iAmpDX Kit IFU
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iAmpDX Kit IFU - 1

iAmpDX SARS-CoV-2 LAMP Kit V2 colorimetric reactions, so be careful not to include them in the 사용목적 Use Intended The iAmpDX SARS-CoV-2 LAMP Kit V2 of Attoplex Inc. is an in vitro diagnostic medical device that helps diagnose SARS-CoV-2 by quantifying the genetic material of Coronavirus-19 (SARS-CoV-2) extracted from the nasopharynx and oropharynx of patients suspected of respiratory infection with Loop-mediated isothermal amplification (LAMP). The primer set of this product specifically amplifies the ORF1a sample. For the best results, use purified total nucleic acid eluted in nuclease-free water. • Sample transport media (VTM or UTM) A sample containing more than 0.2 % Tween 20 or Triton X-100 gene and N gene of SARS-CoV-2, and whether or not the target gene is amplified can be visually confirmed through the color 1.1 The sample to be used in this diagnostic product is RNA extracted from specimens collected from the nasopharynx and The product includes a SARS-CoV-2 LAMP primer set, which can specifically amplify the ORF1a gene and N gene of SARS-CoV-2 1.2 For the extraction of RNA from a sample, it is recommended to variants, and LAMP Master Mix for isothermal amplification use a commercially available extraction kit (eg, QIAamp Viral reactions, and provide positive and negative control to evaluate the RNA Mini Kit, QIAGEN and MagNa Pure 96, Roche), and the extraction method follows the instructions for each extraction kit. validity of the test results. Appearance Pink solution Pink solution Positive Control Colorless solution in a clear tube Colorless solution When using the extraction kit, recommended for the elution buffer. 2) Reaction Setup mixed (by pipetting or gently vortexing) and spin-down to collect the solution to the bottom of the tube. ※ It should be noted that the product performance will be affected if it is placed at room temperature for more than 1 hour or continuous freezing and thawing. 2.2 The reaction solution of the total 20 uL is prepared based on • Pipettes and Pipettes tips with aerosol barrier • Vortex mixer • Table-top Centrifuge • Disposable powder-free gloves • Conventional or real-time PCR machine or heating block the amplification composition described in the table below. Components Positive control 사용 방법 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 Discard sample and assay waste according to your local safety regulations. ※ Sample Compatibility The following substances can affect isothermal amplification and APX-IFU-LA002/R01 Nuclease-free water Total Required Material 필요한 장비 및 기구 and Device 2.1 All reagents and samples should be thawed completely at ice, *Packing unit: 100 tests/Kit 2.3 In the case of using N samples, refer to the table above and prepare a reaction solution by adding PC and NTC to the number of samples to be inspected. 2.4 Close the lid of the tube, vortex lightly, spin-down to collect the solution to the bottom of the tube. ※ Before the LAMP reaction, the color of the reaction solution is pink, and if it is a color other than pink, refer to "sample preparation" to ensure that the appropriate sample is used. ※ Do not expose the reaction solution to the air or leave it at room temperature for mo

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iAmpDX Kit IFU - 2

2.5 Place tubes on the tube block of conventional or real-time PCR machine or heating block preheated to 65°C for 20 mins. Add templates to the reaction mixture in clean bench (PCR workstation) or a spatially separated facility 2.6 After 20 minutes, take out the tube and check the color change of the solution. 보관 및 취급방법 Storage Protect all Kit components from light. 3) Interpretation of Results 3.1 According to the color change of each tube, the isothermal amplification reaction is checked and determined by No amplification/Weak and Strong amplification, respectively. Amplification...

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