Roche Kebas automatic new coronavirus nucleic acid detection reagent - Taiwan Registration 816acd3d2ebff8c18eb91604e46e8abf

This product is used in the cobas 5800/6800/8800 system, a real-time reverse transcription polymerase chain reaction (RT-PCR) reagent designed to qualitatively detect the nucleic acid of the new coronavirus (SARS-CoV-2) in nasal, nasopharyngeal, and oropharyngeal swab swab specimens collected by healthcare professionals, who may be anyone, including those suspected of COVID-19 by healthcare professionals, asymptomatic individuals or others suspected of being related to COVID-19. The result was the detection of SARS-CoV-2 RNA. SARS-CoV-2 RNA can usually be detected in respiratory specimens during the acute phase of infection. A positive result is an indicator of the presence of SARS-CoV-2 RNA, and the clinical relevance of history and other diagnostic information needs to be assessed to determine the patient's infection status. A positive result does not rule out bacterial infection or co-infection with other viruses. A negative result does not rule out COVID-19 infection and should not be used as the sole basis for patient management decisions. Negative results must be judged in conjunction with clinical observation, medical history, and information on epidemiological pathology.

QMS/QSD;; 輸入