T/BSAS 003-2025 Animal drug residue colloid gold immunochromatographic rapid detection product evaluation and performance validation specification

Scope

This evaluation refers to the "Technical Specifications for the Evaluation of Food Rapid Detection Methods" issued by the National Medical Products Administration in March 2017, which stipulates the evaluation indicators, evaluation methods, evaluation steps, experimental testing, evaluation results, and report issuance of food rapid detection methods. Technical indicators include sensitivity, specificity, false negative rate, false positive rate, and consistency analysis with reference methods. It also references the technical evaluation specifications for rapid detection products of veterinary drug residues in Jiangxi Province, Hubei Province, Shenzhen City, and Qinhuangdao City to establish a technical evaluation method for rapid detection products of veterinary drug residues. Specific technical requirements include: detection limit and sensitivity, false negative and false positive rates, specificity, detection time, and calculation of evaluation indicators. Detection limit and sensitivity: The detection limit of rapid detection products should not exceed the national limit values or the detection limit of reference methods, that is, the maximum residue limit (for restricted drugs) or the detection limit of reference methods (for prohibited drugs). Sensitivity is expressed as the probability of detecting a positive result in a positive sample (expressed as a percentage). False negative and false positive rates: The false negative rate is expressed as the probability of detecting a negative result in a positive sample (expressed as a percentage). False positive rate is expressed as the probability of detecting a positive result in a negative sample (expressed as a percentage). Specificity: Specificity is expressed as the probability of detecting a negative result in a specific sample (expressed as a percentage). Detection time: The time required to complete the entire detection process according to the instructions, which can be measured by the detection ti

Development Information

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