SARS-CoV-2 (previously 2019-nCoV) is a member of the coronavirus family and the causative agent of coronavirus disease 2019 (COVID-19). Since the first cases of a severe respiratory disease were reported from Wuhan, China, in December 2019, infections have spread rapidly around the world.
Considering the rapid escalation, spread and persistence of COVID-19 worldwide, testing remains essential and is required all over the world.
Reactivity of molecular diagnostic tests is determined by the sequences of the oligonucleotides contained in the reaction mix. RNA viruses in particular have an inherently high mutation rate leading to changes in the genome sequence during every replication event. SARS-CoV-2 is no exception. We at altona Diagnostics are well aware of the importance to constantly monitor the emerging and circulating sequences and we update the reactivity analysis of our assays on a regular basis. Mutations in the viral genome occur in every gene and untranslated region and are not limited to the S gene. Our S gene assay is located in a conserved region coding for the membrane fusion subunit (domain 2) of the spike protein. Until now, we have not found any mutations that would cause our S gene assay to fail.
By now the Omicron viruses account for over 98% of the publicly available sequences since February 2022 and constitute the genetic background from which new SARS-CoV-2 variants will likely emerge. Recent reactivity analysis by altona Diagnostics confirmed that the S gene assays contained in the SARS-CoV-2 associated products of the RealStar®, AltoStar® and FlexStar® product lines detect all described genetic variants including all previously discovered Omicron variants.
The CE-IVD certified RealStar® SARS-CoV-2 RT-PCR Kit 1.0 consists of Master reagents, Positive Control and an Internal Control and delivers highly reliable results. It is designed as a dual target assay and allows rapid screening of all lineage B-betacoronaviruses and confirms the presence of SARS-CoV-2 specific RNA in only one reaction.
The CE-IVD marked AltoStar® SARS-CoV-2 RT-PCR Kit 1.5 extends the altona Diagnostics test kit portfolio for the detection of SARS-CoV-2 specific RNA. The assay is intended for use with the automated AltoStar® Molecular Diagnostic Workflow and complements the existing RealStar® SARS-CoV-2 detection kits for use with open platforms. In addition, altona provides a corresponding kit for influenza virus detection, the AltoStar® Influenza Screen & Type RT-PCR Kit 1.5.
FlexStar® is the quick and flexible real-time PCR product line allowing syndrome-based testing of different pathogens. altona provides dual target detection kits for SARS-CoV-2 (E gene and S gene) and influenza A and B.
Distinguishing respiratory tract infections is vital for patient management and epidemiological control. altona Diagnostics offers CE-marked RealStar® PCR kits for detecting three pathogens, namely SARS-CoV-2, influenza viruses and RSV.
Each kit bundle can be ordered with a total of 384 reactions per included assay and will be available at special prices in your country. For an individual offer please contact your local sales representative.