HSV 1,2 Test Kit-IFU
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Attoplex® HSV 1/2 Real-time PCR Kit 사용목적 Use Intended Media Kit, QIAGEN and MagNa Pure 96, Roche), and the This product is an in vitro diagnostic medical device that qualitatively extraction method follows the instructions for each extraction kit. detects a genetic material of HSV (Herpes simplex virus) extracted from the whole blood, plasma, urine, CSF of patients suspected of HSV infection using Real-time PCR (real-time polymerase chain 2.1 After thawing the frozen component completely on Ice, spin- reaction). The kit includes qPCR Master Mix and Primer & Probe Mix, which can specifically amplify envelope glycoprotein G gene of HSV 1 and HSV 2, and provide positive and negative control to evaluate the validity of the test results. Colorless solution Light purple solution Probe Mix Positive Control in a brown tube Colorless solution in a clear tube if it is placed at room temperature for more than 1 hour or 3) Reaction and PCR Setup Volume 3.1 Extract the viral DNA sample from the specimen using a commercially available viral DNA extraction kit. Colorless solution ※ It should be noted that the product performance will be affected continuous freezing and thawing. down to collect the solution to the bottom of the tube. 3.2 Prepare the reaction solution according to the table below. 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 Volume (μL/rxn) Sample (or Positive/Negative control) *Packing unit: 100 tests/Kit 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 wear protective disposable powder-free gloves when 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 DNA extracted from specimens collected from the whole blood, plasma, urine, CSF 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 Reference Dye (ROX) *IPC: Internal positive control 4) Data Analysis 4.1 Set Threshold and Baseline values according to the table below.

fitting* Auto fitting* Auto *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 HSV 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...