Performance evaluation of ABI7500+BKV-DNA detection system
Objective To verify the performance of the ABI7500+BKV-DNA detection system and evaluate whether it meets the requirements.Methods According to the requirements of the China National Accreditation Service for Conform-ity Assessment(CNAS)series of documents,verify the accuracy,precision,linear range,minimum detection limit,spe-cificity and other performance parameters of the ABI7500+BKV-DNA detection system.Results The accuracy of the ABI7500+BKV-DNA detection system meets the requirements,with intra batch precision of 3.11％and 1.93％,and inter batch precision of 3.82％and 2.20％,respectively.The accuracy meets the requirements.Linear analysis through validation experiments,with a minimum detection limit of 2.0 x 103 copies/mL.Conclusion The accuracy,precision,linear range,minimum detection limit,specificity,and other performance parameters of the ABI7500+BKV-DNA detec-tion system meet the requirements of relevant standards,making it the preferred method for clinical detection of BKV.
BKV related nephropathyBK virusBKV infectionAccuracyPrecisionLinearBKV-DNA
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