FDA clears rapid diagnostic test for urinary tract infections

The US Food and Drug Administration (FDA) has given BacterioScan, Inc. of St. Louis clearance to market its rapid automated diagnostic system, 216Dx, for detection of bacterial urinary tract infections (UTIs).

The system uses an advanced laser sensor to rapidly detect the formation and growth of bacterial colonies in urine within 3 hours. Manual culturing of urine samples for detection of bacteria typically takes more than 2 days to yield a result. Company officials say the quick turnaround time could help promote more judicious use of antibiotics.

"Faster detection of infection means better patient outcomes and diminishes over-prescription of antibiotics," BacterioScan President and CEO Dana Marshall said today in a company press release today. "Inappropriate and excessive antibiotic use promotes drug resistance, a serious and growing global health crisis."

The FDA issued 510(k) Premarket Notification clearance for BacterioScan 216Dx based on clinical studies of more than 3,000 patients, in which the system was able to correctly identify patients with bacterial infections with 98.6% sensitivity and correctly identify patients without bacterial infections with 99.6% specificity. The company said that level of performance matches or exceeds the current standard of care in US hospitals.

Globally, over 150 million UTIs are estimated to occur annually. They are caused by a wide range of gram-negative and gram-positive bacteria and fungi, with uropathogenic Escherichia coli being the most common causative agent in complicated and uncomplicated infections.

The company said it's also working on antimicrobial susceptibility tests and infection detection tests for other human fluids.
May 14 BacterioScan press release

Antibiotics found to be most common cause of surgery-related anaphylaxis

In the largest prospective (longitudinal) study to date, UK anesthesiologists reported yesterday that antibiotics are the most common cause of life-threatening anaphylaxis related to anesthesia and surgery, with teicoplanin spotlighted as a drug of special concern.

Scientists with the Royal College of Anaesthetists (RCoA) published the sixth National Audit Project (NAP6) report, which includes 3 years of data and involved identifying and investigating every case of life-threatening anaphylaxis that occurred in National Health Service hospitals during 1 year, reported by 3 million anesthesiologists (anesthetists). Anaphylaxis is an especially serious allergic reaction.

Antibiotics were identified as an anaphylactic trigger in 47% of cases, followed by muscle relaxants (33%), chlorhexidine (9%), and patent blue dye (5%), used in some breast surgeries. Antibiotics were given to more than half of the surgical patients to prevent infection. The findings are a bit of a surprise, as previous studies found the main culprit to be muscle relaxants, according to an RCoA news release. The authors of the report suggest that anaphylaxis caused by antibiotics may be increasing because of wider use and sensitization in the population.

In addition, the authors indicate that some antibiotic anaphylactic reactions, including deaths, could have been prevented. Teicoplanin was found to be 17 times more likely to cause anaphylaxis than other antibiotics. Teicoplanin, which is not approved for US use but is frequently prescribed throughout Europe, is regularly used for UK patients who report an allergy to penicillin. But 90% of patients who report penicillin allergy are in fact not allergic, the authors noted.

While 96% of patients survived their anaphylactic reactions, 40 had a cardiac arrest and 10 died. Report author Professor Tim Cook said, "More than 95 per cent of patients survive life-threatening anaphylaxis because of timely detection and prompt action by their anaesthetist and the wider medical team. However, our research highlights the importance of this topic and shows evidence of new and growing risk factors."
May 13 RCoA news release
May 13 full NAP6 report

Treating methicillin-susceptible Staph aureus may cost more than MRSA

A new study in Clinical Infectious Diseases has attributed a higher healthcare cost to methicillin-susceptible Staphylococcus aureus (MSSA) than to methicillin-resistant S aureus (MRSA).

Researchers led by experts from the Center for Disease Dynamics, Economics & Policy in Washington, D.C., analyzed data from 2010 through 2014 from the National Inpatient Sample from the US Agency for Healthcare Research and Quality.

They found that, in 2014, adjusted costs were significantly higher for MSSA-related pneumonia than for MRSA-related pneumonia ($40,725 average vs. $38,561) and for other MSSA-related hospitalizations compared with MRSA-related hospitalizations ($15,578 vs. $14,792). "Similar patterns were observed from 2010 to 2013," the investigators wrote, "though crude cost differences between MSSA- and MRSA-related pneumonia hospitalizations rose from 25.8% in 2010 to 31.0% in 2014." MRSA-related hospitalizations, however, had a higher adjusted death rate.

The authors conclude, "Though MRSA infections had been previously associated with higher hospitalization costs, our results suggest that in recent years, costs associated with MSSA-related infections have converged with and may surpass costs of similar MRSA-related hospitalizations."
May 12 Clin Infect Dis abstract