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Three rapid diagnostic tests approved for malaria diagnosis in Haiti

CDC. MMWR. 2010;59:1372-1373.

Issue: December 2010

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Three rapid diagnostic tests for malaria diagnosis have been approved for use in Haiti, and the CDC has advised physicians in Haiti, international aid organizations and health officials to be aware of this policy change, according to a recent Morbidity and Mortality Weekly Report.

In light of the earthquake on Jan. 12, Plasmodium falciparum malaria has become endemic in Haiti. Microscopy, the only approved test for the diagnosis and management of malaria in the country, is limited by lack of equipment or trained personnel, according to CDC officials. However, rapid diagnostic tests (RDTs) require less equipment and training than microscopy.

For this reason, the CDC in collaboration with the Haiti Ministry of Public Health and Population (MSPP) conducted a study that compared the performance of microscopy with two brands of RDTs temporarily introduced for malaria diagnosis. The main criterion for approval of RDTs was a detection rate of at least 97% for P. falciparum at low parasite densities.

Two health facilities utilizing one brand of RDT demonstrated acceptable sensitivy (100% and 84.2%, respectively) and specificity (91.4% and 94%, respectively). A third health facility using another brand of RDT showed poor sensitivy (51.6%), yet adequate specificity (94.4%).

Based on these findings, the MSPP adopted the use of RDTs as part of the national strategy at health centers and clinics without the capacity to house microscopy; in departmental hospitals, community referral hospitals, and specialty hospitals during off-hours; or if microscopy was not available.

The following three brands of RDTs have been approved:

• First Response Malaria Ag HRP2 (Premier Medical Corp.).
• CareStart Malaria HRP2 (Pf) (Access Bio Inc.).
• SD Bioline Malaria Ag Pf (Standard Diagnostics Inc.).

National policies differ in the recommended first-line diagnostic test, depending on the availability of health facility and laboratory infrastructure, financial resources, skilled personnel and local epidemiology of the disease. Both microscopy and RDTs are recommended in the United States.

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