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

Compact, portable and extremely easy to use, the CultureStat System 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 seconds of sample collection, and a second read follows an incubation of only 1 hour for commonly-tested concentration levels. Older samples can be tested following an initial 1 hour incubation. Negative results can be reported to doctors within an hour or two, and positive results can be analyzed and identified by species 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 the CultureStat System 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.
• Problem: High percentage of false positive results. CultureStat Solution: Distinguish between log phase bacteria and lag phase bacteria by measuring the increase in both cell mass and cell numbers, 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 1-2 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, the CultureStat System provides significant improvements in 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 the system, click here.