Applications

 

Who can use CultureStat® ?

, Urinary Tract Infection (UTI) is a significant health problem. It is the number one cause of infection in woman worldwide. It is estimated that 250 million UTIs1 occur yearly world-wide and 21  million cases in the US.  As reported by the American Urological Association, UTI accounts for more than $6 billion in health care expenditures. In pre-menopausal women in the U.S., an annual estimated incidence of UTI is 0.5 – 0.7/person/year. In Medicare beneficiaries 65 years or older, UTI’s account for 1.8 million office visits2 and millions of  tests are used to assist Providers in diagnosing UTI’s each year.

Current regulations and guidelines mandate urine specimens be tested, regardless of method of collection, within 2 hours of harvest.

Since CultureStat is a broth based Point of Care  testing system, samples can be tested within minutes of harvest. This ability maintains the integrity and quality of the urine specimen being tested and provides greater accuracy in reducing false negative results than results from specimens that have violated the 2 hour time limit.

The American Medical Association (AMA), The American Society of Microbiology (ASM) and the American Clinical Laboratory Association  all state urine must be tested within 2 hours of collection to be scientifically significant.  Urine tested outside this time frame is considered invalid and the test results deemed unreliable according to these organizations.  Most of the urine being tested for bacteriuria in the United States fails to meet this guideline.  Although the results from these invalid tests are used everyday in clinical settings these results put patient’s at greater risk. Many results are incorrect yielding false negatives and false positives due to the extended time period that elapses prior to testing.

CultureStat is a Point of Care testing system designed to be used on-site wherever the need for an accurate, rapid test for the absence or presence of infectious bacteria in urine is required. It can be used at the Point of Care by any healthcare Provider.

While Urologists, Obstetricians/Gynecologists, General Practitioners, Family Practice Physicians and Urgent Care Centers treat the majority of  UTI’s outside of a hospital setting, CultureStat can be a valuable tool for any healthcare Provider requiring rapid, accurate Point of Care bacteriuria test results as part of  their patient’s UTI diagnosis.

Point of Care locations include:

  • Urologists                            
  • Ob-Gyn                                    
  • General Practice                 
  • Family Medicine                
  • Urgent Care Center             
  • Retail Health  Clinic         
  • Emergency Department
  • Hospital Laboratory   
  • Assisted Living Facility   
  • Women’s Health Center 

There is significant need for a cost effective test to be used as part of the diagnosis of UTI’s offering greater accuracy than reagent test strips, faster result time than agar plating and lower cost than quantitative polymerase chain reaction (qPCR) or other high cost methods. These users can benefit from CultureStat’s ability to provide highly accurate results at the Point of Care with a cost effective, rapid test.

1 Ronald AR, Nicolle LE, Stamm E, et al. Urinary tract infection in adults: research priorities and strategies. Int J Antimicrob Agents. 2001;17(4):343–348.
2American Urological Association, AUA Case Study: Urinary Tract Infection, pg. 2 (orig pblshd March 2013, amended July 2016)