The analytical performance demonstrates the ability of your device to correctly detect or measure a particular analyte. Analytical performance evaluations are a critical component of the regulatory requirements for in vitro diagnostic (IVD) devices under the In Vitro Diagnostic Medical Devices Regulation (IVDR). IVDR places a strong emphasis on ensuring that IVD devices are safe and effective for their intended use. Performance evaluations, which encompass various aspects of a device's performance, play a central role in meeting these regulatory requirements.
Analytical performance is a foundational concept in In Vitro Diagnostic (IVD) devices. It has been a critical factor since the inception of the In Vitro Diagnostic Directive (IVDD) in 1998. However, with the introduction of the In Vitro Diagnostic Regulation (IVDR), the importance of analytical performance has grown significantly. IVDR seeks to expand on the requirements for analytical performance, emphasising the data that should be provided to ensure the safety and effectiveness of IVD devices.
We have supported numerous manufacturers by performing Analytical Performance Evaluation Studies for:
Rapid tests
POCT devices
Molecular assays
Immunoassays (ELISA)
We can provide full analytical performance services including designing and writing the Study Plan, sourcing of clinical samples, compiling a systematic literature review, limit of detection calculations using reference material and performance comparisons against a gold standard. At PeploBio we specialise in molecular and immunoassay technologies.
All documented procedures, study plans and proposal are drafted and approved by personnel with PhD & HCPC registered scientists and are subsequently archived as controlled documents.
Specimen type, storage, handling and transport
Trueness vs reference method/material, total analytical error, repeatability & reproducibility, sensitivity
Interfering substance & cross-reactivity
Measuring range (LoB, LoD, LoQ), linearity, cut-off
Metrological traceability
Batch-to-batch homogeneity
Carryover
Instrument-to-instrument precision
One of the critical elements emphasised in IVDR is the Analytical Performance Report (APR). The IVDR, while not providing specific guidance on the content and layout of the APR, stipulates that "the manufacturer shall demonstrate the analytical performance of the device in relation to all the parameters described in point (a) of Section 9.1 of Annex I, unless any omission can be justified as not applicable." As a rule, the analytical performance should always be demonstrated based on analytical performance studies.
At PeploBio, we understand the importance of the APR in IVDR compliance. Our services go beyond compliance; we ensure that your APR is meticulously crafted to meet IVDR requirements. It not only complies with regulatory standards but also provides a detailed account of the studies performed, including an explanation of why certain performance characteristics may not be applicable. This comprehensive documentation supports the claims made in the Instructions for Use (IFU), enhancing your device's market presence.
The study plan is designed with the intended certification in mind (including FDA & IVDR) to ensure that the device meets all applicable regulatory standards. Having a third-party evaluation demonstrates to the regulatory a commitment to an objective and comprehensive evaluation of the medical device’s performance.
We are committed to maintaining high-quality standards demonstrated by our laboratory and QMS ISO 15189 accreditation.
Our team of scientists include PhD and HCPC registered biomedical scientists, who provide comprehensive support from study initiation to submission of the clinical performance evaluation report to the regulator.
We have an extensive network of biobanks across the NHS and UK, Europe, US and Asia with appropriate ethical documentation to accssess to patient samples including those from rare disease subtypes.
The study can be designed to provide feedback from patients, healthcare professionals, as well as laboratory technicians.
The well-established links between our clinical laboratory and suppliers allows us to pass on significant savings to our clients through economies of scale when sourcing comparator assays and clinical specimens.
We are ICO registered organisation with clearly defined data privacy policies, and robust data protection systems to ensure third party patient data remains protected.