Seegene, a biotechnology company specializing in molecular diagnostics, said Thursday that it has won revised CE-IVD permits in Europe for its two in-vitro diagnostic kits that test Covid-19 from saliva.
The two products are Allplex SARS-CoV-2 Assay, which can diagnose four target genes for Covid-19, and Allplex SARS-CoV-2/FluA/FluB/RSV Assay, which can simultaneously diagnose the new coronavirus and flu.
With the newly added feature, Seegene’s diagnostic kits can use nasopharyngeal samples interchangeably with saliva following the polymerase chain reaction (PCR) test.
The existing method of scraping nasopharyngeal samples often caused discomfort to the subjects as the swab had to be slide deep inside the nose. Some people sneeze while healthcare providers collect their specimens, posing a risk of infection if carrying the virus.
Due to the possible secondary infection, inspectors also have to change their medical gloves, masks, and protective clothing worn each time they collect the sample.
The new feature allows an easier way to collect samples from people as it can test Covid-19 just from saliva, unlike the previous method requiring educated healthcare inspectors.
Seegene said it believes the new products could help facilitate the mass diagnosis and support the fight to control the virus with relatively shorter time and fewer workforce, considering Europe is experiencing difficulties testing due to the high number of infections,
“We hope the recently approved testing method to help improve the pandemic situation with the rising number of confirmed patients in Europe,” a Seegene official said. “The recently refurbished marking will serve as an opportunity to strengthen our position as a global molecular diagnostics company with more countries using the products along with the existing users.”
By : KBR(http://www.koreabiomed.com)