
Nucleic acid detection reagent packaging sheet
The nucleic acid test kit consists of a premix, a control group, a label and an outer packaging, and the pre-packaged product additionally contains a lysate.
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1 Composition of the product
The nucleic acid test kit consists of a premix, a control group, a label and an outer packaging, and the pre-packaged product additionally contains a lysate.
2 Sensitivity
The detection sensitivity of nucleic acid test kits is 10-100copies/test.
3 Appearance
Appearance: clear and flat printing; label: clear and flat printing, no degumming.
4 Specificity and accuracy requirements
According to the requirements of GB 4789.28-2013, select and prepare working strains, extract the genome and use them as quality control samples and positive controls (or reasonable dilution of positive plasmids). The positive controls detected by the pathogenic bacteria series and animal-derived series nucleic acid test kits have obvious S-type amplification curves, and there is no obvious S-type amplification curve for the nucleic acid of non-target strains. The pre-packaged product lysate was tested negatively for the corresponding kit. Quick detection series and gene detection series kits, the positive control has a Ct value of not more than 30 in the corresponding detection channel, and in the non-positive channel, there is no obvious S-type amplification curve or the Ct value is not less than 30 (refer to the corresponding product manual for details). Virus detection series kits, the positive control has an obvious S-type amplification curve, and there is no obvious S-type amplification curve for the detection of non-target strain nucleic acid. The standard curve (the detection of MS2 in food is 4 points, and the quantitative detection is 6 points) satisfies R2 ≥ 0.98, the amplification efficiency is 70% -130% (the quantitative detection is 80% -120%).
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