Principle of Procedure |
Real time PCR |
Target |
FAM for HPV 16, HEX for HPV 18, Cy5 for the internal control |
Tests for Package |
96 tests/kit |
Reagent Type |
Lyophilized (Freeze-dried) in PCR tube |
Limit of Detection (LoD) |
0.5 copies/μL |
Precision |
Respectively detect the reference specimen of high and low concentrations in
different time ranges-10 times, and the precision values of intra-assay and inter-assay
Ct values were all <2%. |
Specificity |
• Analytical specificity : 100 %
• Clinical Sensitivity : #16 (92.37%), #18 (95.00%), #HR (91.63%)
• Clinical Specificity : #16 (99.48%), #18 (99.70%), #HR (96.59%) |
Sample Types |
Cervical, Vaginal, Genital specimens |
Shipping/Storage |
Shipping and Storage at room temperature for 12 months |
Compatible Instruments |
CLEO™ Q16 (Wizbiosolutions), CFX96 (Bio-Rad), QuantStudio™ 5 (ThermoFisher) |