Definition
Molecular diagnostics encompasses nucleic acid testing methods such as PCR, hybridization, and sequencing-based assays. The LIS must preserve chain-of-custody style traceability from accession through amplification and detection to authorized release.
Workflow
Typical flows include batching by extraction instrument, plate maps, controls placement, and integration with thermal cyclers or sequencers. Failures should route to exception queues with reason codes rather than silent drops.
Implementation
Implementation focuses on dictionary design (panels, targets, CT/threshold semantics where captured), mapping instrument output fields to LIS observations, and training technologists on hold/release policies.
Interoperability
Instrument vendors supply file or message-based outputs; some sites use middleware. Hospital orders may arrive via HL7 while devices use proprietary or ASTM-like transports. The LIS should unify results into one validation queue.
Compliance framing
US labs operate under CLIA and applicable state law; CAP checklists may apply for accredited sites. Software supports controls and documentation, but accreditation remains an organizational responsibility.
Frequently asked questions
Does Medrara replace a LIMS for research use?
Medrara is marketed for diagnostic laboratory operations. Research or biobanking LIMS requirements may differ; evaluate fit with your quality system.
