Eiken Chemical Co., Ltd. · TSE:4549
Eiken Chemical — Technical Presentation (October 2023)
17 slides from Eiken Chemical's technical presentation, October 2023
Slide 1: Malaria-LAMP: A Highly Sensitive Molecular Diagnostic Method for Detecting Plasmodium DNA
Malaria-LAMP: A Highly Sensitive Molecular Diagnostic Method for Detecting Plasmodium DNA Akane Kyotani*, Yasuyoshi Mori*, Shigeyuki Kano** Sales Manager *Eiken Chemical Co., Ltd., 4-19-9 Taito, Taito-ku, Tokyo, Japan **National Center for Global Health and Medicine, 1-21-1 Toyama Shinjuku-ku, Tokyo
Slide 2: Outline
Outline ➢ Background - World Malaria Situation - Malaria Overview - How to Diagnose Malaria ➢ Novel DNA Detection Kit for Malaria ‘Malaria-LAMP’ ➢ Evaluation Studies with ‘Malaria-LAMP’ - Case1 Haiti - Case2 Thailand ➢ Conclusion and Discussion LAMP-086-002 2023年10月作成
Slide 3: Background: World Malaria Situation
Background World Malaria Situation In 2021, nearly half of the world's population was at risk of malaria. There were an estimated 247 million cases of malaria worldwide. The estimated number of malaria deaths stood at 619,000 in 2021. WHO Malaria (who.int) Key facts LAMP-086-002 2023年10月作成
Slide 4: Background: World Malaria Situation
Background World Malaria Situation Malaria mostly spreads to people through the bites of infected female Anopheles mosquitoes. There are main 5 Plasmodium parasite species that cause malaria in humans 5 Plasmodium parasite species P. falciparum P. vivax P. malariae P. ovale P. knowlesi Left untreate
Slide 5: Background: How to Diagnose Malaria
Background How to Diagnose Malaria Conventional Malaria Diagnostic Methods Strong Points Weak Points ✓ Rapid ✓ Low sensitivity Rapid Diagnostic Test ✓ Easy to Use ✓ Results depend on operators ✓ Affordable ✓ Difference of quality among test devices ✓ Rapid ✓ Low sensitivity Microscopy ✓ Easy to Use
Slide 6: Background: How to Diagnose Malaria
Background How to Diagnose Malaria It is well known that there exist a large population of asymptomatic patients with low parasite density, so they cannot be detected by microscopy or RDT. High Symptomatic RDT, Microscopy Parasite density Asymptomatic NAAT (e.g. PCR, LAMP) Low LAMP-086-002 2023年10月作
Slide 7: Novel DNA Detection Kit for Malaria 'Malaria-LAMP'
Novel DNA Detection Kit for Malaria ‘Malaria-LAMP’ Conventional malaria diagnosis methods Strong Points Weak Points ✓ Rapid ✓ Low sensitivity Rapid Diagnostic Test ✓ Easy to Use ✓ Results depend on operators ✓ Affordable ✓ Large differences among reagent manufacturers ✓ Rapid ✓ Low sensitivity Micro
Slide 8: Novel DNA Detection Kit for Malaria 'Malaria-LAMP'
Novel DNA Detection Kit for Malaria ‘Malaria-LAMP’ Malaria-LAMP is the Novel Solution for Malaria Elimination. What ‘s good about Malaria-LAMP? • Sensitivity Malaria-LAMP is more sensitive than microscopy and RDT ◀ Instrument • Specificity Pan Malaria-LAMP: 5 Plasmodium parasite species detection Pf
Slide 9: Malaria-LAMP Specification
Novel DNA Detection Kit for Malaria ‘Malaria-LAMP’ Malaria-LAMP Specification LAMP Test Kit Extraction PURE Store at 2-30 ºC (Room Temperature) Shelf life 18 months Regulation IVDR (Class C) Instrument and Solar Panel Maintenance Free Life expectancy 5 years Regulation IVDR (Class A) Target Resource
Slide 10: How to use 'Malaria-LAMP'
Novel DNA Detection Kit for Malaria ‘Malaria-LAMP’ How to use ‘Malaria-LAMP’ Step1. Sample Transfer and Lysis Step2. PURE DNA Extraction Step3. Loop-mediated isothermal amplification Step4. Result Reading LAMP-086-002 2023年10月作成
Slide 11: Evaluation Studies: Case 1 Haiti
Evaluation Studies of ‘Malaria-LAMP’ Case1 Haiti Performance of the procedure for ultra-rapid extraction and loop-mediated isothermal amplification (PURE-LAMP) methods to detect malaria in Haiti Target 902 febrile people and 172 afebrile people Division Nippes, Sud and Grand’Anse in Haiti Study peri
Slide 12: Evaluation Studies of 'Malaria-LAMP'
Evaluation Studies of ‘Malaria-LAMP’ Performance of PURE-LAMP, RDT and microscopy against nested PCR as reference Malaria-LAMP showed the high performance to detection Plasmodium. This study recommends Malaria-LAMP’s use in targeted mass screening and treatment activities in low endemic areas of mal
Slide 13: Evaluation Studies: Case 2 Thailand
Evaluation Studies of ‘Malaria-LAMP’ Case2 Thailand Evaluation of Malaria Detection Function Leveraging New Products in Thailand Unpublished data of NCGM (Principal Investigator: Professor Shigeyuki Kano, MD., Ph.D.) Target 3,315 Asymptomatic malaria-infected patients Division the malaria endemic ar
Slide 14: Evaluation Studies of 'Malaria-LAMP'
Evaluation Studies of ‘Malaria-LAMP’ Usual Diagnosis Index Case Finding Symptomatic patient Malaria positive patient Malaria LAMP Malaria Elimination and Reemergence Prevention Campaigns LAMP-086-002 2023年10月作成
Slide 15: Comparison between Pan Malaria LAMP and Microscopy Test
Evaluation Studies of ‘Malaria-LAMP’ Comparison between Pan Malaria LAMP and Microscopy Test Microscopy Accuracy 98.76% Total Positive Negative Sensitivity 100.00% Pan Positive 13 41 54 Specificity 98.76% Malaria-LAMP Negative 0 3261 3261 PPV 24.07% Total 13 3302 3315 NPV 100.00% Pan Malaria-LAMP te
Slide 16: Conclusion and Discussion
Conclusion and Discussion ✓ Malaria elimination requires highly sensitive tests to detect asymptomatic parasite carriers. ✓ Malaria-LAMP is a novel molecular test that enables highly sensitive test easier, faster and more robust. ✓ Two different studies have shown that Malaria-LAMP test is highly se
Slide 17: Thank you very much for your attention!!
Thank you very much for your attention!!
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