STANDARD M10 Arbovirus Panel
STANDARD M10 Arbovirus Panel test is a multiplex real-time reverse transcription polymerase chain reaction (real-time RT-PCR) test intended for use with STANDARD M10 system for the qualitative detection of viral RNA from Arbovirus; Dengue virus (DENV) including 4 serotypes (Dengue virus 1~4), Zika virus (ZIKV), Chikungunya virus (CHIKV), Yellow Fever virus (YFV) and West Nile virus (WNV) in serum or plasma collected from patients with symptoms.
Generally
STANDARD M10 Arbovirus Panel is a molecular in vitro diagnostic assay that aids in the simultaneous detection and differentiation of DENV-1, DENV-2, DENV-3, DENV-4, ZIKV, CHIKV, YFV and WNV RNA based on nucleic acid amplification technology, real-time RT-PCR. STANDARD M10 Arbovirus Panel cartridge contains viral RNA extraction buffers and RT-PCR reagents for the in vitro qualitative detection of DENV-1, DENV-2, DENV-3, DENV-4, ZIKV, CHIKV, YFV and WNV RNA in human serum and plasma.
STANDARD M10 tests are used in combination with STANDARD M10 system consisting of a console (user interface) and one or more modules (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 test workflow
- All-in-one cartridge (nucleic acid extraction and PCR amplification)
- Minimal hands-on time, results available in 60 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 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 | SD BIOSENSOR STANDARD M10 Arbovirus Panel Test |
| Use | For in vitro diagnostic use |
| Method | Real-time PCR amplification |
| Sample type | Serum and plasma |
| Instrument information | 155067 SD BIOSENSOR STANDARD M10 CONSOLE 155068 SD BIOSENSOR STANDARD M10 MODULE |
| Time to result | 60 minutes |
| Reading of the result | Automatic |
| Storage | Between +2 and +28 oC |
| Sensitivity | YFV: 100.00% (95% CI 69.15% to 100.00%) DENV-1: 100.00% (95% CI 69.15% to 100.00%) DENV-2: 100.00% (95% CI 54.07% to 100.00%) DENV-3: 100.00% (95% CI 69.15% to 100.00%) WNV: 100.00% (95% CI 2.50% to 100.00%) ZIKV: 100.00% (95% CI 73.54% to 100.00%) CHIKV: 80.00% (95% CI 44.39% to 97.48%) |
| Specificity | YFV: 98.08% (95% CI 93.23% to 99.77%) DENV-1: 98.08% (95% CI 93.23% to 99.77%) DENV-2: 100.00% (95% CI 96.64% to 100.00%) DENV-3: 100.00% (95% CI 96.52% to 100.00%) WNV: 100.00% (95% CI 96.79% to 100.00%) ZIKV: 100.00% (95% CI 96.45% to 100.00%) CHIKV: 100.00% (95% CI 96.52% to 100.00%) |
| Transportation | Between +2 and +28oC |
| Additionally needed | STANDARD M10 instrumentation, Blood collection tubes, Sample transfer pipettes, |
| Country of origin | South Korea |
| Registration | CE IVDD |
About Arbovirus
Arboviruses are transmitted by arthropods, including those responsible for the current pandemic, flaviviruses (Dengue, Zika, Yellow Fever and West Nile, etc) and alphavirus (Chikungunya, Mayaro and Ross River, etc).These viruses are transmitted by Aedes mosquitoes, especially Aedes albopictus and Aedes aegypti are the presumed vector. The illnesses caused by arbovirus have similar clinical presentation with prominent fever, headache, rash, vomiting, fatigue, myalgias (muscle aches), arthralgias (joint aches) and other unspecific illnesses can be observed.
Dengue viruses are widely distributed throughout the tropical and subtropical areas of the world. There are four known distinct serotypes of dengue virus (DENV-1, DENV-2, DENV-3 and DENV-4). Rapid and reliable tests for primary and secondary infections of dengue are essential for patient management.