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FDA gives go ahead to market Dengue test

Posted Feb 08 2012 12:00am

Normally, you go to the doctor’s office with complaints of a flu-like illness.  Is it Dengue?  Is it not?  

The physician listens and compares what you relate with the observations made during your examination.  Is it Dengue?  Is is not?

To confirm the doctor’s suspicions, you are invariably sent to the laboratory across the hall, or maybe across town, to have your blood drawn for testing by a technician who must identify antibodies in the blood specific to the Dengue virus that would confirm you have actually succumbed to the illness.

Now, physicians are being armed with a new tool to help them hasten the diagnostic process for Dengue, one that uses the signs and symptoms of the disease as evidence. The DENV Detect IgM Capture ELISA test detects the antibodies to the Dengue virus, if it is circulating in your bloodstream, one step ahead of the confirmatory tests.   This is thought to be a boon for improved patient care and management.

This is a significantly important development considering the high rate of misdiagnosis that goes on in doctors’ offices resulting in patients being sent home not realising that they are incubating a potentially lethal disease.  No diagnosis does not necessarily mean no Dengue.

Complicating matters, even if doc makes a correct call and refers you to the lab to confirm Dengue before the onset of fever, there is a fifty-fifty chance that the Lab test would detect the IgM antibody response to the Dengue virus, which is more likely 3-5 days after the onset of the fever.  In other words, the test might come back negative but you could still have Dengue.

With the DENV Detect IgM Capture ELISA test, the hope is that physicians will be less likely to mistake Dengue for the common cold or the flu.

The test was approved for marketing by the U.S. Food and Drug Administration (FDA) in April 2011.  It is patented by the Centers for Disease Control (CDC) and is manufactured by Inbios Inc. based in Seattle, Washington.  Although the risk is low to moderate, the test is not recommended for persons who do not display clear signs and symptoms of Dengue.  If properly used, a positive test should be considered presumptive evidence of Dengue.

Source: U.S. Food and Drug Administration


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