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Methods Manual for Product Testing of Malaria Rapid Diagnostic Tests

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Methods Manual for Product Testing of Malaria Rapid Diagnostic Tests METHODS MANUAL FOR PRODUCT TESTING OF MALARIA RAPID DIAGNOSTIC TESTS Manual of Standard Operating Procedures for Assessment of Malaria Rapid Diagnostic Tests within the Product Testing Programme of the World Health Organization At the US Centers for Disease Control and Prevention, Atlanta Version Seven 2018 For internal use Foundation for Innovative New Diagnostics (FIND) Geneva, Switzerland WHO Global Malaria Programme (GMP) Geneva, Switzerland National Center for Global Health, Division of Malaria and Parasitic Diseases, United States Centers for Disease Control and Prevention (CDC), Atlanta, USA WHO-FIND-CDC Malaria RDT Product Testing Methods Manual (Version 7) – 2018 Acknowledgements This manual was developed from the recommendations of WHO informal consultations on malaria rapid diagnostic test quality assurance in Manila 2003 & 2004, Geneva 2006, Kisumu 2006, Atlanta 2006, Philadelphia 2007 1 , subsequent meetings of the WHO-FIND malaria RDT evaluation programme steering committee, and the WHO Methods Manual for Laboratory Control Testing of Malaria Rapid Diagnostic Tests, with which it is designed to be used. Version One of this manual was compiled by WHO-Regional Office for the Western Pacific, WHO-Special Programme for Research and Training in Tropical Diseases (TDR), the Foundation for Innovative New Diagnostics (FIND), US Centers for Disease Control and Prevention (CDC), Australian Army Malaria Institute (AMI), Research Institute for Tropical Medicine (Philippines), Hospital for Tropical Disease UK (HTD), and the Kenya Medical Research Institute. Version Two modifications by FIND, in consultation with WHO/TDR Version Three modifications by FIND, WHO/TDR, WHO/GMP and US CDC Version Four modifications by HTD, CDC, WHO/TDR and FIND Version Five modifications by FIND and CDC Version Six modifications by FIND, WHO/GMP, CDC, HTD Version Seven modifications by FIND, WHO/GMP, CDC, HTD SOPs in Chapter 4 are included courtesy of CDC; SOPs in Chapter 5 are included courtesy of CDC, AMI and HTD. The project has received funding from multiple sources, predominantly The Bill & Melinda Gates Foundation (until 2012), the Global Fund to fight AIDs, Tuberculosis and Malaria, the Australian Agency for International Development, and since 2013 predominantly from Unitaid. Address for Correspondence [email protected] or Jane Cunningham Sandra Incardona Global Malaria Programme Foundation for Innovative New World Health Organization Diagnostics (FIND) Avenue Appia 20 Campus Biotech9 chemin des 1211 Geneva 27 Mines Switzerland 1202 Geneva [email protected] Switzerland mailto:[email protected] 1 Malaria rapid diagnosis: making it work. Meeting report 20–23 January 2003. Manila: World Health Organization; 2003; Towards quality testing of malaria rapid diagnostic tests: evidence and methods. Manila: World Health Organization; 2006. 2 WHO-FIND-CDC Malaria RDT Product Testing Methods Manual (Version 7) – 2018 MALARIA RDT PRODUCT TESTING METHODS MANUAL TABLE OF CONTENTS CHAPTER 1: INTRODUCTION .................................................................................................... 5 1.1 LIST OF ABBREVIATIONS ........................................................................................................... 7 1.2 OBJECTIVES AND SCOPE OF THIS METHODS MANUAL ................................................................ 8 1.3 INTRODUCTION ........................................................................................................................ 9 1.4 SPECIMEN BANK TERMS OF REFERENCE................................................................................. 10 1.5 WHO-FIND RDT EVALUATION PROGRAMME STEERING COMMITTEE ....................................... 12 1.6 OUTLINE OF PRODUCT TESTING PROTOCOL ............................................................................ 14 1.7 RDT PRODUCT TESTING FLOW CHART EXPANDED .................................................................. 15 1.8 SELECTION OF EVALUATION (CHALLENGE) PANEL ................................................................... 16 1.9 NOTING AND VARYING PROCEDURES IN THIS MANUAL ............................................................. 18 CHAPTER 2: PRODUCT TESTING ........................................................................................... 20 SOP 2.1 RDT REGISTER ............................................................................................................. 22 SOP 2.2 RULES FOR EVALUATING RDTS ..................................................................................... 23 SOP 2.2A EVALUATING PERFORMANCE AGAINST THE CHALLENGE PANEL (PANEL DETECTION SCORE/FALSE POSITIVE RATE) ........................................................................................ 27 SOP 2.2B RDT TEMPERATURE STABILITY ASSESSMENT ................................................................ 32 SOP 2.2C EASE OF USE DESCRIPTION .......................................................................................... 36 SOP 2.2D ASSESSMENT OF RDT PRODUCT LABELLING .................................................................. 38 SOP 2.2E ASSESSMENT OF INSTRUCTIONS FOR USE ...................................................................... 39 SOP 2.2F STABILITY ASSESSMENT AT MANUFACTURING SITE ......................................................... 40 SOP 2.3 PERFORMING A RAPID DIAGNOSTIC TEST (RDT) ............................................................. 44 SOP 2.4 RESULT COMMUNICATION PATHWAY .............................................................................. 46 SOP 2.5 PROPER STORAGE OF RDTS ......................................................................................... 48 SOP 2.6 RDT INTERPRETATION STANDARDIZATION ...................................................................... 50 CHAPTER 3: PANEL ................................................................................................................. 52 SOP 3.1 RECEIPT AND STORAGE OF PANEL SAMPLES .................................................................. 54 SOP 3.2 PANEL SAMPLE CHARACTERIZATION .............................................................................. 56 SOP 3.3 USE OF PANEL SAMPLES ............................................................................................... 58 SOP 3.4 PACKAGING OF QUALITY CONTROL SAMPLES FOR TRANSPORT ....................................... 59 SOP 3.5 DOCUMENTATION OF TRANSPORTED PANEL SAMPLES .................................................... 66 SOP 3.6 COORDINATION OF TRANSPORT OF PANEL SAMPLES ....................................................... 70 SOP 3.7 PREPARATION OF PANEL SAMPLES FROM CULTURED PARASITES .................................... 72 SOP 3.8 LABELLING OF BANK (PANEL) SAMPLES .......................................................................... 75 CHAPTER 4: CDC MALARIA CULTURE PROCEDURE ......................................................... 78 SOP 4.1 PREPARATION OF REAGENTS AND MEDIA FOR CULTURE OF MALARIA PARASITES .......... 80 SOP 4.2 THAWING AND INOCULATION OF GLYCEROLYTE-CRYOPRESERVED PARASITES ................. 83 SOP 4.3 DAILY MAINTENANCE OF MALARIA PARASITE CULTURES ................................................. 86 SOP 4.4 INOCULATION OF NEW MALARIA CULTURE FLASKS .......................................................... 89 SOP 4.5 MALARIA MICROSCOPY: BLOOD FILM PREPARATION, STAINING AND READING .................. 93 SOP 4.6 SYNCHRONIZATION METHODS FOR PLASMODIUM SPECIES .............................................. 94 SOP 4.7 FREEZING PARASITES IN GLYCEROLYTE ......................................................................... 97 CHAPTER 5: SAMPLE CHARACTERIZATION ...................................................................... 100 SOP 5.1 CELLABS PTY HRP2 ELISA KIT PROCEDURE ............................................................... 102 SOP 5.2 QUALISA PLDH ELISA FOR MALARIA ANTIGEN IN BLOOD .............................................. 107 SOP 5.3 BIOTINYLATION OF MONOCLONAL ANTIBODIES FOR ALDOLASE ELISA PROCEDURE ........ 113 SOP 5.4 CDC ALDOLASE ELISA FOR MALARIA ANTIGEN IN BLOOD ............................................ 119 SOP 5.5 DILUTION PROTOCOL FOR RECOMBINANT PLDH, HRP2 REAGENTS AND BLOOD SAMPLES (ELISA) ...................................................................................................................... 126 SOP 5.6 PROTOCOL FOR RECORDING ELISA RESULTS .............................................................. 127 3 WHO-FIND-CDC Malaria RDT Product Testing Methods Manual (Version 7) – 2018 SOP 5.7 EXTRACTION OF GENOMIC DNA FROM WHOLE BLOOD USING QIAAMP PROTOCOL ........ 129 SOP 5.8 IDENTIFICATION OF PLASMODIUM SPECIES BY PCR ASSAY ............................................ 131 SOP 5.9 AMPLIFICATION AND SEQUENCING OF P. FALCIPARUM HISTIDINE-RICH PROTEIN 2 GENE PFHRP2 ..................................................................................................................... 135 CHAPTER 6: EQA .................................................................................................................... 140 SOP 6.1 EQUIPMENT TEMPERATURE MONITORING ..................................................................... 142 SOP 6.2 DOCUMENT CONTROL.................................................................................................. 143 SOP 6.3 DOCUMENT STORAGE .................................................................................................. 145 SOP 6.4 CORRECTIVE ACTION..................................................................................................
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