Recommended
Recommended
More Related Content
What's hot
What's hot (20)
Viewers also liked
Viewers also liked (18)
Similar to WHO prequalification of IVDs for HIV self-testing
Similar to WHO prequalification of IVDs for HIV self-testing (20)
More from Cheryl Johnson
More from Cheryl Johnson (20)
Recently uploaded
Recently uploaded (20)
WHO prequalification of IVDs for HIV self-testing
- 1. IAS 2015, Vancouver | 19-22 July 20151 | WHO prequalification of IVDs for HIV self-testing Side-event on HIV self testing 18 July 2015 Vancouver Anita Sands Prequalification Team – Diagnostics Essential Medicines and Health Products
- 2. IAS 2015, Vancouver | 19-22 July 20152 | Full WHO prequalification assessment Pre-submission form Dossier review Site inspection Performance evaluation Dossier incomplete Prequalification decision. UN procurement eligibility. Dossier complete Dossier screening Priority product Yes No Review of safety and performance through product dossier; Review of quality management system through on- site inspection; and Evaluation of product performance and operational characteristics through independent testing
- 3. IAS 2015, Vancouver | 19-22 July 20153 | Intended use of an IVD Intended use – What analyte it detects; – Function (e.g., screening, monitoring, diagnostic or aid to diagnosis, staging or aid to staging of disease); – Specific disorder, condition or risk factor of interest it is intended to detect, define or differentiate; – If it is automated or manually operated; – If it is qualitative or quantitative; – Specimen type(s) (e.g. serum, plasma, whole blood, sputum, urine, etc.). Intended testing population – E.g. neonates/adults, antenatal women, symptomatic individuals, etc. Intended user – Professional use (laboratory staff and/or HCW at POC) – Self-testing use Intended setting of use – Laboratory, at POC, community
- 4. IAS 2015, Vancouver | 19-22 July 20154 | Different regulatory versions Manufacturers produce different versions of apparently the "same product" Different regulators have different requirements for the same intended use – Labelling, instructions for use, lot QC release, etc. Different intended use means a different product – So different validation and verification studies are required
- 5. IAS 2015, Vancouver | 19-22 July 20155 | Implications for PQ assessment RDTs for oral fluid and/or for capillary whole blood that have been validated and verified by the manufacturer for HIVST as their intended use will be considered for PQ Regulatory status of candidate products Expected PQ pipeline New to market 5 products Version approved for HIVST by GHTF 3 products Predecessor version approved for professional use by GHTF* or WHO 3 products Predecessor version approved for professional use by non-GHTF 1 product *GHTF founding member: EU, USA, Canada, Japan, Australia
- 6. IAS 2015, Vancouver | 19-22 July 20156 | Sample product dossier Manufacturers likely have little expertise in validation/verification studies required for a claim of HIVST intended use WHO is producing a sample product dossier for HIVST – Due for release end of 2015 – Will be made available at http://www.who.int/diagnostics_labo ratory/evaluations/en/
- 7. IAS 2015, Vancouver | 19-22 July 20157 | Post-market surveillance of HIVST Reactive PMS Issuance of Field Safety Notice Complaint Field Safety Corrective Action WHO prequalified IVD Manufacturer has obligation to conduct PMS activities Users should ensure complaint reporting to the manufacturer so they can monitor quality, safety, performance of RDTs used for HIVST
- 8. IAS 2015, Vancouver | 19-22 July 20158 | How to assure quality for HIVST Adapt facility-based QA measures for HIVST Process control – QC, including storage conditions Training – Encourage validation of additional information material (e.g. YouTube videos, job aids) by the manufacturer
- 9. IAS 2015, Vancouver | 19-22 July 20159 | Contact us By email – diagnostics@who.int Sign up to our mailing list – By emailing diagnostics@who.int Via our website – http://www.who.int/diagno stics_laboratory/en/ – http://www.who.int/diagno stics_laboratory/postmark et/en/
Editor's Notes
- 5 September, 2015
- Only for selected IVDs, with focus on rest of world regulatory versions Entirely voluntary process, manufacturer can withdraw at any time up until PQ decision Product must fulfil requirements for all three PQ components before it can be WHO PQed Once PQed a LTA is signed with WHO for a price to supply WHO Member States.
- The objective intent of the manufacturer regarding the use of a product as reflected in the specifications, instructions and information provided by the manufacturer. The intended use for an IVD should define the IVD function such as diagnosis, aid to diagnosis, screening, monitoring, predisposition, prognosis, prediction, and physiological status determination. Other relevant aspects include the specific disorder, condition or risk factor of interest, the testing population, specimen type(s), and, the intended user.
- Exceedingly difficult to have one regulatory version to fit all markets.
- Scenario 1 Scenario 2 Scenario 3 Regulatory version submitted for PQ has been stringently assessed Regulatory version submitted for PQ has not been stringently assessed but a regulatory version exists that has been Regulatory version submitted to PQ has not been stringently assessed