QIAGEN reaffirms effectiveness of its SARS-CoV-2 PCR tests in light of the new coronavirus variant B.1.1.529

QIAGEN has announced its polymerase chain reaction (PCR) tests remain accurate and effective in detecting SARS-CoV-2 infections in light of the emergence of a new variant of concern detected in South Africa.

QIAGEN has successfully assessed its SARS-CoV-2 PCR tests against the genetic mutations of the variant, which is known by its scientific name, B.1.1.529. The assessment was made against data available in the GISAID and GenBank public databases.

This applies to all of QIAGEN’s PCR tests for detection of the SARS-CoV-2 virus involving:

• artus SARS-CoV-2 Prep&Amp UM Kit, a CE-marked SARS-CoV-2 test that integrates sample preparation and detection in a single kit, enabling a throughput of more than 670 tests per PCR cycler in an eight-hour shift
• QIAstat-Dx syndromic testing system, which includes the CE-marked test QIAstat-Dx Respiratory 4 Plex Flu A-B/RSV/SARS-CoV-2 to quickly identify in about an hour whether patients have common seasonal respiratory infections or SARS-CoV-2. QIAGEN also offers the QIAstat-Dx Respiratory+ test in the U.S., Europe, and other markets for the detection of more than 20 respiratory illnesses, including COVID-19 infections.
• NeuMoDx 96 and 288 integrated PCR testing systems used in laboratory testing. QIAGEN offers tests worldwide for use on this system for the detection of the SARS-CoV-2 virus. In the U.S., the NeuMoDx Flu A-B/RSV/SARS-CoV-2 VantageAssay is available for use in testing patients with suspect infections.

Furthermore, the new variant is reliably detected by:

• QIAGEN’s QIAcuity digital PCR solution, which uses a SARS-CoV-2 wastewater surveillance assay developed in collaboration with GT Molecular, Inc.
• QIAGEN’s QIAprep& Viral RNA kit, which uses qPCR genotyping assays that are available in collaboration with biomers.net.

QIAGEN has been closely monitoring – and will continue to do so – the performance of its PCR tests as new variants emerge in the global fight against the coronavirus pandemic. Surveillance of genetic variations will continue on a biweekly basis.

“The best way to fight the global COVID-19 pandemic is a combination of extensive vaccinations, rigorous testing with gold-standard PCR tests, aggressive surveillance of new variants, and above all compassionate treatment for those infected with the SARS-CoV-2 virus,” said Dr. Davide Manissero, M.D., Chief Medical Officer of QIAGEN N.V.

“We are pleased to report that the emergence of this new variant of concerns, as has been the case with other variants, has had no impact on the effectiveness of our SARS-CoV-2 PCR tests. Further genomic sequencing of SARS-CoV-2 samples worldwide will vastly increase transparency and help us identify and respond to potentially dangerous mutations of the virus, while at the same time broadening the database we can use to verify if vaccines and tests continue to be effective,” Manissero said.

The new variant of concern joins a list of other variants with potentially increased transmissibility. These include the Alpha variant (B.1.1.7, first detected in the United Kingdom), the Beta variant (B.1.351, identified in South Africa), and the Delta variant (B.1.1.28 P1, detected in Brazil). As a virus that is encoded by RNA nucleotides, SARS-CoV-2 frequently mutates due to erroneous or ineffective replication of the virus genome. These mutations can sometimes produce viruses with altered properties or even entirely new strains.

To better identify and differentiate potentially dangerous variants, countries around the world are increasing the frequency of sequencing positive SARS-CoV-2 samples to monitor the occurrence of potential mutations.

To support these initiatives, QIAGEN offers the QIAseq DIRECT SARS-CoV-2 solution for rapid and comprehensive monitoring of sequence drift of the virus around the world, as well as QIAGEN Digital Insights bioinformatic analysis solutions.

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