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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

  1. 50°C for 15 minutes, 1 cycle;
  2. 95°C for 3 minutes, 1 cycle;
  3. 95°C for 5 seconds to 60°C for 40 seconds, 5 cycles;
  4. 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

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