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14 Types of HPV Nucleic Acid Typing Detection Kits(Fluorescence PCR)

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14 Types of HPV Nucleic Acid Typing Detection Kits(Fluorescence PCR)

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Introduction

[Product Name] 14 Types of HPV Nucleic Acid Typing Detection Kits(Fluorescence PCR) [Packaging Size] 50 tests/kit
[Intended Use]

The kit can in vitro qualitative typing detection the 14 types of human papillomaviruses (HPV16、18、 31、33、35、39、45、51、52、56、58、59、66、68) nucleic acid. It can only provide auxiliary means for the diagnosis and treatment of HPV infection.
Cervical cancer is one of the most common malignant tumors in the female reproductive tract. The studies have shown that persistent infection and multiple infections of human papillomavirus is one

of the important cause of cervical cancer. At present, there is still a lack of recognized effective treatment methods for HPV. Therefore, early detection and early prevention of cervical HPV is the key to blocking canceration. The establishment of a simple, specific and rapid pathogenic diagnostic method is of great significance in the clinical diagnosis of cervical cancer.
This test results cannot be used independently or in preference to cervical cytology, and it is not recommended to be used alone for cervical cancer screening in any age group. It cannot replace cervical cytology and should not be used alone as the basis for patient management. Due to the lack of corresponding clinical trials, it should not be used for clinical purposes related to cervical cancer screening.

[Test Principle]

This kit is a multiplex PCR intended for qualitative detection of HPV. It realizes the typing detection of 14 types of HPV through 4 kinds of reaction buffer. Highly specific primers and probes are designed according to the L1 gene sequences of various types of HPV. Specific probe 5' is labeled with FAM (HPV16, 58, internal reference), VIC (HEX) (HPV18, 33, 51, 59), CY5 (HPV35, 45, 56, 68), ROX (HPV31, 39, 52, 66). 3' quencher is BHQ1 or BHQ2. In the process of PCR amplification, specific primers and probes bind to their respective target sequences. When Taq enzyme encounters the probe bound to the target sequence, it exerts the function of 5′-end exonuclease, making the reporter and the quencher is separated, so that the fluorescence monitoring system can receive the fluorescent signal, that is, each time a DNA chain is amplified, a fluorescent molecule is formed, and the accumulation of the fluorescent signal is completely synchronized with the formation of the PCR product. The 14 kinds of HPV nucleic acid in the sample can be qualitatively typing detected, which provides an auxiliary means for the diagnosis and treatment of HPV infected patients.

[Storage Condition and Shelf-life]

The kit should stored below -18°C protected from light. The shelf life is 12 months. After the kit is opened, please use it up within 3 months. The number of repeated freezing and thawing should not be more than 4 cycles. The kit can be stored stably for 5 days when transported protected from light below -18°C.

[Applicable Instruments]

SLAN® -96P Real-Time PCR Systems(Shanghai Hongshi Medical Technology Co., Ltd. ), Applied Biosystems 7500 Real-Time PCR Systems, QuantStudio® 5 Real-Time PCR Systems, LightCycler® 480 Real-Time PCR system, LineGene 9600 Plus Real-Time PCR Detection System(FQD-96A, Bioer technology), MA-6000 Real-Time Quantitative Thermal Cycler (Suzhou Molarray Co., Ltd.).

[ Requirements for Samples]

1. Sample Collection
Before sampling, use a cotton swab to gently wipe the excess secretions from the cervix, and use another cotton swab infiltrated with the cell preservation solution or the cervical exfoliated cell sampling brush to be close to the cervical mucosa and turn clockwise 3 to 5 cycles to obtain cervical exfoliated cells. Slowly take out the cotton swab or brush, put it into a sample tube with 1 mL of sterile normal saline, rinse thoroughly, squeeze the cotton swab or brush against the wall, squeeze dry and discard, tighten the cap, and place it in the sample tube. Label the sample name (or number) and type on the tube.
2. Storage
The sample to be tested should not be stored for more than 48 hours at 2~8°C; below -18°C for no more than six months; it can be stored for a long time below -70°C. Repeated freezing and thawing should be avoided.
3.Shipping
Ultra-low temperature transportation of liquid nitrogen and dry ice is recommended.

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