Zhang Lei*, Yang Feng, Zhu Junzhe
Background: In the 21st century, malaria continues to be a serious public health threat. This infectious disease has been responsible for millions of deaths globally, especially in tropical regions. It is difficult to distinguish infection with Plasmodium causes clinical presentation from other fever-causing pathogens. Rapid and accurate diagnosis becomes important for effective malaria case management and surveillance. Although microscopy was once widely used in parasite-based malaria diagnosis, it was apt to face obstacles when using microscopy in peripheral health care settings. The landscape of malaria diagnostic testing has changed since malaria rapid tests were first commercialized in the early 1990s.
Objective: The main purpose of this evaluation report was to explore the reliability and performance of the All Test Malaria Rapid Test Kits for the qualitative detection of circulating antibodies of P. falciparum (P.f.), P. vivax (P.v.), P.ovale (P.o.). And P. malariae (P.m.) in whole blood to aid in the diagnosis of malaria infection.
Method: Run a rapid in vitro diagnostic test device for detection of Malaria P.f./P.v./Pan in Whole Blood and compare with traditional thick and thin blood films microscopic analysis for validation of the performance.
Results: The results show that the relative sensitivity of the Malaria P.f./P.v./Pan Rapid Test Cassette (Whole Blood) is >98.7% and the relative specificity is >99.0%.
Conclusion: The Malaria P.f./P.v./Pan Rapid Test Cassette (Whole Blood) is a rapid test to qualitatively detect the presence of P. falciparum - specific HRP-II, P. vivax (P.v.) and four kinds of circulating plasmodium falciparum (P.f.), P. vivax (P.v.), P. ovale (P.o.), and P. malariae (P.m.). The test kit is simple to operate and results are obtained quickly. The use of the test kit will help in the diagnosis of malaria in situations where microscopes are unavailable and professional microscopists are inadequate. Additionally, the test kit has a very high accuracy (99.1%), sensitivity (98.7%), and specificity (99.3%). Patients can obtain accurate test results by using All Test Malaria P.f./P.v./Pan Rapid Test Cassette
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