Meridian Bioscience, Inc's Alethia CMV Assay Test System Approved By FDA For Herpes Virus, cytomegalovirus (CMV) Detection In Newborns.

CMV-infected pneumocytes with large, intranuclear, basophilic inclusions with haloes at their periphery as well as small, granular cytoplasmic inclusions. Yale Rosen - Flickr

Today the U.S. Food and Drug Administration permitted marketing of a new diagnostic test to aid in detecting a type of herpes virus called cytomegalovirus (CMV) in newborns less than 21 days of age.

“Although most people who become infected with cytomegalovirus face little to no risk of serious illness, the virus has the potential to cause serious illness for people with weak immune systems and in newborn babies, This test for detecting the virus, when used in conjunction with the results of other diagnostic tests, may help health care providers more quickly identify the virus in newborns and determine the best approach for the child.”said Tim Stenzel, director of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health. 

The Alethia CMV Assay Test System is used as an aid in the diagnosis of congenital CMV infection by detecting CMV deoxyribonucleic acid (DNA) from a saliva swab. Test results should be used only in conjunction with the results of other diagnostic tests and clinical information.

The FDA evaluated the analytical and clinical performance of the device. Data from a prospective clinical study showed that 1,472 saliva samples out of 1,475 samples collected from newborns were correctly identified by the device as negative for the presence of CMV DNA. Three samples were incorrectly identified as positive when they were negative. Five collected saliva specimens were correctly identified as positive for the presence of CMV DNA. The FDA also reviewed data from a testing of 34 samples of archived specimens from babies known to be infected with CMV in which all the archived specimens were correctly identified by the device as positive for presence of CMV DNA. The FDA reviewed the Alethia CMV Assay Test System through the de novo premarket review pathway, a regulatory pathway for novel, low-to-moderate-risk devices of a new type. Along with this authorization, the FDA is establishing criteria, called special controls, which determines the requirements for demonstrating accuracy, reliability and effectiveness of tests intended to be used as an aid in the diagnosis of congenital CMV infection. These special controls, when met along with general controls, provide a reasonable assurance of safety and effectiveness for tests of this type.
This action also creates a new regulatory classification, which means that subsequent devices of the same type with the same intended use may go through the FDA’s 510(k) process, whereby devices can obtain marketing authorization by demonstrating substantial equivalence to a predicate device.
The FDA granted marketing authorization of the Alethia CMV Assay Test System to Meridian Bioscience, Inc.

Cleaning Your Baby's Pacifire by Sucking on It, may Prevent Allergies.

If you thought that sucking a baby's pacifier to clean it and then popping it in the baby's mouth, whether you are doing it to your baby or someone else to their baby, is gross, better think again.
New research suggests a link between parental sucking on a pacifier and a lower allergic response among young children. This was revealed by the new research being presented at the American College of Allergy, Asthma and Immunology (ACAAI) Annual Scientific Meeting.

"We interviewed 128 mothers of infants multiple times over a period of 18 months and asked how they cleaned their child's pacifier. We found the children of mothers who sucked on the pacifier had lower IgE levels." #IgE is a type of antibody related to allergic responses in the body. Although there are exceptions, higher IgE levels indicate a higher risk of having allergies and allergic asthma."  says allergist Eliane Abou-Jaoude, MD, ACAAI member and lead author on the study conducted by Henry Ford Health System in Detroit. 

Further information about this study could be found at #ACAAI site.

Be Informed About Avian Influenza In British Colombia, Canada

Avian influenza (AI) is a contagious viral infection that can affect several species of food producing birds as well as pet birds and wild birds. AI viruses can be classified into two categories: low pathogenicity (LPAI) and highly pathogenic (HPAI) forms, based on the severity of the illness caused in birds.
Avian influenza viruses, such as the highly pathogenic H5N1 virus present in Asia, may, on rare occasions, cause disease in humans. Transmission to humans has occurred through close contact with infected birds or heavily contaminated environments.
In Canada, highly pathogenic avian influenza and low pathogenicity H5 and H7 avian influenza viruses are considered to be Notifiable Avian Influenza, which is a reportable disease under the Health of Animals Act. All cases must be reported to the Canadian Food Inspection Agency (CFIA).
More Info at CFIA

The Canadian Food Inspection Agency (CFIA) Works To Control Avian Influenza In British Columbia

 After testing by the Province of British Columbia, CIFA has confirmed the presence of H5 avian influenza on two farms in the Fraser Valley; a turkey farm in Abbotsford and a broiler breeder farm in Chilliwack.

CFIA continues avian influenza investigation in British Columbia

The Canadian Food Inspection Agency (CFIA) is continuing its investigation into an outbreak of avian influenza on two farms in British Columbia's Fraser Valley.
The two farms continue to be under quarantine to control disease spread, and two additional farms in the Fraser Valley have been placed under quarantine today. These farms were determined to be at high risk since they received birds from one of the original farms. Birds on these new farms were also showing signs of illness.
As avian influenza is highly contagious and can spread rapidly, it is possible that additional at-risk farms may be identified in the coming days. Poultry farmers are encouraged to report any suspicious symptoms to the CFIA.
The CFIA will continue to advise the public and the poultry industry if additional farms are confirmed to be affected.
Testing continues in order to confirm pathogenicity. Results are expected within days.
In the coming days, the CFIA will humanely euthanize and dispose of all birds on the infected premises in accordance with provincial environmental regulations and internationally accepted disease control guidelines.
When animals affected by a disease are ordered destroyed by the CFIA under the Health of Animals Act, the farmer is also informed that they will receive compensation. The CFIA is dedicated to working directly with affected producers so that the compensation process runs as smoothly as possible.
For animals ordered destroyed, the CFIA bases compensation amounts on the animal's market value (up to a maximum amount as stipulated in the Compensation for Destroyed Animals Regulations), taking into consideration factors such as genetic background, age and production records. For example, a normal eating chicken is assigned a rate of $20 per bird, a breeding chicken is $1200 per bird, a turkey is $70 per bird, and a breeding turkey is $1050 per bird. Please refer to the Schedule in the Regulations for accurate amounts.
Normally, a producer can expect compensation in 6 to 10 weeks.
Beyond the CFIA's compensation, other financial assistance may be available through programs administered by Agriculture and Agri-Food Canada, and, in some cases, provincial or territorial governments. Costs and losses considered by these programs may include business disruption and other extraordinary costs incurred due to disease.
Avian influenza viruses do not pose risks to food safety when poultry and poultry products are properly handled and cooked. Avian influenza rarely affects humans that do not have consistent contact with infected birds. Public health authorities stand ready to take precautionary measures as warranted.
The CFIA has mobilized all available resources to manage this situation. The Agency continues to work closely with the Province of British Columbia, the owners of the infected birds, and the poultry industry to manage this outbreak.

CDC Rapid Ebola Preparedness (REP) teams have assessed more than 50 facilities in 15 states and D.C.

The Hospitals Equipped With Ebola Treatment Centers In USA As Of 12/2/2014

This list will be updated weekly. The 35 hospitals with Ebola treatment centers listed alphabetically state-wise as of 12/2/2014 are :

• Kaiser Oakland Medical Center; Oakland, California
• Kaiser South Sacramento Medical Center; Sacramento, California
• University of California Davis Medical Center; Sacramento, California
• University of California San Francisco Medical Center; San Francisco, California
• Emory University Hospital; Atlanta, Georgia
• Ann & Robert H. Lurie Children’s Hospital of Chicago; Chicago, Illinois
• Northwestern Memorial Hospital; Chicago, Illinois
• Rush University Medical Center; Chicago, Illinois
• University of Chicago Medical Center; Chicago, Illinois
• Johns Hopkins Hospital; Baltimore, Maryland
• University of Maryland Medical Center; Baltimore, Maryland
• National Institutes of Health Clinical Center; Bethesda, Maryland
• Allina Health’s Unity Hospital; Fridley, Minnesota
• Children’s Hospitals and Clinics of Minnesota - Saint Paul campus; St. Paul, Minnesota
• Mayo Clinic Hospital - Rochester, Saint Marys Campus; Rochester, Minnesota
• University of Minnesota Medical Center, West Bank campus, Minneapolis, Minnesota
• Nebraska Medicine - Nebraska Medical Center; Omaha, Nebraska
• North Shore System LIJ/Glen Cove Hospital; Glen Cove, New York
• Montefiore Health System; New York City, New York
• New York-Presbyterian/Allen Hospital; New York City, New York
• NYC Health and Hospitals Corporation/HHC Bellevue Hospital Center; New York City, New York
• Robert Wood Johnson University Hospital; New Brunswick, New Jersey
• The Mount Sinai Hospital; New York City, New York
• Children's Hospital of Philadelphia; Philadelphia, Pennsylvania
• Hospital of the University of Pennsylvania; Philadelphia, Pennsylvania
• University of Texas Medical Branch at Galveston; Galveston, Texas
• Methodist Hospital System in collaboration with Parkland Hospital System and the University of Texas Southwestern Medical Center; Richardson, Texas
• University of Virginia Medical Center; Charlottesville, Virginia
• Virginia Commonwealth University Medical Center; Richmond, Virginia
• Children’s Hospital of Wisconsin, Milwaukee; Milwaukee, Wisconsin
• Froedtert & the Medical College of Wisconsin – Froedtert Hospital, Milwaukee; Milwaukee, Wisconsin
• UW Health – University of Wisconsin Hospital, Madison, and the American Family Children’s Hospital, Madison; Madison, Wisconsin
• MedStar Washington Hospital Center; Washington, D.C.
• Children's National Medical Center; Washington, D.C.
• George Washington University Hospital; Washington, D.C.

World Aids Day 2014. "Focus, Partner, Achieve: An AIDS-Free Generation"

On December 1, the whole world observe World AIDS Day. Mainly to raise awareness of the global impact of HIV/AIDS, to share the pains, achievements of those affected by it, both triumphant and defeated. Most importantly to raise awareness and achieve more positive results in the upcoming year. It is estimated that closer to 35 million people are living with HIV/AIDS worldwide. The theme for World AIDS Day 2014 – “Focus, Partner, Achieve: An AIDS-Free Generation” – reflects the drive to focus on interventions proven to work and to partner with a broad range of stakeholders to achieve control of the HIV epidemic and, ultimately, an AIDS-free generation.