| Limit of Detection | 1 copy in the reaction is detected within 40 cycles |
| Sensitivity | 100%† |
| Specificity | 100%† |
| Sample Type | Plasma or Serum (EDTA or Sodium Citrate) |
| HBV Genotype Detection | Designed to detect all genotypes, validated on genotypes A-F |
| 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 HBV was validated for sensitivity and specificity on a panel of 96 clinical samples. 12 high concentration and 12 low concentration samples containing HBV genetic material were spiked randomly into 96 nucleic acid samples extracted from HBV negative blood. The Simplex HBV test had 100% sensitivity and 100% specificity in this blinded study. Thus the sensitivity of Simplex HBV is estimated at 100% when circulating virus is present in the sample and the specificity is estimated at 100%.
Simplex HBV Linearity
Order of magnitude dilutions of HBV 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 HBV Sensitivity and Specificity
Simplex HBV 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 HBV genetic material were spiked randomly into the 96 nucleic acid samples extracted rom HBV negative blood. The Simplex HBV test had 100% sensitivity and 100% specificity in this blinded study.
Simplex HBV Genotype Detection Using a world-wide panel of HBV strains provided by SeraCare, Simplex HBV was able to detect genotypes A (three different isolates), B, C, D, E, and F. The Simplex HBV test has no cross reactivity with Hepatitis C or Human Immunodeficiency Virus -1 samples (also provided by SeraCare).
Simplex Design
Simplex HBV 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.
