Adenovirus Test Kit-IFU
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Attoplex® Adenovirus Real-time PCR Kit extraction method follows the instructions for each extraction kit. 사용목적 Use Intended This product is an in vitro diagnostic medical device that qualitatively detects a genetic material of Adenovirus extracted from the Human EDTA plasma of patients suspected of Adenovirus infection using 2.1 After thawing the frozen component completely on Ice, spin- Real-time PCR (real-time polymerase chain reaction). The kit includes qPCR Master Mix and Primer & Probe Mix, which can specifically amplify HEXON gene of Adenovirus, and provide positive and negative control to evaluate the validity of the test results. Light purple solution 3.1 Extract the viral DNA sample from the specimen using a 3.2 Prepare the reaction solution according to the table below. Colorless solution in a brown tube Colorless solution Positive Control Colorless solution commercially available viral DNA extraction kit. *Packing unit: 100 tests/Kit or CFX96™ Real-Time PCR Detection System Sample (or Positive/Negative control) ※ If air bubbles remain in the tube, remove them as they may affect the real-time PCR reaction. mixed, real-time PCR is performed immediately. • Table-top Centrifuge • Pipettes and Pipette tips with aerosol barrier 3.4 After setting the real-time PCR program according to the PCR • Disposable powder-free gloves conditions and fluorescence channels of the table below, the amplification proceeds. Procedure 사용방법 ※ Warnings and Precautions Always wear protective disposable powder-free gloves when handling kit components. Avoid microbial and nuclease (DNase/RNase) contamination of Denaturation Denaturation Always use DNase/RNase-free disposable pipette tips with aerosol barriers. ※ After preparing the reaction solution in which all components are • Vortex mixer Volume (μL/rxn) the solution to the bottom of the tube. • Applied Biosystems™ 7500 Fast Real-time PCR Instrument system 3.3 Close the lid of the tube, vortexing lightly, spin-down to collect 필요한 장비 및 기구 Required Material and Devices if it is placed at room temperature for more than 1 hour or continuous freezing and thawing. down to collect the solution to the bottom of the tube. ※ It should be noted that the product performance will be affected 1.1 The sample to be used in this diagnostic product is DNA extracted specimens oropharyngeal (throat) swab, sputum, and serum of humans. 1.2 For the extraction of DNA from a sample, it is recommended to use a commercially available extraction kit (eg, QIAamp MiniElute Media Kit, QIAGEN and MagNa Pure 96, Roche), and the APX-IFU-RPT001/R01 1) Sample Preparation from Discard sample and assay waste according to your local safety *IPC: Internal positive control 4) Data Analysis 4.1 Set Threshold and Baseline values according to the table below. Target Adenovirus

보관 Storage 및 취급방법 Protect all Kit components from light. Apply Fluorescence Drift Correction Components 2X qPCR Master Mix 4.2 Based on the Cut-off Ct value in the table below, the positive or negative of each target gene is determined. Positive (+) Positive Control *Setting → Baseline setting → Baseline Subtracted Curve Fit and Nuclease-free water Expired 6 months after production 3 months 6 months after production 3 months 6 months after production 3 months 6 months after production 3 months **The Ct value of IPC is determined as a result of the negative control. LOT and expiry date 제조번호...