)
c.1706-1G>Ap.(=)c.1436T>Cp.(Leu479Pro)
c.1706-1G>Ap.(Cys677Arg)c.1474G>Ap.(Asp492Asn)
c.2029T>Cp.(Pro685Leu)c.501C>Ap.(Cys167*)
c.2054C>Tp.(Trp483Arg)c.662A>Gp.(Asp221Giy)
c.1447T>Cp.(Gly478Arg)c.682G>Tp.(Glu228*)
c.1447T>Cp.(Asp72Thrfs*134)c.1150C>Tp.(Gln384*)
c.214delGp.(Trp87Gly)c.938G>Ap.(Cys313Tyr)
c.259T>Gp.(Arg633Cys)c.136T>Gp.(Cys46Gly)
c.1897C>Tp.(Asp227Glu)c.2042G>Cp.(Cys681Ser)
c.681C>Gp.(Asn688Glnfs*29)c.1618G>Ap.(Ala540Thr)
c.1285G>Ap.(Val429Met)c.680_681delACp.(Asp227Glyfs*12)
KRAS, BRAF, PIK3CA ARRAY
KRAS Gene Targets
G12AG12RG12DG12C
G12SG12VG13DG13C
G13RQ61KQ61LQ61R
Q61H(1)Q61H(2)A146TA146P
BRAF Gene Targets
V600EG12R
PIK3CA Gene Targets
E542KE545KH1047R
RESPIRATORY MULTIPLEX ARRAY II
Viral
Influenza AInfluenza BAdenovirus A/B/C/D/EBocavirus 1/2/3
Coronavirus 229E/NL63Coronavirus OC43/HKUIEnterovirus A/B/CMetapneumovirus
Parainfluenza virus 1Parainfluenza virus 2Parainfluenza virus 3Parainfluenza virus 4
Respiratory syncytial virus A/BRhinovirus A/B/C
Bacterial
Legionella pneumophilaBordetella pertussisChlamydophila pneumoniaeHaemophilus influenzae
Moraxella catarrhalisMycoplasma pneumoniaeStreptococcus pneumoniae
SEXUALLY TRANSMITTED INFECTION (STI) ARRAY
Pathogens
Chlamydia trachomatis (CT)Neisseria gonorrhoea (NG)Trichomonas vanginalis (TV)Mycoplasma genitalium (MG)
Treponema pallidum (Syphilis) (TP)Herpes simplex virus 1 (HSV-1)Herpes simplex virus 2 (HSV-2)Haemophilus ducreyi (HD)
Mycoplasma hominis (MH)Ureaplasma urealyticum (UU)
URINARY TRACT INFECTION (UTI) ARRAY
Bacterial
Acinetobacter baumanniiCitrobacter freundiiCitrobacter koseriKlebsiella aerogenes
Enterobacter cloacaeEnterococcus faecalisEnterococcus faeciumEscherichia coli
Klebsiella oxytocaKlebsiella pneumoniaeMorganella morganiiProteus spp.
Pseudomonas aeruginosaProvidencia rettgeriProvidencia stuartiiSerratia marcescens
Staphylococcus aureusStaphylococcus epidermidisStaphylococcus saprophyticusStreptococcus agalactiae (GBS)
Fungal
Candida albicans
Antibiotic Resistance Markers
mecA (incl MRSA)Trimethoprim Resistance 1Trimethoprim Resistance 2Trimethoprim Resistance 3
S mecA (incl MRSA)Trimethoprim Resistance 4Trimethoprim Resistance 5Van A (Vancomycin Resistance A)
Van B (Vancomycin Resistance B)

Testing for STIs with Confidante At Home Testing Kit

Sexually Transmitted Infections (STIs)

Sexually transmitted infections (STIs) are passed from one person to another typically through unprotected sex or genital contact.1 Some of the most common STIs are Chlamydia, Genital Warts, Herpes, Gonorrhoea, HIV and Viral Hepatitis. Over one million STIs are acquired every day worldwide.2

Not all STIs cause noticeable symptoms. You could have an STI and not know. Therefore it is essential to get regular health checks. Some STIs, like chlamydia, can be asymptomatic – i.e. they display no symptoms but can cause long-term complications like infertility.3

STI symptoms in women

  • yellow or green vaginal discharge
  • smelly discharge (often fish-like)
  • bleeding between periods
  • bleeding after sex
  • pain during sex

STI symptoms in men

  • discharge from penis tip
  • irritation of the urethra
  • swollen testicles

STI symptoms in both genders

  • pain when urinating
  • itching, burning or tingling around the genitals
  • blisters, sores, lumps or a rash around genitals or anus

Confidante At-Home STI Testing Kit

If you have recently entered a new relationship, experienced unprotected sex or are planning a family you should get tested for STIs, and may want to avail of our 10-plex STI test.

We offer a home testing sexually transmitted infection kit called ‘Confidante’ which enables you to be tested for 10 of the most common STIs. Confidante is designed to ensure a simple, hassle-free process where you will receive your results in 7 working days of posting your sample via email or telephone.

The process is straightforward and so simple: Buy Online / Register Kit Online / Collect Sample / Post / Receive Results.

For healthcare professionals, we also offer a Multiplex Sexually Transmitted Infection Array allowing you to outsource samples for STI testing. The CE-marked STI Array provides excellent precision, specificity, sensitivity and accuracy for STI diagnoses, which reduces the risk of false reporting and unnecessary confirmatory tests. Our simultaneous multiplex testing means smaller sample volumes are required, enabling faster throughput and rapid patient diagnosis saving you time and money.

STI Multiplex Array detects the following;

  • Chlamydia Trachomatis
  • Neisseria Gonorrhoea
  • Herpes Simplex 1
  • Herpes Simplex 2
  • Treponema Pallidum
  • Mycoplasma Hominis
  • Ureaplasma Urealticum
  • Mycoplasma Genitalium
  • Haemophilius Ducreyi
  • Trichomonas Vaginalis

Randox Clinical Laboratory Services

Tests for each of the STIs detailed above are run in Randox Clinical Laboratory Services (RCLS) in Antrim, Northern Ireland. RCLS is built upon Randox’s 35 years of experience and provides a clinical laboratory service designed to meet the time-sensitive, bespoke requirements of clinical and research projects globally.

RCLS have 4 UKAS ISO 17025 accredited testing laboratories No. 9329 – with unrivalled facilities across the UK. They are situated in Liverpool, London, Holywood and Randox Science Park Antrim. Within each of the locations there are a team of experienced scientists to support your project while you save money, time and labour.

There are a variety of analyser platforms available across the RCLS laboratories including the RX series of clinical chemistry analysers, along with our Evidence Series of multiplex immunoassay/molecular diagnostic systems, which utilise our intelligent Biochip Array Technology.  Each site also offers alternative third-party analysers.

To find out more information about Confidante sexual health testing, or RCLS, visit: https://www.confidantetest.com/ or email info@rcls.com. To find out more information about our STI Array visit: https://www.randox.com/sti-array/ or email info@rcls.com

  1. https://www.nhsinform.scot/illnesses-and-conditions/sexual-and-reproductive/sexually-transmitted-infections-stis
  2. https://www.who.int/news-room/fact-sheets/detail/sexually-transmitted-infections-(stis)
  3. https://onlinedoctor.lloydspharmacy.com/uk/info/sexual-health-information/what-is-a-sti

 

 

 

 

 

 

 

 

 


Molecular Testing on the Evidence Investigator

The Evidence Investigator is a compact, semi-automated benchtop analyser which is renowned for its versatility, robustness and effective reporting methods. The Evidence Investigator has offered efficient and comprehensive testing in a wide range of laboratory settings for many years including, clinical diagnostics, molecular, research, toxicology and food diagnostics.

The Evidence Investigator is the perfect fit for medium throughput laboratories seeking maximum use of bench space and can process up to 44 results from a single sample, with a maximum throughput of up to 2376 tests per hour.

It is extremely well equipped to provide reliable and accurate results because results are generated using Charge Coupled Device (CCD) camera, which quantifies chemiluminescent light. The light then measures the degree of binding between the sample and specific biochip bound ligands. The Evidence Investigator image processing software translates light signal generated from chemiluminescent reactions into analyte concentrations which removes the need for any manual processing of data.

Our molecular product range offers diagnostic, prognostic and predictive solutions across a variety of disease areas including sexually transmitted infection (STI), respiratory tract infection, colorectal cancer, familial hypercholesterolemia (FH) and cardiovascular disease (CVD). Additionally, we can provide a wide range of assay formats including single nucleotide polymorphisms (SNP) genotyping, pathogen detection and mutation detection. The technology allows simultaneous detection of multiple analytes from a single sample for efficient and cost-effective testing.

Pathogen Detection

STI and Respiratory Arrays

Sexually transmitted infections (STIs) affect more than 1 million people every day and each year 500 million new cases of STIs occur.1 Therefore, it is vital for early and accurate detection. Randox’s Sexually Transmitted Infections Multiplex Array simultaneously detects 10 bacterial, viral and protozoan including primary, secondary and asymptomatic co-infection for a complete infection profile. The assay is based on a combination of multiplex PCR and biochip array hybridisation. Innovative PCR priming technology permits high discrimination between multiple targets.

Respiratory tract infections are caused by many viral and bacterial pathogens and are the second most common cause of morbidity and mortality worldwide.2 The Respiratory Multiplex Array is the most comprehensive screening test for infections of both the upper and lower respiratory tracts, simultaneously detecting 22 bacterial and viral pathogens from a single sputum lavage or nasopharyngeal sample.

Both arrays detect the most common and frequently requested infections in sexual and respiratory health. These comprehensive, highly sensitive and specific tests enable identification of co-infections simultaneously, often in asymptomatic patients and enable antibiotic stewardship.

Mutation Detection

KRAS, BRAF, PIK3CA Array and Familial Hypercholesterolemia Arrays I & II

The colorectal cancer (CRC) is the third most common cancer worldwide. Overall, the lifetime risk of developing colorectal cancer is: about 1 in 22 (4.49%) for men and 1 in 24 (4.15%) for women.3 The KRAS, BRAF, PIK3CA Array simultaneously detects 20 point mutations within the KRAS, BRAF and PIK3CA genes. The assay is validated for use with the DNA extracted from fresh/frozen and formalin fixed paraffin embedded tissue. The array is CE marked for routine clinical use.

Familial Hypercholesterolemia (FH) is a genetic disorder of lipoprotein metabolism. 4It is the most common autosomal dominant, or inherited disease and affects the plasma clearance of LDL-cholesterol, resulting in premature onset of cardiovascular disease and higher mortality risk.5 Early diagnosis is crucial as by the time the FH sufferer enters early adulthood they will have accumulated >20 years of continuous exposure to build up of fatty or lipid masses in the arterial walls and are at the hundred-fold greater risk of a heart attack than other young people. The Familial Hypercholesterolemia (FH) Arrays I & II are rapid, simple and accurate detection of 40 FH-causing mutations within the LDLR ApoB and PCSK9 genes.

These unique biochip assays permit high discrimination between multiple targets in several genes with a rapid turnaround time (3 hours). The arrays enable detection of the most frequently occurring mutations known to cause disease (FH) and adversely affect patient treatment (KRAS, BRAF, PIK3CA).  A unique primer set is designed for each target which will hybridise to a complimentary oligo-nucleotide probe spotted on a biochip discrete test region (DTR).

SNP Genotyping

Cardiovascular Risk Prediction Array

Coronary Heart Disease is the leading cause of death in the developed world and its prevention is a core activity for public health systems worldwide.6 Randox have the Cardiac Risk Prediction Array which will allow for 19 SNPs to be genotyped simultaneously, which incorporate a test to identify patients predisposed to statin-induced myopathy.

This array identifies individuals with a genetic predisposition to coronary heart disease (CHD). The innovative multiplex primers are designed to discriminate DNA sequences which differ only at one base.

For more information on our Evidence Series or Molecular range of Assays, contact us at info@biosciencesrandox.com

  1. https://www.who.int/news-room/fact-sheets/detail/sexually-transmitted-infections-(stis)
  2. https://www.ncbi.nlm.nih.gov/pubmed/25189349
  3. https://www.cancer.org/cancer/colon-rectal-cancer/about/key-statistics.html
  4. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4472364/
  5. https://www.ncbi.nlm.nih.gov/books/NBK395572/
  6. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2864143/

 

 

 

 

 

 

 

 

 


Cutting-edge research and testing centre opens at Randox Science Park

Following the success of the first ever Randox Health Grand National, global health diagnostics company Randox has today announced the official opening of its new central laboratory, Randox Clinical Laboratory Services (RCLS), at the recently acquired Randox Science Park in Antrim, Northern Ireland.

Situated at this new state of the art biohub, the RCLS accredited lab now houses Randox’s latest blood screening equipment – the pioneering Evolution machine.  This new technology enables the labs to conduct a full range of niche and standard research testing, as well as current health testing for the company’s Randox Health division, which offers the world’s most comprehensive full body health analysis.

Research areas at the newly accredited laboratory include but are not exclusive to cancer, fertility, heart, inflammation, stroke and kidney health, both in-house and collaboratively with external organisations.  Current and past collaborations include an Acute Kidney Injury Study with the Royal Victoria Hospital, a Bladder Cancer Study in partnership with Queen’s University Belfast and The Belfast Trust, a Stroke and Brain Injury study with Cambridge University, and key partnerships with a number of major pharmaceutical companies.

A staggering 222 clinical diagnostic tests are currently run routinely with the lab, with more tests pending accreditation in the coming months.

Ann-Marie Jennings, Laboratory Manager for Randox Clinical Laboratory Services, explained that the new facilities will allow RCLS to increase their output and enter new markets;

“Randox Clinical Laboratory Services has been operational for a number of years in our headquarters in Crumlin, near the Belfast International Airport.  Now that we have moved to our new, purpose-built labs in the Randox Science Park, we have the ability to increase the output of both our health testing and our research testing. This involves expanding our team of experienced scientists, working towards further accreditations and furthermore setting up independent labs in Dubai, LA, Holywood and Liverpool in addition to our current labs in Antrim and London.”

Thanks to the new Randox Science Park facilities, the company will now be able to provide an increasingly wide range of testing services to Biotechnology and In Vitro Diagnostic companies, and will deliver to pharmaceutical companies the testing services required to support their drug development projects, in addition to the testing provided to research organisations,

With the ability to conduct an unrivalled range of health testing – haematology, biochemistry and immunoassay – all under one roof, the laboratory offers unparalleled support services to the dynamic and growing healthcare industry.  With a greater understanding of human complexity, pharmaceutical companies are now focusing on developing safer drugs tailored to specific patient groups or sub-groups and the expansion plans in motion at RCLS will help these organisations bring new drugs to market faster.

Ann-Marie continued;

“On our patented Randox Biochip Array Technology we can customize bespoke testing platforms based on the requirements of each drug development project, which can be a challenging process. From initial product development to clinical trial stages there can be a number of barriers and time constraints before drugs are successfully released to the public.  We’re confident that our newly enhanced capabilities will benefit patients suffering from conditions in most need of research by offering pharmaceutical companies at the forefront of pioneering research, with the latest technological developments.”

For more information about RCLS please contact Randox PR on 028 9442 2413 or email RandoxPR@randox.com


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