Table 1 Comparison between commercial kits and in-house developed methods for mycoplasma detection.
Parameter | Biofire Mycoplasma (Biomérieux) | Commercial PCR Kits (e.g., Lifetech MycoSeq (Thermofisher), MycoTOOL (Roche), VenorGEMq oneStep (Minervabiolabs), MicroSART® (Sartorius)) | In-house developed qPCR or ddPCR method |
|---|---|---|---|
Commercial Analytical Kit | Yes | Yes | No |
Compliance with EP 2.6.7 | Yes | Yes | According to the validation performed |
Sensitivity | <10 CFU/mL (as stated by the supplier) | <10 CFU/mL (as stated by the supplier) | According to the validation performed |
Method Validation | * Validation performed by the supplier across the entire test, including the extraction kit. * In-house validation required: detection limits and no interference with each matrix used. | * Validation performed by the supplier across the entire test, including the extraction kit and thermocycler. * In-house validation required: detection limits and no interference with each matrix used. | * Full validation to be performed by the laboratory, in accordance with ICH Q2 guidelines. * This validation will include no interference with each matrix used. |
Number of Strains Detected | >120 strains | Between 70 and 140 strains depending on the kit | At least the strains recommended by the EP. According to method validation. |
Specific Equipment Required | Yes However, if the thermocycler used is not the one used for validation by the supplier, more extensive in-house validation will be required | No | No |
Implementation Difficulties | + | +/++ | +++ (related to method validation) |
Time from sample to result | 1-hour assay | Under 5 h | Under 5 h |
Cost | +++++ | ++ | + |
