Driving a return to normal life

Detect SARS-CoV-2 neutralising antibodies from a small finger prick of blood in only 20 minutes.

Show whether someone has IgG neutralising antibodies present following vaccination.

Boxes of 25 tests at £250.00+VAT per kit.

FAQs.

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Making a difference

  • Where and why immunity to COVID-19 might be developing
  • How mass-immunisation campaigns could be designed

 

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Why use AbC-19™ Rapid Test?

  • Confirms the presence of SARS-CoV-2 IgG neutralising antibodies in a small blood sample in 20 minutes
  • Sensitivity: 98.03%, Specificity: 99.56%*
  • Minimal operator training required
  • Approved for professional use**
  • Manufactured under ISO 13485 by Abingdon Health
  • For use in multiple testing locations such as workplaces, pharmacies or doctors’ surgeries
  • 24/7 international customer support helpline
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AbC-19™ Rapid Test and vaccines

Vaccines “train” the immune system by using harmless viruses that have been altered to resemble dangerous ones. In the case of SARS-CoV-2 vaccine developers have focused on mimicking the Spike protein. Three of the leading vaccine candidates all feature full-length SARS-CoV-2 spike trimers: Oxford University / AstraZeneca, Pfizer / BioNTeh, and Moderna.

Professor Lawrence S. Young, Virologist at University of Warwick Medical School:

”The AbC-19™ Rapid Test targets the IgG antibodies to the full spike protein of the SARS-CoV-2 virus and therefore has the potential to help identify the immune system’s response to the current three Medicines and Healthcare products Regulatory Agency (MHRA) approved vaccines.

The assay could help establish whether people’s immune systems are responding to the vaccine in the right way, and, ultimately, could be predictive of a protective immune response”.

Download the AbC-19™ White Paper
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Frequently Asked Questions

  • A COVID-19 rapid neutralising antibody test, such AbC-19TM Rapid Test, is a lateral flow test that detects IgG antibodies to the SARS-CoV-2 spike protein.

  • The body produces antibodies that targets two specific parts of the SARS-CoV-2 virus: the Nucleocapsid protein and the Spike protein. The coronavirus nucleocapsid protein is a multi-functional protein whereas the spike protein is integral in penetrating human cells and initiating infection.

    Neutralising antibodies bind to the Spike protein thus interfering the virus’ ability to enter human cells. Immunologically, antibodies to the Nucleocapsid protein are necessary but in the context of pandemic the antibodies to Spike protein hold the key.

  • If taken at least 14 days following the onset of symptoms then the AbC-19™ Rapid Test has a sensitivity of 98.03% and a specificity of 99.56%. More details here.

    As detailed in the table below a known population of 450 negative samples were tested alongside 203 known positive samples. The positive population of 203 samples were obtained from donors at least 14 days after the onset of COVID-19 symptoms and were verified as positive using a commercial IgG SARS-CoV-2 ELISA kit.

    Positive Negative
    ELISA Positive 199 4
    Negative 2^ 448*

    * 98 pre-pandemic negative samples not tested by ELISA
    ^ 2 pre-pandemic negative samples not tested by ELISA

    Clinical Sensitivity and Specificity is as follows:
    Positive Predictive Agreement (Sensitivity): 98.03% (95% Cla : 95.03% – 99.46%)
    Negative Predictive Agreement (Specificity): 99.56% (95% Cla : 98.40% – 99.95%)

    Cross reactivity:
    Known positive serum samples from other viral infections were tested as follows (value in square brackets refers to the number tested) Seasonal Coronavirus (HCoV-NL63 [x5] and HCoV-229E [x5]), Influenza A [x5], H5N1 Influenza [x1], influenza B [x6] Respiratory Syncytial Virus (RSV) [x6], Haemophilus influenzae type b [x5] and Bordetella pertussis [x1]. No cross reactivity was observed, with all tests demonstrating a negative result using the AbC-19™ Rapid Test.
    Interference: A range of substances were tested using the AbC-19™ Rapid Test for positive and negative interference. No false positives or false negatives were recorded at the concentrations in the table below;

    Substance Upper limit of normal serum levels mg/dL Level Tested mg/dL
    Unconjugated Bilirubin 2 40
    Cholesterol (total) <200 400
    Triglyceride 200 1,500
    IgG 1,400 4,200
    IgM 250 750
    Haemoglobin 17.5 1,000
    Biotin 0.117 0.351
    Acetaminophen (paracetamol) 5.2 15.6
    Acetylsalicylic acid (asprin) 1 3
    Ibuprofen 7.3 22
    Caffeine 3.6 11
  • This SARS-CoV-2 IgG antibody test is approved for professional use by healthcare professionals, such as doctors, nurses, pharmacists and healthcare workers.

    Laboratory professionals or trained lay providers may use the test, also. The test cannot be used by anyone else.

  • The following can order AbC-19™:

    • Any organisation who intends to roll out testing conducted by employees or suppliers who meet one of the criteria for ‘Who can use AbC-19™’.
    • Medical device distributors
    • Healthcare organisations such as hospitals, health clinics, testing centres, pharmacists etc
    • Laboratories
  • From a finger-prick sample of blood, AbC-19™ antibody rapid test detects the SARS-CoV-2 IgG neutralising antibodies to the full spike protein produced in response vaccination. The rapid antibody test will determine if the body has produced a measurable immune response post-vaccination. It will not confirm if you are currently infected by the virus.

  • AbC-19™ was developed by UK lateral flow manufacturer Abingdon Health on behalf of the UK Rapid Test Consortium (UK-RTC). Led by Abingdon Health, AbC-19™ is manufactured across several UK sites.

    About Abingdon Health

    Abingdon Health plc is a world leading developer and manufacturer of high-quality lateral flow rapid tests across all industry sectors, including healthcare and COVID-19. Abingdon Health is the partner of choice for a growing global customer base and takes projects from initial concept through to routine and large-scale manufacturing and has also developed and marketed its own lateral flow products.

    • Lateral flow experts with a combined 150+ years of development and manufacturing experience
    • Multiple state-of-the-art manufacturing facilities
    • Capacity to manufacture millions of test each month
    • Certified to ISO 9001 and ISO 13485. See our quality standards page.
    • International logistics partners
    • Established network of approved material suppliers
  • The line closest to the sample hole is the test line (T-line). The presence of a T-line alongside a C-line is a POSITIVE result, the absence of a T-Line alongside a C-line is a NEGATIVE result.

  • 25 x AbC-19™ Rapid Tests
    30 x Lancets
    30 x Test Solution Vials (containing 30 units)
    30 x Blood Collectors
    25 x Waste Bags
    1 x IFU (Instructions for Use)

  • For additional assistance when performing and interpreting the AbC-19™ Rapid Test please contact our helpline:
    Tel: +44 (0) 2890 394 258
    Email: abc19support@mplcontact.com

    Support lines are open 24 hours, seven days a week.