METHODS MANUAL FOR LABORATORY QUALITY CONTROL TESTING OF MALARIA RAPID DIAGNOSTIC TESTS Manual of standard operating procedures for: Laboratory-based quality control testing of malaria rapid diagnostic tests using stored dilutions of malaria parasites and Preparation of quality control samples from malaria parasite field collections. Version Seven June 2014 Foundation for Innovative New Diagnostics (FIND), Geneva, Switzerland. WHO Global Malaria Programme (GMP), Geneva, Switzerland For internal use only Document: Malaria RDT QC Methods Manual Subject: Introductory note Revision Date: July 2014 Section: INTRODUCTORY NOTE Version: 7 Page: 2 of 299 WHO Global Malaria Programme WORLD HEALTH ORGANIZATION ORGANISATION MONDIALE DE LA SANTE Methods Manual for Laboratory Quality Control Testing of Malaria RDTs Important introductory note This manual is intended for internal WHO and FIND use and for collaborating institutions of the WHO- FIND malaria RDT evaluation programme. Careful reference should be made to the notes under ‘Objectives and Scope of the Methods Manual’ when using this manual. The designations employed and the presentation of the material in this publication do not imply the expression of any opinion whatsoever on the part of the World Health Organization concerning the legal status of any country, territory, city or area or of its authorities, or concerning the delimitation of the frontiers or boundaries. The mention of specific companies or of certain manufacturers products does not imply that they are endorsed or recommended by the World Health Organization in preference to others of a similar nature that are not mentioned. Errors and omissions excepted, the names of proprietary products are distinguished by initial capital letters. The World Health Organization does not warrant that the information contained in this publication is complete and correct and shall not be liable for any damages incurred as a result of its use. The Foundation for Innovative New Diagnostics does not warrant that the information contained in this publication is complete and correct and shall not be liable for any damages incurred as a result of its use. Document: Malaria RDT QC Methods Manual Subject: Acknowledgements and address for correspondence Revision Date: July 2014 Section: ACKNOWLEDGEMENTS Version: 7 Page: 3 of 299 WHO Global Malaria Programme WORLD HEALTH ORGANIZATION ORGANISATION MONDIALE DE LA SANTE Acknowledgements This previous versions of this procedure manual were developed by WHO Regional Office for the Western Pacific, in collaboration with the Foundation for Innovative New Diagnostics (FIND), and the UNICEF / UNDP / World Bank / WHO Special Programme for Research and Training in Tropical Disease (TDR), in support of the WHO-FIND malaria RDT evaluation programme. The manual includes input from numerous sources, including research laboratories, manufacturers and developers of malaria rapid diagnostic tests and quality assurance specialists. Particular acknowledgement is due to the Parasitology Department of the Research Institute of Tropical Medicine (RITM), Muntinlupa, Philippines; University of Philippines; Department of Health, Republic of the Philippines; Institut Pasteur, Phnom Penh, Cambodia; the National Center for Parasitology, Entomology and Malaria Control, Cambodia, the Malaria Branch, Division of Parasitic Diseases, Centers for Disease Control and Prevention, Atlanta, USA; the Clinical Parasitology Department, Hospital for Tropical Disease, London, UK; the participants for the 2003, 2004, 2006, 2007, 2008 and 2009 WHO informal consultations on quality assurance of malaria rapid diagnostic tests; Rebecca Guy, Burnet Insititute, Australia; Ken Lilley, Army Malaria Institute, Australia; Katherine Grady, US CDC; Pernille Jorgensen, Berlin, Germany; Jennifer Luchavez, RITM, Philippines; and Wellington Oyibo, University of Lagos, Nigeria. Version 7 includes changes recommended by the WHO malaria specimen bank steering Committee consultations in London, 2011, Geneva, 2012 and in Phnom Penh, 2013. Address for correspondence Sandra Incardona FIND, Geneva, Switzerland [email protected] Jane Cunningham WHO, GMP, Geneva, Switzerland [email protected] Nora Champouillon FIND, Geneva, Switzerland [email protected] [email protected] Key to Procedure History revisions: AA – Audrey Albertini, Foundation for Innovative New Diagnostics (FIND), Geneva, Switzerland DB - David Bell, external consultant, Geneva, Switzerland CS – Charuni Senanayake, Malaria, Vectorborne and Other Parasitic Diseases, WHO-Regional Office for the Western Pacific, Philippines JB – John Barnwell, Centers for Disease Control and Prevention, Atlanta, USA JG – Jeffrey Glenn, Centers for Disease Control and Prevention, Atlanta, USA JL – Jennifer Luchavez, Research Institute of Tropical Medicine, Muntinlupa, Philippines KB - Katherine Bowers, Hospital for Tropical Diseases, London, UK KGL - Ken Lilley, Australian Army Malaria Institute, Brisbane, Australia NC – Nora Champouillon, Foundation for Innovative New Diagnostics (FIND), Geneva, Switzerland PLC - Peter Chiodini, Hospital for Tropical Diseases, London, UK PJ – Pernille Jorgensen, independent consultant, Berlin, Germany RG - Rebecca Guy, formerly MacFarlane Burnet Institute for Public Health and Medical Research, Melbourne, Australia RRC – Roxanne Rees-Channer, Hospital for Tropical Diseases, London, UK QC – Qin Cheng. Army Malaria Institute, Australia SI – Sandra Incardona, Foundation for Innovative New Diagnostics (FIND), Geneva, Switzerland WO – Wellington Oyibo, University of Lagos, Lagos, Nigeria Document: Malaria RDT QC Methods Manual Subject: Table of contents Revision Date: July 2014 Section: TABLE OF CONTENTS Version: 7 Page: 4 of 299 WHO Global Malaria Programme WORLD HEALTH ORGANIZATION ORGANISATION MONDIALE DE LA SANTE Methods Manual for Laboratory Quality Control Testing of Malaria RDTs TABLE OF CONTENTS CHAPTER 1: INTRODUCTION ........................................................................................................................... 7 1.01 LIST OF ABBREVIATIONS ........................................................................................................................ 8 1.02 OBJECTIVES AND SCOPE OF THIS METHODS MANUAL ........................................................................ 10 1.03 INTRODUCTION ..................................................................................................................................... 12 1.04 MAJOR CHANGES FROM VERSION 6 ..................................................................................................... 15 1.05 TERMS OF REFERENCE FOR MALARIA SPECIMEN COLLECTION AND RDT LOT QA TESTING SITES .... 16 1.06 LIST OF LABORATORIES INVOLVED IN LABORATORY QC TESTING OF MALARIA RDTS ..................... 18 1.07 NOTING AND VARYING PROCEDURES IN THIS MANUAL ..................................................................... 20 CHAPTER 2: RDT QUALITY CONTROL PROCEDURE ........................................................................... 21 SOP 2.01 Organization of the Lot Testing laboratory ............................................................................... 22 SOP 2.02 Receipt, storage and dispatch of Malaria RDTs ....................................................................... 27 SOP 2.03 RDT QC Communication pathway ............................................................................................ 30 SOP 2.04 Performing an RDT with QC sample aliquots .......................................................................... 34 SOP 2.05 RDT Lot Testing Procedure........................................................................................................ 36 SOP 2.06 RDT Laboratory External Quality Assurance Programme ...................................................... 52 SOP 2.06a RDT Laboratory EQA Programme – Use of Proficiency Testing Panels ................................ 56 SOP 2.06b RDT Laboratory EQA Programme – Production of Proficiency Testing Panels ................... 59 CHAPTER 3: RDT QC SAMPLE PREPARATION ........................................................................................ 63 PART 1: OVERVIEW, REQUIREMENTS AND PREPARATORY ACTIVITIES .............................................................. 64 SOP 3.01 Preparation of Quality Control Samples: Overview and requirements ................................... 65 SOP 3.02 Preparation of Quality Control Samples: Preparatory activities ............................................. 71 PART 2: PATIENT RECRUITMENT AND BLOOD SAMPLE COLLECTION IN THE FIELD ........................................... 74 SOP 3.03 Preparation of Quality Control Samples: Field collection procedure ..................................... 75 SOP 3.04 Transport and storage of RDTs in the field ............................................................................... 80 SOP 3.05 Finger-prick blood collection and preparation of malaria RDTs and blood films.................. 82 SOP 3.06 Venous blood collection and preparation of blood films .......................................................... 85 SOP 3.07 Preparation of blood spots on filter paper, using fresh finger-prick or venous blood ............ 87 PART 3: PREPARATION OF RDT QC SAMPLE DILUTIONS IN THE LABORATORY ................................................. 89 SOP 3.08 Preparation of Quality Control Samples: Dilution Procedure................................................. 90 SOP 3.09