Scientist working in laboratory

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

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 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
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.
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.
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.
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.

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

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.
NeuMoDx — a revolutionary molecular diagnostic solution
Critical decisions for patient care are dependent on accurate and timely clinical laboratory results. To meet this demand, your lab needs full automation, faster turnaround times, scalability, and streamlined laboratory-developed test workflows. NeuMoDx systems address these needs – and more.
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.