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SdAbs
SdAbs
Our scientists highly recommend the use of Single Domain Antibody Fragments (sdAb) as they are more stable, adaptable and easily humanised, making them ideal for therapeutic products. We have a specialised offering of sdAbs for research and therapeutic applications.
SdAbs provide a new mechanism for the generation of antibody therapeutics and offer numerous advantages such as better tissue penetration, ease of expression, stability and uniformity of product.
| Oncology |
|---|
| Anti Alpha 1 Acid Glycoprotein (orosomucoid or AAG) clone 2076.22D8 |
| Anti Cancer Antigen 15-3 (CA15-3/mucin 1) clone CA153.1 |
| Anti Epidermal Growth Factor Receptor (EGFR/ErbB1) clone E1A |
| Anti Epidermal Growth Factor Receptor (EGFR/ErbB1) clone E1B |
| Anti ErbB2/HER2 clone ErbB2A |
| Anti ErbB2 (HER2) sdAb clone 6.1H8.F9.G6 |
| Anti ErbB2 (HER2) sdAb clone 6.7A2.A4.D3 |
| Anti ErbB2 (HER2) sdAb clone 6.8A2.B8.A11 |
| Anti ErbB2 (HER2) sdAb clone 6.8E7.A7.A1 |
| Anti ErbB3 sdAb clone 9.21C1.G1.F1.A5 |
| Anti ErbB3 sdAb clone 9.22E1.F5.H10 |
| Anti CD38 sdAb clone 13.6D9 |
| Anti CD38 sdAb clone 13.7E2 |
| Anti CD30 sdAb (TNFRSF8) clone 13B4.E10 |
| Anti CD38 sdAb clone 13.7H4 |
| Anti CD38 sdAb clone 13.1G11 |
| Anti CD38 sdAb clone 13.8E5 |
| Anti CD38 sdAb clone 13.2G8 |
| Anti CD38 sdAb clone 14.2H9 |
| Anti CD3 epsilon (CD3e) sdAb clone 26.7C4 |
| Anti PD1 (Programmed cell death protein 1) sdAb clone 6F7 |
| Anti PD1 (Programmed cell death protein 1) sdAb clone 4H11 |
| Anti PD1 (Programmed cell death protein 1) sdAb clone 3H4 |
| Anti CTLA4 (Cytotoxic T-Lymphocyte-associated Antigen 4) sdAb clone 3G8 |
| Anti CTLA4 (Cytotoxic T-Lymphocyte-associated Antigen 4) sdAb clone 8C7 |
| Anti CTLA4 (Cytotoxic T-Lymphocyte-associated Antigen 4) sdAb clone 4A8 |
| Anti CTLA4 (Cytotoxic T-Lymphocyte-associated Antigen 4) sdAb clone 8G1 |
| Cardiac |
|---|
| Anti Cardiac Troponin I (cTnI) epitope 1-20 clone 1542.2A4 |
| Anti Cardiac Troponin I (cTnI) epitope 13-28 clone 1542.14F10 |
| Anti Cardiac Troponin I (cTnI) epitope 20-40 clone MC71.H6 |
| Anti Cardiac Troponin I (cTnI) epitope 40-50 clone 1542.61H8 |
| Anti Cardiac Troponin I (cTnI) epitope 50-60 clone 001.6C2 |
| Anti Cardiac Troponin I (cTnI) epitope 55-70 clone 001.7B11 |
| Anti Cardiac Troponin I (cTnI) epitope 80-100 clone 001.11D9 |
| Anti Cardiac Troponin I (cTnI) epitope 80-100 clone 1542.14A2 |
| Anti Cardiac Troponin I (cTnI) epitope 100-110 clone 1542.42F9 |
| Anti Cardiac Troponin I (cTnI) epitope 160-175 clone 1542.3H4 |
| Anti Cardiac Troponin I (cTnI) epitope 170-190 clone 1542.31D7 |
| Anti Cardiac Troponin I (cTnI) epitope 190-209 clone 1542.4D1 |
| Anti Creatinine kinase-MB (CK-MB) Clone 2431.3B8 |
| Anti FABP3 (Heart Fatty acid Binding Protein/FABPh) epitope 1 clone MC25G11 |
| Anti FABP3 (Heart Fatty Acid Binding Protein/FABPh) epitope 1 clone 001.11F2 |
| Anti FABP3 (Heart Fatty Acid Binding Protein/FABPh) epitope 1 clone 1360.6H5 |
| Anti FABP3 (Heart Fatty Acid Binding Protein/FABPh) epitope 2 clone MC7D5 |
| Anti Myoglobin scFv clone 1B8 |
| Anti Myoglobin scFv clone 3B3 |
| Hormones |
|---|
| Anti Thyroid-Stimulating Hormone (TSH) epitope 2 clone 1001.1E5.C2 |
| Anti Thyroid-Stimulating Hormone (TSH) epitope 3 clone MC43A2 |
| Anti Thyroid-Stimulating Hormone (TSH) epitope 4 clone 1014.5B10 |
| Anti Thyroid-Stimulating Hormone (TSH) epitope 3 clone 1030.4C1 |
| Anti TSH / HCG / LH / FSH α-chain epitope 1 clone 1001.1E5.E8 |
| Anti Prolactin sdAb clone 10.1F8 |
| Infectious Diseases |
|---|
| Anti Tetanus Toxoid - clone MCTT |
| Anti Hepatitis B env (HBe) scFv clone HBe1 |
| Anti Hepatitis B core (HBc) scFv clone 1C4 |
| Anti Hepatitis B Surface Antigen (HBsAg) scFv clone HBs2 |
| Anti Hepatitis B Surface Antigen (HBsAg) clone MCHBS |
| Anti Cytomegalovirus (CMV) gB antigen scFv clone CMV1 |
| Other |
|---|
| Anti FABP7 (Brain Fatty Acid Binding Protein) epitope 1 clone MC63.E2 |
| Anti FABP7 (Brain Fatty Acid Binding Protein) epitope 2 clone MC65.E1 |
| Anti FABP8 (Myelin Fatty Acid Binding Protein) clone MC61.B3 |
| Anti L-Selectin - clone MC39A10 |
| Anti Norketamine - clone MC32F5 |
| Anti Plasminogen Activator Inhibitor-1 (PAI-1) clone 1040.1F6 |
| Anti Plasminogen Activator Inhibitor-1 (PAI-1) clone 1040.1518.5H8 |
| Anti human IgG (subclasses 1,2,3 & 4) sdAb clone 6.1H3.D9.C6 |
| Anti CRP (C-reactive Protein) sdAb clone 2E4 |
| Anti CRP (C-reactive Protein) sdAb clone 4B9 |
| Anti CRP (C-reactive Protein) sdAb clone 1A6 |
Our Range of BioReagents
Conjugates
Conjugates
Randox’s antigen-HRP conjugates are optimized for use with Randox polyclonal antibodies for the development of immunoassays. All HRP-conjugates are provided in a conjugate stabilising solution, specifically formulated in-house to prolong the shelf-life of newly conjugated material, enhancing the conjugate’s overall performance and reliability within your immunoassay.
Our Range of BioReagents
Recombinant Proteins
Recombinant Proteins
Every time a gene is introduced into a plasmid and transformed in various biological systems such as bacteria and mammalian cells; it expresses to produce recombinant proteins. The production of such proteins in prokaryotes provides multiple advantages, such as low cost, rapid cell growth, high yield, and a relatively short expression period.
On the other hand, whenever a protein is required with post-translational modifications and precise folding, mammalian cells are chosen as the expression hosts. With a wide range of tags used, it is ensured that the expressed proteins are purified to a high standard. In-house experts at Randox are able to provide the recombinant proteins in the desired buffers, thus offering their knowledge in supporting the customers’ research.
Our Range of BioReagents
Monoclonal
Monoclonal
Using sheep as the host species, Randox are able to offer an alternative to current monoclonal antibodies available on the market. Producing a wide range of monoclonal antibodies, offering several advantages including specificity in producing high quality antibody for a required target with high affinity.
Our Range of BioReagents
CDx & BioPharma Services
CDx & BioPharma Services
Offering a collaborative CDx partnership approach.
As an established IVD company, Randox Biosciences offers tailored development and testing solutions to support faster, more effective and safe development of new drugs.
We have a wide range of in-house capabilities, ranging from the selection and patenting of novel biomarkers; manufacture of bio reagents; production of single and multiplex RUO and IVD grade tests; quality control; provision of clinical laboratory services; regulatory expertise and worldwide distribution.
Pharmaceutical and biotech companies are increasingly investing in the research and development of new therapies to address the world’s growing need for earlier and more effective patient treatment.
Randox Biosciences is dedicated to the improvement of personalised diagnostic, prognostic, and predictive assays. We aim to help Pharma Biotechs and CROs move away from a “one treatment fits all” approach and help get a better understanding of the complexity and variability of diseases and increase efficacy of treatment. A key element to realizing the potential for personalized medicine is companion diagnostic (CDx) development. Randox have key expertise in all elements of CDx and diagnostic development and offer a fully flexible partnership to accommodate your needs, providing you with tailored protein & molecular assays.
Randox Biosciences can be your CDx and biomarker assay development partner from early phase trials through to drug launch, addressing all assay requirements in the process, including development of raw materials and assays, verification and validation studies, clinical trial sample analysis, regulatory submissions and co-commercialisation.
Complete CDx Partner Approach
Drug and Diagnostic Development Process Timeline
Randox Biosciences offers an extensive portfolio of over 900 products for a multitude of R&D applications manufactured under ISO13485 accreditation, including more than 500 monoclonal and polyclonal antibodies, 140 human recombinant proteins, as well as antibody fragments such as sdAbs and scFvs. In addition to our range of off-the-shelf raw materials, Randox can custom develop antibodies and proteins for use in new assays.
By using Randox antibodies, the raw material supply chain is controlled in-house which is highly beneficial for CDx development.
Randox offers a range of technologies and platforms for use in clinical trials, including our proprietary multiplex biochip technology that can be used in early exploratory biomarker stages and can be brought through to IVD/CDx grade. Biochip from high throughput to point of care technologies.
With comprehensive Original Equipment Manufacturing (OEM) capabilities, Randox can develop assays on any platform to ensure global reach.
All assays intended for IVD or CDx grade are developed under full design control and ISO13485 accreditation, and we have expertise in a wide range of disease areas and assay formats.
Randox have ISO17025, ISO15189 and GCP accredited laboratories located throughout the UK and Ireland, with US laboratories being mobilised in 2022 and 2023. Our laboratories can be utilised to meet your clinical trial and post approval sample analysis needs. We also have a strong global network with 3rd party laboratories to ensure your clinical trial requirements are met across the world.
Randox performs in depth multi lot verifications following CLSI guidelines to ensure full performance requirements are met and to support regulatory submissions and approvals. We will validate assay performance and reproducibility across multiple sites.
Highly experienced regulatory teams inhouse at Randox can prepare IVD/CDx submissions and applications for approval, thus, providing full regulatory support to help get your drug to the market as quickly as possible.
Development and regulatory teams will work hand-in-hand throughout the whole process and in collaboration with the Pharma partner, to ensure a timely submission while also keeping in line with country specific requirements.
We currently have 954 licenses across the globe and over 3800 licensed products to date, with continuous expansion ongoing including progression to IVDR regulation.
Randox endeavors to start commercialization planning early on in development to ensure all market access requirements are addressed, providing both pre and post-launch support with laboratory, clinician, patient and KOL engagement and can also conduct sample analysis at our clinical laboratories.
We have strong global laboratory and distribution networks, in-house sales and marketing teams, with operations and partners in over 145 countries.
We have capabilities in manufacturing customised sample collection kits and offer CDx specific proficiency testing programmes.
We can provide pre- and post-launch support with laboratory, clinician, patient and KOL engagement and can also conduct sample analysis at our clinical laboratories.
Randox Platforms
Why are Neutralising Antibody tests important now?
27 October 2021- Why are Neutralising Antibody tests important now?
Being prone to more frequent infections may mean that you have a weak immune system. With everything going on in the world, including COVID-19, this is important information that you need to know about yourself. As it stands, the pace of the vaccine booster rollout has slowed down and priority is given to people who are most vulnerable from developing a COVID-19 infection. This will offer those individuals the fullest protection against the virus this winter. According to John Roberts, from the COVID-19 Actuaries Response Group, “At the start of the booster campaign, the health secretary Sajid Javid said: ‘We will protect the most vulnerable through the winter months’. But at the current rate it is going to be well through winter before we get through those first groups.” This was stated on a BBC news article. (1)
This leads into the question that everybody is wondering…. Do we really need the booster vaccine? Infectious diseases expert, Professor Angus Dalgleish has commented during an interview on Good morning Britain that we should try another strategy. A strategy where we should test people’s immunity first to see if they need the booster vaccine. He stated, “It should not be difficult for one test to see what your immune response to your last vaccine is or if you have had very bad COVID, have you got a good immune response and do you need the booster”. (2)
Laith Jamal Abu-Raddad, an infectious-disease epidemiologist at Weill Cornell Medicine—Qatar in Doha has also stated in an article from Nature that “Wasting resources on boosters for those who are already protected against severe disease does not really make too much sense,” (3)
The Randox SARS-CoV-2 Neutralising Antibody tests detects antibody levels post-vaccination to determine eligibility for a booster vaccination. These tests utilise patented biochip technology to detect neutralising antibodies to the Wuhan and Delta SARS-CoV-2 variants. There is a need for tests of this kind to provide an accurate estimate of immunity, monitor vaccine effectiveness and the frequency of post-vaccine breakthrough infections with variants of concern. Recent studies indicate that the delta variant is capable of re-infection even in fully vaccinated individuals and that a significant proportion of fully vaccinated individuals with breakthrough infections can transmit the virus to others.
The SARS-CoV-2 Neutralising Antibody tests are a quick and effective way to determine:
- Longevity of immune response with response to post-vaccine infection, and variants of concern.
- Population surveillance and testing of those at risk of sub-optimal vaccine response.
- Measure antibody levels post-vaccination to determine eligibility for a booster vaccination.
- Accurately detects antibodies that are capable of inhibiting virus replication and neutralizing the infectivity of the virus.
Want to know more?
For more information on SARS-CoV-2 Neutralising Antibody tests please visit the link below,
SARS-CoV-2 Neutralising Antibody Test | Randox Laboratories
Visit booking.randox.ie to book your COVID-19 antibody test today!
Alternatively contact us via email: marketing@randox.com
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CERTIFLY LATERAL FLOW
HOME TEST - PCR
ANTIBODY TEST
LABORATORY TOOLS
SARS-CoV-2 Neutralising Antibody Test
SARS-CoV-2 Neutralising Antibody Tests
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Measuring neutralising antibodies to Wild Type (Wuhan) & Delta variants following vaccination or natural infection
Accurate indicator of protective immunity against SARS-CoV-2 variants
- Determine if an effective antibody response has been generated to circulating SARS-CoV-2 variants following vaccination or natural infection
- Identify individuals with a sub-optimal vaccine response to inform eligibility for booster vaccination
- Provide accurate estimates of herd immunity at a local and national population level
The Randox CE marked SARS-CoV-2 Wild Type Surrogate Virus Neutralisation Assay (EV4454) and Delta SARS-CoV-2 Surrogate Virus Neutralisation Assay (EV4477) detect antibodies that block interaction of the spike protein receptor-binding domain (RBD) and angiotensin-converting enzyme 2 (ACE2).
Rapid, high throughput tests that measure neutralising antibodies against circulating SARS-CoV-2 variants are of significant interest to Clinical, Pharmaceutical, Government and Research organisations. Vaccine breakdown is of growing concern globally with the emergence of SARS-CoV-2 variants such as the now dominant Delta strain. Randox have available innovative testing solutions to accurately measure protection against infection and to identify individuals where booster vaccination is required. This can help reduce infection rates and onward virus transmission by ensuring sufficient levels of herd immunity.
Ordering Information
| Assay | Cat Code |
|---|---|
| Wild Type SARS-CoV-2 Surrogate Virus Neutralisation Assay | EV4454 |
| Delta SARS-CoV-2 Surrogate Virus Neutralisation Assay | EV4477 |
| Evidence Investigator Analyser | EV3602 |
Available Platform
Evidence Investigator
Specificty of 100% and sensitivity of 98% compared ro coventional virus neutralisation tests
Semi-automated solution suitable for medium to high throughput testing
Direct sample addition to biochip well. No off-board sample incubation required
Results available in 1.5 hours without the need for biosafety level 3 cabinet
Limited sample volume requirements
Comprehensive immunoassay and molecular test menu available
Randox Clinical Laboratory Service (RCLS)
RCLS specialise in offering an esoteric biomarker testing service, utilising the experience and knowledge Randox has built over 40 years of producing high quality in vitro diagnostics.
RCLS strive to provide a clinical laboratory testing service to meet the time sensitive, bespoke requirements of research and clinical trial projects globally.
Accredited laboratory service
Cost effective solution
Offers greater flexibility
Want to know more?
Contact us or visit our COVID-19 Monitoring & Management page
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EVidence Investigator
SARS-CoV-2 RBD & NP Array
COVID-19
COVID-19 Disease Management
Randox unveils SARS-CoV-2 antibody test to determine previous COVID-19 infection in just 1.5 hours
21st December 2020
Randox unveils SARS-CoV-2 antibody test to determine previous COVID-19 infection in just 1.5 hours
Randox Laboratories is proud to announce the launch of its new SARS-CoV-2 IgG test, utilising patented Randox Biochip Technology to simultaneously detect IgG antibodies that are reactive to both of the leading COVID-19 diagnostic antigens – Spike Receptor Binding Domain (RBD) and Nucleocapsid protein (NP).
Maximum test sensitivity is ensured through simultaneous detection of both RBD-only and NP-only responders, making it superior to current commercially available COVID-19 IgG tests that are based on RBD or NP alone, from which false negative results can occur.
The Randox SARS-CoV-2 IgG (RBD & NP) Array provides clinicians with an opportunity to discriminate vaccinated individuals from those naturally infected by COVID-19.
Lynsey Adams, Randox Clinical Marketing Manager commented;
“When there is little or no access to molecular testing, serology tests provide a means to quickly triage suspected cases of COVID-19, enabling appropriate case management, and guiding public health measures, such as quarantine or self-isolation.
“The new Randox SARS-CoV-2 IgG (RBD & NP) Array, provides a unique insight into disease severity, is an established method of indirect disease diagnosis, and facilitates epidemiological surveillance as the COVID-19 pandemic progresses.”
The Randox SARS-CoV-2 IgG (RBD & NP) Array has been developed for the Evidence Investigator, a semi-automated benchtop immunoassay analyser delivering accurate results in just 1.5 hours.
Features of the new Randox SARS-CoV-2 IgG (RBD & NP) Array
- Utilises established diagnostic antigen candidates – RBD and NP
- IgG measurement confirms adaptive immune response to SARS-CoV-2
- Clinical specificity of 99.5%
- Clinical sensitivity of 100% ≥ 14 days post SARS-CoV-2 PCR confirmation
- Dual sample matrix: human serum/plasma.
Contact marketing@randox.com for further information on our latest SARS-CoV-2 array or click to find out more!
Randox in the media
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FAQs
SARS-CoV-2 IgG (NP & RBD) DETECTION ARRAY
SARS-CoV-2 IgG (RBD & NP) ARRAY
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Uniquely measuring antibodies reactive to both RBD and NP
Uniquely measuring antibodies reactive to both RBD and NP
- Simultaneous detection of IgG antibodies to RBD & NP maximises assay sensitivity reducing false negatives
- Confirmation of an adaptative immune response to SARS-CoV-2
- Distinguish vaccinated from naturally infected individuals
- Specificity of 99.5% and sensitivity of 100% ≥ 10 days post SARS-CoV-2 PCR confirmation
- Identify incidence of SARS-CoV-2 infection in vaccinated individuals
- Qualitative and semi-quantitative results provided
The Randox CE marked SARS-CoV-2 IgG (RBD & NP) array utilises patented biochip technology to simultaneously detect IgG antibodies against both leading COVID-19 diagnostic antigens; Spike Receptor Binding Domain (RBD) and Nucleocapsid protein (NP). The SARS-CoV-2 IgG (RBD & NP) array is compatible with both capillary and venous blood collection.
Maximum sensitivity is ensured through detection of antibodies against both proteins making the assay superior compared to other commercially available serology tests where false negative results may occur. Measurement of both RBD and NP IgG antibodies also provides an opportunity to discriminate vaccinated versus naturally infected individuals. Spike is one of the major vaccine targets against SARS-CoV-2 with antibodies against Spike RBD correlating well with protection while Nucleocapsid is an immunodominant protein expressed with high immunogenicity during the early stages of SARS-CoV-2 infection.
Highly sensitive and specific serological assays are crucial for surveillance, to help uncover the burden of disease and to get accurate estimates of morbidity and mortality associated with SARS-CoV-2. Serological assays are also required to evaluate immunological response at an individual/population level and during vaccine trials.
Crucially, simultaneous measurement of antibodies to RBD and NP provides a tool to monitor breakthrough SARS-CoV-2 infection in vaccinated individuals. This testing approach has wider societal implications in the context of measuring ongoing vaccine effectiveness against evolving SARS-CoV-2 variants such as the Delta variant.
SARS-CoV-2 IgG (RBD & NP) Array
The S protein consisting of S1 and S2 subunits is located on the surface of the SARS-CoV-2 virus making it highly immunogenic. The S protein plays an important role in viral attachment, fusion and entry to the host cell, as such it serves as a target for the development of antibodies, entry inhibitors and vaccines. The Receptor Binding Domain (RBD) located on the S1 subunit is the key target for neutralising antibodies. Unlike N protein, RBD is associated with less cross reactivity with other coronaviruses and is therefore highly specific to SARS-CoV-2.
The nucleocapsid protein (NP) is abundantly expressed in individuals infected with SARS-CoV-2 and is highly immunogenic. N protein is normally very conserved, because of this homology recent research cautions against the use of serology tests that detect antibodies against the N protein alone.
Ordering Information
| Description | Cat Code |
|---|---|
| SARS-CoV-2 IgG (RBD & NP) Array | EV4447 |
| SARS-CoV-2 IgG (RBD & NP) Array Control Kit | EV4448 |
Available Platforms
Evidence Investigator
Cost effective and efficient semi-automated multiplex testing solution
Medium to high throughput (54 samples in 1.5 hours)
Limited sample volume requirement (10ul)
Comprehensive immunoassay and molecular test menu available
Evidence+
Fully automated batch immunoanalyser for
faster testing & accurate results
High throughput (2070 samples per day)
Limited sample volume requirement (10ul)
Comprehensive immunoassay test menu available
Want to know more?
Contact us or visit our COVID-19 Monitoring & Management page
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