Spiroplasma DNA Detection Kit

This kit is based on the fluorescence quantitative PCR method and is designed with primer probes targeting the conserved sequences of spiroplasma. It is used in conjunction with the nucleic acid extraction or purification kit (i-magnetic bead method) from Zhuhai Baorui Biotechnology Co., Ltd. to rapidly and qualitatively detect potential spiroplasma contamination in production raw materials, cell banks, virus seeds, virus or cell harvest fluids, and therapeutic cells.

Comprehensive verification of detection limit, specificity and durability was carried out strictly in accordance with the relevant requirements of EP2.6.7 for mycoplasma detection, and it can detect an equivalent genome of 10CFU/mL or as recommended by regulatory guidelines.

This kit, when used in conjunction with the nucleic acid extraction or purification kit from Baorui Biology, can complete the test in as fast as 1.5 hours.

1. Detection limit

The standard strain of spiroplasma (10 CFU/mL) was detected, with 24 replicates for each sample, and the detection rate was no less than 95%.

Figure 1: Amplification diagram of the detection limit of spiroplasma

2. Summary of the performance of the reagent kit products

Performance Summary of Spiroplasma DNA Detection Kit