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(SARS-CoV-2)核酸檢測試劑盒(實時熒光探針法)
Novel Coronavirus (SARS-CoV-2) Nucleic Acid Detection Kit (Real-Time RT-PCR Method)
FiregenSARS-CoV-2?核酸檢測試劑盒

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Novel Coronavirus (SARS-CoV-2) Nucleic Acid Detection Kit (Real Time RT-PCR Method)

Instructions for Use

Intended Use

The Firegen^TM Novel Coronavirus (SARS-CoV-2) Nucleic Acid Detection Kit is a real-time multiplex RT-PCR test intended for the qualitative detection of SARS-CoV-2 viral RNA. It is suitable for upper respiratory specimens, such as nasopharyngeal, oropharyngeal swab, and bronchoalveolar lavage specimens. In a single RT-PCR reaction, it is able to detect ORF1ab and N RNA sequences, and in addition, human RNase P as an internal control.

Principles

This kit uses the real-time fluorescent RT-PCR technology, with prime and probe sets designed targeting the ORF1ab and N gene sequences. Each probe is labeled at the 5 ' end a fluorescence reporter group and 3' end a quenching group. The 3’ primers enable the reverse transcriptase to generate cDNA from viral RNA, and subsequently Taq polymerase performs multiple rounds of amplification of the target DNA. During primer extension steps, the 5 '→ 3' exonuclease activity of the Taq enzyme hydrolyzes the probes, and the reporter fluorescence group is free from the quencher, and therefore a fluorescent signal is emitted. The target detection can be achieved from the amplification curve and the Ct value.

This kit contains an endogenous internal control (IC), which targets human RNase P gene sequences. The IC is used to monitor the collection, transportation, extraction and amplification of the test specimen to avoid false negativity.

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