28 Types of Human Papillomavirus (16/18/45Typing) Nucleic Acid Detection Kit (Fluorescence PCR)

Short Description:

[Product Code] HWTS-CC024

[Intended Use]

This kit is suitable for in vitro qualitative detection of 28 types of human papillomavirus (HPV 6, 11, 16, 18, 26, 31, 33, 35, 39, 40, 42, 43, 44, 45, 51, 52, 53, 54, 56, 58, 59, 61, 66, 68, 73, 81, 82, 83) nucleic acids in clinical urine sample, female cervical swab sample and female vaginal swab sample, as well as HPV 16/18/45 typing detection, while the remaining types cannot be completely distinguished, providing an aid in the diagnosis and treatment of HPV infection.

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28 Types of Human Papillomavirus (16/18/45Typing) Nucleic Acid Detection Kit (Fluorescence PCR)

Epidemiology

Human Papillomavirus (HPV) belongs to the Papillomaviridae family of a small-molecule, non-enveloped, circular double-stranded DNA virus, with a genome length of about 8000 base pairs (bp). HPV infects humans through direct or indirect contact with contaminated items or sexual transmission. The virus is not only host-specific, but also tissue-specific, and can only infect human skin and mucosal epithelial cells, causing a variety of papillomas or warts in human skin and proliferative damage to reproductive tract epithelium.

Cervical cancer is one of the most common malignant tumors of the female reproductive tract. Studies have shown that HPV persistent infections and multiple infections are one of the main causes of cervical cancer. Currently, the recognized effective treatments are still lack for cervical cancer caused by HPV, so early discovery and prevention of cervical infection caused by HPV is the key to preventing cervical cancer. It is of great significance to establish a simple, specific and rapid etiology diagnostic test for the clinical diagnosis and treatment of cervical cancer.

Technical Parameters

Storage	≤ -18℃
Shelf-life	12 months
Specimen Type	Urine sample, Female cervical swab sample, Female vaginal swab sample
CV	<5.0%
LoD	Limit of Detection (LoD): LoD of the kit is 300Copies/mL
Specificity	There is no cross reaction with similar pathogens.
Applicable Instruments	Applied Biosystems 7500 Real-Time PCR System, Applied Biosystems 7500 Fast Real-Time PCR Systems, QuantStudio®5 Real-Time PCR Systems, SLAN-96P Real-Time PCR Systems (Hongshi Medical Technology Co., Ltd.), LightCycler®480 Real-Time PCR Systems, LineGene 9600 Plus Real-Time PCR Detection Systems (FQD-96A, Hangzhou Bioer technology), MA-6000 Real-Time Quantitative Thermal Cycler (Suzhou Molarray Co., Ltd.), BioRad CFX96 Real-Time PCR System and BioRad CFX Opus 96 Real-Time PCR System.

Channel:

Reaction Buffer	Fluorophore	Quencher
PCR-Mix1/PCR-Mix2	FAM	none
	VIC(HEX)	none
	ROX	none
	CY5	none

Work flow: See the Kit IFU for details

Solution 1 (Automated nucleic acid extraction)

Solution 2: (Macro & Micro-Test Sample Release Reagent)

Reagents need but not provided: Macro & Micro-Test Sample Release Reagent (HWTS-3005-8), Macro & Micro-Test Viral DNA/RNA Kit (HWTS-3017) (which can be used with Macro & Micro-Test Automatic Nucleic Acid Extractor (HWTS-EQ011)) by Jiangsu Macro & Micro-Test Med-Tech Co., Ltd., Macro & Micro-Test Viral DNA/RNA Column (HWTS-3020-50).

Consumables need but not provided: 1.5mL DNase/RNase free centrifuge tubes, DNase/RNase free Tips, 0.2mL of PCR tubes, desktop centrifuge, desktop oscillation mixer.