- AnteoTech’s (ADO) COVID-19 antigen rapid test has been independently approved by Spanish lateral flow developer and manufacturer, Operon
- The study sought to validate the efficacy of AnteoTech’s rapid test against lab-based polymerase chain reaction (PCR) tests, which are widely accepted as a very reliable measure of testing for COVID-19 infection
- The test reliably detected positive results, even in nine of the 25 positive samples which had very low viral loads
- Such high sensitivity is vital to detecting early-stage infections, which have lower viral loads than heavily infected cases
- Testwork will continue to identify the lower cutoff point to distinguish between low viral loads and negative samples ahead of planned clinical trials
- AnteoTech is trading grey for 12.5 cents
AnteoTech’s (ADO) COVID-19 antigen rapid test has been independently validated by Spanish lateral flow developer and manufacturer, Operon.
The study
The study sought to validate the efficacy of AnteoTech’s rapid test against lab-based polymerase chain reaction (PCR) tests, which are widely accepted as a very reliable measure of testing for COVID-19 infection.
When testing for viruses, samples go through a series of ‘amplification cycles’, with each amplification stage doubling the intensity of detection for the viral DNA from the previous cycle.
Results are returned either when viral DNA is detected, or when the test process exhausts all available amplification cycles without detecting the viral DNA, which is deemed a negative sample.
Positive tests are given a ‘Ct number’, which reflects how many amplification cycles a sample has undergone before the detection of viral DNA.
Essentially, the higher the Ct number, the more sensitive the test — given a larger number of amplifications required for a positive result indicates a smaller viral load in the sample.
Typically, tests with a Ct number above 30 are considered highly sensitive.
Most point of care tests can detect viral antigen in samples with a Ct value of 25 or lower as these samples are usually characterised by high viral load.
Ct values of 30 and above indicate the sample is taken from someone either in the very early or very late stages of infection as their viral load is smaller than those at the peak of their infection.
AnteoTech’s rapid test detected all 25 positive samples identified by PCR testing, including nine samples with a Ct number above 30, indicating the test’s high sensitivity.
AnteoTech CEO Derek Thomson says the validation is an important step towards the commercialisation of the antigen rapid test.
“The control of COVID-19 requires highly sensitive testing to ensure all positive patients are identified and isolated at the point of care to ensure they don’t continue to spread the disease,” Derek said.
“We believe we are making an important contribution to the control of the disease and we look forward to entering clinical trials following the final stages of our validation phase which we believe will lead to making our test available to global markets very soon,” he concluded.
The next steps
The next phase of testing will seek to pin down the low-level cutoff for AnteoTech’s test, in order to differentiate between samples with very low viral loads and negative samples.
To determine this cutoff point, further development work and validation testing will be required.
Finalisation of the lower limit of detection and subsequent clinical trial will produce final sensitivity and specificity statistics.
AnteoTech will continue working with Operon to accurately determine the lower limit of detection settings that will finalise the design and enable progress towards a clinical trial.
This process will require detailed testing of both negative and low viral load samples to obtain a broad data set.
That data will be used to determine the settings which will be used in the upcoming clinical trial for regulatory approval.
AnteoTech’s test can be administered via nasopharyngeal swab samples with results returned in as little as 15 minutes.
AnteoTech is trading grey for 12.5 cents at 1:31 pm AEDT.