More reports on the diagnostics technology used in detecting H1N1 on Clinica.co.uk.
Created by Clinica on 05/05/2009
Last updated: 12/03/10 at 01:14
The latest EUA goes to Cepheid's Xpert Flu A Panel, a PCR-based test that can provide results in under an hour. The company also plans to CE mark the device for sale in Europe
TessArae's TessArray RM-Flu test, which can identify the 2009 H1N1 virus, is the next diagnostic to receive an EUA from the agency
The FDA grants another EUA, this time for DxNA's H1N1 test on its portable GeneSTAT platform
The FDA approves an updated label for Nanosphere's respiratory virus test on the Verigene SP system, including claims of H1N1 detection. The test can distinguish between influenza A and B viruses, but cannot differentiate specific subtypes
Reports emerge of a Tamiflu-resistant strain of H1N1 being transmitted between hospital patients in the UK – thought to be the first confirmed cases of person-to-person transmission in the world
Focus Diagnostics CE marks its Simplex Influenza A H1N1 (2009) test for sale in Europe. It received an EUA on October 16
Correspondence is published in the NEJM showing that a rapid, antibody-based test (Quidel's QuickVue A+B) identifies only 25% of 21 H1N1 cases, compared with 81-100% with RT-PCR testing
Another test gets an EUA from the FDA – Roche's RealTime ready Influenza A/H1N1 detection set
Gen-Probe's Prodesse ProFlu-ST test is granted an EUA by the FDA, for use in CLIA high-complexity labs; non-profit Translational Genomics Research Institute (TGen) asks for an EUA for its H1N1 test, which also detects resistance to Tamiflu
http://www.clinica.co.uk/marketsector/ivds/Gen-Probes-flu-test-gets-emergency-use-authorisation-179931?autnID=/contentstore/clinica/codex/ee8ffef5-c53b-11de-99bb-6390657a44e2.xml
A small study in the American Journal of Roentgenology suggests that CT is better than X-ray at detecting H1N1 cases
http://www.clinica.co.uk/marketsector/imagingit/Study-CT-better-than-X-rays-at-detecting-H1N1-179626?autnID=/contentstore/clinica/codex/b41fd535-c2f3-11de-be9a-abbd73d3d051.xml
The FDA grants an EUA for a second of Focus Diagnostics' flu tests, Simplexa Influenza A H1N1 (2009), for CLIA labs
http://www.clinica.co.uk/marketsector/ivds/Second-Focus-Diagnostics-flu-test-cleared-via-emergency-use-authorisation-178814?autnID=/contentstore/clinica/codex/69e005b6-bc9d-11de-9f23-b9f41eb3f75d.xml
Nanosphere's influenza A and B respiratory syncytial virus test receives 510(k) clearance from the FDA on the firm's Verigene SP system, which can give results in under three hours
http://www.clinica.co.uk/marketsector/ivds/FDA-clears-Nanospheres-flu-test-on-Verigene-SP-178628?autnID=/contentstore/clinica/codex/932a402a-b977-11de-ba25-bb90ef15700c.xml
The UK's only provider of adult extracorporeal membrane oxygenation (ECMO) therapy, Leicester's Glenfield Hospital, says it could double the number of facilities. The therapy increases the chance of survival without disability in patients with severe acute respiratory failure, and could be crucial in severe H1N1 cases
http://www.clinica.co.uk/policyregulation/UK-agrees-to-double-adult-ECMO-capacity-in-the-face-of-H1N1-threat-177793?autnID=/contentstore/clinica/codex/0e10f380-af5b-11de-a4df-45429c510645.xml
A study published in JAMA finds that regular surgical masks are as good as more costly N95 respirators in preventing the spread of flu in nurses
http://www.clinica.co.uk/home/blogopensurgery/p--Surgical-masks-boosted-by-flu-study---p-178438?autnID=/contentstore/clinica/escenic/178438.xml
There is a jump in mortality from H1N1 worldwide – a 12% increase in the week up to Sep 22, compared with 6% in previous weeks. The global number of deaths now exceeds 4,000
http://www.clinica.co.uk/home/news/Re-escalation-of-H1N1-deaths-as-global-total-exceeds-4000-177383?autnID=/contentstore/clinica/codex/cf314214-a9da-11de-b15a-d3110472be41.xml
Scotland plans to buy 40 adult and 15 paediatric ventilators worth £1.4m to prepare for an increase in H1N1 infections
http://www.clinica.co.uk/marketsector/H1N1-triggers-1.4m-Scottish-investment-in-ventilators-176990?autnID=/contentstore/clinica/codex/8a17c11b-a443-11de-969b-a3fa2cc8b591.xml
Two rapid flu tests, Quidel's QuickVue Influenza A+B test and Meridian Bioscience's Tru Flu, can now include labelling claims for H1N1 detection, after the FDA grants clearance for updated package inserts
http://www.clinica.co.uk/marketsector/ivds/FDA-gives-special-clearance-for-H1N1-claims-from-Quidel-and-Meridian-176986?autnID=/contentstore/clinica/codex/aa4cb82d-a435-11de-969b-a3fa2cc8b591.xml
The FDA clears Diagnostic Hybrids' D3 FastPoint L-DFA Respiratory Virus Identification Kit, which provides results in under 30 minutes. The firm claims it "would be expected to detect" the H1N1 virus
Qiagen launches its artus Influenza/H1 RG/LC RT-PCR Kit, with a turnaround time of approximately 40 minutes, worldwide.
Cepheid accelerates the development of a 45-minute test for the flu A virus for use on the GeneXpert system. The firm expects the test to be approved by the FDA under an EUA in the upcoming flu season, and hopes to start shipping it in January 2010.
The US FDA authorises the emergency use of a flu test for troops serving abroad. The emergency use authorisation (EUA) covers the CDC's swH1N1 (swine) Influenza Real-Time RT-PCR; Nanosphere submits its already-approved influenza respiratory syncytial virus test to the FDA for use on its new system, Verigene SP. The firm also provides data on the test's ability to detect H1N1.
Focus Diagnostics expands launch of its H1N1 diagnostic (the Influenza A H1N1 (2009) Real Time RT-PCR test) to other US labs with CLIA certification.
A human case of H3N2 is confirmed, but is dismissed as unrelated to the H1N1 pandemic. H3N2 is common in pigs but rare in humans.
The US CDC says that rapid, point-of-care tests for the H1N1 virus could miss up to 60% of infections, and recommends that patients are treated based on symptoms and the knowledge that the virus is circulating.
The FDA grants an EUA for Focus Diagnostics' H1N1 RT-PCR test, making it the "first commercial H1N1 test" to receive such authorisation.
The FDA clears an updated label for Luminex's xTAG respiratory viral panel to include data on its performance in diagnosing H1N1.
The WHO says it plans to scale down lab testing for H1N1 and move towards clinical diagnosis of the disease.
The first case of Tamiflu-resistant H1N1 is found, in Denmark.
The UK becomes first country outside Americas to report a death from H1N1.
The WHO raises the H1N1 pandemic alert to level 6, representing widespread human infection.
Focus Diagnostics launches the "first commercial test" for H1N1 in the US (Influenza A H1N1 (2009) Real Time RT-PCR test); Osmetech submits a request to the FDA for an EUA for its Respiratory Pathogen Test Panel.
Qiagen claims that two of its tests can be used to screen for H1N1: the artus Influenza LC RT PCR Kit and the Resplex II 2.0 Kit.
The WHO raises its pandemic alert to phase 5; the first death outside Mexico occurs, a 23-month old Mexican baby in Texas.
The first three cases in the western Pacific region are confirmed in New Zealand.
Europe's first case of H1N1 is confirmed in Spain; two cases are confirmed in the UK; the WHO raises the pandemic alert to level four; the FDA issues EUAs for the US Centers for Disease Control and Prevention's (CDC) rRT-PCR Swine Flu Panel diagnostic, as well as for flu drugs Tamiflu and Relenza in populations in which the drug is not currently approved.
The US FDA declares a state of emergency due to H1N1. This allows the agency to issue emergency use authorisations (EUAs) allowing the use of unapproved products, or unapproved uses for approved products.
The Mexican Health ministry issues a nationwide alert.
The Mexican Health department notifies the Pan American Health Organization – a regional office of the WHO – of the H1N1 outbreak.
The first death attributed to H1N1 flu, of a 39-year-old woman, occurs in Mexico.
The WHO issues its first Disease Outbreak Notice on the pandemic.
The first US case of what would later be identified as H1N1 "swine" flu is reported.
Reports surface of a respiratory illness in Mexico. It is later confirmed as influenza H1N1 infection
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