COVID-19 Test Kit V2-IFU
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Attoplex® SARS-CoV-2 Real-time PCR Kit V2 of humans. 사용목적 Use Intended This product is an in vitro diagnostic medical device that qualitatively 1.2 For the extraction of RNA from a sample, it is recommended to use a commercially available extraction kit (eg, QIAamp Viral RNA detects a genetic material of COVID-19 (SARS-CoV-2) extracted from Mini Kit, QIAGEN and MagNa Pure 96, Roche), and the extraction the nasopharynx and oropharynx of patients suspected of respiratory method follows the instructions for each extraction kit. infection using Real-time RT-PCR (real-time reverse transcriptase polymerase chain reaction). In particular, five mutations (Q493R, G496S, Q498R, N501Y, and Y505H) of the region coding the receptor-binding motif (RBM) in the 2.1 All reagents and samples should be thawed completely on ice, receptor binding domain (RBD) among the S gene can be specifically mixed (by pipetting or gently vortexing) and centrifuged briefly before use. detected. The kit includes RT-qPCR Master Mix and Primer & Probe Mix, which It should be noted that the product performance will be affected can specifically amplify S gene, ORF1a, and N gene of SARS-CoV-2 if it is placed at room temperature for more than 1 hour or variants and provide positive and negative control to evaluate the continuous freezing and thawing. validity of the test results. 3.1 Extract the RNA sample from the specimen using a commercially Colorless solution Light purple solution Positive Control Colorless solution in a clear tube Colorless solution Cap color Green Brown available RNA extraction kit. Volume 3.2 Prepare the reaction solution according to the table below. Components Sample (or Positive/Negative control) Volume (μL/rxn) 2X One-step RT-qPCR Master Mix 3.3 Close the lid of the tube, vortexing lightly, spin-down to collect the solution to the bottom of the tube. *Packing unit: 100 tests/Kit ※ If air bubbles remain in the tube, remove them as they may affect 필요한 장비 및 기구 Required Material and Devices ※ After preparing the reaction solution in which all components are • Applied Biosystems™ 7500 Fast Real-time PCR Instrument system or CFX96™ Real-Time PCR Detection System • Pipettes and Pipettes tips with aerosol barrier • Vortex mixer • Table-top Centrifuge • Disposable powder-free gloves 사용방법 Procedure ※ 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. Always use DNase/RNase-free disposable pipette tips with the real-time PCR reaction. 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 Annealing & Extension Running time aerosol barriers. • Discard sample and assay waste according to your local safety 1.1 The sample to be used in this diagnostic product is RNA extracted from specimens collected from the nasopharynx and oropharynx APX-IFU-RPT002/R01

4.1 Set Threshold and Baseline values according to the table below. Threshold fitting* Auto fitting* Auto fitting* Auto fitting* *Setting → Baseline setting → Baseline Subtracted Curve Fit and Apply Fluorescence Drift Correction 4.2 Based on the Cut-off Ct value in the table below, the positive or negative of each target gene is determined. Cut-off Ct General Precautions 사용시 주의사항 • This product should be used for in vitro diagnostics and never for other purposes. • It should be used by skilled experts, and be sure to follow the instruction for use. • Be sure to follow the instructions when...