GB SARS-CoV-2 Real-Time RT-PCR (E / ORF1ab (RdRp))

For in-vitro Qualitative Detection of 2019-Novel Coronavirus in Human
Respiratory Specimens

Intended Use:

The GB SARS-CoV-2 Real-Time RT-PCR is an in vitro nucleic acid amplification test (NAT) for the qualitative detection of novel coronavirus (SARS-CoV-2) in the respiratory tract specimens (i.e., nasopharyngeal/oropharyngeal swabs, nasal swabs and mid-turbinate swabs specimens), utilizing Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) and TaqMan probe technology. The design for this kit was based on the conserved region of E gene and ORF1ab (RdRp) region followed by the technical guidance of the World Health Organization (WHO) announcement.

Performance:

● Limit of Detection (LoD):5×102 copies/ml
● All serial dilutions of in-vitro transcription RNA of the target gene can be detected. (102, 104, 106, 108 copies/ml < 37 Ct)
● Including IC (internal control) as an indicator of the RT-PCR performance, which can reduce the results of false-negative.

Clinical Performance

Clinical evaluation of the GB SARS-CoV-2 Real-Time RT-PCR was conducted with contrived nasopharyngeal/nasal swabs. Thirty swabs samples were contrived with the virus particles isolated from USA-WA1/2020 (ZeptoMetrix Co., Cat. Number: NATSARS(COV2)-ST). The results are summarized in the table below and demonstrated a PPA (Positive Percent Agreement) of 100% and NPA of 100%.

Reactivity/inclusivity

In silico analysis concluded that GB SARS-CoV-2 Real-Time RT-PCR will detect all analyzed SARS-CoV-2 sequences in the NCBI database (n=443).

Product Information:

Reagents Supplied

Each kit provides reagents sufficient for performing 100 tests and consists of the following:

1. GB one-step Real-time RT-PCR reagent
2. Ready-to-use primer and probe mixture for E gene and ORF1ab (RdRp) region of SARS-CoV-2 in one tube
3. Nuclease-free water
4. Positive Controls
5. Internal Controls

Ordering Information

4PCO002E     GB SARS-CoV-2 Real-Time RT-PCR (E / N / ORF1ab (RdRp))     100 tests
4PCO052E     GB SARS-CoV-2 Real-Time RT-PCR (E / ORF1ab (RdRp))    100 tests