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FDA OKs emergency use for first commercial Zika test
Filed Under:
Zika
Lisa Schnirring | News Editor | CIDRAP News
| Apr 29, 2016
In the latest Zika virus developments, the US Food and Drug Administration (FDA) yesterday issued an emergency use authorization (EUA) for the first commercially available test, and the United States reported its first death from the disease, in a man from Puerto Rico who suffered complications.
Meanwhile, Zika activity increased in some parts of the Americas affected later by the virus, as Saint Barthelemy reported its first local case.
FDA action clears way for broader Zika testing
The FDA announced yesterday that it authorized the use of a real-time polymerase chain reaction (RT-PCR) test made by Focus Diagnostics, Inc., for qualified labs to detect Zika virus RNA in blood samples of those meeting Centers for Disease Control and Prevention (CDC) clinical criteria or of people who may have lived in or traveled to an affected location or had other exposure to the virus.
Until now, the only authorized Zika tests were available from the CDC for use in CDC-designated labs. In a statement yesterday, Quest Diagnostics, the parent company of Focus Diagnostics, said it would make the test broadly available to physicians, including those in Puerto Rico, starting on May 2.
In an accompanying letter to providers, the FDA said Zika RNA may be detected in blood 4 to 7 days after symptom onset and that the best time for testing is within a week of clinical onset. Aside from symptomatic travelers, the CDC recommends testing for asymptomatic pregnant women who traveled to Zika-hit countries or have sex partners who have been in those areas, and for babies born to women who lived in or traveled to affected regions.
Quest Diagnostics said it will offer serologic testing if the FDA issues an EUA for serologic test kits.
Puerto Rico's fatal case, outbreak details
News of the first US fatality came in an update on the territory's outbreak by CDC and Puerto Rican health officials reporting in an early-release article from Morbidity and Mortality Weekly Report (MMWR). The patient was a man in his 70s, NBC News reported today, citing CDC sources.
Zika virus produces a generally mild infection, and deaths from the disease are very rare. Brazil and Colombia have each reported a handful of fatal cases, and a report from Colombian researchers earlier this month on four fatal cases noted underlying health problems in each of the patients.
As of Apr 14, surveillance revealed that of 6,157 people in Puerto Rico who were tested for the disease, 683 (11%) were positive for acute or recent Zika infection. Of 17 people who were hospitalized for their illnesses, 5 had suspected Guillain-Barre syndrome (GBS) and 1 patient died after developing severe thrombocytopenia. (Of the four patients described in the Colombian fatal-case series, three had severe thrombocytopenia.)
The fatal case highlights the possibility of severe cases and the need to raise provider awareness of complications that might lead to severe disease or death, the group wrote.
The authors also note that women made up the majority of cases (64%), which could reflect targeted outreach and testing of childbearing-age women. So far 65 women with symptoms have tested positive for Zika virus, and a Zika-related pregnancy surveillance system has been set up in Puerto Rico to monitor for adverse maternal and fetal health outcomes. Home-based vector-control programs aimed at pregnant women are underway.
Americas trends, Saint Barthelemy case, travel advisory addition
See also:
Apr 28 FDA announcement
Apr 28 Quest Diagnostics press release
Apr 29 MMWR report
Apr 29 NBC News report
Apr 8 CIDRAP News story "Report outlines patterns in rare fatal Zika infections"
FDA OKs emergency use for first commercial Zika test
Filed Under:
Zika
Lisa Schnirring | News Editor | CIDRAP News
| Apr 29, 2016
In the latest Zika virus developments, the US Food and Drug Administration (FDA) yesterday issued an emergency use authorization (EUA) for the first commercially available test, and the United States reported its first death from the disease, in a man from Puerto Rico who suffered complications.
Meanwhile, Zika activity increased in some parts of the Americas affected later by the virus, as Saint Barthelemy reported its first local case.
FDA action clears way for broader Zika testing
The FDA announced yesterday that it authorized the use of a real-time polymerase chain reaction (RT-PCR) test made by Focus Diagnostics, Inc., for qualified labs to detect Zika virus RNA in blood samples of those meeting Centers for Disease Control and Prevention (CDC) clinical criteria or of people who may have lived in or traveled to an affected location or had other exposure to the virus.
Until now, the only authorized Zika tests were available from the CDC for use in CDC-designated labs. In a statement yesterday, Quest Diagnostics, the parent company of Focus Diagnostics, said it would make the test broadly available to physicians, including those in Puerto Rico, starting on May 2.
In an accompanying letter to providers, the FDA said Zika RNA may be detected in blood 4 to 7 days after symptom onset and that the best time for testing is within a week of clinical onset. Aside from symptomatic travelers, the CDC recommends testing for asymptomatic pregnant women who traveled to Zika-hit countries or have sex partners who have been in those areas, and for babies born to women who lived in or traveled to affected regions.
Quest Diagnostics said it will offer serologic testing if the FDA issues an EUA for serologic test kits.
Puerto Rico's fatal case, outbreak details
News of the first US fatality came in an update on the territory's outbreak by CDC and Puerto Rican health officials reporting in an early-release article from Morbidity and Mortality Weekly Report (MMWR). The patient was a man in his 70s, NBC News reported today, citing CDC sources.
Zika virus produces a generally mild infection, and deaths from the disease are very rare. Brazil and Colombia have each reported a handful of fatal cases, and a report from Colombian researchers earlier this month on four fatal cases noted underlying health problems in each of the patients.
As of Apr 14, surveillance revealed that of 6,157 people in Puerto Rico who were tested for the disease, 683 (11%) were positive for acute or recent Zika infection. Of 17 people who were hospitalized for their illnesses, 5 had suspected Guillain-Barre syndrome (GBS) and 1 patient died after developing severe thrombocytopenia. (Of the four patients described in the Colombian fatal-case series, three had severe thrombocytopenia.)
The fatal case highlights the possibility of severe cases and the need to raise provider awareness of complications that might lead to severe disease or death, the group wrote.
The authors also note that women made up the majority of cases (64%), which could reflect targeted outreach and testing of childbearing-age women. So far 65 women with symptoms have tested positive for Zika virus, and a Zika-related pregnancy surveillance system has been set up in Puerto Rico to monitor for adverse maternal and fetal health outcomes. Home-based vector-control programs aimed at pregnant women are underway.
Americas trends, Saint Barthelemy case, travel advisory addition
- Overall confirmed and suspected Zika infections in the Americas are showing a downward trend, in line with patterns observed for this time of year with other mosquito borne diseases, the Pan American Health Organization (PAHO) said today in its weekly Zika virus update. However, activity is increasing in locations that reported their first local cases in 2016, such as the Dominican Republic and Guadeloupe.
- Saint Barthelemy, a French territory in the Caribbean, yesterday reported its first local Zika virus case, the European Centre for Disease Prevention and Control (ECDC) said today in its weekly communicable disease update.
- The CDC today added Papua New Guinea to its level 2 travel advisory for pregnant women and those considering getting pregnant. Its advisory included a map showing which parts of the country are above and below 6,500 feet, a level above which mosquitoes that carry Zika virus don't live.
See also:
Apr 28 FDA announcement
Apr 28 Quest Diagnostics press release
Apr 29 MMWR report
Apr 29 NBC News report
Apr 8 CIDRAP News story "Report outlines patterns in rare fatal Zika infections"