The EURORealTime SARS-CoV-2 from EUROIMMUN is now validated for use with saliva as sample material as an alternative to throat swabs. Collection of saliva specimens is easier and less distressing for patients than taking nasal or throat swabs, especially for children.
The CE-marked assay provides fast and simple real-time PCR-based detection of SARS-CoV-2 in RNA isolated from the patient samples. Reverse transcription and real-time PCR are performed in one step, so that only one reaction is required per sample.
The test provides high sensitivity due to simultaneous detection of two defined target sequences in the ORF1ab and N genes of the viral genome. The variants alpha (B.1.1.7 lineage), beta (b.1.351 lineage), gamma (P.1 lineage) and delta (B1.617.2 lineage) can be reliably detected.
The test contains an internal amplification control, which serves as an inhibition and extraction control. A SARS-CoV-2 positive control provided in the test kit is analysed as an external control in every test run ensuring dependable results. The complementary EURORealTime Analysis software provides fully automated and standardised evaluation and documentation of results, including all control results. Comprehensive automation options for sample preparation, PCR setup and PCR performance are available.