HPV 6,11 Test Kit-IFU
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HPV 6,11 Test Kit-IFU - 1

Attoplex® HPV 6/11 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 HPV (Human Papillomavirus) extracted from the cervix with the brush or swab of patients suspected of HPV 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 L1 gene of HPV 6 and HPV 11, and provide positive and negative control to evaluate the validity of the test results. Light purple solution Probe Mix Positive Control in a brown tube Colorless solution in a clear tube 3.2 Prepare the reaction solution according to the table below. Colorless solution commercially available viral DNA extraction kit. *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 • Always wear protective disposable powder-free gloves when handling kit components. Avoid microbial and nuclease (DNase/RNase) contamination of the specimens and the components of the kit. Volume (μL/rxn) Sample (or Positive/Negative control) 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 Denaturation Denaturation Always use DNase/RNase-free disposable pipette tips with aerosol barriers. continuous freezing and thawing. 3.1 Extract the viral DNA sample from the specimen using a Colorless solution 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 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 DNA extracted from specimens collected from the cervix with the brush or swab 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 Reference Dye (ROX) *IPC: Internal positive control 4) Data Analysis 4.1 Set Threshold and Baseline values according to the table below. Target

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HPV 6,11 Test Kit-IFU - 2

fitting* Auto fitting* *Setting → Baseline setting → Baseline Subtracted Curve Fit and Apply Fluorescence Drift Correction • 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 HPV infection, and the doctor should be determined in consideration of clinical symptoms. 4.2 Based on the Cut-off Ct value in the table below, the positive or negative of each target gene is determined. Storage 보관 및 취급방법 Protect all Kit components from...

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