14th December 2021

Public Health Wales uses Seegene assay to discriminate Omicron and Delta

Public Health Wales is using Seegene’s Allplex SARS-CoV-2/Flu A/Flu B/RSV Assay and Allplex SARS-CoV-2 Variant Assay to help with the nation’s fight against SARS-CoV-2. 

Seegene’s Allplex SARS-CoV-2 Master Assay is a new PCR test that screens for COVID-SARS-2 whilst simultaneously discriminating Omicron from Delta strains in a single tube.

Seegene’s Variant assays have been implemented in regional laboratories to report positive results within 24 hours. The Wales Specialist Virology Centre in Cardiff has also validated the Seegene Allplex SARS-CoV-2 Master Assay, which the company says is the only CE marked assay for rapid detection and discrimination of Omicron or Delta strains.

Seegene’s Allplex SARS-CoV-2/Flu A/Flu B/RSV Assay or ‘winter assay’ was the first multiplex, real-time, PCR assay providing high throughput automated testing for COVID-19, Flu A & B and RSV. Results from the convenient one tube test are known within two hours after extraction providing critical, timely information for the management of influenza-like illnesses in patients across Wales.

Dr Catherine Moore, consultant clinical scientist at the Wales Specialist Virology Centre recently shared her experiences in using Seegene’s winter assay.

“We started using the assay just before the winter in 2020. The NHS was under so much pressure at the time that we wanted a mechanism to help us recognise not only COVID but other infections that might also be contributing to hospitalisations in the background of the pandemic. The assay is very simple to use, allowing us to screen up to 94 samples plus controls at any time.”

Public Health Wales manages a network of microbiology laboratories across Wales. There are 10 main laboratories and then a network of ‘hot labs’ which also have use of rapid testing platforms. The network is using Seegene’s Allplex SARS-CoV-2 Variant assays to rapidly detect S gene mutations to identify Omicron much earlier that by using sequencing alone. The rapid detection of Omicron and Delta variants supports the tracking of COVID-19 outbreaks and variant analysis in hospitals and care homes across Wales.

Dr Moore adds: “At the beginning of the pandemic, a sample from a hospitalised patient would be sent to Cardiff to be analysed on our rapid platform. However, there is an inherent delay with the samples in transit, especially for patients based in North Wales. With the escalation of cases, we quickly realised that we needed to provide a faster, local testing system. By offering the test in the hospital where the patient is based, you are immediately reducing the time from sampling to getting the results – which lead to increased efficiencies and, most importantly, an improvement in patient care.”

Public health authorities and healthcare providers need rapid insight to understand the appearance and transmission of COVID variants within the population to take action within communities to limit their spread. Therefore, in addition to the winter assay, Public Health Wales has adopted the latest Allplex variant assay tests in response to the evolving pandemic and public health needs.

Seegene’s multiplex, real-time PCR testing system allows detection of 20 different S gene mutations and the RdRP gene in six tubes. Seegene’s automated solution offers an efficient workflow process providing users with high throughput testing and short turnaround times.

Commenting on the use of Seegene’s variant assays, Dr Moore said: “The vast majority of COVID samples would normally go for whole genome sequencing as this is considered to be the gold standard for virus variant analysis. However, there are a proportion of samples that you are unable to sequence because they have a lower viral load, or sometimes we simply need to provide a very quick result. This might happen where there is a known outbreak, or where there is concern about a particular variant – such as Omicron- causing that outbreak. In that situation, we need to turn the samples around very quickly, much faster than would normally be possible with whole genome sequencing. With Seegene’s variant assays, we can get the result the same day. In terms of epidemiology, the variant assay helps to address gaps because we can analyse those samples that are not suitable for genome sequencing, and we can also target certain outbreaks.”

Seegene is a specialist in symptom-based in vitro molecular diagnostics focussing on advancing science to develop multiplex molecular technologies and to manufacture multiplex in vitro diagnostic devices and reagents to improve the quality of life and health of people.

Dr Moore adds: “With regards to the assays, the chemistry is very good, and we have found Seegene to be very reactive throughout the pandemic. Within a month or two of a new variant gene announced they have made an assay available for it.

“The key benefit here is that we haven’t had to change our workflow – a significant advantage for us. Although this has required some software updates, these have been implemented remotely. Overall, I am pleased with the product and the company.”