Test for COVID-19

SARS-CoV-2 Nucleic Acid Detection Kit (RT-qPCR with Taqman-Probe) 

Sample type:

· Total RNA from clinical sample

Gene target(s):

· ORF1ab and N gene from SARS-CoV-2
· ACTB from human as internal control

Reagents included in the kit:

·Buffer mix, Enzyme mix, Positive Control, Negative Control

Control material:

· Positive Control: IVT-RNA of target genes
· Negative Control: Total RNA from Human cell line

Number of reactions per kit:

· 24 rxn per kit

PCR platform compatibility:

· ABI 7500 / QuantStudio 5

Extraction system compatibility:

· QIAamp Viral RNA Mini Kit, cat.52904

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Limit of Detection (LOD):

•10 copies/PCR rxn
 

Accuracy:

•100% positive coincidence rate and 100% negative coincidence rate for 35 clinically diagnosed positive samples and 80 negative samples. With current sample number: the sensitivity is 100% (95% CI: 90.00-100.00%); the specificity is 100% (95% CI: 95.49-100.00%)

Clinical performance test

West China Hospital in Chengdu, Sichuan Province, compare with local CDC

• positive coincidence rate:100%(n=66)
• negative coincidence rate:100%(n=29)

 

Jingzhou Central Hospital in Jingzhou, Hubei Province, compare with local CDC

• positive coincidence rate:100%(n=60)
• negative coincidence rate:100%(n=32)

 

Tianjin CDC, in Tianjin Province

• over 100 positive clinical samples
• will be reported in March 15

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Tel:400-0618-001

mail: genskey@genskey.com

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