This kit employs the PCR fluorescence probe method. Primer probes are designed for the conserved sequence of the 18S gene coding region of fungi to qualitatively detect fungal DNA in samples. This kit, when used in conjunction with Zhuhai Baorui's Bacterial & Fungal Nucleic Acid Extraction or Purification Kit, can complete the test 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, Aspergillus Niger and Candida albicans 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
Figure 1 Amplification curve of the fungal DNA detection kit
2. Specificity
Cross-reaction is used to determine the DNA of common cell lines, common bacteria, mycoplasma, etc. with this kit The selected cross-species DNA (MDBK, PK15, CHO, HEK293T, C6, CRFK, SF9, Human, Pseudomonas aeruginosa, Staphylococcus aureus, Escherichia coli, Mycoplasma pneumoniae) had no cross-reaction with the fungal DNA detection reagent.
3. Summary of the performance of the reagent kit products
Table 2: Performance Summary of Fungal DNA Detection Kits
The above data is for reference only. For specific product performance indicators, please refer to the performance verification report of the corresponding item number.
