Mycoplasma contamination is common in most cell culture and tissue culture laboratories. In biological drug safety control, most of pharmacopeias, including EP, USP, and JP, recommend using nucleic acid amplification testing (NAT) as a complementary or alternative method for mycoplasma release test. ResiQuant® Mycoplasma Detection Kit (Taqman) targeting the highly conserved gene fragment of mycoplasma, is able to detect approximately 202 species including the eight specified in EP 2.6.7 for the assay validation. The performance has been validated in accordance with the mycoplasma testing requirements outlined in EP 2.6.7, JP XVIII, and USP<77>. With a limit of detection (LOD) as low as 10 CFU/mL, the kit fulfills the criteria for alternative rapid detection compared with standard 28-day culture method.
ResiQuant® Mycoplasma Detection Kit (Taqman) targeting the highly conserved gene fragment of mycoplasma, is able to detect approximately 202 species including the eight specified in EP 2.6.7 for the assay validation.The limit of detection (LOD) as low as 10 CFU/mL.
The ResiQuant® Mycoplasma DNA Isolation Kit optimized the whole process of Mycoplasma DNA extraction, gives corresponding suggestions to different types of complicated sample matrix, enabling reliable isolation of trace amounts of mycoplasma DNA from variable biological samples, such as master cell bank, working cell bank, virus seed lot and cell products.
| Item No. | Product | Size | Term of validity |
|---|---|---|---|
| CRB00-0031/0032 | ResiQuant® Mycoplasma DNA Isolation Kit | 15T/30T | 12 months |
| CRB00-1011/1012 | ResiQuant® Mycoplasma Detection Kit(Taqman) | 50T/100T | 12 months |
The LOD was determined to be less than 10 CFU/mL with respect to the following mycoplasma references
| Species | Source | GC/CFU* | Positive/Total |
|---|---|---|---|
| Mycoplasma pneumoniae | ATCC 15531 | 9.4 | 24/24 |
| Acholeplasma laidlawii | ATCC 23206 | 5.1 | 24/24 |
| Mycoplasma orale | ATCC 23714 | 6.9 | 24/24 |
| Mycoplasma hyorhinis | CVCC 361 | 9.5 | 24/24 |
| Mycoplasma fermentans | ATCC 19989 | 7.1 | 24/24 |
| Mycoplasma arginini | ATCC 23838 | 10.2 | 24/24 |
| Mycoplasma gallisepticum | ATCC 19610 | 0.7 | 24/24 |
| Mycoplasma hominis | ATCC 23114 | 7.9 | 24/24 |
*The ratio of genome copies (GC) and colony forming units (CFU)
The detection limit is 10 CFU/mL
Capable of detecting approximately 202 species of mycoplasma
Adopts touch-down qPCR technology to reduce non-specific amplification and background interference, and incorporates a UNG anti-contamination system to minimize pollution caused by amplification products, thereby effectively avoiding false positives
Utilizes a dual-channel detection method, including PC (Positive Control) and RC (Recovery Control), to monitor sample recovery and matrix interference, thus effectively preventing false negatives
Validated in accordance with EP,JP and USP.
The PC plays as a critical quality control monitoring both assay sensitivity and test sample recovery. It contains both the positives for mycoplasma and recovery control, was directly applied to qPCR assay without further extraction process. The FAM channel signal indicated the mycoplasma test was effective and the Ct from its VIC channel was set as a control for the evaluation of sample recovery after DNA extraction using ResiQuant® Mycoplasma DNA Isolation Kit. Usually the less VIC Ct between the PC and test sample suggests a higher recovery from the extraction process. As the recovery is especially critical to a negative report, a valid test normally has a limited acceptable VIC Ct within the range of ± 2, which should be validated at the beginning of the assay setup based on the practical operation conditions.
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