| Limit of Detection | 1 copy in the reaction is detected within 39 cycles |
| Sensitivity | 100%† |
| Specificity | 98.6%† |
| Sample Type | Whole Blood (EDTA or Sodium Citrate) |
| Syphilis Genotype Detection | Designed to detect Treponema pallidum subspecies pallidum, endemicum, pertenue |
| 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 Syphilis was validated for sensitivity and specificity on a panel of 96 clinical samples. 12 high concentration and 12 low concentration samples containing T.pallidum genetic material were spiked randomly into 96 nucleic acid samples extracted from T.pallidum negative blood. The Simplex Syphilis test initially had 100% sensitivity and 98.61% specificity in this blinded study. Upon repeat the specificity increased to 100%. Thus the sensitivity of Simplex Syphilis is estimated at 100% when circulating virus is present in the sample and the specificity is estimated at 100%.
Simplex Syphilis Linearity
Order of magnitude dilutions of T.pallidum genetic material were made from 600,000 copies to 60 copies and the cycle thresholds were recorded for each. The results were plotted to show linearity and the cycle at which 1 copy can be detected.
Simplex Syphilis Sensitivity and Specificity
Simplex Syphilis was validated for sensitivity and specificity on two different panels of 48 clinical samples (96 total). 12 high concentration and 12 low concentration samples containing T.pallidum genetic material were spiked randomly into the 96 nucleic acid samples extracted from T.pallidum negative blood. The Simplex Syphilis test had 100% sensitivity and 98.61% specificity in this blinded study. Upon repeat the Simplex Syphilis test had 100% sensitivity and 100% specificity.
Simplex Design
Simplex Syphilis 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.
