• Manufacturer Product Catalogue number Product Name Manufacturer Format Shelf life (months) Recommended storage temperature 1 IR016025 Advantage P.f. Malaria J.Mitra & Co. Pvt. Ltd Card 24 4-300c 2 RG19-11 Bionote Malaria P.f. Ag Rapid Test Kit Bionote Inc Casette ___ ___ 3 G0141 CareStart Malaria HRP2(Pf) Access Bio, Inc Casette 24 4-300C 4 G0181 CareStart Malaria HRP2/pLDH Pf Test Access Bio, Inc Casette 24 4-300C 5 VB01 Clearview Malaria P.f. Vision Biotech (Pty) Ltd Casette 24 4-400c 6 MAL-190020 Core Malaria P.f Core Diagnostics Casette ___ ___ 7 KMFD6007 diagnosticks- Malaria (Pf) SSA Diagnostics & Biotech Systems Dipstick 24 4-450c 8 I13FRC30 First Response Malaria Ag HRP2 Premier Medical Corporation Ltd Casette 24 4-400c 9 2100CB-25 FirstSign Malaria Pf Unimed International Inc - 24 4-400c 10 HR3023 HiSens Malaria Ag P.f. HRP2 HBI Co., Ltd Card ___ ___ Version-9 January 2014 According to Global Fund Quality Assurance Policy for Diagnostic Products (http://www.theglobalfund.org/en/procurement/policy ), in force since 1st March 2011, Grant Funds may only be used to procure Malaria RDTs if they have been: (1) recommended by WHO for use in malaria programs, based on a technical review of quality and performance indicators, OR (2) approved by authorities member of Global Harmonization Task Force (US, EU, Canada, Japan, Australia); the Global Fund may request expert advice to determine the acceptability for procurement of such malaria RDTs for use by Recipients. The list is an overview of malaria RDTs to assist Principal Recipients (PRs) of Global Fund grants to identify the status of Malaria RDTs according to the Global Fund Quality Assurance Policy. It includes products recommended for use after technical evaluation by WHO Malaria RDT Product Testing Programme (Round 1-4) and/or WHO Prequalification of Diagnostics Programme. It should be used together with the WHO Information Note on Recommended Selection Criteria for Procurement of Malaria Rapid Diagnostic Tests (http://www.who.int/malaria/diagnosis_treatment/diagnosis/RDT_selection_criteria.pdf )-20 Dec 2012. The list is not exhaustive; PRs can procure product(s) not listed below as long as PRs demonstrate that the product is compliant with one of the above mentioned requirements. The list is updated regularly based on evidence received by the Global Fund. LIST OF RAPID DIAGNOSTIC TEST (RDT) KITS FOR MALARIA classified according to the Global Fund Quality Assurance Policy For the detection of Plasmodium falciparum only (Pf) Products on bold followed by an * are subject to a WHO Notice of Concern. For the immediate future, the WHO Procurement Criteria (as specified above) for malaria RDTs remains unchanged and products meeting those criteria can be considered for procurement so long as systematic lot testing occurs, as specified in the Global Fund Quality Assurance Policy for diagnostic products, at the pre-shipment level using the WHO/FIND Lot Testing of Malaria Rapid Diagnostic Tests Programme and its recognized laboratories (http://www.wpro.who.int/sites/rdt/who_rdt_evaluation/lot_testing.htm). 1/4
  • Manufacturer Product Catalogue number Product Name Manufacturer Format Shelf life (months) Recommended storage temperature For the detection of Plasmodium falciparum only (Pf)11 ML01 ICT Diagnostics Malaria P.f. ICT Diagnostics Casette 24 4-400c 12 0519K25 Immunoquick Contact falciparum Biosynex Casette 24 2-300C 13 0502_K25. Immunoquick Malaria Falciparum Biosynex Dipstick ___ ___ 14 0502_K50. IMMUNOQUICK® Malaria Falciparum Biosynex, Strasbourg, France Dipstick ___ 15 0502_K100. IMMUNOQUICK® Malaria Falciparum Biosynex, Strasbourg, France Dipstick ___ 16 IMA-402 Malaria Plasmodium falciparum Rapid test Device (Whole Blood) Acon Laboratories, Inc Casette ___ ___ 17 MAT-PF-50 Maleriscan Malaria Pf Antigen test Bhat Bio-Tech India (Pte.) Ltd. Casette 24 2-30 0 C 18 RMAF10 NanoSign Malaria Pf Ag Bioland, Ltd Casette ___ ___ 19 522352 One Step Malaria P.F Test Blue Cross Bio-Medical (Beijing) Co., Ltd. Casette 24 4-300c 20 W37-C One Step Malaria P.f Test Guangzhou Wondfo Biotech Co.Ltd. Casette 24 4-300c 21 R0114C Onsite Pf Ag Rapid Test CTK Biotech, Inc Casette 18 2-30 0 c 22 30301025 Paracheck Pf Device-Rapid test for P.falciparum Malaria Ver.3 * Orchid Biomedical Systems Casette 24 4-45 0 c 23 55IC102-50 ParaHIT - f (Device) Span Diagnostics ltd Casette 24 4-40 0 c 24 55IC101-50 ParaHIT - f (Dipstick) Span Diagnostics ltd Dipstick 24 4-40 0 c 23 05FK90 SD Bioline Malaria Ag Pf (HRP2 / pLDH) Standard Diagnostics, Inc Casette 24 1-40 0 c 24 05FK50. SD Bioline Malaria Ag Pf Standard Diagnostics, Inc Casette 24 1-40 0 c 25 05FK53. SD BIOLINE Malaria Ag P.f Standard Diagnostics, Inc., Giheung-ku, Republic of Korea 26 A03-11-322 TrustyTM Malaria Antigen P.f. test Artron Laboratories Inc. Casette, 1T/kit 18 2-350c 1 RG19-08 Bionote Malaria P.f.& Pan Ag Rapid Test Kit Bionote Inc Casette ___ ___ 2 GO121 CareStart Malaria pLDH 3 Line Test Access Bio, Inc Casette ___ ___ 3 G0131 CareStart Malaria HRP2 / pLDH (Pf/PAN) COMBO Access Bio, Inc Casette 24 4-300c 4 GO231 CareStart Malaria Screen Access Bio, Inc Casette 24 4-300c For the detection of Pf and all Plasmodium species (Pf and Pan) 2/4
  • Manufacturer Product Catalogue number Product Name Manufacturer Format Shelf life (months) Recommended storage temperature For the detection of Plasmodium falciparum only (Pf)5 GO221 CareStart Malaria/Pregnancy Combo (pLDH / HRP2 / HCG) Access Bio, Inc Casette 24 4-300c 6 I16FRC30 First Response Malaria pLDH/ HRP2 Combo Test Premier Medical Corporation Ltd Casette 24 4-300c 7 HR2923 HiSens Malaria Ag P.f./P.v. (HRP2/pLDH) HBI Co., Ltd Card ___ ___ 8 RMAP10 NanoSign Malaria Pf/Pan Ag Bioland, Ltd Casette 2-300c 9 55IC204-10 ParaHIT - Total Ver. 1.0 (Device) Span Diagnostics Ltd. Casette 24 4-400c 10 05FK60. SD Bioline Malaria Ag Pf/Pan Standard Diagnostics, Inc Casette 24 1-400c 11 05FK63. SD Bioline Malaria Ag Pf/Pan Standard Diagnostics, Inc Casette 24 1-400c 12 05FK66. SD BIOLINE Malaria Ag Pf/ Pan Standard Diagnostics Inc. - 24 1-400c 1 RG19-12 Bionote MalariaA P.f.& P.v Ag Rapid Test Kit Bionote Inc Casette 2 G0161 CareStart Malaria HRP2/PLDH (Pf/Pv) COMBO Access Bio, Inc Casette 24 2-400c 3 G0171 CareStart Malaria HRP2/PLDH (Pf/VOM) COMBO Access Bio, Inc Casette 24 2-400c 4 50300025 Falcivax Rapid Test for Malaria Pv/Pf (device) Zephyr Biomedicals Casette 24 4-300c 5 HR3123 HiSens Malaria Ag P.f/P.v Combo card HBI Co., Ltd. Casette 24 2-300c 6 HR3323 HiSens Malaria Ag P.f/VOM Combo card HBI Co., Ltd. Casette 24 2-300c 7 AMFV-7025 Humasis Malaria P.f/P.v Antigen Test Humasis, Co., Ltd. Casette 24 1-300c 8 M161 Medisensor Malaria HRP2/pLDH Pf/Pv) COMBO Medisensor, Inc. Casette 24 2-400c 9 M171 Medisensor Malaria HRP2/pLDH (Pf/VOM) COMBO Medisensor, Inc. Casette 24 2-400c 10 R0112C OnSite Malaria Pf/Pv Ag Rapid Test CTK Biotech, Inc. Casette 18 2-300c 11 G0161 ParaCare Malaria HRP2/pLDH (Pf/Pv) COMBO Access Bio Ethiopia Casette 24 2-400c 12 G0171 ParaCare Malaria HRP2/pLDH (Pf/VOM) COMBO Access Bio Ethiopia Casette 24 2-400c 13 MAL-PFVCAS/25(100) RAPID 1-2-3® HEMA CASSETTE MALARIA PF/PV TEST Hema Diagnostic Systems, LLC Casette 18 4-300c 14 05FK100 SD BIOLINE Malaria Ag Pf/ Pf/ Pv Standard Diagnostics Inc. Casette 24 1-400c For the detection of Plasmodiumfalciparum and vivax ( Pf and Pv) 3/4
  • Manufacturer Product Catalogue number Product Name Manufacturer Format Shelf life (months) Recommended storage temperature For the detection of Plasmodium falciparum only (Pf)15 05FK80 SD Bioline Malaria Ag Pf/Pv Standard Diagnostics, Inc Casette 24 1-400c 16 05FK83 SD Bioline Malaria Ag Pf/Pv Standard Diagnostics, Inc Casette 24 1-400c 1 G0111 CareStart TM Malaria pLDH (PAN) Access Bio, Inc Casette 24 4-300c 1 05FK70 SD Bioline Malaria Ag Pv Standard Diagnostics, Inc Cassete 24 1-400c WHO Notices of Concerns: WHO Notice of Concern related to Tulip Group , 20 July 2012 for 2 manufacturing site in India . :Tulip Group, Inc., Qualpro Diagnostics/Orchid Biomedical Systems: 88/99 Phase II, C, Verna Industrial Estate, Verna, Goa 403722, India; and Zephyr Biomedicals: Plot Nos.M46-47, Phase 111B, Verna Industrial Estate, Goa 403722, India. Disclaimer:The Global Fund does not endorse or warrant the fitness of any product on the List for a particular purpose. In addition, the Global Fund assumes no responsibility for any misstatement or omission from the list and directs Principal Recipients of Global Fund grants to conduct their own independent confirmation that the information on a given product on the list is accurate before relying on it to make a purchase order for that product, and to ensure that any purchase is in compliance with all the requirements of the Global Fund’s quality assurance policy. The Global Fund does not warrant or represent that the products listed have obtained regulatory approval for use in any particular country of the world, or that their use is otherwise in accordance with the national laws and regulations of any country, including, but not limited to, intellectual property laws. The Global Fund disclaims any and all liability and responsibility for any injury, death, damage or loss of any kind whatsoever that may arise as a result of, or in connection with the procurement, distribution and use of any product included in the list. .Updated with the WHO PQ list 29 August 2013 and Performance of malaria RDTs in Rounds 1-4 of WHO Malaria RDT Product Testing Programme-Selection Criteria table-Dec 2012 For the detection of all Plasmodium species (Pan) For the detection of Plasmodium vivax only (Pv) 4/4
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PSM QADiagnostics Malaria List

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  • Manufacturer Product Catalogue number Product Name Manufacturer Format Shelf life (months) Recommended storage temperature 1 IR016025 Advantage P.f. Malaria J.Mitra & Co. Pvt. Ltd Card 24 4-300c 2 RG19-11 Bionote Malaria P.f. Ag Rapid Test Kit Bionote Inc Casette ___ ___ 3 G0141 CareStart Malaria HRP2(Pf) Access Bio, Inc Casette 24 4-300C 4 G0181 CareStart Malaria HRP2/pLDH Pf Test Access Bio, Inc Casette 24 4-300C 5 VB01 Clearview Malaria P.f. Vision Biotech (Pty) Ltd Casette 24 4-400c 6 MAL-190020 Core Malaria P.f Core Diagnostics Casette ___ ___ 7 KMFD6007 diagnosticks- Malaria (Pf) SSA Diagnostics & Biotech Systems Dipstick 24 4-450c 8 I13FRC30 First Response Malaria Ag HRP2 Premier Medical Corporation Ltd Casette 24 4-400c 9 2100CB-25 FirstSign Malaria Pf Unimed International Inc - 24 4-400c 10 HR3023 HiSens Malaria Ag P.f. HRP2 HBI Co., Ltd Card ___ ___ Version-9 January 2014 According to Global Fund Quality Assurance Policy for Diagnostic Products (http://www.theglobalfund.org/en/procurement/policy ), in force since 1st March 2011, Grant Funds may only be used to procure Malaria RDTs if they have been: (1) recommended by WHO for use in malaria programs, based on a technical review of quality and performance indicators, OR (2) approved by authorities member of Global Harmonization Task Force (US, EU, Canada, Japan, Australia); the Global Fund may request expert advice to determine the acceptability for procurement of such malaria RDTs for use by Recipients. The list is an overview of malaria RDTs to assist Principal Recipients (PRs) of Global Fund grants to identify the status of Malaria RDTs according to the Global Fund Quality Assurance Policy. It includes products recommended for use after technical evaluation by WHO Malaria RDT Product Testing Programme (Round 1-4) and/or WHO Prequalification of Diagnostics Programme. It should be used together with the WHO Information Note on Recommended Selection Criteria for Procurement of Malaria Rapid Diagnostic Tests (http://www.who.int/malaria/diagnosis_treatment/diagnosis/RDT_selection_criteria.pdf )-20 Dec 2012. The list is not exhaustive; PRs can procure product(s) not listed below as long as PRs demonstrate that the product is compliant with one of the above mentioned requirements. The list is updated regularly based on evidence received by the Global Fund. LIST OF RAPID DIAGNOSTIC TEST (RDT) KITS FOR MALARIA classified according to the Global Fund Quality Assurance Policy For the detection of Plasmodium falciparum only (Pf) Products on bold followed by an * are subject to a WHO Notice of Concern. For the immediate future, the WHO Procurement Criteria (as specified above) for malaria RDTs remains unchanged and products meeting those criteria can be considered for procurement so long as systematic lot testing occurs, as specified in the Global Fund Quality Assurance Policy for diagnostic products, at the pre-shipment level using the WHO/FIND Lot Testing of Malaria Rapid Diagnostic Tests Programme and its recognized laboratories (http://www.wpro.who.int/sites/rdt/who_rdt_evaluation/lot_testing.htm). 1/4
  • Manufacturer Product Catalogue number Product Name Manufacturer Format Shelf life (months) Recommended storage temperature For the detection of Plasmodium falciparum only (Pf)11 ML01 ICT Diagnostics Malaria P.f. ICT Diagnostics Casette 24 4-400c 12 0519K25 Immunoquick Contact falciparum Biosynex Casette 24 2-300C 13 0502_K25. Immunoquick Malaria Falciparum Biosynex Dipstick ___ ___ 14 0502_K50. IMMUNOQUICK® Malaria Falciparum Biosynex, Strasbourg, France Dipstick ___ 15 0502_K100. IMMUNOQUICK® Malaria Falciparum Biosynex, Strasbourg, France Dipstick ___ 16 IMA-402 Malaria Plasmodium falciparum Rapid test Device (Whole Blood) Acon Laboratories, Inc Casette ___ ___ 17 MAT-PF-50 Maleriscan Malaria Pf Antigen test Bhat Bio-Tech India (Pte.) Ltd. Casette 24 2-30 0 C 18 RMAF10 NanoSign Malaria Pf Ag Bioland, Ltd Casette ___ ___ 19 522352 One Step Malaria P.F Test Blue Cross Bio-Medical (Beijing) Co., Ltd. Casette 24 4-300c 20 W37-C One Step Malaria P.f Test Guangzhou Wondfo Biotech Co.Ltd. Casette 24 4-300c 21 R0114C Onsite Pf Ag Rapid Test CTK Biotech, Inc Casette 18 2-30 0 c 22 30301025 Paracheck Pf Device-Rapid test for P.falciparum Malaria Ver.3 * Orchid Biomedical Systems Casette 24 4-45 0 c 23 55IC102-50 ParaHIT - f (Device) Span Diagnostics ltd Casette 24 4-40 0 c 24 55IC101-50 ParaHIT - f (Dipstick) Span Diagnostics ltd Dipstick 24 4-40 0 c 23 05FK90 SD Bioline Malaria Ag Pf (HRP2 / pLDH) Standard Diagnostics, Inc Casette 24 1-40 0 c 24 05FK50. SD Bioline Malaria Ag Pf Standard Diagnostics, Inc Casette 24 1-40 0 c 25 05FK53. SD BIOLINE Malaria Ag P.f Standard Diagnostics, Inc., Giheung-ku, Republic of Korea 26 A03-11-322 TrustyTM Malaria Antigen P.f. test Artron Laboratories Inc. Casette, 1T/kit 18 2-350c 1 RG19-08 Bionote Malaria P.f.& Pan Ag Rapid Test Kit Bionote Inc Casette ___ ___ 2 GO121 CareStart Malaria pLDH 3 Line Test Access Bio, Inc Casette ___ ___ 3 G0131 CareStart Malaria HRP2 / pLDH (Pf/PAN) COMBO Access Bio, Inc Casette 24 4-300c 4 GO231 CareStart Malaria Screen Access Bio, Inc Casette 24 4-300c For the detection of Pf and all Plasmodium species (Pf and Pan) 2/4
  • Manufacturer Product Catalogue number Product Name Manufacturer Format Shelf life (months) Recommended storage temperature For the detection of Plasmodium falciparum only (Pf)5 GO221 CareStart Malaria/Pregnancy Combo (pLDH / HRP2 / HCG) Access Bio, Inc Casette 24 4-300c 6 I16FRC30 First Response Malaria pLDH/ HRP2 Combo Test Premier Medical Corporation Ltd Casette 24 4-300c 7 HR2923 HiSens Malaria Ag P.f./P.v. (HRP2/pLDH) HBI Co., Ltd Card ___ ___ 8 RMAP10 NanoSign Malaria Pf/Pan Ag Bioland, Ltd Casette 2-300c 9 55IC204-10 ParaHIT - Total Ver. 1.0 (Device) Span Diagnostics Ltd. Casette 24 4-400c 10 05FK60. SD Bioline Malaria Ag Pf/Pan Standard Diagnostics, Inc Casette 24 1-400c 11 05FK63. SD Bioline Malaria Ag Pf/Pan Standard Diagnostics, Inc Casette 24 1-400c 12 05FK66. SD BIOLINE Malaria Ag Pf/ Pan Standard Diagnostics Inc. - 24 1-400c 1 RG19-12 Bionote MalariaA P.f.& P.v Ag Rapid Test Kit Bionote Inc Casette 2 G0161 CareStart Malaria HRP2/PLDH (Pf/Pv) COMBO Access Bio, Inc Casette 24 2-400c 3 G0171 CareStart Malaria HRP2/PLDH (Pf/VOM) COMBO Access Bio, Inc Casette 24 2-400c 4 50300025 Falcivax Rapid Test for Malaria Pv/Pf (device) Zephyr Biomedicals Casette 24 4-300c 5 HR3123 HiSens Malaria Ag P.f/P.v Combo card HBI Co., Ltd. Casette 24 2-300c 6 HR3323 HiSens Malaria Ag P.f/VOM Combo card HBI Co., Ltd. Casette 24 2-300c 7 AMFV-7025 Humasis Malaria P.f/P.v Antigen Test Humasis, Co., Ltd. Casette 24 1-300c 8 M161 Medisensor Malaria HRP2/pLDH Pf/Pv) COMBO Medisensor, Inc. Casette 24 2-400c 9 M171 Medisensor Malaria HRP2/pLDH (Pf/VOM) COMBO Medisensor, Inc. Casette 24 2-400c 10 R0112C OnSite Malaria Pf/Pv Ag Rapid Test CTK Biotech, Inc. Casette 18 2-300c 11 G0161 ParaCare Malaria HRP2/pLDH (Pf/Pv) COMBO Access Bio Ethiopia Casette 24 2-400c 12 G0171 ParaCare Malaria HRP2/pLDH (Pf/VOM) COMBO Access Bio Ethiopia Casette 24 2-400c 13 MAL-PFVCAS/25(100) RAPID 1-2-3® HEMA CASSETTE MALARIA PF/PV TEST Hema Diagnostic Systems, LLC Casette 18 4-300c 14 05FK100 SD BIOLINE Malaria Ag Pf/ Pf/ Pv Standard Diagnostics Inc. Casette 24 1-400c For the detection of Plasmodiumfalciparum and vivax ( Pf and Pv) 3/4
  • Manufacturer Product Catalogue number Product Name Manufacturer Format Shelf life (months) Recommended storage temperature For the detection of Plasmodium falciparum only (Pf)15 05FK80 SD Bioline Malaria Ag Pf/Pv Standard Diagnostics, Inc Casette 24 1-400c 16 05FK83 SD Bioline Malaria Ag Pf/Pv Standard Diagnostics, Inc Casette 24 1-400c 1 G0111 CareStart TM Malaria pLDH (PAN) Access Bio, Inc Casette 24 4-300c 1 05FK70 SD Bioline Malaria Ag Pv Standard Diagnostics, Inc Cassete 24 1-400c WHO Notices of Concerns: WHO Notice of Concern related to Tulip Group , 20 July 2012 for 2 manufacturing site in India . :Tulip Group, Inc., Qualpro Diagnostics/Orchid Biomedical Systems: 88/99 Phase II, C, Verna Industrial Estate, Verna, Goa 403722, India; and Zephyr Biomedicals: Plot Nos.M46-47, Phase 111B, Verna Industrial Estate, Goa 403722, India. Disclaimer:The Global Fund does not endorse or warrant the fitness of any product on the List for a particular purpose. In addition, the Global Fund assumes no responsibility for any misstatement or omission from the list and directs Principal Recipients of Global Fund grants to conduct their own independent confirmation that the information on a given product on the list is accurate before relying on it to make a purchase order for that product, and to ensure that any purchase is in compliance with all the requirements of the Global Fund’s quality assurance policy. The Global Fund does not warrant or represent that the products listed have obtained regulatory approval for use in any particular country of the world, or that their use is otherwise in accordance with the national laws and regulations of any country, including, but not limited to, intellectual property laws. The Global Fund disclaims any and all liability and responsibility for any injury, death, damage or loss of any kind whatsoever that may arise as a result of, or in connection with the procurement, distribution and use of any product included in the list. .Updated with the WHO PQ list 29 August 2013 and Performance of malaria RDTs in Rounds 1-4 of WHO Malaria RDT Product Testing Programme-Selection Criteria table-Dec 2012 For the detection of all Plasmodium species (Pan) For the detection of Plasmodium vivax only (Pv) 4/4
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