Novel Coronavirus(2019-nCoV)Nucleic Acid Detection Kit (Fluorescence PCR) eShow Global
Novel Coronavirus(2019-nCoV)Nucleic Acid Detection Kit (Fluorescence PCR)

北京金豪制药股份有限公司

Beijing Kinghawk Pharmaceutical Co,. LTD

China    City:Beijing

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Product Details

 

【Product Name】

Novel Coronavirus2019-nCoVNucleic Acid Detection Kit  (Fluorescence PCR)

 

Packing Specifications 

48 Test / Box

 

Intended Use

This kit is used for qualitative detection of the coronavirus ORF1ab and N genes in throat swabs and sputum samples of patients suspected of being infected with the novel coronavirus (2019-nCoV). It is used for qualitative detection of novel coronavirus, as well as auxiliary diagnosis and epidemiological monitoring of 2019-nCoV infection.

 

This kit uses a fluorescent PCR detection method developed jointly with the Military Medical Research Institute of the Academy of Military Sciences to detect 2019-nCoV nucleic acids in throat swabs and sputum samples. The test results of this reagent are for clinical reference only, and are not used as the sole standard for clinical diagnosis. It is recommended to conduct a comprehensive analysis of the condition in combination with the clinical manifestations of patients and other laboratory tests.

 

Principle of  Detection 

According to the principle of fluorescent PCR technology, specific primers and Taqman probes are designed for the 2019-nCoV target genes ORF1ab and N genes, and detected by a fluorescent PCR detector to achieve qualitative detection of 2019-nCoV. The kit uses the mRNA of ribonuclease P (RNase P, RNP), which widely present in normal human epithelial cells as a normal human cell control to monitor the extraction and detection process.

Main Components

Component 

Size 48T

Quantity

Main composition

2019-nCoV ORF1ab/N   reaction solution

 

0.9ml /vial

 

1 vial

DNTPs, MgCl2, 2019-nCoV ORF1ab, N gene and RNP-specific, PCR primers and fluorescent probe mixture

Enzyme mixture

100μl/vial

1 vial

Reverse transcriptase, DNA polymerase, RNA Enzyme inhibitor

Negative control

1.0ml/vial

1 vial

Nuclease-free water

Positive control

200μl/vial

1 vial

ORF1ab gene, N gene, RNP pseudovirus mixture

 

Each component of this product must not be interchanged with the corresponding component in other products or products with different lot numbers.


Storage Conditions and Validity

Date of manufacture of the kit, batch number and expiration date: see the package box.

The kit is stored frozen at -20 ± 5 ℃, and the validity period is 6 months from the manufacturing date.

After the reagent is unsealed, the shelf life is 7 days at 2-8 ℃ and 6 months from the manufacturing date at -20 ± 5 ℃. However, repeated freeze-thaw should not exceed 5 times. The positive control should always be stored at -20 ± 5 ℃, and the number of repeated freeze-thaw cycles should not exceed 5 times.

 

Applicable InstrumentsRoche Light Cycler series, Shanghai Hongshi SLAN-48P / 96S, ABI Prism 7500, STRATAGENE Mx3000p automatic fluorescence PCR detector.




 

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