GBS Test Kit-IFU
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Attoplex® Group B Streptococcus 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 Streptococcus agalactiae (Group B Streptococcus, GBS) extracted from urine or vaginal-rectal swabs of patient suspected of Streptococcus agalactiae infection using Real- 2.1 After thawing the frozen component completely on Ice, spin- time PCR (real-time polymerase chain reaction). The kit includes qPCR Master Mix and Primer & Probe Mix, which can specifically amplify cfb gene of Streptococcus agalactiae, and provide positive and negative control to evaluate the validity of the test results. 3.2 Prepare the reaction solution according to the table below. in a clear tube Light purple solution Probe Mix Positive Control in a brown tube Colorless solution in a clear tube Colorless solution 3) Reaction and PCR Setup 3.1 Extract the DNA sample from the specimen using a commercially Colorless solution • 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. • 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 Annealing & Extension Always use DNase/RNase-free disposable pipette tips with aerosol barriers. Volume (μL/rxn) 필요한 장비 및 기구 Required Material and Devices Sample (or Positive/Negative control) *Packing unit: 100 tests/Kit if it is placed at room temperature for more than 1 hour or ※ 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. 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 urine or vaginal-rectal swabs 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. Target

fitting* Auto 보관 Storage 및 취급방법 Protect all Kit components from light. *Setting → Baseline setting → Baseline Subtracted Curve Fit and Components 2X qPCR Master Mix Apply Fluorescence Drift Correction 4.2 Based on the Cut-off Ct value in the table below, the positive or Cut-off Ct Positive (+) Positive Control negative of each target gene is determined. Target 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 *U.D: Undetermined (or N/A: Not Applicable) **The Ct value of IPC...