CDC releasing new Zika virus test, confirms 9 cases among pregnant US residents

CDC officials have announced they will be “rolling out” a new test for the Zika virus to members of its Laboratory Response Network over the next several weeks.

The test can detect the infection up to at least several months after the initial infection. Another test, which checks for active Zika infection, is already in place in more than 20 laboratories across the United States, according to CDC Director Tom Frieden, MD, MPH. Speaking during a conference call with members of the media, Frieden said the new test is part of an effort to increase access to Zika infection diagnosis.

“This is a test that has been developed over years in the CDC laboratories, and in just weeks, we’ve been able to scale up production with the support of the FDA, and get through regulatory approvals, and we’re now rolling this test out to laboratories throughout the United States,” Frieden said. “It will take time before it is widely available, and we’ve completed all the quality assurance checks with all the laboratories that are doing it, but it’s an encouraging step forward.”

According to Julie Villanueva, PhD, the laboratory team lead at the CDC Zika Virus Response Team, the new test, called the CDC Zika IgM antibody capture enzyme-linked immunosorbent assay (MAC-ELISA), detects immunoglobulin M antibodies produced by the body in response to infection.

She added that the test was approved by the FDA under emergency rules, after HHS Secretary Sylvia Burwell declared that circumstances exits to allow the expedited process.

“This new test will be available in qualified U.S. public health laboratories through the laboratory response network,” Villanueva said during the telephone conference. “The CDC was able to make the test available quickly, because we worked very closely with our colleagues in the FDA using a special expedited process to authorize its use, called the Emergency Use Authorization. It is a tool that FDA can use to allow the use of certain medical products for emergency use based on scientific data.”

CDC officials also confirmed for the first time that, as of Feb. 17, they have received reports of nine pregnant U.S. residents who, after traveling abroad, returned home and were later confirmed to have Zika virus disease. In addition, there are 10 additional reports of Zika virus disease in pregnant women currently under investigation.

According to officials, there have been no hospitalizations or deaths in connection with the nine confirmed cases.

Of the six women who showed symptoms during the first trimester, two had miscarriages, two terminate their pregnancies, one delivered an infant with microcephaly, and one is continuing her pregnancy without complication.

Of the two women who began experiencing symptoms during the second trimester, one has delivered an apparently healthy infant, and the other is continuing the pregnancy. The remaining women, who began experiencing symptoms in the third trimester, had delivered a healthy infant.

No other information regarding the women is being released by the CDC.

“This is important information and even though the numbers are small, they are of considerable interest,” Frieden said. “We understand that the occurrence of fetal malformation, fetal loss or miscarriage, or a child with a birth defect, is something that can be devastating to a family. That’s why we’re working so hard to understand more what’s happening and how it can be prevented.” – by Jason Laday

Additional information:

http://www.cdc.gov/mmwr/volumes/65/wr/mm6508e1er.htm?s_cid=mm6508e1er.htm_w

http://www.cdc.gov/mmwr/volumes/65/wr/mm6508e2er.htm?s_cid=mm6508e2er.htm_w