Freeze-dried Nucleic Acid Detection Kit

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 2019-nCOV viral RNA extracted from nasopharyngeal swabs, oropharyngeal swabs and sputum of patients suspected to have clustered cases and other patients requiring diagnosis.

B. 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.

C. Main Parameter

D.  Advantage&Features

1、Transportation conditions: compared with normal liquid PCR detection kit, the freeze-dried product can be transported at room temperature (not more than 1 month);

2、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;

3、Simple operation: directly add RNase-free H2O and nucleic acid to freeze-dried powder，no need of reagent preparation and sub-package. 

4、Applicable equipment: ABI 7500; LightCycler 480; Bio-rad CFX96；SLAN-96S; BTK-96.

E. Kit Components

F. 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

G. Product Qualification(By Dec.2nd,2022）