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Product Name: Malaria (Vector) Dipstick Assays
Commercial Name: Malaria VecTEST
Application: detects Plasmodium circumsporozoite protein in the mosquito vector or insect
Date fielded: 1996
Type of product: antigen detection device
Company of manufacture: : NAVIX, Medical Analysis Systems, VecTor Test Systems, Inc.

Target microorganism/associated disease: Malaria is an acute and chronic disease caused by obligate intracellular protozoa of the genus Plasmodium. The four species that cause human malaria (P. malariae, P. vivax, P. falciparum and P. ovale) are transmitted to humans via the bite of female mosquitoes of the genus Anopheles, usually at night (and less commonly via transfusion of infected red blood cells). The clinical course of malaria is characterized by high fever, chills, anemia, and enlargement of the spleen. P. falciparum may quickly cause serious or fatal complications (such as brain infection), and P. vivax and P. ovale can cause relapsing disease. Malaria can quickly decimate troop strength in soldiers lacking immunity to malaria parasites in tropical and some subtropical regions. The disease has had a major impact on several wars involving U.S. troops, including the Spanish-American War, the Pacific Theater in World War II, and the Vietnam War. The availability of prophylactic drug regimens and personal protective measures such as insect repellent and bed nets does not guarantee protection against this disease. Service members may develop malaria after leaving a malarious area because of an inadequate prophylaxis regimen or lack of compliance with this regimen. Some civilian medical workers may not be prepared to recognize and treat these infections. Also, because vectors capable of transmitting malaria exist in the United States, malaria in returning troops can be transmitted to other humans.

Reasons for development: The malaria vecTEST was developed so that preventive medicine personnel could detect the malaria antigens in mosquitoes around deployed troops and initiate appropriate measures prevent malaria in military personnel.

Role of Department of Defense in product development:: The malaria vectest assay was deby NAVIX Inc (subsequently Medical Analysis Systems,and now VecTOR Test Systems, Inc.) via U.S. Army funds supporting the Small Business Innovative ResearProgram (SBIR). Dr. Kirti Dave has been the individual involved in development of this assay at all 3 companies.

Malaria VecTest regulatory issues: The product was fielded in 1996, and is used by the U.S. Army. FDA clearance is not required for this type of assay. Prior tbeing assigned a National Stock Number (NSN), data onthis assay was reviewed by the Armed Forces Pest Management Board (AFPMB). The AFPMB approthis product, and recommended that a NSN be assigned.

Current status: The malaria dipstick assay is not available at the present time, due to the reality that assay kits were mostly utilized by military organizations and few were purchased. However, efforts are underway to bring this product back to the market.

References: 1. Sattabongkot J, Kiattibut C, Kumpitak C, Ponlawat A, Ryan JR, Chan AS, Dave K, Wirtz RA, Coleman RE. 2004. Evaluation of the VecTest Malaria Antigen Panel assay for the detection of Plasmodium falciparum and P. vivax circumsporozoite protein in anopheline mosquitoes in Thailand. J Med Entomol. 41:209-14.

2. Appawu MA, Bosompem KM, Dadzie S, McKakpo US, Anim-Baidoo I, Dykstra E, Szumlas DE, Rogers WO, Koram K, Fryauff DJ. 2003. Detection of malaria sporozoites by standard ELISA and VecTestTM dipstick assay in field-collected anopheline mosquitoes from a malaria endemic site in Ghana. Trop Med Int Health. 8:1012-7.

3. Ryan JR, Dave K, Collins KM, Hochberg L, Sattabongkot J, Coleman RE, Dunton RF, Bangs MJ, Mbogo CM, Cooper RD, Schoeler GB, Rubio-Palis Y, Magris M, Romer LI, Padilla N, Quakyi IA, Bigoga J, Leke RG, Akinpelu O, Evans B, Walsey M, Patterson P, Wirtz RA, Chan AS. 2002. Extensive multiple test centre evaluation of the VecTest malaria antigen panel assay. Med Vet Entomol. 16:321-7.

4. Ryan JR, Dave K, Emmerich E, Garcia L, Yi L, Coleman RE, Sattabongkot J, Dunton RF, Chan AS, Wirtz RA. 2001. Dipsticks for rapid detection of plasmodium in vectoring anopheles mosquitoes. Med Vet Entomol. 2001 15:225-30

Scrub Typhus | Malaria Parasite | West Nile Virus