SALDA In Vitro Diagnostics in South Africa Welcome December 2015
Is the IVD industry ready for regulations?
What is our collective mandate? We have been asked to ensure the safety and effectiveness of in vitro diagnostic tests, protecting the public against poor quality assays, while expediting access to beneficial new devices. We have been asked to create regulatory capacity to assess a range of sophisticated instruments right down to simple lateral flow devices.
What is our collective mandate? The regulatory process must be consistent with current legislation The rules and processes prescribed by the regulatory authority must be clearly articulated for those who must comply with them
What is our collective mandate? IVD safety requires oversight and risk analysis in the use of IVDs We need to harmonize efforts with our African counterparts We require stewardship in our resource scarce country where laboratories are centralised which results in the reliance of point of care tests which increases the risk analysis.
Challenges specific to IVDs The enormous volume of IVDs where pharma has a couple of hundred products, IVDs have thousands IVDs are assessed by clinical utility; screening, diagnostic, confirmatory, monitoring and compatibility
Challenges specific to IVDs Assays are divided into many disciplines according to the pathologist and technologists qualification and skill set: Immunology Chemistry Haematology Molecular Microbiology Virology Serology Blood Transfusion Tissue Typing
Characteristics used in the assessment of assays Sensitivity, specificity and reproducibility Precision and Clinical performance Detection limitations Quantification limits of different methods used Quality of manufacture Target analyte Bound complex Assay cut off
Characteristics used in the assessment of assays Laboratory error, Total analytical error Stability and interference The potential of displaying false positive The potential of displaying false negative The type and quality of specimen Testing patients underlying clinical conditions Immunosuppression and co-infection Target population Therapy evaluation
Characteristics used in the assessment of assays Microbials display different performance parameters therefore using percentage probabilities to predict reactions Assays used in conjunction with other assays of equal quality to achieve a final result Multiplex assays with a mixture of analytes in one test platform The enormous cost of product evaluation studies
Meet the team Pillars of Pathology Patients Phlebotomists Medical Technologists Pathologists SANSA Accreditation Suppliers
How do we manage the risk? South African Bureau of Standards ISO/TC212 Clinical laboratory testing and in vitro diagnostic test systems 41 ISO standards developed by global consensus CLSI Clinical and Laboratory Standards Institute CLSI
The next step? Training activities Technical assistance Provision of information Standards and regulatory expertise Conformity assessment bodies
Potential bumps in the road Regulatory controls should be proportional to the level of risk Expertise of the intended user Impact of the result Capable of accommodating future technological advancements in automation software and connectivity Accountability
Potential bumps in the road Operation of a quality system Documentation of clinical evidence to support manufacturers specified intended use Technical data Product testing resources for clinical performance study of an IVD used to demonstrate compliance with the relevant Essential Principles with respect to clinical performance.
Potential bumps in the road Product testing resources for clinical performance assessment of an IVD which looks at characteristics such as analytical specificity and sensitivity (cross-reactivity, substance interference), precision, reproducibility etc. and clinical/diagnostic sensitivity and specificity. Frequent independent external audit Independent external review of manufacturer s technical data Understanding serious device adverse event in the context of IVDs
So Are We Ready?
THANK YOU Presented by Robyn Howes SALDA Regulatory Committee