Randox unveils SARS-CoV-2 antibody test to determine previous COVID-19 infection in just 1.5 hours

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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% ≥ 14 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 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).  

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 are common.   Measurement of both RBD and NP IgG antibodies also provides an opportunity to discriminate vaccinated versus naturally infected individuals based on leading vaccine candidates.

Serology testing plays a pivotal role in both research and surveillance of SARS-CoV-2, helping to overcome some of the many challenges presented by the pandemic.  As well as validating the effectiveness of vaccine trials, antibody tests may be used to effectively determine the percentage of a population that have already been infected and to measure antibody levels in plasmapheresis donations.  It may also be used to complement PCR testing, antibody detection in combination with RT-PCR increases the detection window and minimises false negative PCR results.

The new array has a specificity of 99.5% and sensitivity of 100% more than 14 days post PCR test with a sensitivity of 92.3% 0-14 days post PCR confirmation. The Randox SARS-CoV-2 antibody array will also include a calibrator and controls are available to order.

 

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

  • Receptor Binding Domain (RBD)
  • Nucleocapsid (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.

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

Related Products

SARS-CoV-2 Rapid Test

SARS-CoV-2 Pooling Test

Vivalytic

Vivalytic Test Menu


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.

Our Randox Products and Services

REAGENTS

RX SERIES

ACUSERA

BIOCHIP


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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