SARS-CoV-2 Virus Detection Diagnostic Kit (RT-qPCR Method)

2020-3-20



Three Genes + Endogenous Quality Control 

No Missed Detection


Intended use:

Qualitative detection of SARS-CoV-2 virus RNA


Package:50 Tests/Kit; 200 Tests/Kit


Packing Size&Weight:6.5*4*5 cm & 20g/35g


Specimen Type:

Sputum, throat swabs and other respiratory specimens


Applicable Instruments:

Applied Biosystems® 7500/7500Fast real-time PCR systems.


Limit of Detection:1000 Copies/mL


Cut-off Value:40(Ct)


Test Time:2 Hours



Detection targets


Gene detected Fluorescence channel 
ORF1ab geneFAM
S gene ROX
N gene CY5
Internal reference (human RNA)   VIC


Features

1)Multi-target detection of ORF1ab, N, S genes to avoid missed detection due to rapid mutation of SARS-CoV-2; 

2)Anti-pollution system to avoid false positives caused by PCR aerosol pollution caused by increasing detection number; 

3)Endogenous quality control of human RNA to avoid false negative RNA degradation caused by improper sample collection, transfer or storage


Kit Components

             Components       Main ingredients   50 Tests/Kit 200 Tests/Kit
    SARS-CoV-2 Master Mix  RT-PCR primer/probe sets,
dNTP, Mg2+, dUTP, Buffer
 
  770 μL×1     1540 μL×2
SARS-CoV-2 Enzyme Solution    

Reverse transcriptase, 

Uracil-DNA glycosylase, 

HotStart DNA Polymerase, 

Glycerol

   60 μL×1
   240 μL×1
 SARS-CoV-2 Positive Control
Recombinant plasmids
including the targets and
human RNA fragments

   50 μL×1
   200 μL×1
SARS-CoV-2 Negative Control
Nuclease-free H2O1000 μL×1      1000 μL×4


Clinical significance

1)Positive, early identification of SARS-CoV-2, helps prognosis and management 

2)Negative two times one day apart, eliminates SARS-CoV-2 infection, reduces prevention and control pressure, and reduces social panic


Specimen Handling (Reagents and devices are not provided in this kit)

Specimen sampling 

1)upper respiratory specimens: nasopharyngeal and/or oropharyngeal swabs using flocked swabs and VTM (Recommend Copan, PN 365C/366C/368C) 

2)and/or lower respiratory specimens: sputum (if produced) and/or endotracheal aspirate or bronchoalveolar lavage


Specimen shipment and storage 

Kits should be cold-chain shipped with gel pack or dry ice. During transportation, it can be kept upto 14 days at a temperature of -80 ~ 2°C and upto 7 days at a temperature of 2 ~ 8°C.


Nucleic acid extraction 

1)RNeasy Mini Kit (Qiagen, PN 74104) 

2)QIAsymphony RNA Kit (Qiagen, PN 931636) 

3)or automated TANBead® extract system (Taiwan Advanced Nanotech, PN SLA-32/ Maelstrom 9600) with a TANBead Viral Auto Plate kit (Taiwan Advanced Nanotech, PN 665A46) 

4)Other extraction methods can be used after validated by laboratory quality control system 

Extracted nucleic acid should be used as template in this kit immediately.


Example results


Ordering Information

本网站由阿里云提供云计算及安全服务 Powered by CloudDream