Reliable Solution for
the COVID-19 Outbreak
Ezplex SARS-CoV-2 G
CE IVD
Korean MFDS (Ministry of Food and Drug Safety)
• This product has not been FDA cleared or approved; but has been authorized by the FDA under an Emergency Use Authorization (EUA) for use by laboratories certified under the Clinical Laboratory Improvement Amendments (CLIA) of 1988, 42 U.S.C. §263a, that meet requirements to perform high complexity tests.
• This product has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens.
• The emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. §360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked sooner.
Features and Benefits
Fast Results
Produces test results within 2.5 hours post extraction.
Real-time PCR
Detection and identification of target genes (RdRP, N) specific for COVID-19 in a single tube.
Specimen Pooling Capability
Five times as many tests can be conducted within the same time period. (FDA EUA and CE IVD)
Sensitivity
Reference material was repeatedly tested through serial dilution to show high analytical sensitivity. FDA SARS-CoV-2 Reference Panel detection limit of 1200 NDU*/mL.
•NAAT Detectable Units/mL
Accessibility
Test results can be easily analyzed with dedicated user-friendly Genetree Viewer software.
Downloadable Resources
Product Specifications
- Nextractor NX-48 (Genolution) - CE IVD only
Intended Use
Kit components
100 tests
NO. | Kit Component | Volume | Lid Remarks |
1 | RQ Mixture | 1 vial, 1,000uL | RQ |
2 | P+P | 1 vial, 500uL | P+P |
3 | Positive Control | 1 vial, 50uL | PC |
4 | Negative Control | 1 vial, 50uL | NC |
5 | Internal Control | 1 vial, 20uL | IC |
Storage
Work Flow