Intended use
Novel Coronavirus (SARS-CoV-2) RNA detection kit contains the reagents and controls for a real-time reverse transcription polymerase chain reaction (RT-PCR) test intended for the qualitative detection of nucleic acid from SARS-CoV-2 in nasopharyngeal swabs, oropharyngeal swab, sputum, bronchoalveolar lavage (BAL) specimens from individuals suspected of COVID-19 by their healthcare provider.
Novel Coronavirus (SARS-CoV-2) RNA detection kit is for professional use only.
Certificates
1. CE
2. ISO13485
Characteristics
1. Easy and fast operation
Using one-step RT-PCR reaction system, only the extracted products of the samples to be tested can be added.
2. High specificity
The specific region of the virus was selected for primer design to avoid the influence of other coronaviruses with high homology.
3. High sensitivity
Sensitivity 500 copies/test, It can be detected in the early stage of infection to achieve early diagnosis and early treatment.
4. Internal reference gene quality control
Internal standard participates in the whole process of nucleic acid extraction, purification and amplification, realizes the whole process monitoring and avoids false negative.