Fyler

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Key Features

• Detects HPV 16, 18, and pooled high-risk HPV types in one real-time PCR assay
• Lyophilized ready-to-use mix — no reagent setup required
• High sensitivity and specificity
• Internal control included for assay quality
• 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, ROX for high-risk HPV, Cy5 for the internal control
Reagent Type	Lyophilized (Freeze-dried) in PCR tube
Limit of Detection (LoD)	5 ag/μL
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%
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 <5%.
Sample	Vaginal swab or urine specimens
Compatible Instruments	CLEO™ Q16 (Wizbio), CFX96 (Bio-Rad)

Protocol

Technical Data

Storage & Shipping

Room temperature (4 - 25℃)

Ordering Information

Product Name	Cat No.	Package
WizDx™ CrystalMix HPV-HR	DX1240	96 Tests