WizDx™ COVID-19 CrystalMix™ PCR Kit
1 / 4Pages

Catalog excerpts

WizDx™ COVID-19 CrystalMix™ PCR Kit - 1

WizDx™ COVID-19 CrystalMix™ PCR Kit INTENDED USE WizDx™ COVID-19 CrystalMix™ PCR Kit is intended to be used to achieve qualitative detection of Severe acute respiratory syndrome coronavirus, (SARS-CoV-2) viral RNA extracted from nasopharyngeal swabs, oropharyngeal swabs, and sputum from patients. handling biohazardous agents in compliance with national regulations. • Always use sterile, filtered pipette tips. • Take care of the handling of the specimen to minimize the risk of infection. • Dispose of waste in compliance with national or regional regulations after the test. WizDx™ COVID-19 CrystalMix™ PCR Kit combines all the reagents necessary for successful one-step real-time RT-PCR in a convenient individually aliquot and lyophilized in 8-strip qPCR tube. WizDx™ COVID-19 CrystalMix™ PCR Kit uses dual-labeled hydrolysis probes that target two distinct regions in RdRP (RNA-dependent RNA polymerase) gene and E (Envelop) gene of SARS-CoV-2 genome. Detection probe for RdRP gene is labeled with FAM and the probe for E gene is labeled with HEX reporter dye. 1) Add 10µl of prepared RNA samples to each COVID-19 CrystalMix tubes. 2) For positive template control (PTC), add 10µl of Positive control to COVID-19 CrystalMix tube. For negative template control (NTC), add 10µl of RNase-Free water to COVID-19 CrystalMix tube. ☞ To avoid contamination, close the cap immediately after placing the sample in the tube. 3) Vortex for 10sec. and briefly spin down for 10sec. 4) Store for 3 minutes at room temperature. 5) Transfer 10µl of COVID-19 (RdRP) CrystalMix to the ODD WELL and 10µl of COVID-19 (E) CrystalMix to the EVEN WELL of the PCR chip. ☞ If white particles are visible in the reagent, dissolve sufficiently until the particles are not visible, then add to the PCR chip. • Store at 4 ~ 25°C, Do not freeze. • Do not use once the cone-shape mix shrinks as dot-form. It damaged by re-hydration. KIT CONTENTS Component COVID-19 (RdRP) CrystalMix COVID-19 (E) CrystalMix COVID-19 Positive control * RNase-Free water * PCR Chip Amount 48 tube 48 tube 1 vial 1 vial 15 chip * Before using the positive control, add 200μl of RNase-Free water and dissolve sufficiently before use. * Positive control & RNase-Free water are shipped at room temperature. After receipt, please store in refrigerated or frozen. [Step 1] RNA Preparation Different brand RNA extraction kits are available. For the RNA extraction, please follow the manufacturer’s instructions. The recommended extraction kit is WizPrep™ Viral DNA/RNA Mini Kit (REF. W73050, manufactured by Wizbiosolutions Inc.) [Step 2] Prepare PCR Reaciton RdRP (ODD WELL) E (EVEN WELL) REAGENT AND EQUIPMENT TO BE SUPPLIED BY THE USER • WizDx™ F-150 Real-Time PCR System (CE validated device; Manufactured by Genesystem Co., Ltd.) • Micropipette & sterile pipette tips • Vortex mixer & microcentrifuge • Protective ware and Disposable gloves TEST SAMPLE • Sputum, oropharyngeal swab, and nasopharyngeal swab samples SAMPLE COLLECTION, STORAGE AND TRANSPORTATION • Collect samples in sterile tubes. • Specimens can be extracted immediately or frozen at -20°C to -80°C. • Transportation of clinical specimens must comply with local regulations for the transport of etiologic agents. QUALITY CONTROL 6) Sealing the PCR chip with tape ☞ After sealing the tape, make sure that there are no bubbles in the reaction well of the PCR chip. ☞ Tilt the PCR chip to remove air bubbles, as the reaction may not produce good results if air bubbles are present. 7) Insert the PCR chip to the WizDx™ F-150 PCR system and power on the WizDx™ F-150 PCR system. [Step 3] Run PCR Reaction 1) Open the ‘WizDx Recorder’ program. 2) Check the ‘Device Connected’ indication. ☞ When it is connected normally, the red light flashes every 1 second. ☞ If the connection is not successful, it blinks every 3~5 seconds. At this time, please turn off the power of the equipment and the program and turn it on again. In accordance with Wizbiosolutions Inc. ISO 13485-certified Quality Management System, each lot WizDx™ COVID-19 CrystalMix™ PCR Kit is tested against predetermined specifications to ensure consistent product quality. Carefully read this instruction before starting the procedure. Only use by authorized person. Use only for in vitro diagnostic purpose. Do not use any reagent after the expiration date. Always wear personal protective equipment (gloves and a mask) when 3) Select 'Load Protocol' on the F-150 system and press the dial to enter. 4) Select ‘P01: PCR’ on the F-150 system and press the dial to enter. 5) Push the ‘START/STOP

Open the catalog to page 1
WizDx™ COVID-19 CrystalMix™ PCR Kit - 2

6) Please enter the sample name in the ’WizDx Recorder’ program. 7) When the PCR reaction is completed, the instrument sounds the alarm. [Step 4] Analysis of Results 1) Please check the Ct values of the ‘WizDx Recorder’ program. 2) The test results are analyzed based on the Cut-off CT value of the following table. Cut-off CT value RdRP > 0.0 0.0 DATA ANALYSIS AND INTERPRETATION E Valid Valid The specimen is COVID-19 positive Retest; If still same result, COVID-19 positive Retest; If RdRP(-), E gene (+), the specimen might be other type of Beta coronavirus positive. Below the detection limit...

Open the catalog to page 2
WizDx™ COVID-19 CrystalMix™ PCR Kit - 3

2. Interference In order to evaluate the PCR reaction interference effect of substances and drug components contained in the specimen, three times repeated interference effect test was performed with three different concentrations (106, 104, 102) of in vitro-transcribed RNA standard of E gene and RdRp gene of SARS-CoV-2 with or without interference substance. Results of interference effect test showed that WizDx™ COVID-19 CrystalMix™ PCR Kit was not affected by interference substance (Table below). Conc. (Copy number) Interference Substances Nasal spray Aver. SD Aver. SD Aver. SD Aver. SD...

Open the catalog to page 3

All Wizbiosolutions Inc. catalogs and technical brochures