About CultureStat
The CultureStat System is comprised of four components: the CultureStat ampoule, the CultureStat reader, the CultureStat Database Software Program embedded on a computer, and a bar code scanner.

Compact, portable and extremely easy to use, CultureStat is designed to solve the problems inherent to the current plating methodology:

• Problem: Results not available in a timely fashion. CultureStat Solution: Conduct culture in an ampoule with a dissolving reagent rather than on an agar plate. Conducting the culture in the CultureStat ampoule allows for shorter incubation times and readings by a light spectrophotometer. A first read can be conducted within 30-60 minutes of sample collection, and a second read follows an incubation of only 2 hours for commonly-tested concentration levels. Positive/negative results can be reported to doctors in a time-relevant manner, and positive results can go to a C&S much more quickly.
• Problem: Extremely difficult for labs to test samples within 2 hours of collection as recommended by the Clinical and Laboratory Standards Institute (formerly NCCLS) guidelines because of sample custody issues including (1) infrequent collection of samples, (2) the need to transport the samples to the central lab, (3) inconsistent refrigeration of samples, (4) backlogs in the lab and (5) poor recordkeeping of sample custody prior to delivery in the lab. CultureStat Solution: Because the ampoules are read by a light spectrophotometer, testing with CultureStat can be conducted outside of the laboratory. By placing the system at locations where samples are collected, samples are tested well within the 2-hour guidelines and the other sample custody problems are resolved.  If the sample must go to a central lab, transport using the CultureStat ampoules ensures compliance with time-to-test standards.
• Problem: High percentage of false positive results. CultureStat Solution: Distinguish between log phase bacteria and lag phase bacteria by measuring both respiration and the increase in cell mass, so that samples containing only lag phase bacteria are properly called negative. In addition, because fresh samples are tested and the two CultureStat readings are conducted within 3 hours, bacterial contaminants that are not in log phase upon collection do not have time to enter log phase and cause a false positive result.
• Problem: Sample is not representative because (1) the calibrated loop only draws from the surface of the sample, (2) only 1 microliter is analyzed and (3) streaking of plate causes the microbes to adapt to a non-urine environment. CultureStat Solution: Collect a full 7 ml from the middle of the sample in the vacuum-sealed ampoule and test the entire 7 ml sample (7,000 times larger than the amount tested on the plate). The sample remains true to the previous urine environment, and the ampoule protects the sample from potential contamination.

In addition to addressing these primary issues, CultureStat provides significant improvements in patient/sample identification (utilizing methods designed to enhance HIPAA compliance by hospitals and other health care providers), required operator time, the ability to determine the presence of log phase bacteria in a mixed sample, electronic recording of results, and test controls. There are shipping and storage advantages to the CultureStat ampoule as well compared to agar plates—because the reagent in the CultureStat ampoule is freeze-dried and contained in a vacuum within the ampoule, the ampoule has a four-year shelf life and does not require refrigeration.  For information about the operation of CultureStat, click here.