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Spiroplasma DNA Detection Kit (qPCR), BP-QN299, provides qualitative detection of Spiroplasma contamination in biopharmaceutical materials using probe-based qPCR with an internal control.

Spiroplasma DNA Detection Kit (qPCR), BP-QN299

USD
$0.00
BP-QN299-50

Product information published by Zhuhai Biori Biotechnology Co., Ltd.

Features
  • Probe-based qPCR assay targeting conserved Spiroplasma 16S rRNA regions.
  • Internal control supports extraction-efficiency evaluation and amplification-inhibition monitoring.
  • UDG enzyme helps prevent amplification-product carryover contamination.
  • Manual-stated detection limit: up to 10 CFU/mL when used with BIORI nucleic acid extraction or purification reagent kits.
  • 50 reactions per kit.
  • Qualitative detection of Spiroplasma contamination in production raw materials and cell banks.
  • Testing of viral seeds and viral or cellular harvest solutions.
  • Testing of therapeutic cells in research-use workflows.
Component Specification (50 Reactions)
Spi qPCR MIX 1.0 mL × 1 tube
Spi Positive Control 1.5 mL × 2 tubes
Spi Negative Control 1.5 mL × 2 tubes
Spi Internal Control 1.0 mL × 1 tube
Instructions 1 copy
Condition Recommendation
Shipping Temperature Ship frozen on dry ice or with validated frozen cold-chain packaging.
Storage Temperature ≤ -18°C, protected from light.
Shelf Life 24 months. Avoid more than 7 freeze-thaw cycles.

Performance Data

Spiroplasma DNA Detection Kit (qPCR) | Catalog No. BP-QN299-50

A product-specific validation study evaluated analytical sensitivity for Spiroplasma citri, cross-reactivity with non-target DNA materials, and performance across common matrices.

Key Performance at a Glance

Selected performance summary for BP-QN299-50
Performance parameter Selected result
Limit of detection 10 CFU/mL for S. citri
Cross-reactivity panel 14 non-target DNA materials
Matrix panel 6 source-listed matrices

Analytical Sensitivity

Observed in this validation study: at 10 CFU/mL, Spiroplasma citri was detected in 24 of 24 replicates.

Analytical-sensitivity result (source Table 1)
Strain Concentration (CFU/mL) Detection rate
Spiroplasma citri 10 24/24 detections (100%)

Cross-Reactivity

Observed in this validation study: both replicates were negative for each of the 14 evaluated non-target DNA materials.

Cross-reactivity results (source Table 2)
No. Sample Replicate 1 Replicate 2
1 Hi5 Negative Negative
2 Sf9 Negative Negative
3 Clostridium sporogenes Negative Negative
4 SP2/0 Negative Negative
5 C6 Negative Negative
6 E. coli Negative Negative
7 Pseudomonas aeruginosa Negative Negative
8 Mycoplasma orale Negative Negative
9 Mycoplasma pneumoniae Negative Negative
10 Micrococcus sp. Negative Negative
11 Cutibacterium acnes Negative Negative
12 Streptococcus pyogenes Negative Negative
13 HeLa Negative Negative
14 Vero Negative Negative

Matrix Interference

The selected tables retain results for spiked matrices and their corresponding unspiked matrix controls.

Results for Spiroplasma-spiked matrices (source Table 3)
No. Matrix / medium Result 1 Result 2
1 RPMI 1640 + Spiroplasma 30.41 30.33
2 DMEM + Spiroplasma 30.34 30.37
3 Mycoplasma broth + Spiroplasma 30.11 29.76
4 DMEM (20% FBS) + Spiroplasma 29.61 29.32
5 PBS + Spiroplasma 30.25 30.35
6 DMEM (20% FBS + 10% DMSO) + Spiroplasma 30.00 29.91
7 Kit negative control + Spiroplasma 29.90 29.59
Results for unspiked matrix controls (source Table 4)
No. Matrix / medium Result 1 Result 2
1 1640 Negative Negative
2 DMEM Negative Negative
3 Mycoplasma broth Negative Negative
4 DMEM (20% FBS) Negative Negative
5 PBS Negative Negative
6 DMEM (20% FBS + 10% DMSO) Negative Negative

Study Scope and Limitations

Results apply to S. citri, the evaluated non-target panel, matrices, and study conditions. This selected upload version does not make a universal Spiroplasma coverage claim. Users should verify suitability with their own organism, sample matrix, and workflow.

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