FDA clears single test for 12 respiratory viruses

first_imgEditor’s note: This story was revised Jan 8 to correct information about the location of the test’s manufacturer. Jan 7, 2008 (CIDRAP News) – A single test that can identify up to 12 different respiratory viruses, including three kinds of influenza, from one sample has won the Food and Drug Administration’s (FDA’s) approval.The test, called the xTAG Respiratory Viral Panel (RVP), is the first that can detect and distinguish influenza A subtypes H1 and H3 and also detect influenza B, the FDA said in announcing the approval on Jan 3. Influenza A is the most severe type of flu in humans and has been the cause of pandemics, the agency noted.The new test panel is also the first test for human metapneumovirus (hMPV), which was first identified in 2001, the FDA said.The test is made by Toronto-based Luminex Molecular Diagnostics, part of Luminex Corp, headquartered in Austin, Tex. In a news release, the company called the xTAG RVP “a ground breaking test that, with a single patient sample, can assess the presence or absence of 12 viral targets and provide qualitative results in a few hours.”Conventional testing for the same viruses requires a number of separate tests and can take several days, the company said. The new product will help physicians provide appropriate treatment and prevent inappropriate antibiotic use that has helped spawn resistant microbes, the statement said.The FDA said, “The xTAG panel is the first FDA-cleared test for infectious respiratory disease viruses that uses a multiplex platform, allowing several tests to be processed using the same sample.”The test uses polymerase chain reaction (PCR) to amplify viral genetic material in samples from patients, according to Jeremy Bridge-Cook, vice president of Luminex Molecular Diagnostics. The FDA said the test uses secretions from the back of the throat.The test uses tiny color-coded beads, or microspheres, that are coated with reagents specific to material from particular viruses, according to information on the Luminex Web site.”There’s a different color-coded bead for each virus in the test,” Bridge-Cook told CIDRAP News. “The Luminex instrument can identify the different color-coded beads and whether the viral target was amplified. If any of the beads is positive, that indicates whether the viral target was present in the sample.”The use of PCR to reproduce viral material “speeds up the usual process of detecting and identifying respiratory viruses, which can take up to a week,” Daniel D. Schultz, MD, director of the FDA’s Center for Devices and Radiological Health, said in the news release.The FDA said viruses identified by the xTAG RVP, in addition to the three forms of influenza and human metapneumovirus, include:Respiratory syncytial virus subtypes A and B, both of which are leading causes of infant pneumonia and bronchiolitis and often contribute to the development of long-term lung diseaseParainfluenza 1, 2, and 3—all leading factors in croup and the common coldRhinovirus, the most common viral infective agent in humans and another cause of the common coldAdenovirus, a cause of respiratory tract infections often similar to strep throat or tonsillitisThe 12 viruses covered by the test account for more than 85% of respiratory viral infections, the Luminex statement said.The company said the test’s ability to identify influenza subtypes H1 and H3 will be important in efforts to detect quickly any emerging pandemic flu virus. The test will make it possible to sort H1 and H3 viruses, which make up the vast majority of influenza A subtypes, from rare forms of influenza A. “This way, the few samples that do test positive for influenza A but cannot be identified as H1 or H3 subtypes can be flagged for further investigation by the CDC or local public health labs,” the company said.Bridge-Cook said the time needed to run the test will vary, but “I’d say maybe 6 hours might be a typical time.”As for the cost, he said he couldn’t give a specific figure, but added, “From a ballpark standpoint, basically the number is in the low hundreds [of dollars], as opposed to thousands of dollars, with respect to what it costs the healthcare system as a whole when the test is run.”Bridge-Cook said the test requires specially trained personnel, so it’s likely to be used mainly in hospital laboratories. But he said many hospital labs take samples from outpatient clinics, so the test would not be limited to use on inpatients.The FDA said that because the test is specific to the 12 viruses listed, it should be used with other diagnostic information, such as patient data, bacterial or viral cultures, and x-rays.See also: Jan 3 FDA news releasehttp://www.fda.gov/bbs/topics/NEWS/2008/NEW01770.htmlJan 3 Luminex news releasehttp://phx.corporate-ir.net/phoenix.zhtml?c=79403&p=irol-newsArticle&ID=1091216&highlight=last_img read more

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Flyers finish off Mustangs to start two-game weekend

first_imgThe third period was much of the same, with the Flyers scoring once, thanks in part to Huskies call up Cody Hildebrand, who fought hard for his own rebound.Hythe managed to score two quick ones near the conclusion of the game, ending the Friday evening tilt 6-3 in favour of Fort St. John.As the game progressed, play on the ice became more and more chippy, some would even describe the game as getting dirty. Not only was the physicality of hockey on full display Friday, but the game also involved a lot of extra-curricular nastiness in between the whistles.  Following the win, coach Darrel Leahy said a strong first period was a key part of Friday’s win.Advertisement “It was a focus for the start of the game was to have a good first period and we did. We did a lot of things right in the first. We came out, did some bumpin’ and dumpin’ and passes were on, puck went in the net. Everything worked great in the first period.”Coach Leahy also mentioned how he realized the game was getting chippy, and how he wanted it to conclude as fast as possible.“I was just hoping the clock would hurry up and get the game over with, because I didn’t want any more penalties or possible misconducts for tomorrow’s game.”The Senior Flyers will now shift their focus to the Dawson Creek Senior Canucks, a team the Flyers lost to last Friday 5-4 in an emotional shootout loss at home. Leahy says the team will be short-benched for the game, but expects it to be a good test for his squad, who will be playing their third game in four days.Tonight’s game hit the ice in Dawson Creek at 8:30 p.m.Advertisement After Wednesday’s win, Senior Flyers head coach Darrel Leahy said despite the lop-sided victory, his team still needed to be better out of the gate. Well, message received Friday night.The Flyers hit the North Peace Arena ice in full stride Friday, out-shooting the Mustangs 17-7 in the first, and scoring the only four goals of the opening frame, providing the home team a four-goal cushion entering the remaining two periods.A hat-trick and two assists in game one wasn’t enough for forward Paul Wiens, who picked up right where he left off Wednesday, scoring Friday evening’s opening goal for the Senior Flyers 3:14 into the first.- Advertisement -Much like Wiens, Jeff Shipton also had a great Wednesday on the ice, and he too transferred that success to Friday. With the Flyers leading 1-0, Shipton scored twice in the first, a power-play goal at 5:23, followed by an even-strength goal three minutes later.The offence wasn’t done there, as Clayton Bahm made a nice play to steal the puck from the Mustangs goaltender, getting to puck to Jeff Fast, who finished the passing play to the period’s final goal scorer, Arlo Hadland with 6:14 left in the first.Hythe managed to get on the board in the second period courtesy of a breakaway goal, but Fort St. John restored the four goal lead, as Gerard Dicaire was sent in on a partial breakaway, making no mistake with some soft hands, sliding the puck five-hole for the 5-1 lead.Advertisementlast_img read more

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Arsenal hero says Gunners won’t be playing Champions League football next season

first_imgMartin Keown expects Arsenal’s late charge for a top four finish to end in failure.The Gunners are up to fifth in the Premier League table after following up their victory over rivals Manchester United by beating Southampton on Wednesday night.They are now just three points behind Manchester City, who sit fourth, and four points off third-placed Liverpool, who have played a game more.With their remaining fixtures against Stoke, Sunderland and Everton, Arsene Wenger’s side look to be in with a real shot of securing Champions League football for the 21st consecutive season.But Keown believes their resurgence has come too late, telling talkSPORT: “It was a huge win [against Southampton], but I can’t see they are going to do it. “City are purring at the moment. Liverpool are maybe just limping over the line.“Arsene Wenger has shown a good reaction from the terrible form they were in. He has turned it around, he is heading towards the FA Cip final against Chelsea, but I can’t see Arsenal doing it.“Wenger every year gets back on track and rebalances as a group but they have been too short of quality.”Martin Keown was speaking at the launch of The McDonald’s Player Escort Programme. McDonald’s is giving you the chance to register a child for the opportunity to be a Player Escort at the UEFA Women’s EURO 2017 match between England and Scotland. To find out more click here.last_img read more

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