Seegene Inc. has received CE-IVD marking for its saliva-based testing application for Allplex™ SARS-CoV-2 Assay and Allplex™ SARS-CoV-2/FluA/FluB/RSV Assay. 

With the newly added feature, the saliva sample collection test can be used interchangeably with nasopharyngeal specimen collection test, normally used for multiplex real-time PCR tests for screening the novel coronavirus.

Seegene said its saliva sample collection test provides an easy, safe and convenient sampling method without compromising the sensitivity and specificity of the test.

Separately, a study conducted by Children’s National Hospital in Washington DC taken in the July-to-September period in 2020 showed Seegene’s Allplex™ 2019-nCoV Assay, an earlier version of the company’s COVID-19 diagnostic test was found to be best suited among the four competing FDA EUA-approved COVID-19 PCR assays for testing saliva specimens collected from participants. It added that the sensitivity of viral detection was equivalent to that of nasopharyngeal specimens when tested on Seegene’s Allplex™ 2019-nCoV Assay.

Seegene’s saliva sample collection feature can also eliminate the need for materials and labor associated with nucleic acid extraction, as the test is being performed directly from the raw saliva collected from participants. An official from Seegene said the saliva sample collection feature, together with the extraction-free application, also CE-IVD marked in November, will enable labs to carry out massive testing.

The extraction-free application allows labs without extraction equipment, previously a prerequisite for molecular diagnostic testing, and was recently made available in Europe for Allplex™ SARS-CoV-2/FluA/FluB/RSV Assay.

Seegene has exported more than 55 million COVID-19 tests to more than 60 countries in 2020. 

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