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Product Description
MicroSHENTEK® Fungi DNA Detection Kit is a real-time PCR (qPCR) based qualitative assay designed to detect fungal DNA contamination in cells, cell products, vaccines and related matrices. The kit is intended to be used together with the MicroSHENTEK® Fungi & Bacteria DNA Extraction Kit for sample preparation. The assay has been validated according to USP, EP, JP and Ch.P standards and demonstrates a Limit of Detection of not more than 35 CFU/reaction. The assay covers approximately 92% of known fungal species (~5,000 species/subspecies) and has been validated across a variety of matrices and tested against non-fungal species, production cell lines and engineered bacteria. The kit includes qPCR master mix components, primer/probe mix, internal control (IC), positive control (PC) and DNA dilution buffer (DDB).
Technical Specifications
| Parameter | Details |
|---|---|
| Intended use | Qualitative detection of fungal DNA contamination in cells, cell products and vaccines (used with MicroSHENTEK® Fungi & Bacteria DNA Extraction Kit). |
| Detection limit (LOD) | Not more than 35 CFU/reaction |
| Species coverage | Covers ~92% of known fungal species (approximately 5,000 species/subspecies) |
| Validation / Standards | Validated according to USP, EP, JP and Ch.P (listed references: USP<71>, EP<2.6.21>, EP<2.6.7>, EP<2.6.16>, EP<2.6.1>, JP<4.06>, Ch.P<1101>, Ch.P<0234>) |
| Total reactions per kit | Reagents for 50 reactions |
| qPCR reaction volume | 30 µL total per reaction (10 µL qPCR MIX + 20 µL sample/controls) |
| qPCR MIX composition (per reaction) | Fun qPCR Reaction Buffer 8 µL; Fun Primer & Probe MIX 1.5 µL; Fun Internal Control (IC) 0.5 µL; total 10 µL qPCR MIX (UNG enzyme 0.1 U per reaction recommended) |
| Thermal cycling conditions (recommended) | UNG treatment: 25 °C 10:00 (1 cycle); Activation: 95 °C 10:00 (1 cycle); Denaturation: 95 °C 00:15; Annealing: 55 °C 00:30; Extension: 72 °C 01:00; 45 cycles. Fluorescence read during Extension step. |
| Controls and interpretation thresholds (example) | Control acceptance criteria: NTC FAM Ct ≥ 39.00 (or no amplification). PC and PCS FAM/VIC Ct < 35.00 with effective 'S'-type amplification. Test sample positive when FAM Ct < 39.00 (at least one well) and VIC Ct <40.00 with effective 'S'-type amplification. See user guide tables for full decision matrix. |
| Instrument compatibility | Compatible with SHENTEK-96S Real-time PCR System, Roche LightCycler 480 II, and other real-time PCR systems supporting probe assays (FAM and VIC channels). |
| Reaction setup recommendation | Perform reactions with duplicate wells for each sample; include NTC, NCS, PC and PCS as controls; prepare qPCR MIX in a negative area, add samples/controls in designated laboratory areas to avoid contamination. |
Features
- High coverage: Detects approximately 92% of known fungal species (~5,000 species/subspecies) based on validated primer/probe design.
- Sensitive detection: Limit of detection ≤35 CFU/reaction when method acceptance criteria are met.
- Pharmacopoeia-validated: Assay performance validated according to USP, EP, JP and Ch.P guidance and methods.
- Complete QC controls: Includes internal control (IC), positive control (PC) and guidance for NTC/NCS/PCS to ensure run validity and detect PCR inhibition.
- Instrument flexibility: Compatible with common real-time PCR instruments (example: SHENTEK-96S and LightCycler 480 II); customizable program settings provided.
- Contamination control workflow: Recommended divided laboratory workflow (negative/sample/positive areas), UNG treatment and explicit plate-loading order to reduce contamination risk.
Applications
- Qualitative detection of fungal contamination in cell cultures
- Quality control testing of cell-derived products and biologics (e.g., vaccines)
- Sterility testing workflows per pharmacopeia guidance
- Contamination monitoring in production cell lines and biological manufacturing
Kit Contents
Fun qPCR Reaction Buffer (Part No. NNB017) — 220 µL × 2 tubes-20 °C (protect from light)
Fun Primer & Probe MIX (Part No. NNC086) — 50 µL × 2 tubes-20 °C
Fun Internal Control (IC) (Part No. NNA038) — 600 µL × 1 tube-20 °C
Fun Positive Control (PC) (Part No. NNA042) — 500 µL × 1 tube-20 °C
DNA Dilution Buffer (DDB) (Part No. NND001) — 1.5 mL × 2 tubes-20 °C
* Total: 50 reactions | Method: qPCR
Attention
• For Research Use Only (not for diagnostic or clinical use); follow MSDS and local safety procedures.
• Wear appropriate PPE: protective eyewear, mask, clothing and gloves.
• Prevent nucleic acid contamination: disinfect work area, irradiate surfaces, pipettes and tubes with UV for 60 minutes and use 75% ethanol and nucleic acid scavenger.
• Divide laboratory into Negative, Sample and Positive areas and use a single sterile desktop per area; add NTC and NCS in negative area, samples in sample area, and PCS/PC in positive area.
• Thaw kit components at 2–8 °C or on ice; vortex and briefly spin before use.
• Use RNase/DNase-free low-retention tubes and filtered tips; use recommended plate/strip types and sealing films.
• Include appropriate controls (NTC, NCS, PCS, PC) and run in duplicate; follow acceptance criteria in the user guide for Ct thresholds and result interpretation.
• UNG enzyme is recommended (0.1 U per reaction) to control carryover contamination — verify enzyme amount and compatibility with your instrument.
• If PCR inhibition or ambiguous results occur (invalid results), repeat extraction and testing or contact technical support.
Quality Management & Certifications
Quality System
Download QMSQMS (ISO, GMP)
Download CertificateQuality Advantages
View ReportQuality Control Process
Download ProcessTechnical Resources & Downloads
Frequently Asked Questions (FAQ)
Q1: What is the assay's sensitivity (limit of detection)?
The kit has been validated to a detection limit of not more than 35 CFU per reaction when run according to the instructions and acceptance criteria provided in the user guide.
Q2: Which instruments are compatible with this kit?
The kit is compatible with common real-time PCR instruments. The user guide explicitly lists SHENTEK-96S and Roche LightCycler 480 II as examples; other qPCR systems supporting probe assays (FAM and VIC channels) can be used with appropriate program setup.
Q3: How many reactions are included and what is the reaction volume?
The kit supplies reagents for 50 reactions. The recommended total reaction volume is 30 µL (10 µL qPCR MIX + 20 µL sample or control).
Q4: What controls should be included in each run?
Include a No Template Control (NTC), Negative Control Sample (NCS), Positive Control Sample (PCS) and Positive Control (PC) as specified. Run samples in duplicate and follow the Ct acceptance criteria in the user guide to validate the run.
Research Use Only
✔
Research Use Only (RUO). Assay performance validated per USP, EP, JP and Ch.P guidance. – This product is intended for laboratory research purposes only and not for clinical or regulatory diagnostic use.
✔
Not intended for use in USDA or FDA regulated diagnostic testing or official compliance testing.
When can I expect my order to ship?
Most orders are filled and shipped within 2-3 business days from the time they are received.
Our standard shipping usually take 2-5 days.
We also provide express shippping for time-sensitive deliveries.
Email contact@biofargo.com if you have any requirements.
