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Molecular Test for Malaria
The Current Situation of Malaria
Malaria is a disease transmitted by the bite of an Anopheles mosquito carrying the malaria parasite. Symptoms such as fever, chills, headache, vomiting, joint pain, and muscle pain typically occur after an incubation period of approximately 1 to 4 weeks. There are main 5 Plasmodium parasite species that cause malaria in humans: P. falciparum, P. vivax, P. malariae, P. ovale, and P. knowlesi (a type of monkey malaria). Among these, P. falciparum is the most severe and can often lead to death if not treated within 24 hours of onset.
Globally, it is estimated that 249 million malaria cases occurred in 85 countries, resulting in 608,000 deaths. Of these, 94% of cases and 95% of deaths occurred in Africa [1].
The world has set a goal of zero malaria by 2030 (SDG 3.3). However, progress toward achieving this goal has been slow, and millions of people are lacking access to essential services needed to prevent, detect, and treat the disease. Early and accurate diagnosis is critical for the effective treatment and management of malaria.
The WHO recommends rapid diagnosis of malaria using microscopy or Rapid Diagnostic Tests (RDTs) for all patients suspected of having malaria. However, the diagnostic accuracy of microscopic examinations largely depends on the experience and skill of the examiner, and the reliability of RDTs is significantly reduced in cases of low-density parasitemia (LDP), where the blood density of protozoa is less than 100/μl [2]. LDPs (low-density parasite carriers) and asymptomatic protozoan carriers (APCs) are difficult to detect due to the absence of symptoms. They persist as sources of infection if untreated and are often missed by conventional diagnostic methods such as microscopy and rapid diagnostic tests (RDTs). Therefore, advanced diagnostic methods capable of detecting these infections are required. The presence of LDPs and APCs represents a major obstacle to the complete control of malaria transmission. Identifying LDPs and APCs is crucial for the successful elimination of malaria. [3] [4]
The Advantages of Malaria-LAMP
It has been reported that about 20-70% of malaria infections are not detected by non-nucleic acid tests such as microscopy and rapid diagnostic tests (RDTs) [5]. Malaria-LAMP (Loop-mediated Isothermal Amplification), a gene amplification technology developed by Eiken Chemical, can detect low-density protozoa with a blood density of 100/μl or less, which cannot be detected by microscopy or RDTs. The detection limit of Malaria-LAMP is 1-2 parasites/μl [6], significantly lower than that of microscopy and RDTs, with a sensitivity of 84-94% and a specificity of more than 92%. Additionally, the Malaria-LAMP method can distinguish between P. falciparum and P. vivax, which are species of malaria parasites that cannot be differentiated by RDTs [7].
Malaria-LAMP is a simple, accurate, robust, and affordable manual molecular test, capable of processing 70 samples per day, with 14 samples per run. The diagnostic accuracy is less influenced by the experience and skill of the examiner, as is the case with microscopy.
Malaria-LAMP has the potential to serve as a reference standard in resource-constrained environments and as a surveillance and screening tool when sensitive testing methods are required.
Differences from PCR Testing
Malaria-LAMP is a field-friendly alternative to PCR testing. It offers several operational advantages over the PCR method, such as requiring minimal equipment (just heat blocks), a short processing time of 40 minutes, low cost, and results that are visible to the naked eye under blue LED light.
Academic Presentations
- “Experience with Malaria-LAMP in Laos and Haiti: Importance of submicroscopic/asymptomatic malaria detection toward malaria elimination.”
- Shigeyuki Kano, MD.,PhD. Department of Tropical Medicine and Malaria, Research Institute, National Center for Global Health and Medicine (NCGM), Tokyo, Japan
- “Plasmodium vivax: challenges in diagnosis, treatment, and elimination.”
- Xavier Ding, PhD. Malaria Team Leader, Foundation for Innovative New Diagnostics (FIND).
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“Malaria LAMP: A Highly Sensitive Molecular Diagnostic Method for Detecting Plasmodium DNA”
- Akane Kyotani,*, Yasuyoshi Mori*, Shigeyuki Kano**
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*Eiken Chemical Co., Ltd., Tokyo, Japan,**National Center for Global Health and Medicine, Tokyo, Japan
Product Information
HUMAN Gesellschaft für Biochemica und Diagnostica mbH sells products above. (except Japan, China, Korea, Taiwan and Thailand). Please visit HUMAN GmbH website.
If you have any question about using Malaria products, please refer to FAQ about Malaria LAMP. *This link will direct you to a website of HUMAN GmbH.
References
- World malaria report 2023. Geneva: World Health Organization; 2023. CC BY-NC-SA 3.0 IGO.
- National Institute of Infectious Diseases. (2012). Malaria Testing Manual. Retrieved from
https://www.niid.go.jp/niid/images/lab-manual/malaria.pdf (Access date:May16,2024) - Lindblade, K. A., et al. (2013). The silent threat: asymptomatic parasitemia and malaria transmission. *Expert Review of Anti-infective Therapy*, 11(6), 623-639.
- Stresman, G. H., et al. (2015). High Levels of Persistent Asymptomatic Malaria Infections in a Setting of Declining Plasmodium falciparum Transmission in Zanzibar. *The Journal of Infectious Diseases*, 212(11), 1745-1754.
- Malaria rapid diagnostic test performance: summary results of WHO product testing of malaria RDTs: round 1-8 (2008–2018). Geneva: World Health Organization; 2018. Licence: CC BY-NC-SA 3.0 IGO.
- Howes RE, Battle KE, Mendis KN, et al. Global Epidemiology of Plasmodium vivax. Am J Trop Med Hyg. 2016 Dec 28;95(6 Suppl):15-34.
- Mohon AN, Getie S, Jahan N, et al. Ultrasensitive loop mediated isothermal amplification (US-LAMP) to detect malaria for elimination. Malar J. 2019;18(1):350