Qiagen to Complement COVID-19 Testing Portfolio with Novel Kit That Simplifies and Accelerates PCR Analysis for Research

(Venlo, Netherlands) plans to launch a novel straightforward approach to viral RNA epidemiology that will significantly simplify and accelerate PCR analysis and remove key testing bottlenecks for SARS-CoV-2 and other RNA viruses.

QIAGEN’s innovative QIAprep& Viral RNA UM Kit combines a liquid-based sample preparation step completed in only two minutes with real-time PCR detection in a streamlined workflow that can be automated with standard lab equipment for any throughput, any assay and any reaction need from single to multiplex testing. The kit, which uses the most common transport media such as Universal Transport Media (UTMTM) as the starting material, includes both sample extraction components and optimized PCR reagents for only one procedure.

The QIAprep& workflow is simple, swift and straightforward, consisting of only three steps: an aliquot is taken from a primary sample (nasopharyngeal, oropharyngeal or nasal swab) in transport media and added to a sample preparation buffer that is optimized to prepare the viral RNA template without degradation. This is next combined with the RT-qPCR reaction mix, which provides reliable and sensitive results for RNA viruses in UTM. The sample then undergoes a routine real-time PCR in a cycler using any assay.

The streamlined workflow takes under one hour to deliver a result from start to finish – including incubation and hands-on time, compared to approximately three hours for standard extraction-based quantitative PCR processes and can handle up to 2,600 samples per eight-hour shift per cycler. As a result, labs can significantly accelerate the time to result and the frequency of viral testing. With only three small pipette tips needed per sample, the kit keeps plastic usage to a minimum, while providing significant cost savings by reducing reagent use and labor utilization. QIAGEN’s QIAprep& Viral RNA UM Kit will be available for research applications in mid-October.

“We are excited to launch the first integrated liquid-based sample preparation and amplification method for testing of viral RNA with any assay, including SARS-CoV-2,” said Dr. Thomas Schweins, Senior Vice President of the Life Sciences Business Area at QIAGEN. “Unlike other products, QIAprep& does not eliminate the sample preparation step at the expense of performance. Instead, it streamlines the gold standard in sample preparation set by QIAGEN to a process completed in under two minutes to enable an immediate, fast real-time PCR run on any cycler that delivers results in under one hour. We are planning to ramp up the production capacities later in 2020 to levels that ensure a guaranteed supply and address effectively the challenge of long PCR turnaround times that are slowing down the frequency of testing.”

“QIAprep& makes the most of our expertise in both sample preparation and PCR,” said Thierry Bernard, Chief Executive Officer of QIAGEN. “PCR is the gold standard for detection of SARS-CoV-2 and other RNA viruses, and QIAprep& makes it faster – without compromising performance. The launch of this new product will complement our efforts to build the broadest portfolio of COVID-19 testing solutions that addresses the varying needs for clinical and research applications in the fight against the pandemic.”