Influenza A,B Test Kit-IFU
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Influenza A,B Test Kit-IFU - 1

Attoplex® Influenza A/B Real-time PCR Kit 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 Influenza virus extracted from the nasopharynx and oropharynx of patients suspected of Influenza virus 2.1 After thawing the frozen component completely on Ice, spin- infection using Real-time PCR (real-time polymerase chain reaction). The kit includes qPCR Master Mix and Primer & Probe Mix, which can specifically amplify Matrix protein gene of Influenza A and hemagglutinin gene of Influenza B, and provide positive and negative control to evaluate the validity of the test results. Colorless solution in a clear tube Light purple solution Probe Mix Positive Control in a brown tube Colorless solution in a clear tube continuous freezing and thawing. available RNA extraction kit. 3.2 Prepare the reaction solution according to the table below. Volume (μL/rxn) 2X One-step RT-qPCR Master Mix Sample (or Positive/Negative control) Colorless solution 3.1 Extract the RNA sample from the specimen using a commercially Volume *Packing unit: 100 tests/Kit 필요한 장비 및 기구 Required Material and Devices • Applied Biosystems™ 7500 Fast Real-time PCR Instrument system or CFX96™ Real-Time PCR Detection System • Vortex mixer • Table-top Centrifuge • Pipettes and Pipette tips with aerosol barrier • Disposable powder-free gloves Procedure 사용방법 ※ Warnings and Precautions • if it is placed at room temperature for more than 1 hour or down to collect the solution to the bottom of the tube. ※ It should be noted that the product performance will be affected Always wear protective disposable powder-free gloves when 3.3 Close the lid of the tube, vortexing lightly, spin-down to collect the solution to the bottom of the tube. ※ If air bubbles remain in the tube, remove them as they may affect the real-time PCR reaction. ※ After preparing the reaction solution in which all components are mixed, real-time PCR is performed immediately. 3.4 After setting the real-time PCR program according to the PCR conditions and fluorescence channels of the table below, the amplification proceeds. Step Avoid microbial and nuclease (DNase/RNase) contamination of Always use DNase/RNase-free disposable pipette tips with aerosol barriers. • Discard sample and assay waste according to your local safety regulations. 1) Sample Preparation 1.1 The sample to be used in this diagnostic product is RNA extracted from specimens collected from the nasopharynx and oropharynx of humans. 1.2 For the extraction of RNA from a sample, it is recommended to use a commercially available extraction kit (eg, QIAamp Viral RNA Mini Kit, QIAGEN and MagNa Pure 96, Roche), and the extraction APX-IFU-RPT009/R01 Reference Dye (ROX) *IPC: Internal positive control 4) Data Analysis 4.1 Set Threshold and Baseline value

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Influenza A,B Test Kit-IFU - 2

unidirectional manner. fitting* Auto fitting* Auto fitting* *Setting → Baseline setting → Baseline Subtracted Curve Fit and Apply Fluorescence Drift Correction and the reagent is discarded according to the laws of the country. • Do not use components of the kit that have passed their expiration date. • Only the components of the same lot (LOT) are used, and the lot is not mixed. • The results of this product alone cannot be diagnosed with Influenza virus infection, and the doctor should be determined in consideration of clinical symptoms. 4.2 Based on the Cut-off Ct value in the table...

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