Verification project
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Eligibility criteria
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Result
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Detection limit
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The numbers of positives in CHO cells samples spiked with 10 CFU/mL mycoplasma was ≥23 out of 24 times.
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PASS
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Exclusiveness
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9 types of pathogenic bacteria and 4 types of cellular genomic DNA were not detected.
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PASS
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Examination range
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Philomycetes species
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174
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Free-thaw stability
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The detection kit can detect 10 CFU/mL mycoplasma spiked samples after 15 free-thaw cycles.
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PASS
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Instrument suitability
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ABI7500/Bio-Rad CFX96 instrument can detect 10 CFU/mL mycoplasma spiked samples.
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PASS
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Interfering
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CHO/293/T cell sample(5×106); cell culture supernatant; serum sample; serum culture medium sample; cell cryopreservation solution 10 CFU/mL mycoplasma spiked sample can be detected
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PASS
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Pharmacopoeia culture method concurrent verification
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Comparable to pharmacopoeia culture method detection level
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PASS
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