AbC-19™ Rapid Neutralising Antibody Test

Driving a safe return to normal life

A flexible COVID-19 antibody testing and certification solution for unlocking businesses and communities

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 infection or 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.

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.

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AbC-19™ provides a flexible and accurate neutralising antibody testing solution that can adapt to multiple scenarios. Creating a reliable solution for unlocking industries such as aviation, travel, and entertainment.

About AbC-19™ Rapid Test?

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.

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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.

 

*What is the sensitivity and specificity of AbC-19™ Rapid Test?

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.

PositiveNegative
ELISAPositive1994
Negative2^448*

* 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;

SubstanceUpper limit of normal serum levels mg/dLLevel Tested mg/dL
Unconjugated Bilirubin240
Cholesterol (total)<200400
Triglyceride2001,500
IgG1,4004,200
IgM250750
Haemoglobin17.51,000
Biotin0.1170.351
Acetaminophen (paracetamol)5.215.6
Acetylsalicylic acid (asprin)13
Ibuprofen7.322
Caffeine3.611

**Who can use AbC-19™?

This SARS-CoV-2 IgG antibody test is CE marked for professional use by healthcare professionals, such as doctors, nurses, pharmacists and healthcare workers, and meets UK and European Union (EU) health and safety requirements.

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