Contributing to cell safety!
Aseptic testing is generally required to be conducted using the final processed product as the test specimen, based on the aseptic testing method specified in the Japanese Pharmacopoeia General Test Method (4.06). This testing method requires a culture period of more than 14 days to obtain results. On the other hand, for specific cell processing products, it is desirable to obtain the results of the aseptic test before administration to the patient. However, due to the time required to obtain results from the pharmacopoeia-compliant aseptic test, it is often the case that test results are determined after administration. Additionally, for specific cell processing products, due to limitations such as the amount of specimen available and the time required for testing, it may not be possible to apply the aseptic testing method compliant with the pharmacopoeia. In such cases, consideration may be given to the "Rapid Microbial Testing Method" (as referenced in the 18th revision of the Japanese Pharmacopoeia). Our company has developed a rapid aseptic testing method using PCR that covers a wide range of microorganisms, including not only those listed in the pharmacopoeia but also environmental bacteria and human-derived bacteria, allowing for detection in a short time.
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basic information
The greatest feature of the sterile testing reagents developed by our company is the availability of two protocols: the "Rapid Testing System," which provides results in about 4 hours, and the "High Sensitivity Testing System," which allows for more sensitive measurements through pre-culturing. The "Rapid Testing System" involves PCR measurement after sample preprocessing and nucleic acid extraction, confirming the presence of microbial nucleic acids in the sample. The sensitivity is 100 CFU/mL, and the testing time is approximately 4 hours from sample preparation to measurement, allowing results to be obtained on the same day. However, there is a possibility of false positives due to nucleic acids from the sample or the environment, as well as the potential to detect dead bacteria in the sample. The "High Sensitivity Testing System" involves pre-culturing using a specially formulated medium, followed by sample preprocessing, nucleic acid extraction, and PCR measurement, observing changes in nucleic acid quantity due to microbial growth during the pre-culturing period. The testing time is approximately the pre-culturing period plus 4 hours, but the detection sensitivity is very high at <10 CFU/mL (theoretically 1 CFU/mL), making it a detection method that is less likely to be affected by false positives from sample or environmental nucleic acids and the influence of dead bacteria.
Price range
P3
Delivery Time
P3
Applications/Examples of results
The bacterial gene detection kit BactFinder and the fungal gene detection kit FungiFinder both have a capacity for 50 tests. Our developed sterile testing reagents have two distinctive features: 1. Includes PCR 8-tube caps and 1.5mL tubes for reagent preparation. Since our reagents use nucleic acid amplification methods, the materials and operating environment can easily affect the measurement results. To reduce unintended contamination, we recommend using the included PCR tube caps and reagent preparation tubes (which have been treated for cleanliness). 2. Introduction of Internal Control DNA (IC). By adding IC during the sample processing stage, it is possible to monitor the success of nucleic acid extraction and PCR inhibition while simultaneously determining the sample's negative or positive status.
Detailed information
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Two protocols: rapid testing system and high-sensitivity testing system.
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Pre-treatment protocol to reduce the impact of environmental bacteria and dead bacteria.
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Pre-culture protocol enabling high-sensitivity detection
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Company information
"Creating new businesses through open innovation, providing services and standards globally online." Shimadzu Diagnostics Co., Ltd. is a company engaged in the development of a wide range of products, including diagnostic reagents that meet diverse needs in clinical testing and industrial reagents that support hygiene management in the food industry. We are committed to providing high-quality products and services more quickly to meet our customers' expectations.
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