STANDARD™ M10 SARS-CoV-2 Test
STANDARD™ M10 SARS-CoV-2 test is an automated PCR cartridge test for qualitative measurement of SARS-CoV-2 virus either from nasopharyngeal or oropharyngeal swab specimen. STANDARD M10 SARS-CoV-2 test is used in combination with STANDARD M10 random access platform, which is easily scalable with up to 8 detection units (modules).
Generally
The STANDARD™ M10 SARS-CoV-2 test is an in vitro diagnostic PCR test that aids in the detection and diagnosis of SARS-CoV-2 virus. The STANDARD M10 SARS-CoV-2 test contains primers, probes and internal control (IC) used in RT-PCR for the in vitro qualitative detection of SARS-CoV-2 RNA in nasopharyngeal or oropharyngeal swab specimens. The test detects ORF1ab gene and E gene of SARS CoV-2.
STANDARD M10 SARS-CoV-2 test is used in combination with STANDARD M10 system which consists of console (user interface) and module (cartridge analysis function). The system is a modular random access platform which can be easily scaled with up to 8 modules, offering a customized throughput.
Easy and simple SARS-CoV-2 test workflow
- All-in-one cartridge (nucleic acid extraction and PCR amplification)
- Minimal hands-on time, results in 60 min, with early detection call function from 30 min
- Intuitive touch screen user interface
- Automated result interpretation, amplification curves provided
STANDARD M10 benefits
Versatile and flexible solution ― suitable for any healthcare settings
- RT-PCR and isothermal amplification (LAMP) technology in one system
- Multiplex capability, with up to 11 targets + internal control
- Random access, scalable with up to 8 modules
Technical data
| Products available |
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| Use | For in vitro diagnostic use |
| Method | Real-time PCR amplification |
| Sample type | Nasopharyngeal or oropharyngeal swab |
| Instrument information |
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| Time to result | 60 min, early call function from 30 min |
| Reading of the result | Automatic |
| Storage | Between +2 and +28 °C |
| Clinical sensitivity | 100% (109/109), 95% CI: 96.67% -100% |
| Clinical specificity | 100% (120/120), 95% CI: 96.97% -100% |
Transportation | Between +2 and +28°C |
| Size and weight | 317 x 130 x 81 mm, 1.04 kg |
| Additionally needed | STANDARD M10 instrument, transfer pipette, swabs and transport media |
| Country of origin | South Korea |
| Registration | CE IVD |
| Registered trademark | STANDARD M10Ⓡ |
About SARS-CoV-2
Acute respiratory infection can be caused by a variety of viruses and bacteria, including SARS-CoV-2 recently introduced. Acute respiratory infection of SARS-CoV-2 outbreak in Wuhan, China has widely spread out into the world since 2019. Common signs of a person infected with SARS-CoV-2 include respiratory symptoms, fever, cough, shortness of breath, and dyspnea. In more severe cases, the infection generates pneumonia, acute respiratory syndrome, kidney failure, or even death.
This kit is supportive for the diagnosis of SARS-CoV-2 infection. The test results are only for clinical reference and cannot be used as a basis for confirming or excluding cases by itself.