In patients with Staphylococcus aureus bacteremia, Infectious Diseases pharmacist intervention based on the results of mecA tests resulted in a a 25.4 hour reduction in the time to optimal antimicrobial therapy, from 64.7 ± 36.8 to 39.3 ± 15.5 hours (p = 0.002), which may result in decreased mortality.
The Finnish biotechnology company Mobidiag announced the Prove-it(TM) Bacteria test that sets a world record by being able to detect 50 dangerous bacteria simultaneously - including the widespread "superbug" MRSA. This is an important milestone in the battle against infectious diseases, most importantly life-threatening sepsis. Sepsis is a growing cause of death worldwide - there are around 3 million sepsis cases annually, over 500,000 of them resulting in death. Sepsis is an infection caused by a number of micro-organisms spreading in the bloodstream. The challenge in sepsis treatment is starting adequate treatment with the appropriate antibiotics on time. Currently, the diagnostics of causative pathogen(s) needed for the antibiotic treatment decision takes 2-5 days based on blood culturing and subsequent pathogen identification. Using Mobidiag's Prove-it(TM) Bacteria, the pathogen detection is available 1-3 days earlier compared to current diagnostics. The PCR and microarray-based test takes less than three hours to complete. Achieved time saving rationalizes antibiotic treatment and improves patient outcomes and decreases mortality considerably.
Link: A Bug Rises, and With It a Company - New York Times.
Patients might not particularly like the new admission procedure at a growing number of hospitals: having what looks like an elongated Q-Tip stuck up their noses. But it smells great to Cepheid. Cepheid, a biotechnology company in Silicon Valley, sells a rapid genetic test to detect MRSA, an antibiotic-resistant “superbug” that has received considerable media coverage and kills more Americans than AIDS. With fear of the germ rising, and some states calling for mandatory screening, hospitals are snapping up Cepheid’s product in order to test incoming patients by using it with a nasal swab.
Cepheid (Nasdaq: CPHD - News) today announced that Health Canada has issued a medical device license for the Xpert(TM) MRSA test for the rapid detection of Methicillin Resistant Staphylococcus aureus (MRSA) on nasal swabs and the GeneXpert� System. Xpert MRSA test results are available in approximately 70 minutes thereby enabling rapid identification of carriers of the potential pathogen in less than two hours, from the acquisition of the patient sample to returning the result to the floor.
Link: AMNews: Jan. 28, 2008. Rapid MRSA test gets FDA OK ... American Medical News.
Those working to control the spread of methicillin-resistant Staphylococcus aureus say this task is about to get easier. In January, the Food and Drug Administration approved the first blood test that can differentiate it from the methicillin-susceptible variant in two hours, rather than the 24 to 48 hours or longer that currently available technology takes. "[This] test is good news for the public health community," said Daniel G. Schultz, MD, director of the FDA's Center for Devices and Radiological Health. The BD GeneOhm StaphSR Assay assesses a blood sample for genetic material specific to the two main forms of these bacteria. Studies leading to the test's approval found that it could identify 100% of MRSA samples and 98% of the susceptible types. According to an FDA statement, this test should be used in patients already suspected of having a staph infection but not to monitor treatment or initially detect it. Doctors still might have to conduct follow-up testing to pin down precisely what will kill particular bacteria, but physicians say the information provided by this product will be enough to narrow down treatment choices early on.
Link: Superbug test approved, cuts days off MRSA diagnosis.
This new rapid PCR test could not only save millions in terms of healthcare costs, it should allow physicians to control an outbreak of MRSA by breaking the chain of transmission. It works by using real-time polymerase chain reaction (PCR) for the amplification of MRSA DNA, detecting the amplicon linking the staphylococcal cassette chromosome mec (SCCmec) carrying methicillin-resistance (mecA) with a sequence unique to S. aureus found in the orfX gene. Unlike most PCR tests, it does not require dedicated equipment and space and can be performed without a dedicated clean area. "This allows for more appropriate isolation procedures and agent-specific antimicrobial therapy, resulting in reduced patient morbidity and mortality as well as an overall reduction in healthcare costs," said Dr Thomas Davis, Director of Clinical Microbiology, Wishard Memorial Hospital, US. The assay works directly with blood cultures and requires less technologist time than traditional microbiology assays, which can take two days to get results. BD has also submitted subsequent nasal swab and wound applications to the FDA. The firm is also developing tests for the detection of two other organisms that cause severe HAIs. These tests will identify the vanA and vanB genes associated with vancomycin-resistant enterococci and the toxin gene associated with Clostridium difficile.
Link: FDA OKs 1st Quick MRSA Blood Test.
The FDA today announced that it has cleared for marketing the first rapid blood test for MRSA (methicillin-resistant Staphylococcus aureus), a drug-resistant staph bacterium that can cause deadly infections. The new MRSA blood test -- called the BD GeneOhm StaphSR assay -- delivers results in two hours. Other tests take several days. "The BD GeneOhm test is good news for the public health community," the FDA's Daniel Schultz, MD, says in a news release. The new test allows for "more effective diagnosis and treatment," says Schultz, who directs the FDA's Center for Devices and Radiological Health.
Link: Small Times - VA hospitals to get easier access to Cepheid's MEMS-based test kits.
Cepheid Inc. (Nasdaq: CPHD) says it has received two Veterans Affairs Federal Supply Service Schedule contracts for the company's GeneXpert System and the Xpert MRSA test for the rapid detection of Methicillin-resistant Staphylococcus aureus, a type of bacteria that is resistant to the most-common antibiotics used in hospitals. The two contracts are expected to streamline the acquisition process and ensure VA hospitals and other federal agencies can purchase GeneXpert Systems and Xpert MRSA test kits without individual negotiations as they await funding for the next fiscal year, the company said in a news release. The kits use microfluidic technology.
Link: HighWire Press -- Medline Abstract.
The study is a prospective two-period cross-over study set in 7 surgical wards covering different surgical specialities. A total of 10,000 patients > 18 years will be tested over 16 months. The only difference between the two study periods is the method used for the detection of MRSA in each ward (rapid v conventional culture), with all other infection control practices remaining consistent between the arms. The study has been designed to complement routine practice in the NHS. Outcomes are MRSA cross-infection rates (primary outcome) and need for antibiotic therapy and MRSA-related morbidity. Parallel economic and modelling studies are being conducted to aid in the interpretation of the results and to evaluate the cost-effectiveness of the rapid PCR screening strategy. DISCUSSION: This paper highlights the design, methods and operational aspects of a study evaluating rapid MRSA screening in the surgical ward setting.
Link: New Data Presented Confirms The Efficacy And Value Of Rapid MRSA Detection Test, UK.
The recently launched culture based rapid MRSA test demonstrates continued efficiency and reliability in the fight against Methicillin-resistant Staphyloccocus aureus (commonly referred to as MRSA), according to a UK study presented at the Infectious Diseases Society of America 45th annual meeting1. The study confirms that the 3M BacLite rapid MRSA test provides consistent, fast and accurate results as the first rapid culture test that can effectively and reliably detect the absence of MRSA in just five hours. The multi-centre study based on results from three hospitals in the United Kingdom processed 458 nasal and groin MRSA screening swabs using the 3M BacLite rapid MRSA test, a five-hour culture-based test that detects the potentially deadly bacteria direct from clinical specimens. Of the 248 nasal screening swabs analysed, results demonstrated a diagnostic sensitivity of 94.6% and a diagnostic specificity of 96.9%. >From the 210 groin swabs, the 3M BacLite rapid MRSA test provided a diagnostic sensitivity of 95.9% and a diagnostic specificity of 88.8%1.
A short introduction from Dave Roberts
This 12 minute introduction will help you grasp the key facts and the key issues surrounding drug resistant staph aureus (mersa, mursa)
