The BinaxNOW® Malaria test is a
rapid point of care test for the differential diagnosis
of a malaria infection. The simple, three-step test provides
results in 15 minutes, allowing for accurate treatment and improved
patient outcomes.
Intended Use
The BinaxNOW® Malaria test is an in
vitro immunochromatographic assay for the qualitative detection of
Plasmodium antigens circulating in human venous and capillary EDTA
whole blood of individuals with signs and symptoms of malarial
infection. The test targets the histidine-rich protein II (HRPII)
antigen specific to Plasmodium falciparum (P.f.) and a
pan-malarial antigen, common to all four malaria species capable of
infecting humans - P. falciparum, P. vivax
(P.v.), P. ovale (P.o.), and P. malariae (P.m.).
It is intended to aid in the rapid diagnosis of human malaria
infections and to aid in the differential diagnosis of
Plasmodium falciparum (P.f.) infections from other less
virulent malarial infections. Negative results must be confirmed by
thin / thick smear microscopy.
Clinical performance has not been adequately established for
P. ovale (P.o.) and P. malariae (P.m.). The user
must establish performance characteristics of this test with these
Plasmodium species.
The test is not intended for use in screening asymptomatic
populations.
Product Details
| Sample Type: |
Whole blood |
| Time to Result: |
15 minutes |
| Kit Size: |
5 or 25 tests |
| Performance data: |
P. falciparum
Sensitivity/Specificity– 99.7% /
94.2%* |
| |
P. vivax
Sensitivity/Specificity– 93.5% / 99.8% |
| Regulatory: |
Cleared for distribution by the FDA and CE
marked, |
| |
available in 11 languages |
For instructions for use, see package insert
About Malaria
Malaria is caused by Plasmodium falciparum, P.
vivax, P. ovale, as well as P. malariae. The
disease is transmitted through the bite of the Anopheles
mosquito. Upon transmission of the Plasmodium parasite to
a human by the mosquito, the parasite invades the liver. Within 2
weeks, an immature form of the parasite is released into the blood
stream where maturation takes place. Red blood cells that are
infected then lyse and cause symptoms of the
disease1.
The symptoms of malaria can include fever,
chills, malaise, aching and stiff muscles, headache,
gastroenteritis and cough. Untreated, malaria can lead to organ
damage, anemia, coma and death. P. falciparum or
"malignant" malaria usually causes the most severe cases of
disease. In fact, even when managed in intensive care units, severe
P. falciparum malaria has a mortality rate of
20%2.
The World Health Organization estimates that 300-500 million
cases of malaria occur and more than 1 million people die of
malaria yearly. Approximately 90% of these deaths occur in Africa
and most occur in children under five years of age3.
For more information about Malaria, please see
the links below:
CDC: Malaria
CDC: Global Malaria
Prevention and Control Program
World Health Organization: Malaria
World Health Organization: World Malaria
Report 2008
References
1. Levitz, RE.
2003. Infectious Disease Emergencies: Recognition and Initial
Management in the Medical Management of Infectious Disease. CJ
Grace, ed. p. 33. Marcel Dekker, Inc., New York.
2. Kirkpatrick,
BD. 2003. Evaluation of the International Traveler in Medical
Management of Infectious Disease. CJ Grace, ed. p. 761. . Marcel
Dekker, Inc., New York.
3. The World
Health Organization.
Fact Sheet No. 94.
*For parasitemia levels
>5,000 (parasites/µl). Please refer to the Product Insert for
complete performance data as established in clinical trials.