连云港Mycoplasma DNA Detection Kit

Mycoplasma is the smallest and simplest prokaryote known to proliferate using artificial culture media, with a size range of 0.1 to 0.8 μm. Animal cells, commonly used in laboratories and the production of biological products, are prone to mycoplasma contamination during cell culture. Pharmacopeias and regulatory guidelines worldwide have established clear requirements for mycoplasma testing in the production of biological products. Traditional mycoplasma detection methods require at least 28 days of culture to yield results, which is time-consuming. The EP (European Pharmacopoeia) guidelines state that if the sensitivity of a NAT (Nucleic Acid Testing) method is comparable to that of the classical culture method, and it exhibits robustness and specificity, NAT can replace the classical culture method for mycoplasma detection. The qPCR kit provides a very fast and user-friendly solution for mycoplasma control in laboratories or on production lines.

Product Name:

Mycoplasma DNA Detection Kit

Methodology:

PCR-Fluorescent Probe

Product Code:

BP-QN08-50

Product Advantage:

1.     High Sensitivity

The Biori Mycoplasma DNA Detection Kit has a detection limit of 5 CFU/mL (containing 10⁶ cells as matrix). Internal validation tested the species of mycoplasma required by EP10-2.6.7, covering the detection of over 200 species of mycoplasma. For 10 common mycoplasma standard strains (5 CFU/mL), 24 extractions and tests were performed separately, with a detection rate of 24/24 for each. The results are shown in table below:

2.     High Specificity

The kit was validated against 27 structural analogs of mycoplasma and DNA from commonly used cell lines (HEK293, HEK293T, MRC-5, CHO, NS0, Vero, Sf9, MDCK), as well as DNA from various organisms (E. coli, Pichia pastoris, Lactobacillus acidophilus, Acinetobacter baumannii, Enterobacter aerogenes, Streptococcus pneumoniae, Streptococcus mutans, Staphylococcus epidermidis, Staphylococcus saprophyticus, Candida albicans, Campylobacter jejuni, Micrococcus luteus, Pseudomonas aeruginosa, Salmonella enterica subspecies, Streptococcus agalactiae, Staphylococcus aureus, Monascus, Propionibacterium, Staphylococcus intermedius, etc.), with no cross-reactivity observed.

3.     Convenient and Rapid Operation

a) The kit utilizes a single-tube reagent system where the extracted nucleic acid is directly added to the PCR reaction mix, eliminating the need for multiple component mixing.

b) The entire process from sample extraction to detection completion takes only 1.5 hours.

4.     Reliable System

a) The kit includes internal controls (IC) and positive controls (PC), effectively preventing false-negative and false-positive results.

b) The UDG enzyme anti-contamination system is used to minimize the risk of contamination.

5.     High Precision

The kit was tested with high, medium, and low concentration mycoplasma samples, with 10 replicates for each, and the coefficient of variation (CV%) was less than 5% in all cases.

6.     Instrument Compatibility

The Biori Mycoplasma DNA Detection Kit (PCR-Fluorescence Probe Method) is compatible with various instrument models, including but not limited to the ABI 7500, Bio-Rad CFX96, SLAN-96P, SLAN-96S, and Roche LightCycler 480 II.