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Key Features

• Detects HPV 16 and HPV 18 in one real-time PCR assay
• Lyophilized ready-to-use mix — no reagent preparation needed
• High sensitivity and specificity
• Internal control included for assay validation
• Hot-start PCR technology minimizes non-specific PCR reactions and increases specificity.
• Uracil-DNA glycosylase (UDG) technology prevents carryover contamination.
• Using CLEO Q16, the PCR setup can be easily set up with QR code recognition, and test results can be automatically analyzed, allowing for quick and intuitive confirmation of results.

Specifications

Principle of Procedure	Real-time PCR
Target	FAM for HPV 16, HEX for HPV 18, Cy5 for the internal control
Reagent Type	Lyophilized (Freeze-dried) in PCR tube
Limit of Detection (LoD)	0.5 copies/μL
Analytical specificity	100 %
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	For analytical specificity, cross-reactivity was evaluated by testing related pathogens and microorganisms that are likely to be present in the cervical, vaginal, and genital. The test was repeated three times and showed no cross-reactivity.
Sample	Vaginal swab or urine specimens
Compatible Instruments	CLEO™ Q16 (Wizbio), CFX96 (Bio-Rad), QuantiStudio5 (ThermoFisher)

Protocol

Technical Data

Storage & Shipping

Room temperature (4 - 25℃)

Ordering Information

Product Name	Cat No.	Package
WizDx™ CrystalMix HPV 16/18	DX1224	96 Tests