Mycobacterium DNA Detection Kit (qPCR), BP-QN15, is a 50-reaction fluorescent probe qPCR kit for qualitative detection of Mycobacterium DNA contamination in biological materials. The assay includes an internal control and UDG-containing chemistry to support contamination-monitoring workflows.
Mycobacterium DNA Detection Kit (qPCR), BP-QN15
Product information published by Zhuhai Biori Biotechnology Co., Ltd.
Features
- Qualitative fluorescent probe qPCR assay for Mycobacterium DNA.
- Targets conserved regions of the Mycobacterium genome using specific primers and probes.
- Internal control can support extraction-efficiency evaluation or amplification-inhibition monitoring.
- UDG-containing chemistry helps prevent contamination from amplified products.
- Supplied as a 50 Reactions kit.
- Manual-stated detection limit: up to 10 CFU when used with BIORI nucleic acid extraction or purification reagent kits.
Application
- Qualitative detection of Mycobacterium contamination in biological materials.
- Testing of cells, cellular products, virus seed lots, virus harvest fluids, vaccines, and other biological products.
- Biopharmaceutical quality-control and contamination-monitoring workflows.
- Real-time PCR workflows using compatible instruments such as SLAN-96P, SLAN-96S, ABI 7500, ABI QuantStudio 5, Roche LightCycler 480, and Bio-Rad CFX96 systems.
Components
| Component | Specification (50 Reactions) |
|---|---|
| Mycobacterium qPCR MIX | 1.0 mL x 1 tube |
| Mycobacterium positive control | 1.5 mL x 2 tubes |
| Mycobacterium negative control | 1.5 mL x 2 tubes |
| Mycobacterium internal control | 1.0 mL x 1 tube |
| Instructions | 1 copy |
Shipping and Storage
| Condition | Recommendation |
|---|---|
| Shipping Temperature | Ship frozen or under validated cold-chain conditions that maintain the required frozen storage condition. |
| Storage Temperature | Store at -20°C or below, protected from light. |
| Shelf Life | 24 months according to the instruction manual. |
| Handling | Avoid repeated freeze-thaw cycles; do not exceed 10 freeze-thaw cycles. |
Data
Performance Data
Mycobacterium DNA Detection Kit (qPCR) | Catalog No. BP-QN15-50
A product-specific validation study evaluated analytical sensitivity and target detection across a panel of Mycobacterium strains. This upload version retains the strain-level evidence with the clearest value for product selection.
Key Performance at a Glance
| Perf |
Sele |
|---|---|
| Limi |
10 CFU/ |
| Eval |
12 stra |
| Anal |
8 eval |
| Stud |
<5% acro |
| Free |
Thro |
Analytical Sensitivity
Observed in this validation study: at 10 CFU/reaction, each of the 12 evaluated strains produced 24 positive results in 24 replicates.
| Stra |
Posi |
Stra |
Posi |
|---|---|---|---|
| M. aviu |
24/ |
M. terr |
24/ |
| M. shim |
24/ |
M. kans |
24/ |
| M. asia |
24/ |
M. scro |
24/ |
| M. gord |
24/ |
M. chel |
24/ |
| M. fort |
24/ |
M. phle |
24/ |
| M. tube |
24/ |
M. smeg |
24/ |
Target Detection Panel
Observed in this validation study: eight evaluated Mycobacterium species produced positive results in the analytical specificity assessment.
| No. | Myco |
Test resu |
|---|---|---|
| 1 | M. phle |
Posi |
| 2 | M. smeg |
Posi |
| 3 | M. aviu |
Posi |
| 4 | M. kans |
Posi |
| 5 | M. tube |
Posi |
| 6 | M. scro |
Posi |
| 7 | M. gord |
Posi |
| 8 | M. fort |
Posi |
Study Scope and Limitations
Results apply to the evaluated strains and study conditions. This selected upload version does not make a universal species-coverage claim. Users should verify performance with their own strains, matrices, and workflow.
