nCoV RNA COVID-19 test

SKU: VIA_DaAnGene-nCov_NAEK Category: Tags: ,

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The DaAn Gene nCov RNA Kit is a Detection Kit for 2019 Novel Coronavirus (2019-nCoV) RNA (PCR-Fluorescence Probing). This is not a rapid test. This test requires a Real-Time PCR instrument.
• Units per Pack: 48
• Minimum Order Quantity (MOQ): 4800 tests
• Company Location: China
• Warranty Term: Not applicable
• Regulatory Approval: CE, CFDA

Description

The DaAn Gene nCov RNA Kit is used for the in vitro qualitative detection of novel coronavirus (2019-nCoV) ORFlab and N gene in the throat swabbed sputum specimens of suspected pneumonia patients infected by novel coronavirus, suspected clustering cases, and others needing diagnosis or differential diagnosis for novel coronavirus.

Detection of novel coronavirus RNA shall meet the requirements of related guideline, clinical diagnostic/disease control and other documents, so as to carry out the regulations on biosafety. The
detection results of this kit are for clinical reference only and should not be used as the sole criteria for clinical diagnosis. It is recommended to conduct a comprehensive analysis on the condition in combination with the clinical manifestations of the patient and other laboratory tests.

This kit is based on one-step RT-PCR technique. In practice, 2019 Novel Coronavirus (2019-nCoV) ORF1ab and N genes are selected as amplification target regions. Specific primers and fluorescent probes are designed for the detection of 2019 Novel Coronavirus RNA in the specimens. This kit also includes an endogenous internal standard detection system, which is used for monitoring over the processes of specimen collection, RNA and PCR amplification, thereby reducing false negative results.

Key Features

Detection Sensitivity
The analytical sensitivity of this kit is 500 copies/ml.

Cross-reaction
No cross-reaction with other pathogens.

Specifications

Storage Conditions & Validity

  • When the kit is stored at -20±5°C, the validity period is 6 months
  • The reagent can be stored at 4°C for 3 days
  • The kit can be stored at 37°C for 3 days
  • Repeated freezing and thawing should be avoided; repeated freezing and thawing cycles should not exceed 7 times and the times of decapping the reagent should not exceed 7 times
  • See the product label for the date of manufacture and validity of the kit

Required Instruments

  • Works with any of: ABI 7500, LightCycler480, AGS4800, Bio-Rad CFX96

Detection Precision

  • CV < 5%

Standard Accessories

Not applicable

Optional Accessories & Add-ons

Not applicable

Product Documents, Manuals & Brochures

Brochure

Instruction Manual

Regulatory Certificates

CE Certificate

CFDA Certificate

Videos

Not available at this time

 

FAQ

Where has this test been used?
This test has been used in Europe, The Middle East, Africa, and South East Asia.
What machines work with this test?
The test can be processed by any of: ABI 7500, LightCycler480, AGS4800, Bio-Rad CFX96.

Studies & Trials

Not available at this time

 

Package Contents

  • 1x NC(ORF1ab/N) PCR reaction liquid A 900 μl/ tube 1 – Main constituents: specific primers, probes, tris(hydroxymethyl)aminomethane-hydrochloric acid buffer
  • 1x NC(ORF1ab/N) PCR reaction liquid B 200 μl/ tube – Main constituents: Hot start Taq DNA polymerase, c-MMLV reverse transcriptase
  • Warranty

    Not applicable

    Testimonials

    Not available at this time

     

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