HPV Human Papillomavirus Detection Kit Multiplex Real-time PCR Instructions In Vitro Diagnostic Re

Human Papillomavirus Detection Kit(Multiplex Real-time PCR)

INTENDED USE

This kit is intended for the in-vitro qualitative detection of nucleic acids of 18 high-risk HPV types (16,18,26,31,33,39,39,45,51,52,53,56,58,59,66,68,73,82) in cervical exfoliated cells,and genotyping for 16 and 18 HPV types. An additional primer pair and probe target the human β-globin gene to provide a process control..

SUMMARY

• Human Papilloma virus (HPV), belonging to the Papillomaviridae family, is a small, circular, non-enveloped, double-stranded DNA virus, with a genome length of about 8,000 base pairs (bp). HPV infection is very common in women. About 80% of women have been infected with HPV in their lifetime, and 90% of them can be naturally cleared within one to two years. Based on their oncogenic potential, HPVs are classified as low-risk, associated with benign warts or epithelial lesions, or high-risk, that can cause oropharyngeal and anogenital malignancies, including cancers of the cervix, vulva, and anus. High-risk HPV (hrHPV) types are responsible for ~5% of all human cancers and are detected in 99.7% of cervical cancer cases, the fourth most common cancer in women, accounting for 7.5% of all cancer-associated deaths in women worldwide per year.

Technical Parameters:

PRINCIPLE

It was used for qualitative detection of 18 high-risk human papillomavirus nucleic acid DNA (HPV16,18,26,31,33,39,39,45,51,52,53,56,58,59,66,68,73,82) in vitro in cervical exhumation cells, and typing of HPV16 and 18 types.

The PCR amplification reaction system of this kit also contains the Uracil-N-Glycosylase and can selectively break the uracil glycosiside bond in the PCR fragment containing dUTP, effectively reducing false positives due to contamination of the PCR product.

TEST PROCEDURE

1.Reagent preparation

1)Take out the Positive Control (Freeze-Dried) from the kit. Transfer it to the sample processing area.

2)Take out the (n+2) HPV Reagent Strip (Freeze-Dried), tear open the packaging bag, and place the 8-tube strips labeled with numbers 1 to 8, aligning the numbers, on the PCR rack, and remove the silicone plug.

Note:

• n is the sample size;
• Each PCR test must contain one PC (positive control) and one NTC (negative control).

3)Add 20 μL of Nuclease-Free Water into tube 1 to 8 of HPV Reagent Strip (Freeze-Dried) and close the Tube cap to transfer the reagent to the sample handling area. Mark strips with S1, S2…… Sn, NTC, PC.

2.Sample preparation and Positive Control preparation

1)If GPDX Sample Extraction Solution(NO. 600220) was used, Aspirate 1mL of sample, centrifuge at 12000 rpm for 2 min, discard the supernatant, and add 100uL nucleic acid releaser, 95°C metal bath for 10min, centrifuge at 12000rpm for 2min, and supernatant into DNA.

2)If GPDX Sample Extraction Solution(NO. 600220) was not available, it is recommended to use the GPDX nucleic acid extraction kit (No. 600210), refer to the instruction manual.

3)Add 200uL nuclease-free water to Positive Control (Freeze-Dried) , then vortexed for 2 min. Dissolved Positive Control should be vortexed and mixed well before use.

Note:

The Dissolved Positive Control needs to be stored at -20±5℃.

3.Add samples

1)Take out (n+2)HPV Reagent strips (n for samples, NTC and PC), and Centrifuge at 3,000 rpm for 1 min to concentrate all the reagent at the bottom. Mark strips with S1, S2…… Sn, NTC, PC. Then gently uncover the caps prior to use.

Add 5 µL DNA of sample 1 into Tube 1, and cap the PCR tubes. Prepare other sample strip, NTC and PC strip in the same manner as for sample 1.

2)Centrifuge at 3,000 rpm for 1 min to concentrate all the reagent at the bottom.

3)Place the HPV Reagent Strip into the real-time PCR system and set up the reaction program according to Table 2

Support and Services:

Our PCR Reagent product comes with dedicated technical support and services to ensure that our customers are able to use and optimize the product to its fullest potential. Our team of experts is available to answer any technical questions and troubleshoot any issues that may arise during the use of the product. Additionally, we offer training and educational resources to help customers improve their understanding of the product and its applications. Our goal is to provide a comprehensive and seamless experience for our customers, from initial purchase to ongoing support and maintenance.

Packing and Shipping

Product Packaging:

• The PCR Reagent product will be packaged in a sterile, sealed vial.
• The vial will be labeled with the product name, lot number, and expiration date.
• The vial will be further packaged in a sealed plastic bag to prevent contamination during shipping.

Shipping:

• The PCR Reagent product will be shipped in a temperature-controlled container to maintain product stability.
• The shipping container will be labeled with the product name, lot number, and expiration date.
• The product will be shipped via a reliable courier service to ensure timely and safe delivery.