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, Japan

LAMP-086-002 2023年10月作成

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

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

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. ovaleP. knowlesi

Left untreated, P. falciparum malaria can progress to severe illness and deathwithin 24 hours.
The first symptoms may be mild, similar to many febrile illnesses,
hence it is difficult to diagnose malaria definitively.

WHO Malaria (who.int)
LAMP-086-002 2023年10月作成

Background How to Diagnose Malaria
Conventional Malaria Diagnostic Methods

Strong Points

Weak Points

Rapid Diagnostic Test✓ Rapid✓ Easy to Use✓ Affordable✓ Low sensitivity✓ Results depend on operators✓ Difference of quality among
test devices

Microscopy✓ Rapid✓ Easy to Use✓ Affordable✓ Low sensitivity✓ Results depend on operators✓ High sensitivity✓ Fewer differences
between operators✓ Complex procedure✓ Highly demanding
operating environment✓ Expensive

Molecular Test

LAMP-086-002 2023年10月作成

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.
HighSymptomaticRDT, MicroscopyParasitedensity
AsymptomaticNAAT(e.g. PCR, LAMP)Low
LAMP-086-002 2023年10月作成

Correlation of Parasite Density, Symptom and Diagnostics

Novel DNA Detection Kit for Malaria ‘Malaria-LAMP’
Conventional malaria diagnosis methods

Strong Points

Weak Points

Rapid Diagnostic Test

✓ Rapid✓ Easy to Use✓ Affordable✓ Low sensitivity✓ Results depend on operators✓ Large differences among
reagent manufacturers

Microscopy✓ Rapid✓ Easy to Use✓ Affordable✓ Low sensitivity✓ Results depend on operators

Easier, faster and more robust!!
Molecular Test

✓ High sensitivity✓ Fewer differences
between operators✓ Complex procedure✓ Highly demanding
operating environment✓ Expensive
LAMP-086-002 2023年10月作成

Novel DNA Detection Kit for Malaria ‘Malaria-LAMP’
Malaria-LAMP is the Novel Solution for Malaria Elimination.

What ‘s good about Malaria-LAMP?
• Sensitivity◀ Instrument
Malaria-LAMP is more sensitive than microscopy and RDT• Specificity
Pan Malaria-LAMP: 5 Plasmodium parasite species detection
Pf Malaria-LAMP: Only P. falciparum detection
Pv Malaria-LAMP: Only P. vivax detection▲ Reagent• Easy3 Days Training• Fast70 Tests/day▲ Solar panel• Robust
Minimum Instrument → Implementation Solar panel & Battery system
LAMP-086-002 2023年10月作成

Novel DNA Detection Kit for Malaria ‘Malaria-LAMP’
Malaria-LAMP Specification
LAMP Test Kit
Extraction

PURE

Store at2-30 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)

TargetResource limited setting
LAMP-086-002 2023年10月作成

Novel DNA Detection Kit for Malaria ‘Malaria-LAMP’
How to use ‘Malaria-LAMP’
Step1. Sample Transfer and Lysis

Step3. Loop-mediated isothermal amplification

Step2. PURE DNA Extraction

Step4. Result Reading

LAMP-086-002 2023年10月作成

Evaluation Studies of ‘Malaria-LAMP’
Case1 Haiti
Performance of the procedure for ultra-rapid extraction and loop-mediatedisothermal amplification (PURE-LAMP) methods to detect malaria in Haiti
Target902 febrile people and 172 afebrile people

Division

Nippes, Sud and Grand’Anse in Haiti

Study period

Summer season (2017 and 2018)

MethodMicroscopy, RDT, Malaria-LAMP and nested PCRGold standard Nested PCR

Analysis

Sensitivity, specificity, positive and negative
predictive values and kappa statistics

Performance of the procedure for ultra-rapid extraction and loop-mediated isothermal amplification (PURE-LAMP) methods to detect malaria in Haiti (nih.gov)
LAMP-086-002 2023年10月作成

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 treatmentactivities in low endemic areas of malaria.
Performance of the procedure for ultra-rapid extraction and loop-mediated isothermal amplification (PURE-LAMP) methods to detect malaria in Haiti (nih.gov)
LAMP-086-002 2023年10月作成

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.)

Target3,315 Asymptomatic malaria-infected patients

Division

the malaria endemic areas and the service areas ofthe Faculty of Tropical Medicine

Study Period

December 2019 - February 2022

MethodMicroscopy, RDT, XN-31 (Sysmex Corporation),
Malaria-LAMP and Nested PCR

Analysis

Sensitivity, specificity, positive and negative
predictive values

LAMP-086-002 2023年10月作成

Evaluation Studies of ‘Malaria-LAMP’
Index Case Finding

Usual Diagnosis

Symptomatic patient

Malaria LAMP

Malaria positive patient

Malaria Elimination andReemergence Prevention
Campaigns
LAMP-086-002 2023年10月作成

Evaluation Studies of ‘Malaria-LAMP’Comparison between Pan Malaria LAMP and Microscopy Test
Microscopy
Total
Positive NegativePanMalaria-LAMP
Total

Positive
Negative

Accuracy
Sensitivity

98.76%
100.00%130413261

543261

Specificity
PPV

98.76%
24.07%

1333023315

NPV

100.00%

Pan Malaria-LAMP test shows higher sensitivity than the microscopic examination

LAMP-086-002 2023年10月作成

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 sensitive.

Malaria-LAMP is helpful for healthcare workers with limited experience in microscopic

examination, especially in the areas where malaria is being eliminated or where there
is no malaria, and for population screening for asymptomatic parasite carriers undermalaria elimination and reemergence prevention campaigns.
LAMP-086-002 2023年10月作成

Thank you very much for your attention!!