This kit is used for in vitro qualitative detection of novel coronavirus (SARS-CoV-2) ORF1ab and N gene in specimens, including nasopharyngeal swab, oropharyngeal swab, saliva, sputum, bronchoalveolar lavage fluid, for diagnosis of the COVID-19 infection, the suspected cluster cases and of the patients who need differential diagnosis of COVID-19 infection.

Principle

This kit used a multiplex TaqMan probe-based one-step reverse transcription polymerase chain reaction (RT-PCR), which enables simultaneous qualitative detection of ORF1ab and N gene of SARS-CoV-2 as well as a human RNaseP gene ( internal control ) in one reaction. The detection results are automatically interpreted by the instrument of Automatic Medical PCR Analysis System（Sanity 2.0 System; Xiamen Zeesan Biotech Co., Ltd.) according to the Ct value of ORF1ab and N gene. For ease of storage and transportation, the amplification reagent is designed as pre-distributed dry reagent.

CE-IVD Marked