Laboratory-Developed Testing Solutions

LDT workflow

Sample collection and nucleic acid stabilization

Sub-optimal storage conditions and prolonged shipping times influence the quality and the integrity of human and pathogen RNA and DNA in the sample material. Sample stabilization during collection is a crucial first step in many molecular assays to avoid rapid degradation after collection, particularly for blood samples, and to ensure reliable interpretation of results.

Sample collection and stabilization for many sample types

QIAGEN offers PAXgene reagents for convenient, room-temperature stabilization of DNA, ccfDNA, RNA and protein to help you overcome the challenges associated with sample collection and sample stabilization, giving you confidence in your results

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Sample preparation

Nucleic acid extraction is a critical part of IVD and laboratory-developed test workflows. The integrity, quality and quantity of the isolated nucleic acid has key influence on the reproducibility and reliability of the assay and the final interpretation.

QIAGEN Instruments for developing laboratory tests

QIAGEN purification systems purify top-quality nucleic acids from nearly all sample materials and collection devices as well as from a wide range of sample quality. QIAGEN has developed a portfolio of instruments that are ideally suited to the kind of rigorous extraction you need to be sure you can develop your LDTs with the convenience, throughput and reliability you need. Get the most out of your nucleic acid purification instrument with the gold standards in nucleic acid purification:

Easy integration into your existing lab workflows
Reproducibly high nucleic acid quality and yield
QIAGEN IVD extraction systems for IVD use
Purified samples that are compatible with various downstream analysis technologies

ccfDNA extraction. Perfected. Automated.

The use of cell-free DNA (ccfDNA) is transforming how we understand and manage clinical care. See how the QIAsymphony DSP Circulating DNA Kits can help you can improve your ccfDNA extraction protocols.

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QIAsymphony SP

The easy-to-integrate QIAsymphony SP is a sample prep platform for processing liquid biopsy, blood and tissues for genetic testing, oncology and infectious disease. This flexible platform is ideal for processing variable sample volumes – from small to large for liquid biopsy and is compatible with qPCR, NGS and digital PCR.

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QIAcube Connect MDx

Modern, the QIAcube Connect MDx is designed to perform automated purification of nucleic acids with separate modes for IVD purification with DSP kits and for clinical research. Fully automate and track your trusted QIAGEN spin-column extraction and purification protocols – at the push of a button.

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EZ1 Advanced XL solutions for LDTs

Reduce the risk of human error and contamination with the reliable and reproducible laboratory-developed test automated workflows on the EZ1 Advanced XL. This platform performs automated nucleic acid purification for a wide range of sample types. Push-button automation, prefilled cartridges and effortless data management with full traceability ensure high-performance results in purification procedures. The speed, flexibility and ease of use makes it an ideal instrument for a daily routine with quick response-time tests.

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QIAcuityDx Digital PCR System

QIAcuityDx is a single digital PCR (dPCR) instrument designed for IVD applications. It’s all your lab needs in just one machine. It'll help you save time, space and get results fast. It’s quick and simple qPCR-like workflow seamlessly integrates partitioning/processing, PCR and analysis, reducing hands-on time. It lets you simultaneously run multiple plates with different settings, and continually remove and load new plates. The Utility Mode and off-the-shelf IVD consumables empower your lab with a simplified route to establish and run your own self-developed assay menu using an IVD medical device instrument.

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Automated IVD sample processing within your reach

QIAcube Connect MDx and QIAamp DSP Kits are a reliable match for standardizing your sample processing. Run IVD applications with ease and full confidence and boost your productivity.

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QIAGEN spin column-based kits for IVD use

QIAamp and RNeasy DSP Kits for manual sample preparation

We provide a wide range of dedicated sample purification kits tailored to your needs. Our dedicated QIAamp DSP kits for DNA and RNeasy DSP kits for RNA ensure your manual sample processing yields highly pure nucleic acid that is free of contaminants and inhibitors for results you can trust. To address your workflow needs, our sample purification kits are optimized for your specific sample types. These kits can be automated on the QIAcube Connect MDx for hands-off processing.

Assay setup

Reduce manual handling steps and minimize the risk of sample contamination of processed samples with automated assay setup.

QIAsymphony SP AS, Instrument, sample preparation

Fully integrated automation of assay setup

The QIAsymphony AS is for automated PCR assay setup, which, in combination with the Rotor-Gene Q MDx and QIAGEN real-time and end-point PCR kits, enables you to optimize your PCR workflow and maximize your efficiency.

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Quality control

Quality control and fragment analysis

Our QIAxcel Advanced System for effortless DNA and RNA analysis and QIAxpert System for accelerated DNA, RNA and protein quantification and quality control replace traditional, labor-intensive gel analysis of DNA and RNA. Streamline your laboratory-developed test workflows and reducing time to result.

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Amplification and detection

PCR instruments need to deliver fast-cycling protocols and accurate, sensitive results to satisfy the increasing demands of molecular detection. We offer a range of PCR and qPCR instruments for rapid, reproducible results in broad a range of PCR applications.

Quantitative, real-time PCR with Rotor-Gene Q MDx (IVD)

This high-precision PCR cycler is suited for in vitro diagnostic applications, delivering outstanding performance for infectious disease research, genetic analysis or companion diagnostics as well as for developing LDTs. Designed for maximum ease of use and reduced need for maintenance, the rotary format also provides an unrivaled optical range for sensitive results with multiple applications.

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Want to learn about QIAGEN solutions for your LDTs?

View a list of our products for implementing your laboratory-developed IVD tests rapidly with scalability to suit changing needs.

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Disclaimers:

QIAcuity Digital PCR instruments are sold under license from Bio-Rad Laboratories, Inc.and exclude rights for use with pediatric applications

QIAcuityDx medical device is currently under development and will be available in 20 countries in H2 2024.