| Limit of Detection | 1 copy in the reaction is detected within 39 cycles |
| Sensitivity | 100%† |
| Specificity | 100%† |
| Sample Type | Plasma or Serum (EDTA or Sodium Citrate) |
| Dengue Genotype Detection | Detects all genotypes (1 through 4) |
| Time to Detection | 30 – 50 minutes, depending on the machine used |
| Thermocycler Compatibility | Spartan Dx-12, AB StepOne, AB 7000, AB 7500, BioRad CFx96, LightCycler 2.0 and most other machines with a FAM channel |
†Simplex Dengue was validated for sensitivity and specificity on a panel of 96 clinical samples. 12 high concentration and 12 low concentration samples containing Dengue Virus genetic material were spiked randomly into 96 nucleic acid samples extracted from Dengue negative blood. The Simplex Dengue test had 100% sensitivity and 100% specificity in this blinded study. Thus the sensitivity of Simplex Dengue is estimated at 100% when circulating virus is present in the sample and the specificity is estimated at 100%.
Simplex Dengue Genotype Detection The Simplex Dengue Test was validated for detection of all genotypes of Dengue Virus using a panel including Type 1 (isolates from Hawaii and Thailand), Type 2 (isolate from New Guinea), Type 3 (isolate from Philippines) and Type 4 (isolate from Philippines). A negative control is also shown.
Simplex Design
Simplex Dengue incorporates the fifth and most advanced iteration of real-time PCR probe technologies, Rapid Probes, which have been shown to be faster than Tentacle Probes and Molecular Beacons. All Simplex assays are designed with proprietary bioinformatics algorithms against variants of pathogen from all over the world, insuring Simplex will detect not only those strains that exist today, but also those strains that will appear in the future.
