Germany-Based QIAGEN Expands QIAcuity Digital PCR Offering for Biopharma, Pharma & Food Safety Sectors

The launch, held on November 9, 2023, is expected to bolster QIAGEN's commitment to providing precise, scalable, and user-friendly digital PCR solutions.

Germany-based QIAGEN, a global leader in life sciences, has unveiled three new QIAcuity kits and a significant software update aimed at broadening the applications of digital PCR technology. 

These advancements cater to critical sectors such as biopharma research, food safety, and pharmaceuticals. The launch, held on November 9, 2023, is expected to bolster QIAGEN's commitment to providing precise, scalable, and user-friendly digital PCR solutions.

Commenting on the same, Nitin Sood, senior vice president and head of the Life Sciences Business Area at QIAGEN, said, "The launch of our new QIAcuity kits and the software update emphasise QIAGEN’s dedication to advancing digital PCR analysis in crucial sectors like pharma, biopharma research, and food and drug safety."

The first kit, known as the QIAcuity Mycoplasma Quant Kit, provides researchers with a reliable method to detect mycoplasma contamination throughout the various stages of cell and gene therapy research and manufacturing. 

This kit streamlines the validation process by adhering to mycoplasma testing frameworks established by regulatory bodies, including the US, the EU, and the Japanese Pharmacopoeia.

Next is the QIAcuity OneStep Advanced EG Kit, designed for highly sensitive quantification of RNA or RNA alongside DNA in a single reaction. The kit employs intercalating dye technology, simplifying procedures and reducing costs compared to fluorescent-probe-based PCR. 

The patent-pending HotStart RT enzyme ensures controlled reaction activity, allowing for a more reliable and efficient workflow.

Completing the trio are the QIAcuity mericon Food Testing Kits, the only ready-to-use digital PCR food tests available. These kits enable researchers to combat product adulteration by authenticating food and animal-feed ingredients with target-specific precision. 

This launch extends QIAGEN's food safety testing portfolio, ensuring increased precision, sensitivity, and reliable data analysis.

In addition to the kits, QIAGEN plans to roll out the QIAcuity Software 2.5 update in November. This update is designed to assist researchers in determining crucial features of digital PCR analyses, including the precise run temperature and required sample dilution. 

As samples are often diluted before digital PCR analysis, the new software calculates the prevalence of targeted material in a sample and any necessary dilution. Post-test, QIAcuity Software 2.5 adjusts for dilution and converts results into user-defined units, automating a task crucial for pharmaceutical companies’ reports and audit trails.

QIAGEN's digital PCR platform, QIAcuity, employs nanoplates to disperse samples over thousands of tiny partitions, enabling simultaneous quantification of even the faintest signals from DNA and RNA. The integrated workflow, combining partitioning, thermocycling, and imaging, significantly reduces processing times to two hours.

The QIAcuity systems are available in one, four, and eight-plate versions, accommodating different sample volumes and processing capacities. The one-plate version can process up to 384 samples in an eight-hour shift, while the eight-plate version can handle up to 1,248 samples in the same timeframe.

In a similar development, Chennai-based Kriya Medical Technologies has received a manufacturing licence for its novel product, the KRIVIDA Trivus Respi Panel RT-qPCR Kit. 

The KRIVIDA Trivus Respi Panel RT-qPCR Kit is a diagnostic tool capable of simultaneously identifying Respiratory Syncytial Virus (RSV), Influenza viruses, and SARS-CoV-2 from a single swab sample. 

After validation by the ICMR-National Institute of Virology, Pune, this kit has demonstrated a high degree of accuracy with 100% specificity and 99.11% sensitivity in detecting these three viruses.