This kit is used for the qualitative in vitro detection of the ORFlab and N gene of the new coronavirus (2019-nCoV) in throat swabs, sputum samples from patients with suspected pneumonia infected by a new coronavirus, suspected clustering cases, and others. That needs a diagnosis or differential. diagnosis of the new coronavirus. For definitions of “suspected cases” and “suspected clustering cases”, please refer to documents (current versions) such as the Diagnosis and Treatment Scheme for Patients with Pneumonia Infected by the Novel Coronavirus and the Follow-up Scheme for Patients with Pneumonia Infected by Novel Coronavirus. the new coronavirus released by the Chinese Center for Disease Control and Prevention (China CDC).
This product is only used for the auxiliary diagnosis and in vitro diagnosis (IVD) of pneumonia infected by a new coronavirus (2019-nCoV) since December 2019 under emergency. Instead, it cannot be used clinically as a general IVD reagent. In use, relevant document requirements such as the diagnosis and treatment scheme for patients with pneumonia infected by the new coronavirus and the monitoring scheme for pneumonia patients infected by the new coronavirus will be followed.
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Detection of novel coronavirus RNA shall meet the requirements of the China CDC Technical Guide for Laboratory Detection of New Coronavirus Pneumonia and other documents, in order to carry out biosafety regulations. The detection results of this kit are for clinical reference only and should not be used as the sole criteria for clinical diagnosis. A full analysis of the condition is recommended in combination with the patient’s clinical manifestations and other laboratory tests.