Driving a return to normal life
AbC-19™ is a SARS-CoV-2 (COVID-19) rapid neutralising antibody test solution that produces results in 20 minutes and creates an antibody certificate via a smartphone app.
This flexible, easy solution shows confirmation to individuals who have developed IgG neutralising antibodies following COVID-19 vaccination.
By leveraging the fact that COVID-19 neutralising antibodies are an important factor in the determination of a person’s immunity status, we have developed the flexible AbC-19™ antibody testing solution which includes a rapid test that is reliable and accurate:
Sensitivity: 98.03%, Specificity: 99.56%
This is paired with an easy-to-use mobile app which allows a trained professional to generate an antibody certificate for storing on a person’s smartphone.
AbC-19™ is currently not TGA approved
Based on the Apple and Google approach for boarding passes, users will not need to install any new apps thanks to the new feature being built using a trusted existing interface compatible with all smartphones. The QR code will be stored in the wallet feature of the smartphone, allowing the individual to control access to their personal results.
The AbC-19™ app and testing solution is a powerful tool for providing businesses and communities with the confidence to return to normal life, safely.
- Get tested
- Receive an antibody certificate
- Prove COVID-19 IgG neutralising antibody status
Making a difference
The AbC-19™ Antibody Rapid Test can be deployed across populations and has the potential to inform vaccination programmes and health policy by showing:
- Where and why immunity to COVID-19 might be developing
- How mass-immunisation campaigns could be designed
Why use AbC-19™ Rapid Test?
- Confirm the presence of SARS-CoV-2 IgG neutralising antibodies in a small blood sample in 20 minutes
- Sensitivity: 98.03%, Specificity: 99.56%*
- CE marked for use by trained professionals**
- Straightforward creation of antibody certificates
- Minimal operator training required
- Manufactured to ISO 13485 and underpinned by an established supply chain
- Use in multiple testing locations such as pharmacies, medical centres or medical rooms in workplaces
- 24/7 international customer support helpline
The AbC-19™ rapid neutralising antibody test is manufactured at scale across multiple UK sites in state-of-the-art automated facilities. Each facility is connected to international logistics hubs. The antibody certificate solution has been developed by BBI Solutions, a member of the UK-RTC, using their Novarum™️ technology.
AbC-19™ Rapid Test and vaccines
Vaccines “train” the immune system to respond to harmful viruses. In the case of SARS-CoV-2 vaccine developers have focused on mimicking the virus’ Spike protein. Three vaccines 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”.
For information on how AbC-19™ could inform vaccine deployment and usage, please download our whitepaper.
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 targeting specific parts of the SARS-CoV-2 (COVID-19) virus with the Nucleocapsid protein and the Spike protein being of importance in the context of antibody tests. The coronavirus nucleocapsid protein is a multi-functional protein whereas the spike protein is integral in penetrating human cells and initiating infection.
Neutralising IgG antibodies target the SARS-CoV-2 Spike protein and interfere with the virus’ ability to enter human cells. IgG antibodies are the most common antibody in blood and have a large part to play in conferring immunity to bacteria or viruses.
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%)
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
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
Support lines are open 24 hours, seven days a week.