Flash DetectTM SARS-CoV-2 Detection Kit

Detection Mode:Fluorescence PCR(Nucleic Acid Extraction Free )

●Easy: Nucleic Acid Extraction free operation

● Safe: Reducing the contact risk between operators and sample

● Fast: 1 min sample, 60~80 mins result

●Application:Specially-used inABI 7500, Bio-rad CFX 96,Mini 8, Flash 20andGentier 48E


Product Details

Novel Coronavirus 2019-nCoV nucleic acid detection kit realizes the rapid screening of the addition of novel Coronavirus samples within 1 minute, without nucleic acid extraction, meeting the needs of high-throughput detection, and can provide a fast, simple, accurate and high-throughput nucleic acid detection solution for epidemic prevention and control.



1.Introduction

Novel Coronavirus 2019-nCoV Nucleic Acid Detection Kit (Fluorescent PCR)

Sample type: throat swab, sputum

[Medical Device Registration Certificate No. / Product Technical Requirement No.] National Instrument Registration Permit 20203400644

 

2. Intended use



This Flash DetectTM SARS-CoV-2 Detection Kit is used for in vitro qualitative detection of novel coronavirus(2019-nCoV) ORF1Ab and N genes in throat swabs 

and sputum samples of suspected cases of pneumonia infected by novel coronavirus(2019-nCoV), suspected clusters of patients, and other patients who need to be diagnosed or differential diagnosed by novel coronavirus infection.


3. Solutions


Novel Coronavirus 2019-nCoV nucleic acid assay is a real-time assay based on nucleic acid free extraction PCR (fluorescent probe method).

• Provide reliable evidence for medical decisions, effectively help identify suspected cases, especially hidden infections, and avoid the spread of the wider epidemic.

• It is easy for medical staff to achieve targeted treatment quickly.

 

4. The impact

Providing rapid patient testing results can:

• Helps patients manage their treatment.

• Helps in rapid triage of patients and prevents cross-infection.

 

5. Product advantages

• Easy to use without nucleic acid extraction, free laboratory staff

• Safely reduce the risk of contact between experimenters and samples

• Add samples quickly in 1 minute and get results in 30 minutes

• Scene central laboratory, laboratory, medical test center, disease control center


6. Applicable people

• A suspected case of pneumonia from Novel Coronavirus

• Suspected cluster cases

• Other persons requiring a diagnosis of Novel Coronavirus infection or differential diagnosis

 

7. Applicable instruments


This kit is suitable for ABI 7500, Bio-Rad CFX96, and Coyote ®Flash20.

Sue machinery wide review (article) : 210712-02561 | taboo content or considerations can be found in the manual.


8. Evaluation Results of Trusted Authority


Novel Coronavirus 2019-nCoV nucleic acid detection kit


9.operational Process


Novel Coronavirus 2019-nCoV nucleic acid detection kit


10.Performance Parameter

Novel Coronavirus 2019-nCoV nucleic acid detection kit


 11.Direct Detect Technology VS Traditional Technology 



Novel Coronavirus 2019-nCoV nucleic acid detection kit


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