Key Takeaways
- •Assistance Publique Hôpitaux universitaires de Marseille (AP-HM), one of France's largest hospital groups, manages intense demands in qPCR diagnostics.
- •AP-HM developed its own in-house qPCR in vitro diagnostic assays, known as laboratory-developed tests (LDTs), using internal molecular expertise.
- •High-throughput labs require LDT preparation that stays efficient amid staff shortages.
High-Volume Diagnostic Pressures at AP-HM
Assistance Publique Hôpitaux universitaires de Marseille (AP-HM), one of France's largest hospital groups, manages intense demands in qPCR diagnostics. The lab handles more than 400 pathogenic targets, including over 150 viral assays, more than 150 bacterial targets, and various parasitic infections. Commercial CE-IVD kits alone prove too costly and limited for this scale.
AP-HM developed its own in-house qPCR in vitro diagnostic assays, known as laboratory-developed tests (LDTs), using internal molecular expertise. Preparing these LDTs entirely internally demands substantial time, traceability, and documentation to meet ISO 15189 validation and In Vitro Diagnostic Regulation (IVDR) Art. 5(5) standards.
Essential Needs for Large LDT Portfolios
High-throughput labs require LDT preparation that stays efficient amid staff shortages. Processes must track multiple assays and reagent lots precisely. They also need to comply with ISO 15189 for diagnostics and IVDR for LDTs, while adapting to new qPCR platforms and consumables.
AP-HM addressed these issues through a standardized, outsourced preparation method. This keeps control over assay design but shifts production burdens externally for better results.
Outsourced Service Tailored to AP-HM Needs
For over 12 years, AP-HM has used a custom service for high-volume qPCR assay preparation. It now covers 35 assays with ready-to-use premixes of primers, probes, and Master Mix in assay-specific strips. Each strip carries unique trigrams for clear identification in routine use.
The process involves cleanroom mixing of components, robotic filling of 8-tube qPCR strips, lot-specific records for validation, and partial shipments to fit limited -20°C storage. Peptide researchers can use similar precision with our Reconstitution Calculator for compound prep.
Tangible Gains in Daily Operations
Dr. Elsa Prudent, Chief Hospital Engineer in Molecular Biology at AP-HM, notes clear advantages from outsourcing LDT preparation in a resource-limited, high-throughput setting. Hands-on time drops significantly, as manual steps vanish even compared to CE-IVD kits.
Dr. Prudent stated: "Even with CE-IVD kits, there is still a manual preparation step involved. With the pre-filled strips, the assay is truly ready-to-use, which is essential for us, given our limited staffing resources."
Cost Savings and Traceability Boost
Budget constraints make pricing critical, and the service delivers assays at five to ten times lower cost per point than commercial kits. Dr. Prudent emphasized: "Price is an important consideration for us, given our tight budget. With your service, price per point is typically five to ten times lower than that of commercial kits."
Cleanroom production and lot documentation provide superior traceability over internal efforts. As Dr. Prudent added: "We dont have an equivalent service internally, and even if we did, working with you provides a higher level of traceability. Your cleanroom production and traceability fully meet the standards we expect from an outsourced partner."
Flexibility and Logistical Support
Compatibility across platforms and plastics supports changing equipment from public tenders. Partial deliveries in two batches manage storage limits effectively.
Dr. Prudent noted: "Having flexibility with plastics and compatibility across different platforms is important, especially since equipment can change with public tenders." She also said: "Staggered deliveries, usually in two batches, are essential for us because our storage space is limited."
Check our Peptide Glossary for terms like primers and probes in research contexts, or use the Dosage & Cycle Planner for protocol planning.
12-Year Partnership and Regulatory Fit
AP-HM now depends on 35 ready-to-use qPCR premixes for its extensive diagnostic work. This setup saves time, allows assay customization, and ensures cleanroom standards with full documentation for IVDR Art. 5(5) compliance.
Dr. Prudent affirmed: "Communication with your team has always been easy and pleasant. Were very happy to work with you, and we hope this collaboration will continue." As regulations evolve, AP-HM intends to maintain this outsourced approach.
Key Takeaway for Diagnostic Labs
Standardized outsourcing streamlines LDT workflows, enhances traceability, and prepares labs for regulatory shifts without losing assay control. AP-HM's experience over 12 years shows efficiency gains in high-volume qPCR. Labs facing similar pressures can achieve comparable results through ready-to-use formats.