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• COVID-19 Real-Time PCR Kit

Genelix™  COVID-19 Real-Time PCR Kit (G409)

· Genelix™  COVID-19 Real-Time PCR Kit is an In vitro  diagnostic medical device that diagnoses Coronavirus disease 2019 (COVID-19) in samples (sputum, oropharyngeal and nasopharyngeal swabs) of suspected patients with respiratory infections.

· Genelix™  COVID-19 Real-Time PCR Kit is able to confirm the presence or absence of a novel coronavirus infection by amplifying and detecting the specific genes (RdRp, E gene) of SARS-CoV-2 using Reverse Transcriptase Real-time PCR technique.

· Genelix™  COVID-19 Real-Time PCR Kit is compatible with CFX 96™ (Bio-rad) and AB 7500 (Thermo-Fisher Scientific) for rapid detection of SARS-CoV-2.

· Kit contents

KIT CONTENTS

REAGENT	VOLUME
1.RT PCR Reaction Mixture	1,000 μl
2.RT PCR Primer/ Probe Mixture(RdRp & E)	400 μl
3.RT PCR Internal Control	100 μl
4.RT PCR Positive Control	50 μl
5.RT PCR Negative Control	50 μl

※ Recommend lightly vortex and spin-down before use

· Protocol

1. Prepare the template RNA from the sample using the commercialized RNA extraction kit.

2. Thaw the product using ice or laptop cooler to prevent the thermal damage.

3. Prepare the PCR reaction mixture according to the table below.

REAGENT	VOLUME
RT PCR Reaction Mixture	10 μl
RT PCR Primer/ Probe Mixture(RdRp & E)	4 μl
RT PCR Internal Control	1 μl
Template RNA	5 μl
Total	20 μl

※ Add 5 μl of extracted RNA into 15 μl of RT PCR Master Mixture and mix well by pipetting. Prepare the Positive control and Negative control with same procedure as samples.

※ Master Mixture for RdRp and E gene duplex (Mixture 1) should be prepared into different tubes.

4. Real-Time PCR run : Set up Real-Time PCR machine under the following conditions as shown in the table below.

GENE	FLUOROPHORE
RdRp	FAM
E	Cy5
Internal Control(IC)	VIC/ HEX

※In case of Internal Control(IC), please set it to VIC or HEX depending on the device.

TEMP. (℃)	TIME	CYCLE
50	30 min	1
95	15 min	1
95	20 sec	45
60	40 sec	45

· CAUTION

1. Make sure to Vortex and Spin-down the well while preparing the reaction solution, in order to avoid creating bubbles in each strip.

2. Kit must be stored at - 20 ℃.