Microchip Test Quickly Spots Flu Strains
U.S. scientists have developed a microchip-based test that could allow labs to diagnose flu strains in less than 12 hours.
The screen, called FluChip, was developed by a team from the University of Colorado and the U.S. Centers for Disease Control and Prevention.
In tests, FluChip successfully distinguished between 72 flu stains, including the deadly H5N1 bird flu virus. The findings appear in the current issue of the Journal of Clinical Microbiology.
Currently, labs across the U.S. can do basic tests to determine the type and subtype of a flu virus within several hours. However, only the CDC and a few other laboratories around the world have the high-level biosafety facilities needed for specialized tests that provide important information about a virus's geographic origin and other features.
The FluChip can be used in lower-level biosafety facilities, which would make it possible for many more labs to gather this type of information about flu viruses.
"The ability to quickly and accurately identify strains of influenza would be invaluable to international flu surveillance efforts. This is an encouraging advance," Dr. Anthony S. Fauci, director of the U.S. National Institute of Allergy and Infectious Diseases, said in a prepared statement.
U.S. Marshals Seize Defective IV Pumps
U.S. Marshals have seized defective intravenous medicine infusion pumps from the Alaris Products' manufacturing facility in San Diego, the U.S. Food and Drug Administration said Monday.
The FDA asked the U.S. District Court for the Southern District of California to issue the warrant for the seizure of Alaris Signature Edition Gold infusion pumps, model numbers 7130, 7131, 7230, and 7231.
Infusion pumps are used for controlled delivery of intravenous solutions and medications to patients.
The seized pumps have a design defect called "key bounce" that may lead to delivery of medications of up to 10 times the intended infusion rate, which can cause serious harm or death. Key bounce occurs when a number pressed on the pump registers twice although the operator only pressed the number key once.
Alaris failed to follow FDA medical device manufacturing regulations, the agency said. The seizure was done to ensure that the infusion pumps are not distributed until the "key bounce" problem is fixed.
No products were seized from healthcare facilities or private individuals and there are no plans to do so, the agency said. In an August 15 recall letter, Alaris told customers it would provide a warning label for the pumps and a permanent correction for the key bounce, once it is available.
The FDA issued warning letters to Alaris in August 1998 and October 1999, but the company failed to correct the manufacturing violations, according to the FDA. The pumps have been sold across the U.S. and in other countries.
FDA Mulls Drug to Prevent Preemie Births
The U.S. Food and Drug Administration is considering approval for the injectable drug Gestiva, meant to help women carry their babies to term. But a clinical trial of the drug found it didn't delay the earliest preterm births that are most often associated with serious health problems and death.
FDA documents released Monday show that the trial results were not "statistically persuasive" in suggesting that Gestiva reduced births before either 32 or 35 weeks' gestation, the Associated Press reported.
The study did find that the drug appeared to reduce births before the 37th week -- considered the cutoff point for a baby to be classified as premature. Even that effect could be important, the FDA documents said, because many preterm births occur after 32 weeks.
Babies born before 32 weeks account for about two percent of births in the U.S. but represent the majority of cases of health problems and death among premature infants. Most babies born after 32 weeks have no serious long-term, developmental problems, the AP reported.
The FDA documents also noted that there is concern that Gestiva may increase the rate of miscarriage and stillborn.
On Tuesday, an outside panel of experts will meet to decide whether to recommend FDA approval of Gestiva, which is made by Adeza Biomedical Corp. of California. If the application is successful, Gestiva would be the only FDA-approved drug for prevention of preterm birth.
Chinese Bird Flu Vaccine 'Safe and Effective'
A Chinese-developed vaccine to protect humans against the H5N1 bird flu virus has been found to be safe in the first round of tests, according to the Chinese government's official Xinhua News Agency.
The tests on six volunteers at a Beijing hospital were conducted between November and June by researchers from the China Center for Disease Control and Prevention and a drug company called Beijing Sinovac Biotech Co.
The tests "proved initially safe and effective," the researchers said. No other details of the results or of any plans for future testing were provided by the news agency, the Associated Press reported.
The vaccine is meant for people at high risk of contracting bird flu, such as poultry workers, Chinese authorities said. They also said the government is ready to start mass production of the vaccine, but more tests are needed before it's approved for use in humans.
U.S. government researchers are also conducting tests on an H5N1 vaccine for humans, the AP reported.
World's Oldest Person Dies at Age 116
The world's oldest person -- 116-year-old Maria Esther de Capovilla of Ecuador -- died Sunday. That makes American Elizabeth Bolden of Memphis, Tenn., the oldest known person alive, according to Guinness World Records.
Bolden is also 116 but 11 months younger than Capovilla, said Robert Young, a senior consultant on gerontology for Guinness World Records.
Capovilla died two days after she came down with pneumonia, the Associated Press reported.
She was born Sept. 14, 1889, the same year as Charlie Chaplin and Adolf Hitler, and got married in 1917. Her husband died in 1949. Three of Capovilla's children are still alive, along with 12 grandchildren, 20 great grandchildren and two great-great grandchildren.
Capovilla always ate three meals a day and never smoked or drank hard liquor. "Only a small cup of wine with lunch and nothing more," her daughter Irma told the AP.
The world's oldest man is Emiliano Mercado Del Toro of Puerto Rico, who turned 115 last week.
The oldest person ever recorded was France's Jeanne Louise Calment. She was 122 years, 164 days when she died on Aug. 4, 1997.
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