The U.S. Food and Drug Administration (FDA) announced on
Wednesday it has given clearance for the first rapid blood test for
the drug-resistant staph bacterium known as MRSA
(methicillin-resistant Staphylococcus aureus).
The test, called the BD GeneOhm StaphSR Assay, is manufactured
by BD Diagnostics, a subsidiary of BD in New Jersey. It can deliver
test results in two hours, said the federal health agency.
Methicillin is an antibiotic that has been used successfully to
treat infections from the Staphylococcus aureus bacterium. Over the
years, the staph bacterium mutated and spawned MRSA, a strain of
staph bacterium that is resistant to methicillin and which has a
higher fatality rate.
The new test uses molecular methods to identify whether a blood
sample contains genetic material from the MRSA bacterium or the
more common, less dangerous staph bacterium that can still be
treated with methicillin.
Clinical trials show that it can identify 100 percent of the
MRSA-positive specimens and more than 98 percent of the more
common, less dangerous staph specimens.
"The BD GeneOhm test is good news for the public health
community. Rather than waiting more than two days for test results,
health care personnel will be able to identify the source of a
staph infection in only two hours, allowing for more effective
diagnosis and treatment," said Daniel G. Schultz, director of the
FDA's Center for Devices and Radiological Health.
Staph infections occur most frequently among persons in
hospitals and health care facilities who have weak immune systems.
Both types of bacteria can also infect healthy people.
Distinguishing between the two sources of infection is
criticalto successful treatment. The more common, less dangerous
strain of staph results in infections that are generally mild and
affect the skin with pimples or boils that can be swollen, painful
and drain pus.
However, the MRSA staph bacterium is difficult to treat with
ordinary antibiotics and can cause life-threatening conditions such
as bloodstream infections, surgical area infections or
pneumonia.
(Xinhua News Agency January 3, 2008)