Features
Comprehensive 3 targets（ORF1ab, N and E genes）detected in 1 tube
Reliable Internal control, UNG enzyme and dUTP were used to reduce risk of contamination and false negative results
Faster results 1h20min post-extraction turnaround time
Sample Type Nasopharyngeal swab/Throat swab/Sputum/Stool
Golden Standard
Clinical sensitivity
99.51%
Clinical specifity
96.44%
Overall coincidence
97.49%
Workflow
Step 1：Reagent preparation
Add n x 6 µL of RT-PCR enzyme and n x 14 µL of 2019-nCOV reaction reagent into the centrifuge tube, mix by shaking, and centrifugate at low speed for a few second, then make aliquots of 20 µL into different PCR reaction tubes.
Step2: Nucleic Acid Extraction
The volume of sample to be extracted is 200 µL, and 5 µL of internal reference A will be added to each sample (including the reference).
Step 3: Template Addition
Add 10 µL of extracted Negative Control, 10 µL of extracted Positive Control, and 10 µL of extracted RNA from sample to different PCR reaction tubes. Centrifuge them at low speed. Then, move them to the PCR instrument.
Step 4: Amplification
- 50°C for 15 minutes, 1 cycle;
- 95°C for 3 minutes, 1 cycle;
- 95°C for 5 seconds to 60°C for 40 seconds, 5 cycles;
- 95°C for 5 seconds to 60°C for 40 seconds, 40 cycles.
The signals of FAM, JOE, ROX and CY5 fluorescence channels will be collected at 60°C
Step 5: Date Analysis
Test date file need to be saved after PCR reaction. Please set the parameters and analysis the result of FAM, JOE,ROX and CY5 channels respectively.
Note: The nucleic acid extraction reagent used in Step 2 is not provided in the kit, which needs to be prepared by the user.
Product Information
Registration certificate
CE：Ref. No.:GZ 8821-2020
China NMPA: GUOXIEZHUZHUN 20203400229
Specification
48 tests/kit;96 tests/kit
Amplification time
1h20min
Instrument
Four-channel RT-PCR instrument(FAM/JOE/ROX/CY5)
Storage & Shelf Life
-25°C~-15°C,12month