Norovirus Test Kit-IFU
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Attoplex® Norovirus 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 Norovirus extracted from the vomitus and stool of patients suspected of Norovirus infection using Real-time 2.1 After thawing the frozen component completely on Ice, spin- RT-PCR (real-time reverse transcriptase polymerase chain reaction). The kit includes RT-qPCR Master Mix and Primer & Probe Mix, which can specifically amplify G-I gene and G-II gene of Norovirus, and provide positive and negative control to evaluate the validity of the test results. if it is placed at room temperature for more than 1 hour or continuous freezing and thawing. Light purple solution Colorless solution Positive Control Colorless solution in a clear tube 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 • 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 Reverse Transcription Avoid microbial and nuclease (DNase/RNase) contamination of Denaturation Annealing & 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 vomitus and stool 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 Reference Dye (ROX) *IPC: Internal positive control 4) Data Analysis 4.1 Set Threshold and Baseline value

unidirectional manner. fitting* Auto fitting* Auto fitting* *Setting → Baseline setting → Baseline Subtracted Curve Fit and Apply Fluorescence Drift Correction • When the test is completed, the hands are wiped out immediately, 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 Norovirus infection, and the doctor should be determined in consideration of clinical...