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2019-nCoV Real-Time RT-PCR Assay
Target genes are ORF1ab and N, designed in accordance with the diagnosis and treatment guideline issued by the National Health Commission.
Benefits
  • Flexible Reagents
    Flexible Reagents
    Open system reagents, applicable for major PCR detection system
  • Multiple Sample Types
    Multiple Sample Types
    Applicable to lower respiratory tract sample (sputum) and swabs
  • Lower Transport Cost
    Lower Transport Cost
    Lyophilized reagents, stable at 10-30℃ for 12 months
  • Whole Process Control
    Whole Process Control
    Internal whole-proess quality monitoring, from extraction, amplification to detection
  • Multiple Target Genes
    Multiple Target Genes
    Precisely targeting ORF1ab and N gene of 2019-nCoV
  • STORAGE AND STABILITY
    1. Store at 10~30℃ in the sealed pouch up to the expiration date printed on the package. The validity period of this product is tentatively 12 months. It can be transported at 10~30℃.
    2. Keep away from sunlight, moisture and heat.
    3. Kit contents are stable until the expiration date printed on the outer box.
    4. RT-PCR Lyophilized reagent should be used within 9 days after taking out from the sealed pouches, and the redissovled IC should be used within 9 days and stored at 2~8℃. Buffer solution should be re-capped in time after use.
  • INTENDED USE
    Wondfo 2019-nCoV Real-Time RT-PCR Assay is a real-time reverse transcription PCR (RT-PCR) assay for rapid, qualitative detection of novel coronaviruses nucleic acid in oropharyngeal swabs, nasopharyngeal swabs and sputum specimens. The test is to be used as an aid in the diagnosis of coronavirus infection disease (COVID-19), which is caused by 2019-nCoV.

    The test provides preliminary test results. Negative results don’t preclude 2019-nCoV infection and they cannot be used as the sole basis for treatment or other management decision.

    For in vitro diagnostic use only. For professional use only.
SPECIFICATION
Description
Target Gene ORF1ab, N gene
Time of Result < 60min after extraction
Storage Condition 10-30℃
Specimen Oropharyngeal swabs/Nasopharyngeal swabs/Sputum
Coincidence Rate >90%
Detection Limit 5.0x10*2 copies/mL

STANDARD OPERATION PROCEDURE
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