This kit employs the PCR fluorescence probe method. Primer probes are designed specifically for the coding region sequence of the 16S gene in bacteria to qualitatively detect bacterial DNA in samples. This kit, when used in conjunction with Zhuhai Baorui's Bacterial & Fungal Nucleic Acid Extraction or Purification Kit, can complete sample extraction and detection in as fast as 1.5 hours.
This kit has undergone comprehensive methodological validation in accordance with relevant regulations, guidelines and other document requirements, and can provide performance validation reports.
1. Detection limit
In accordance with the requirements of the recommended strains for sterility testing in the Chinese Pharmacopoeia, 9 strains were purchased from the National Institutes for Food and Drug Control/Chinese Medical Bacterial Collection Center. After subculture and counting, they were used as standard bacterial solutions for the assessment of the detection limit.
Table 1 Information of Standard Strains and Sensitivity Verification
Figure 1 Amplification curve of the bacterial DNA detection kit
2. Specificity
Cross-reaction is that when this kit is used to determine the DNA of common cell lines, common fungi, mycoplasma, etc., the selected cross-species DNA (MDBK, PK15, CHO, HEK293T, C6, CRFK, Sf9, Human, Candida albicans, Aspergillus Niger, Mycoplasma pneumoniae) has no cross-reaction with the bacterial DNA detection reagent.
3. Summary of the performance of the reagent kit products
The above data is for reference only. For specific product performance indicators, please refer to the performance verification report of the corresponding item number.
