Microbial Culture Test

Timothy Mattimore of MicroBionetics explains the CultureStat Rapid UTI Detection System.

“CultureStat results are extremely accurate despite the short testing cycle”
-Timothy Mattimore

What is the CultureStat Rapid UTI Detection System?
Timothy Mattimore. The CultureStat Rapid UTI Detection System is a true microbial culture test that uses a vacuum-sealed ampoule containing growth media and indicator and is also a small, automated, multi-wavelength light spectrophotometer connected to a computer to detect and measure bacterial growth in a urine sample. CultureStat reduces typical urine culture testing time for UTI detection from 24-48 hours to two hours or less.

The ampoule is twisted with its tip in a urine sample – this breaks the vacuum seal and fills the ampoule with 7 ml of urine. Once at the laboratory, the ampoule is placed in the spectrophotometer, called the CultureStat Reader. The operator clicks the appropriate button on the computer screen, which prompts the CultureStat Reader to perform two simultaneous readings and automatically send the data to the computer. Following a 60-minute incubation, a second set of readings is conducted in the same manner. The CultureStat Database Software Program analyzes the data, displays the results and records all data in an easily searchable format. 

Because CultureStat measures both cell mass increase and respiration of bacteria within the sample using two wavelengths of light with very high sensitivity, CultureStat results are extremely accurate despite the short testing cycle. The advanced testing methodology also enables CultureStat to distinguish between bacteria in log phase and bacteria in lag phase. The equipment is extremely inexpensive, and the cost per test using CultureStat is less than current laboratory testing methods.

How can CultureStat aid in the detection of hospital-acquired infections?
TM. Because Medicare no longer reimburses for the treatment of catheter-associated urinary tract infections, hospitals are seeking accurate, efficient methods for testing both present-on-admission (POA) urinary tract infections as well as hospital-acquired infections (HAIs) for patients who receive catheters during the hospital stay. CultureStat is the perfect solution for testing for POA infections and HAIs for the following reasons: CultureStat requires very little operator time (15-30 seconds per sample), testing is extremely easy to complete, initial results on fresh samples are available in less than a minute, and are confirmed in one hour, and all results are automatically stored in the CultureStat Database, eliminating the need for additional recordkeeping.

Can CultureStat be used for the screening of all urine samples sent to the laboratory for microbial analysis?
TM. Absolutely. Statistically, 75-85 percent of all urine culture samples tested in laboratories are negative. Laboratories have struggled for years to find an accurate, efficient and cost-effective way to properly screen negatives so that microbiologists can concentrate their efforts on the C&S of positive samples. Because CultureStat is a true culture test, it can accurately screen out the negative samples in less than two hours and cut the volume of samples that go to plate by 75-85 percent. By using CultureStat instead of first-round plates, negatives can be determined and reported a day earlier, and positives can rapidly go to C&S.  Laboratories operate more efficiently, and hospitals can test, treat and discharge patients more quickly.

A significant issue regarding the accurate testing of urine samples is the time elapsed between sample harvesting and the initiation of testing. How does CultureStat deal with this issue?
TM. This is a huge problem – a large majority of samples tested far exceed the consensus two-hour time-to-test standard. Most hospital laboratories receive samples both from within the hospital and from outside sources. Some samples are chemically preserved, some are not, and rarely do laboratory personnel know how old a sample is when it arrives. The CultureStat Ampoule serves both as the transport and testing vessel.  Because the testing process begins as soon as a CultureStat Ampoule is filled, facilities can easily become compliant with time-to-test standards by filling CultureStat Ampoules at collection sites and using the ampoule as the transport vessel. The sample is preserved within the ampoule during transport without chemical alteration, and can be rapidly analyzed using the CultureStat Reader when it arrives at the lab. Costs are further reduced because extraneous transport and preservation materials are not required. 

Timothy Mattimore is a Managing Member of MicroBionetics, LLC, and serves as Director of Legal and Regulatory Affairs. Before entering the world of medical devices, he practiced corporate and securities law in New York City and in Wilmington, Delaware. Mattimore is a graduate of Georgetown University’s College of Arts and Sciences and the Georgetown University Law Center, and is a member of the New York Bar.