20 Healthtech Innovations to watch in 2022
HiberGene Diagnostics are delighted to be recognised as one of Irelands ‘20 Healthtech innovations to watch in 2022’.
Thanks to the support from the Health Innovation Hub Ireland, HiberGene were able to work with Bon Secours Health System Ireland, Cork in carrying out a very successful clinical evaluation of its PCR Adapt Covid-19 test, with excellent results.
The Gold Standard diagnostic for COVID-19 is a RT- qPCR test. There is a high demand for tests globally, with governments, citizens, private and public organisations covering the costs to ensure a safer world during this pandemic. COVID-19 testing is impacted by costs, time to result, specificity and accuracy of the test.
Product and Solution
In August 2021, HiberGene successfully completed the CE marking of a new fast molecular COVID-19 test. HiberGene’s PCR Adapt COVID-19 RT-qPCR is a CE marked multi-target SARS-CoV-2 test for nasopharyngeal (NP), oropharyngeal (OP) and anterior nasal swabs. This single tube assay is validated for both direct sample testing and manual/automated extraction. An assay time of 50-70mins enables rapid diagnosis of the disease at the early and highly infectious stage of infection.
HiberGene Diagnostics Ltd worked with HIHI to facilitate the assessment of HiberGene’s PCR Adapt COVID-19 RT-qPCR test against two commercially available standard tests.
The Bon Secours Hospital in Cork operates a private SARS-CoV-2 testing facility, with high throughput testing using alternate test kits. A comparison study (facilitated by the Bon Secours laboratory Scientists) was performed on 100 positive and 150 negative samples, previously tested using another commercially available Sars-CoV-2 RT-qPCR assay kits, all samples were tested with HiberGene’s PCR Adapt test. Samples used were frozen between -18 and -20OC and extracted using standard methods. The results were assessed by the laboratory scientist and concordance value provided for all samples.
The PCR Adapt COVID-19 assay demonstrated excellent concordance (99%) with the other standard commercially available assay kits.
Peter Kidney, CFO, HiberGene Diagnostics commented, HiberGene has had an excellent experience working with the HIHI. Through their guidance and support HiberGene has had the benefit of identifying a key partner organisation, the Bon Secours Hospital, Cork, to carry out a further, highly successful, clinical evaluation of its PCR Adapt COVID-19 test to support the potential introduction/availability of this Irish developed test within the Irish Healthcare System.