产品

本公司产品仅供体外研究使用,不用于临床诊断

2019-Novel Coronavirus(2019-nCoV) RT-qPCR Detection Kit

EH4934 货号
Overview
Pack Size
50T/Kit
INTENDED USE

This product in intended for the qualitative detection of 2019-nCoV ORF1ab and N gene.

The detection result of this product is only for research use or clinical reference, and it should not be used as the only evidence for clinical diagnosis and treatment. It is applicable for in vitro Qualitative detection of throat swab, nose swab or sputum samples from suspected cases or confirmed cases of 2019-nCoV or other possible patients needed to be tested for (2019-nCoV) ORF1ab and N gene.

For the use of the product should follow related laws and regulations in the local countries/regions about the control of pandemics or any documents/guidelines from government. Whenever there is related restrictions for the use on such purpose above mentioned, the user should immediately stop detection and follow the local guidelines. We are not responsible in judging whether our product is suitable for the certain detection, and as we had advised this product only for research use, thus we will not be responsible for any cases with violation to local laws/regulations. We strongly advise the users contact local CDC or other authorities for advice before using it.
PRINCIPLE OF DETECTION
This product is based on TaqMan RT-PCR assay system, use ORF1ab and N gene specifically-designed primer and the TaqMan fluorescent probe to amplify signal via Real-time RT-PCR for detecting of the 2019-nCoV nucleic acid. one- step RT-PCT is used for amplifying and detecting fluorescence signal after nucleic acid collected from patient’s samples, Machine software system will generate real-time amplification curve. Internal control standard had already been set in the kit for reference related to sample collecting, storage and transferring, also the monitoring on nucleic acid extracting, to avoid false-negative results.
PRODUCT CONTENTS

Components

Size(Vial)

Ingredient

Nucleic Acid

amplifying buffer

600 μL×1

Magnesium ion, nucleotide mixture, etc.

Enzyme mixture

200 μL×1

DNA polymerase, reverse transcriptase, uracil-N-glycosylase

ORF1ab/N

reaction buffer

200 μL×1

primer, probe of 2019-nCoV(ORF1ab/N gene)and Internal control RNase P gene

Positive control

500 μL×1

Plasmid including ORF1ab/N gene specific fragments and virus-like particles including RNase P gene specific fragments

Negative Control

500 μL×1

Saline solution

Note:

①Do not mix the components from different batches for detection.

②Additional Materials Required:Nucleic acid extraction reagents.

③Internal control is for monitoring whole processing from extraction to detection, avoiding false negative results.

STORAGE & SHELF LIFE

1. All reagents should be stored at -20℃ with protection from light. The reagents are stable for 6 months when stored at the recommended condition.

2. Avoid freeze-thaw cycle, better less than 6 times.