Background
Impact of the lot-testing programme
Reasons for lot failure | Nb lots failed at reception (nb RDTs) | Nb lots failed after long-term storage (nb RDTs) |
---|---|---|
Non-detection of Pv at 200 p/μl | 20 (5.7 M) | 18 (5.1 M) |
Non-detection of Pf and Pv at 200 p/μl | 0 | 1 (0.3 M) |
Insufficient buffera | 6 (1.7 M) | 24 (6.8 M) |
Total | 26 (7.4 M) | 43 (12.2 M) |
The future of LT
Cost estimate (US$) | Description |
---|---|
375,487.08 | LT functioning1 |
31,341.43 | QC sample collections2 |
39,043.74 | Characterization of samples2 |
197,425.20 | Personnel |
19,117.33 | Operational costs |
662,414.79 | Total costs 2014–2016 |
254.48 | Costs per lot3 |
Building a framework for RDT quality control
Type of resource | Resource | Access |
---|---|---|
Guidance | Post-market surveillance of in vitro diagnostics | |
SOP | Methods manual for laboratory quality control testing of malaria RDTs | |
SOP | Protocol on responding to problems with malaria RDTs | |
Guide | Troubleshooting guide for supervisors overseeing users of malaria RDTs | |
Form | User complaint form for reporting problems and/or adverse events related to diagnostic products | |
Ref material | Plasmodium falciparum antigens (1st International Standard) | |
Ref material | Plasmodium falciparum culture-derived panels | https://www.zeptometrix.com/categories/assay-developers/microorganisms filtered by “malaria” |
Ref material | Plasmodium falciparum and P. vivax recombinant antigens (HRP2, pLDH, aldolase) | |
Training material | Training manuals, job aids, results guides, quizzes and answer keys: available as generic versions for P. falciparum-only, Pf-pan and pan-Pf RDTs, and as RDT product-specific versions. |