COVID-19 (SARS-CoV-2) Nucleic Acid Test Kit (Freeze-dried)

CE marked In vitro diagnostic medical device for professional use.

Manufacturer: Wuhan EasyDiagnosis Biomedicine Co., Ltd.

The COVID-19 (SARS-CoV-2) Nucleic Acid Test Kit(Freeze-dried) is intended for the qualitative detection of nucleic acid from SARS-CoV-2 in oropharyngeal swabs, nasopharyngeal swabs and sputum specimens from individuals suspected of COVID-19.This kit is used in human specimens. For professional use only.

The COVID-19 (SARS-CoV-2) Nucleic Acid Test Kit(Freeze-dried) is a real-time reverse transcription polymerase chain reaction (RT-PCR) test with multiplex PCR-fluorescent probe technology and one-step RT-PCR technology. The oligonucleotide primers and probes for detection of SARS-CoV-2 were selected from the conserved regions of the virus nucleocapsid (N) gene and ORF1ab. After the end of amplification reaction, the results will be determined by analyzing the cycle threshold (Ct) of each channel.In addition, the human housekeeping gene RNaseP, which is used to monitor the sampling, extraction, template addition, amplification and other processes, is designed as the internal control of the kit to effectively prevent the occurrence of false positive and false negative.