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Table 3 List of available resource to support the PMS and correct use of malaria RDTs

From: Keep the quality high: the benefits of lot testing for the quality control of malaria rapid diagnostic tests

Type of resource

Resource

Access

Guidance

Post-market surveillance of in vitro diagnostics

https://apps.who.int/iris/bitstream/handle/10665/255576/9789241509213-eng.pdf;jsessionid = E93138DC88FDD4ABD2D215B6406002AB?sequence = 1

SOP

Methods manual for laboratory quality control testing of malaria RDTs

https://www.who.int/malaria/publications/rdt-lab-quality-manual/en/

SOP

Protocol on responding to problems with malaria RDTs

https://www.finddx.org/wp-content/uploads/2016/10/Malaria-RDT-protocol-24JUN16-FINAL.pdf

Guide

Troubleshooting guide for supervisors overseeing users of malaria RDTs

https://www.finddx.org/wp-content/uploads/2016/10/RDT-supervisors-guide-2016.pdf

Form

User complaint form for reporting problems and/or adverse events related to diagnostic products

http://www.who.int/diagnostics_laboratory/procurement/111121_user_complaint_form_for_adverse_events_and_product_problems_reporting_english.pdf?ua=1

Ref material

Plasmodium falciparum antigens (1st International Standard)

https://www.nibsc.org/products/brm_product_catalogue/detail_page.aspx?catid=16/376

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)

https://www.microcoat.de/Products/malaria-reference-materials-p-falciparum-hrp-2-recombinant/

https://spandiag.com/recombinant-antigens-for-diagnostics/

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.

https://www.finddx.org/reports-and-landscapes/guides-manuals-implementation-tools-for-malaria-rdts/

https://www.who.int/malaria/areas/diagnosis/rapid-diagnostic-tests/job-aids/en/

  1. SOP Standard Operating Procedure, Ref material Reference material