Fungi Detection Kit (qPCR Method) | Rapid Detection​ | Yocon Cell

Product Features

• Rapid Results

  Delivers qualitative detection of fungal contamination in just 2 hours, enabling quick decision-making and reducing turnaround time for critical samples.

• Broad-Spectrum Fungal Detection

  Capable of detecting approximately 500 types of fungi, including clinically relevant species like Candida albicans, Aspergillus niger, Candida tropicalis, Candida glabrata, Penicillium, and Trichoderma, ensuring comprehensive coverage.

• High Sensitivity

  Verified detection limit of 50 CFU/mL for common fungal contaminants such as Candida albicans and Aspergillus niger, ensuring even low levels of contamination are identified.

• Specific Fluorescent Probes

  Utilizes FAM and HEX fluorescent probes to specifically target fungal sequences and an internal control, providing clear and unambiguous detection signals.

• Internal Control Assurance

  Includes an internal control to monitor the entire PCR process, effectively ruling out false-negative results due to inhibition or reaction failure.

• No Cross-Reactivity

  Engineered to show no cross-reaction with common mammalian cells (e.g., stem cells, NK cells, 293 cells), ensuring that results are specific to fungal contamination and not influenced by host DNA.

Product Advantage

• Quick test results:

  with our own supporting extraction kit, the test results can be obtained in as fast as 2 hours.

• High sensitivity:

  the detection limit of Candida albicans and Aspergillus niger is not greater than 10 CFU/mL.

• Compliance with regulatory requirements:

  The performance of the kit has been validated by referring to the "Pharmacopoeia of China 1101 Sterility Test", the "Pharmacopoeia of China 9201 Guidelines for Verification of Alternative Methods for Microbial Testing of Drugs", the "Japanese Pharmacopoeia <2.06>", and the "United States Pharmacopeia <71>".

• Flexible Compatibility:

  Our system offers two performance-grade kits tailored for different scenarios. These can be paired with our proprietary nucleic acid extraction kits (Lot Numbers: MK0103-50, MK0104-50) to handle various sample types including cell suspensions, culture media, and biological products. The Broad-Spectrum Kit requires pairing with the extraction kit (Lot Number: MK0104-50) for optimal performance.

Product Application

• Cell Culture Quality Control

  Indispensable for routine screening of cell culture media, serum, reagents, and established cell lines to prevent and identify fungal contamination that can compromise experimental integrity and research outcomes.

• Biological Product Safety Testing

  Crucial for the quality assurance of biopharmaceutical products, vaccines, gene therapies, and cellular therapies before clinical use or commercial distribution, ensuring product purity and patient safety.

• Research and Development

  Supports R&D efforts by providing a quick and reliable method to verify the sterility of new media formulations, culture systems, or experimental samples, enabling faster progression of research projects.

Performance verification 1. Comparison with culture method sensitivity verification (data from specific fungal detection kit)

The culture methods for Aspergillus niger and Candida albicans, which are required to be validated by the sterility test method in two Chinese pharmacopoeias (1101), were compared with this kit. Nucleic acid extraction was performed using Youkang Nucleic Acid Extraction Kit (Lot: MK0104-50). The sensitivity of this kit for detecting these two fungi is ≤10 CFU/mL extraction, with sensitivity reaching 6 cfu/mL for Aspergillus niger and 2 cfu/mL for Candida albicans. (The broad-spectrum version of the nucleic acid can achieve the same sensitivity)

Performance verification 2. Durability verification (wide-spectrum version of fungal detection kit verification data)

After configuring the detection system without adding samples, the following treatments were performed: immediate machine loading, room temperature (approximately 25℃) storage for 3 hours, and 4℃ refrigeration storage for 3 hours before sample addition. Compared to immediate machine loading, the Ct values for two-channel detection showed no significant difference in the latter two treatments (with fluctuations observed at low concentrations). However, the fluorescence curve of the FAM channel in the reaction system showed a marked decrease when stored at room temperature.

If the system configuration is carried out first, and the operation of extracting and adding samples to the machine is carried out, it is recommended to place the detection system in 4℃ and carry out amplification as soon as possible after adding samples.

Note: The figure shows the amplified curve of the positive control diluted 10 times in two channels. Blue is the FAM channel and green is the HEX channel.

Performance verification 3 repeated stability test

Three batches of specific fungal detection kits were used, and three personnel operated according to the instructions, and magnetic bead extraction kit (MK0103-50) was used to extract fixed bacterial strains. This kit could stably detect Candida albicans and Aspergillus niger at 50 CFU/mL.

Inspector I

Inspection Officer II

Inspection Officer III

* For other relevant experimental verification, please refer to the Technical White Paper of Yocon Biological Products