Warm warning: This product is not available for US market.
A. Description
This kit is used to achieve qualitative detection of ORF 1 ab, N gene of 201 9-nCOV viral RNA extracted from nasopharyngeal swabs, oropharyngeal swabs and sputum of patients suspected to have clustered cases and other patients requiring diagnosis.
B. Product Qualification
CE Certification –CIBG Registration Letter/ CE Certification –EC Declaration of Conformity/ CE Certification –CIBG Website notify/ MHRA Registration/ MHRA Registration-UKCA Declaration of Conformity/ EU Website notify/ Export Qualified Suppliers/ Italy Registration/ Philippines special certification of COVID-19 Diagnostic Kits – PR2019-D/ ISO 13485 Certificate-MDSAP/ ISO 9001 Certificate/ ISO 45001 Certificate/ ISO 14001 Certificate/ IPMS Certificate/ Verified Supplier Certificate
C. Intended Use
This kit is used to achieve qualitative detection of ORF1ab, N gene of 2019-nCOV viral RNA extracted from nasopharyngeal swabs, oropharyngeal swabs and sputum of suspected infected patients suspected to have clustered cases and other patients requiring diagnosis. The kit is a fully premix lyophilized system, which includes materials needed for 2019-nCoV detection: reverse transcriptase, nucleic acid amplification enzyme, reaction buffer, specific primer and probe. RT-PCR detection can be carried out directly after adding the extracted sample RNA and and supplemented with water up to 25 μL.
D. Main Parameter
Brand | Bioteke | Model | PR2019-D |
Name | Novel Coronavirus (2019－nCoV, Nucleic Acid Detection Kit Fluorescence PCR） | Dimension | 60×60×65mm |
Weight | / | Storage | Room temperature (2-30°C) |
Package | As the picture shows | Shelf life | 12 months |
E. Advantage&Features
Transportation conditions: compared with normal liquid PCR detection kit, the freeze-dried product can be transported at room temperature (not more than 1 month);
Storage conditions: compared with normal liquid PCR detection kit which needs to be strictly stored at - 20 ± 5 ℃, the freeze-dried one can be stored at 4 ℃ for 6 months and - 20 ± 5 ℃ for at least one year;
Simple operation: directly add RNase-free H2O and nucleic acid to freeze-dried powder，no need of reagent preparation and sub-package.
Applicable equipment: ABI 7500; LightCycler 480; Bio-rad CFX96；SLAN-96S; BTK-96.
F. Kit Components
G. Comparison results
FAM: COVID-19 ORF1ab gene pseudovirus gradient dilution amplification curve
HEX：COVID-19 N gene pseudovirus gradient dilution amplification curve
Repeatability test result
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