In a recent interview with PharmaShots, Kai te Kaat, the Vice President, Head of Franchise Oncology, MDx at QIAGEN shares his insights and highlights on QIAprep& Viral RNA UM Kit.

Shots:

• QIAGEN to launch the QIAprep& Viral RNA UM Kit, designed to simplify and accelerate PCR swab analysis and remove key testing bottlenecks for Covid-19 and other RNA viruses
• The kit combines a liquid-based sample preparation step completed in the only 2min. 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 workflow takes ~1hr. to deliver a result, compared to ~3hrs. for standard extraction-based quantitative PCR processes and can handle~2,600 samples /8hrs. shift per cycler. The kit complements QIAGEN's COVID-19 testing portfolio and accelerates PCR analysis for research applications

Tuba: Can we have a detailed discussion on QIAprep& Viral RNA UM Kit?

Or

Would you like to discuss the working of the novel kit and how it is accelerating the PCR analysis for research application?

Kai te Kaat: QIAprep& is an innovative ultrafast method that combines liquid-based sample preparation with real-time PCR detection for research purposes and/or epidemiological research debottlenecking the detection of SARS CoV2 and other RNA viruses. The end-to-end liquid-based workflow can be automated with standard lab equipment for any throughput, any assay and any reaction need from single to multiplex testing. It can be implemented on all open platforms, typically liquid handlers, and be used in conjunction with any RT PCR cycler such as Rotor-Gene Q, QIAquant, and others. The kit can also be used with a wide range of transport media from Universal Transport media (UTMTM), Viral Transport Media (VTM), or eSwabTM to Virocult®, physiological salt solution, or phosphate-buffered saline (PBS). Besides, it includes a control concept to increase the value of negative results consisting of a human sample control based on RNAse P and B2M genes to indicate the sufficiency of human material in the sample avoiding false negatives and an inhibition control based on artificial sequences to indicate the absence of inhibition by the sample matrix.

Source: QIAGEN

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 (8 uL) and added to a sample preparation buffer (2 uL) that is optimized to prepare the viral RNA template without degradation. This is next combined with the RT-qPCR reaction mix (10 uL), which provides reliable and sensitive results for RNA viruses in transport media. The sample then undergoes a routine real-time PCR in a cycler using any assay for SARS-CoV2 RNA detection. The output is finally interpreted, delivering test results in under one hour from start to finish  including incubation and hands-on time  depending on the cycler used.

As the kit only uses three small pipette tips (10 uL and 50uL) per sample, the kit helps to keep consumption of plastic materials to a minimum, and thereby addresses the current major bottleneck of pipette tips at the market while providing significant cost savings by reducing reagent use and labor utilization. In addition, the QIAprep& kit can also be used manually with a multi-pipette in lower resources settings or to cover capacity peaks.

QIAprep& is a research-based kit and not a diagnostic test and hence cannot be compared to other typical COVID tests that are in the marketplace right now.

Tuba: As mentioned in a press release, QIAprep& complements QIAGEN's efforts to build the broadest portfolio of COVID-19 solutions. Comment over the statement.

Kai te Kaat: Since the beginning of the coronavirus pandemic, we focus on building the most comprehensive portfolio of solutions for COVID-19 testing that addresses the varying needs for clinical and research applications in the fight against the pandemic. These include the production of viral RNA extraction for use on our QIAcube, QIAsymphony, and EZ1 platforms as well as third-party instruments; building up a range of PCR tests on the QIAstat-Dx and NeuMoDx systems that enable COVID-19 detection while analyzing samples at the same time for other respiratory infections and are developing novel easy-to-use solutions for antibody and antigen testing running on a portable device that provides highly accurate results in less than 15 minutes. We are also providing universal next-generation sequencing (NGS) solutions for research use with any sequencer, in particular gene panels integrated with bioinformatics for analysis of the SARS-CoV-2 virus, and are scaling up production capacity for reagents sold to other companies for use in their own COVID-19 tests. With the launch of QIAprep& that includes both sample extraction components and optimized PCR reagents for only one procedure we now complement our COVID-19 testing portfolio further removing key testing bottlenecks for SARS-CoV-2.

Image Source: QIAGEN

Tuba: How confidently you can pitch about its accuracy since it delivers results in under one hour?

Kai te Kaat: It is a research-based kit with which we achieve a detection limit of less than 8 viral copies/reaction and a high concordance to established extraction-based methods.

Tuba: What are your other targets except for COVID-19. Are you specifically working on something?

Kai te Kaat: The product is optimized for the mentioned transport media and detection of enveloped RNA viruses such as SARS-CoV2. We are further qualifying additional transport media for the workflow to increase its universal applicability. Further, we are looking into deploying the same workflow for other respiratory viruses.

Tuba: When can we expect QIAprep& Viral RNA UM Kit's availability for research applications?

Kai te Kaat: The kit is available worldwide for research applications starting the week of October 19th. Since it is a fully liquid-based workflow, scalability in manufacturing is deep with the potential of more than 20 million reactions per month.

The kit is available worldwide for research applications starting the week of October 19th. Since it is a fully liquid-based workflow, scalability in manufacturing is deep with the potential of more than 20 million reactions per month.

Tuba: What do feel was the biggest roadblock in developing an accurate testing solution for COVID-19?

Kai te Kaat: General roadblocks for the development of accurate testing solutions for COVID-19 are the access to defined standard materials and controls as well as overall supply challenges in the industry, especially on plasticware.

Tuba: What all developments and can you count the name of QIAGEN in providing solutions for the COVID-19 to date?

Kai te Kaat: From the onset of the novel coronavirus outbreak, our teams have been working around the clock to ensure the availability of existing testing solutions and to develop new SARS-CoV-2 tests to address international testing needs. Today, we offer the most comprehensive portfolio of SARS-CoV-2 testing solutions on the market, covering the needs of clinical and research customers, from manual to automated sample processing, low to high throughput, single-plex to multi-plex, and from active infection testing to the detection of previous viral exposure. An overview of our global efforts in the fight against coronavirus can be found here; for background information on our coronavirus testing solutions please download our factsheet.

Tuba: Are you planning to further develop solutions for the COVID-19 testing portfolio?

Kai te Kaat: Based on the technology used in the novel QIAprep& kit we are currently developing IVD test kits for SARS-CoV2 RNA.

Tuba: Do you want to highlight anything else about QIAGEN for our subscribers?

Kai te Kaat: Today, we offer the most comprehensive portfolio of SARS-CoV-2 testing solutions on the market addressing the varying testing needs in the fight against the pandemic covering the needs of clinical and research applications, from manual to automated sample processing, low to high throughput, single-plex to multi-plex, and from active infection testing to the detection of previous viral exposure. Testing will continue to be a dominant factor in the fight against the pandemic: even when the vaccines will come to market, the immune status of the population will need to be assessed and monitored. Here, PCR will continue to remain the gold standard for the detection of SARS-CoV-2 and other RNA viruses, and with our QIAprep& technology, we made it even faster without compromising performance.

 About Kai te Kaat:

Kai te Kaat is the Vice President and the Head of QIAGEN's Oncology Franchise in the Molecular Diagnostics Business Area.  He has joined QIAGEN in 2005 as the Global Business Director Proteins. He has been working for the last 11 years at QIAGEN

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