Our innovative urinary tract infection assay system is able to identify and quantify 16 different gram-negative bacteria, 7 gram-positive bacteria and 6 fungal species alongside 9 of the most important antibiotic resistance genes to cover a vast majority of uropathogens with a sensitivity and specificity far beyond what can be achieved with traditional culture techniques with a turnaround time of mere hours rather than days. What’s even more exciting is that our proprietary algorithmic match system is capable of producing an antibiotic treatment plan with a comprehensive selection of drugs ranked in order of effectiveness rather than just a single treatment choice other competitors currently offer making even the most complex multi-organism infection with multi-drug resistance capable of being treated at the community-based level without the need of an infectious disease specialist. Our algorithms are continuously updated and refined with newly published data and the aid of advanced machine learning.

APRIL 2023

THE MOLECULAR ADVANTAGE

Urinary tract infections (UTIs) are among the most common infections in humans, with and estimated seven million patient visits and a cost of $1.6 billion USD per year.

Interestingly, urine culture was not developed to diagnose UTIs, but rather to identify patients at risk for pyelonephritis. As early as 1963, physicians recognized the need for improved methods of diagnosing bacteriuria. Nevertheless, urine culture is still considered the gold standard for diagnosing UTI.

The development of molecular diagnostic techniques has improved the speed of detection of infectious diseases, most notably during the coronavirus pandemic. Polymerase chain reaction (PCR) based molecular diagnostic techniques are widely used in clinical laboratories and physician offices around the world resulting in improved medical treatment and patient outcomes for numerous ailments.

By Dr. Brian Kelly, J Mass Spectrom Adv Clin Lab. 2023 Apr; 28: 60–62.

DECEMBER 2022

CHALLENGING THE UTI TESTING GOLD STANDARD

Though women and older adults are most vulnerable, many people will experience a urinary tract infection (UTI) during their lifetimes. These common infections of the urinary system impact the kidneys, bladder, or urethra. In the United States alone, UTIs account for more than 8 million doctor visits each year . Though not typically life threatening, UTIs can cause serious complications if left untreated and UTI-related hospitalizations cost an estimated $2.8 billion annually in the United States .

For patients with UTIs, antibiotics are the most prescribed treatment . However, suspected UTI is one of the most common causes of inappropriate antibiotic prescribing in inpatient settings . During a recent webinar, speakers from Acutis Diagnostics, Inc. discussed the benefits of polymerase chain reaction (PCR) testing for diagnosing UTIs compared to standard urine culture. Given the prevalence of UTIs, it’s important that patients receive the right diagnostic test so they can be prescribed the most appropriate treatment.

Urine culture is one of the most widely used diagnostic tests in healthcare and is currently considered the gold standard for diagnosing UTIs . Still, this gold standard is not without its drawbacks, according to Dr. Becky Winslow, BS, PharmD, Clinical Science Liaison at Acutis. While presenting, Dr. Winslow dove into the challenges posed by culture. “The standard urine culture was not actually validated for use in identifying lower urinary tract microorganisms. Yet for more than 60 years, the medical community has relied upon the standard urinary culture for identifying urinary pathogens,” said Dr. Winslow.

According to Dr. Winslow, urine cultures can result in a high number of false negatives. They are biased to grow E-coli, rather than detect slow growing organisms, fastidious and nonaerobic organisms, or most gram-positive organisms. Ultimately, the culture can miss many bacterial species, which can prevent patients from being prescribed the appropriate treatment. Previous exposure to antibiotics can also skew a culture’s results, and polymicrobial infections can be misinterpreted as sample contaminations. Additionally, the culture has a long turnaround time – taking up to 72 hours for a result.

“This has led to undiagnosed and misdiagnosed urinary tract infections, as well as antimicrobial resistance,” said Dr. Winslow.

By Thermofisher Scientific, Dec 15, 2022

MARCH 2023

UROLOGY TIMES: THE STATUS AND FUTURE DIRECTION OF ADVANCED URINE TESTING: MULTIPLEX PCR

More than half of adult women in the United States will have at least urinary tract infection (UTI) with an estimated annual cost burden of $1.6 billion. Among these women, 25% to 50% will develop recurrent UTI (rUTI), which is defined as at least 2 infections in a 6-month period or at least 3 in 1 year. The gold standard for UTI diagnosis is urinalysis and standard urine culture (SUC), where a positive result is defined as 105 colony forming units (CFU). Yet SUC has many shortcomings, including a false negative rate of 20% to 30% among symptomatic subjects.

SUC with final speciation and antibiotic susceptibility testing (AST) can take up to 3 to 5 days, and this does not include assessment for fastidious, anaerobic, and fungal biota, which requires additional time and cost. Lastly, it is established that a urinary microbiome exist. This adds significant complexity to balancing the under- and overdiagnosis of UTI, but it also aids in better understanding the polymicrobial nature of UTI, pathologic microbiomes, and the creation of facultative resistant biofilms. For these reasons, newer technologies, such as polymerase chain reaction (PCR) testing, have been developed to aid in the diagnosis of UTI.

By Stephanie Gleicher, MD, MPH and Roger Dmochowski, MD, FACS