Feature | Description | ||
Certification and Licence |
1 | NMPA | Licence from China National Medical Products Administration |
2 | ISO13485 | Quality licence from International Standard Organization |
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3 | CE | Quality licence from EU | |
Usage |
1 | 1.68 million specimens |
BioGerm has already tested more than 1.68 million specimens in China |
2 | 321 | 321 units belonging to CDCs | |
3 | 273 | 273 hospitals | |
26 | 26 customs and ports | ||
12 | 12 medical laboratories | ||
Feature |
1 | Intend use | SARS-CoV-2 Nucleic Acid Detection Kit contains the assays 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 from individuals suspected of COVID-19. |
2 | Sample Type&Volume | nasopharyngeal swab, oropharyngeal swab, sputum specimens, minimum required sample volume of 0.2ml. |
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3 | Internal and External controls | RNA Internal Control, used to monitor the entire sample preparation and PCR amplification process. In addition, the test utilizes external controls(low titer positive controls and a negative control) |
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4 | Storage temperature | Stored refrigerated 2-8℃ | |
5 | Open-kit stability | 90 days from first usage | |
6 | Assay Specificity | 100% for 481 SARS-CoV-2 specimens | |
7 | Analytical sensitivity | 93.92% for 481 SARS-CoV-2 specimens |
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8 | Detection limit | 5 copies in a 25 ul reaction | |
9 | Test duration | 1.5hours | |
10 | Reagents preparation | 10minutes |