EGFR mutations digital PCR detection kit

Cat.No.: 12517

The EGFR mutations digital PCR detection kit is designed based on droplet digital PCR technology and TaqMan fluorescent probe technology to specifically detect the mutations of EGFR gene in cell free DNA from plasma samples and formalin-fixed paraffin-embedded (FFPE) tissue DNA of patients with non-small cell lung cancer.
1. Sample types: FFPE (Formalin-Fixed, Paraffin-Embedded) tissue, plasma.
2. Analytical Sensitivity (LOD): the kit detects 0.1% of human EGFR gene mutations in plasma samples, and 0.3% of human EGFR gene mutations in FFPE tissue samples.
3. Analytical Specificity (Cross-reactivity): testing on 200 ng of wild-type nucleic acid samples, the test result is negative; no cross-reactivity.
4. Accuracy: accuracy of the kit was established by testing internal positive references and negative references, the detection rates are 100%.
5. Precision: The coefficient of variation (CV, %) of the logarithm of copy numbers has been no more than 5%.

Description

Overview

Specification

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Specification

Product features Parameter
Technology Digital PCR
Target Sequence The mutations of EGFR gene
Specimen Type FFPE (Formalin-Fixed, Paraffin-Embedded) tissue, plasma
Analytical Sensitivity (LOD) Detects 0.1% of human EGFR gene mutations in plasma samples, and 0.3% of human EGFR gene mutations in FFPE tissue samples
Storage -20℃±5℃ and protected from light
Instruments EG02-Q16 applicable TargetingOne Droplet Digital PCR System TD-1, TD-2, and TargetingOne D50 Automatic Digital PCR System

EG02-Y16 applicable TargetingOne Droplet Digital PCR System TD-2, and TargetingOne D50 Automatic Digital PCR System

The TD-1 includes TargetingOne Drop Maker M1 and TargetingOne Chip Reader R1

The TD-2 includes TargetingOne Drop Maker M1 and TargetingOne Chip Reader R2

Spec. 16T
Quality Control ISO 13485 & ISO 9001
Certification CE IVD for in vitro Diagnostics Use

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