VitaPCR SARS-CoV-2 Test Gen 2 (CE-IVD)
Catalog No : CDB-51574
995.00€
0.00€
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| Product name | VitaPCR SARS-CoV-2 Test Gen 2 (CE-IVD) | ||
|---|---|---|---|
| Catalog No | CDB-51574 | ||
| Supplier’s Catalog No | 51574 | ||
| Supplier | Credo Diagnostics | ||
| Source antigen | SARS-CoV-2 | ||
| Reactivity | SARS-CoV-2 | ||
| Cross reactivity | None | ||
| Applications | Qualitative RT-PCR (FAM™/ VIC® / ROX™/ CY5) | ||
| Molecular weight | N/A | ||
| Storage | Room Temperature 15-25°C | ||
|---|---|---|---|
| Other names | SARS-CoV-2, COVID-19, nCoV-2019 | ||
| Grade | CE-IVD | ||
| Purity | N/A | ||
| Form | Lyophilized | ||
| Reactivity life | 12 months when stored properly according to instructions | ||
| Note | For Professional In Vitro diagnostics | ||
| Description | Clinical Performance Due to the difficulty of obtaining clinical specimens from SARS-CoV-2 infected patients, performance characteristics of the VitaPCRTM SARS-CoV-2 Assay has been evaluated using contrived clinical specimens. The in vitro transcribed full length of SARS-CoV-2 RNA (N gene) was used in this testing. This RNA transcript stock with known titer (RNA copies/μL) spiked at different concentrations was prepared for spiking 30 individual negative NP or OP swab specimens at different concentrations. They were blinded, randomized and spiked into Sample Collection Buffer (4 ml) in which individual negative NP or OP swab specimens were washed. 20 NP or OP swab specimens were spiked at 1.5x LoD, 5 at 3x LoD, and 5 at 5x LoD. Another 30 individual negative NP or OP swab specimens were left un-spiked. In brief, we spiked either NP or OP swab specimens into contrived samples with various concentration, then proceeded the next procedure with the VitaPCRTM SARS-CoV-2 assay in this section. All 60 samples were blinded, handed and randomized to unbiased operators to analyze with the VitaPCR TM SARS-CoV-2 Assay to generate the Positive Percentage Agreement (PPA), Negative Percentage Agreement (NPA), and Overall Percentage Agreement (OPA) as a measurement of estimated Diagnostic Accuracy. Positive Percentage Agreement (PPA (95% Cl): 100% (91.5 - 100). Negative Percentage Agreement (NPA (95% Cl): 100% (91.5 - 100). | ||
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