SARS-CoV-2 Antigen Test EI & MultiSTAT

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SARS-CoV-2 Antigen Test EI & MultiSTAT

SARS-CoV-2 Antigen Test

Quantitative measurement of SARS-CoV-2 nucleocapsid protein in nasopharyngeal swab

Simultaneous detection of SARS-CoV-2 nucleocapsid protein

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    Simultaneous detection of SARS-CoV-2 in up to 54 patient samples in 2.5 hours

     

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    Nucleocapsid protein has been confirmed an ideal target for early detection in SARS-CoV-2 infection
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    Early identification of SARS-CoV-2 in asymptomatic high-risk exposure individuals
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    Rapid results allow for better timely therapeutic intervention to limit virus /community spread
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    Antigen detection of SARS-CoV-2 Omicron variant with 97% clinical sensitivity

     

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    Antigen tests can be used in a variety of testing strategies to respond to the SARS-CoV-2 pandemic

Randox have developed an Antigen test for SARS-CoV-2 for the quantitative measurement of SARS-CoV-2 nucleocapsid protein in nasopharyngeal swab samples. Designed to aid in the identification of individuals with SARS-CoV-2, the Randox antigen test provides a timely and accurate diagnosis imperative to limit virus spread and to provide appropriate treatment to patients.

Viral antigens are only expressed when the virus is actively replicating, thus making antigen tests such as the Evidence Investigator SARS-CoV-2 antigen test clinically valuable for identification of acute/early infection.

Ordering Information

DescriptionCat Code
54 Biochip Investigator Kit for SARS-CoV-2 AntigenEV4451/A
Control Kit for SARS-CoV-2 Antigen TestEV4451/B

Available Platforms

Evidence Investigator

Estimated turnaround time: 2.5 hours

Medium throughput (54 samples)

Batch testing

Suitable for laboratory setting

Comprehensive immunoassay and molecular test menu available

Evidence Investigator

Want to know more?

Contact us or visit our COVID-19 Monitoring & Management page

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Why are Neutralising Antibody tests important now?

COVID-19 Testing        News        Contact Us

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

Sources linked-

  1. Covid: Is the pace of the vaccine booster rollout too slow? – BBC News
  2. ‘Don’t Panic’ Professors Questioned On The Rise In Covid Cases In England Sparking Concern | GMB – YouTube
  3. https://www.nature.com/articles/d41586-021-02158-6

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SARS-CoV-2 Neutralising Antibody Test

SARS-CoV-2 Neutralising Antibody Tests

Measuring neutralising antibodies to Wild Type (Wuhan), Delta & Omicron variants following vaccination or natural infection

Accurate indicator of protective immunity against SARS-CoV-2 variants

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    Determine if an effective antibody response has been generated to circulating SARS-CoV-2 variants following vaccination or natural infection
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    Identify individuals with a sub-optimal vaccine response to inform eligibility for booster vaccination
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    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). Randox Laboratories currently have in development an assay designed to detect antibodies against SARS-CoV-2 Omicron variant (EV4490).

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 & Omicron strains. 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

AssayCat Code
Wild Type SARS-CoV-2 Surrogate Virus Neutralisation AssayEV4454
Delta SARS-CoV-2 Surrogate Virus Neutralisation AssayEV4477
Omicron SARS-CoV-2 Surrogate Virus Neutralisation AssayEV4490
Evidence Investigator AnalyserEV3602

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

Evidence Investigator

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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SARS-CoV-2 RBD & NP Array

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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!

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SARS-CoV-2 IgG (NP & RBD) DETECTION ARRAY

SARS-CoV-2 IgG (RBD & NP) ARRAY

Uniquely measuring antibodies reactive to both RBD and NP

Uniquely measuring antibodies reactive to both RBD and NP

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    Simultaneous detection of IgG antibodies to RBD & NP maximises assay sensitivity reducing false negatives
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    Confirmation of an adaptative immune response to SARS-CoV-2
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    Distinguish vaccinated from naturally infected individuals
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    Specificity of 99.5% and sensitivity of 100% ≥ 10 days post SARS-CoV-2 PCR confirmation
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    Identify incidence of SARS-CoV-2 infection in vaccinated individuals
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    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

  • RBD
  • NP

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

DescriptionCat Code
SARS-CoV-2 IgG (RBD & NP) ArrayEV4447
SARS-CoV-2 IgG (RBD & NP) Array Control KitEV4448

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 Investigator

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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COVID-19 Testing: PCR (Diagnostic) vs Antibody

News       About Us       Randox Health

 

18 June 2020

COVID-19 Testing: PCR (Diagnostic) vs Antibody

The advice from the World Health Organisation in relation to the COVID-19 pandemic has been simple; Test. Test. Test.

But what are the different types of COVID-19 tests and what are they used for?

 

Diagnostic (PCR) Testing

This type of testing detects SARS-CoV-2 (the virus that causes COVID-19) within the body and will tell you if you currently have COVID-19. PCR tests cannot tell you if you have had past infection.

Sample collection for a PCR test can vary, though it is usually in the form of a swab, which will gather an individual’s nasopharyngeal (nose and throat) secretions.

PCR tests for COVID-19 all use methods that detect a specific part of the viral genome – for example Viral RNA or Antigen.  

A sample is prepared by extracting the chosen section of the genome, and then PCR (Polyamerase Chain Reaction) techniques are used to amplify (replicate) the genome section, ready for detection.

Viral RNA Tests

This type of test detects the RNA (Ribonucleic acid) contained within the SARS-CoV-2 virus.

It is this type of test, for RNA, that is recommended by The World Health Organisation for COVID-19 diagnosis.

Antigen Tests

Antigens are molecular structures on the surface of viruses that are recognized by the immune system and are capable of triggering an immune response.

Antigen tests detect the presence of the SARS-CoV-2 virus by looking for the antigen on the surface of the virus.

Randox COVID-19 Test

The Randox COVID-19 test, as recommended by the World Health Organisation, detects the RNA contained within the SARS-CoV-2 virus.

After sample extraction and amplification, the virus is detected on our patented Randox Biochip Technology platform.

The Randox Biochip, which can run multiple tests simultaneously, performs two tests for COVID-19 – one specific and one confirmatory – as recommended by the WHO. This delivers extra assurance of the correct diagnosis and avoids the need to repeat the test.

 

Antibody (Serology) Tests

Antibody (also known as serology) tests, are usually performed on a patient blood sample, and look for antibodies (a type of protein) that may have been developed by the patient’s immune system to fight off disease.

If present, antibodies may provide a degree of immunity for the patient against COVID-19 in the future.

However, there is still much unknown about the body’s antibody response to COVID-19, including;

  • Whether all patients who have been infected with SARS-CoV-2 will generate antibodies (recent studies and news reports indicate that this isn’t the case. Click here for an example.)
  • Whether those who have had more severe symptoms as a result of COVID-19 will produce more antibodies than those who had mild symptoms, or were asymptomatic.
  • If antibodies from other coronaviruses previously experienced by the patient may be enough to fight off the virus, therefore eliminating the need for COVID-19 specific antibodies.
  • How long any COVID-19 specific antibody response will last for.
  • How much future immunity is provided by COVID-19 antibodies. Will it prevent the patient from being infected, or will future infection just be less severe?

If antibodies for the SARS-CoV-2 virus are present this can give an indication that the patient has been previously infected with COVID-19. Antibody tests do not confirm the real-time presence of the virus in your system.

For example, a negative antibody result does not necessarily mean the body has not been exposed to the SARS-CoV-2 virus. It could in fact, be currently infected, but has not yet generated antibodies. A diagnostic test will confirm current presence of the virus.

 

Therefore, it is recommended that antibody tests are used in tandem with a diagnostic test to determine a complete overview of the patient’s COVID-19 status.

Randox Health currently offers both diagnostic testing and antibody testing for SARS-CoV-2 (COVID-19).

A combination of diagnostic and antibody testing is available for individual purchase, or as part of our ‘Back to Business’ COVID-19 testing service, for staff screening.

Visit Randox Health to find out more.

Want to know more about Randox?

Contact us or visit our homepage to view more.

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Antibodies & Human Recombinant Proteins

Randox Biosciences is a world-leading primary manufacturer of high quality monoclonal and polyclonal antibodies, antibody fragments and human recombinant proteins. Our team of scientists possess unrivalled expertise which enables us to provide you with a comprehensive suite of products and services dedicated to advancing biopharmaceutical research and diagnostics.

Product Portfolio

Randox Biosciences offers an extensive portfolio of over 900 products for a multitude of R&D applications including more than 500 monoclonal and polyclonal antibodies and over 140 human recombinant proteins as well as antibody fragments, buffers & diluents and plasma.

Monoclonal Antibodies

  • Biochemical markers: Biochemical messengers, fatty acid binding proteins and products with applications in the following therapeutic areas; cardiovascular/cerebrovascular and metabolic/Nutrition
  • Drugs of abuse: Alcohol, anti-depressants, barbituates, hallucinogens, opiates, stimulants
  • Drug Residues: antimicrobial drugs, growth promoters, mycotoxins

Polyclonal Antibodies 

  • Biochemical markers: Biochemical messengers, fatty acid binding proteins and products with applications in the following therapeutic areas; Immunology, Oncology, Cardiovascular/Cerebrovascular and Metabolic/Nutrition
  • Drugs of abuse: Alcohol, Analgesics, Anti‑depressants, Barbituates, Benzodiazepines, Hallucinogens, Opiates, Sedatives, Stimulants, Synthetic Drugs, Therapeutic drugs
  • Drug Residues: Anti-inflammatory Drugs, Antimicrobial Drugs, Anti-Parasitic Drugs, Growth Promoters, Mycotoxins

Recombinant Antibody Fragments

  • Single chain variable fragment (scFvs)
  • Single domain antibodies (sdAbs)

Frozen Human Plasma

  • Available in three formats (Male, Female and Mixed Gender)
  • Highly screened for; HIV, Hepatitis B+C, HTLV I + II, Syphilis, CMV and Procleix WNV

Human Recombinant Proteins (E.Coli & Mammalian)

  • Adhesion Molecules
  • Chemokines
  • Cytokines
  • Proteases
  • Tumour markers

Buffers & Diluents

  • Complementary range available

Key Features & Benefits

  • All products manufactured at our ISO 13485 accredited UK manufacturing plant
  • Product range of over 900 products
  • 30 years’ experience in raw material manufacture and assay development
  • Many unique and novel products including designer drugs, Mycotoxins and oncology markers
  • As our host animals are sheep, our antibodies have higher sensitivity and specificity
  • Excellent reproducibility between lot numbers
  • Products reflect the components used in-house in the production of Randox diagnostic products and research programs
  • Highly experienced in developing difficult targets (i.e. small molecules and novel biomarkers)
  • Full customisation service available
  • A range of pack sizes available including bulk quantities for commercial development
  • Products can be used in a multitude

Custom Development Services

To meet your precise requirements, Randox Biosciences offer customised antibody generation services to the pharmaceutical and biotechnology industry. Our custom development service, which encompasses antibodies and human recombinant proteins has achieved tremendous success within the biopharmaceutical and diagnostic industries. Key components of our custom service are our range of monoclonal antibodies as well as our recombinant antibody fragments (sdAbs, scFvs, fAbs).

Our customisation service has proven incredibly successful in the research and development industries allowing access our expertise to obtain the antibody and protein most relevant to your line of work. With over 300 highly trained research scientists and over 30 years’ experience in commercial assay development, Randox Biosciences can also provide a tailor-made assay development service to meet your specifications in both a timely and cost-effective manner.

For more information contact: info@Randoxbiosciences.com

 

 

 


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