The U.S. Food and Drug Administration (FDA) granted emergency approval for the first commercial test for the presence of Zika virus in the blood of potentially infected individuals on April 28, 2016.
The newly-approved Zika virus tests, developed by Quest Diagnostics, are intended to increase availability of tests for the virus more available to health care providers, something that has been difficult with the present system of testing only available through the U.S. Centers for Disease Control and Prevention (CDC).
Initially, all of the new Zika blood tests will be tested through one center, that of the Quest laboratory that developed the test’s technology in San Juan Capistrano, California. This blood test, which the developers hope to have in the hands of doctors in the United States and Puerto Rico the week of May 2, 2016, will have a shorter turn-around time for results. The current system of Zika virus testing has taken three weeks to obtain results once a sample was sent to the laboratory.
Quest Diagnostics says it has received emergency authorization from the FDA to sell its Zika virus test https://t.co/xkEZMgxCDK
This new commercial test for Zika virus is limited to testing for the presence of the virus in the blood. A negative result in this test does not mean the individual being tested doesn’t have Zika virus within the body, only that if the virus is present it is no longer in the bloodstream. Healthcare practitioners who suspect the individual being tested does have Zika virus can then use the present system of testing to determine if Zika virus infection is present.
Timeliness of FDA Approval of First Commercially Available Zika Virus Blood Test
Zika virus is the mosquito-borne and sexually-transmitted infection that has now been scientifically confirmed to cause microcephaly and other birth defects in some infants born to mothers who were infected with the virus during pregnancy.
More than 425 cases of Zika virus have been confirmed in the United States all of which have been linked to travel to Zika-affected areas. Puerto Rico is experiencing an upswing in the number of Zika virus cases there, with the first Zika virus-related death recorded there on Friday, April 29, 2016. Canada confirmed its first known case of sexually-transmitted Zika virus in Ontario on Monday, April 25, 2016. All of these cases are in addition to the widespread Zika-affected areas in Latin America and the Caribbean.
Public health officials are predicting the potential for small areas of the United States to experience Zika virus transmission via mosquitoes during the summer of 2016.
Who Should Be Tested for Zika Virus?
The current criteria, established by public health officials, to determine those who should be tested for Zika virus include:
Pregnant women who do or do not have symptoms of Zika virus but have traveled to a Zika-affected area within the past 12 weeks and/or have a sexual partner who traveled to a Zika-affected area and had symptoms of Zika virus or a sexual partner who tested positive for Zika virus.
Men or women who have symptoms of Zika virus and have a sexual partner who traveled to a Zika-affected area and developed symptoms of the illness either during or within two weeks of that travel.
Men who traveled to a Zika-affected area and developed symptoms of Zika virus during that travel or within the first two weeks and either have had sexual contact with a pregnant partner or had a sexual partner who has developed symptoms of Zika virus.
Infants whose mother traveled to a Zika-affected during pregnancy and the infant shows symptoms of Zika virus within the first two weeks following birth or were diagnosed with microcephaly or intracranial calcifications or were born to a mother who tested either positive or inconclusive for the presence of Zika virus.
Any individual diagnosed with Gullain-Barre syndrome not established to be due to another condition and had the potential to be exposed to Zika virus before being diagnosed with Guillain-Barre.
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