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Cataloge BSJ01M1

The HPV Genotyping Real-time PCR Kit is a qualitative test designed to detect Human Papillomavirus (HPV) nucleic acid in cervical specimens, identifying 15 high-risk and 3 medium-risk HPV types, along with 2 low-risk types. The kit offers a simple operation with results in approximately 90 minutes, strong specificity, and includes an internal control for reliability. Clinical performance metrics indicate high agreement rates, making it suitable for in vitro diagnostic use.

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23 views2 pages

Cataloge BSJ01M1

The HPV Genotyping Real-time PCR Kit is a qualitative test designed to detect Human Papillomavirus (HPV) nucleic acid in cervical specimens, identifying 15 high-risk and 3 medium-risk HPV types, along with 2 low-risk types. The kit offers a simple operation with results in approximately 90 minutes, strong specificity, and includes an internal control for reliability. Clinical performance metrics indicate high agreement rates, making it suitable for in vitro diagnostic use.

Uploaded by

ttkoanh2807
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd

HPV Genotyping Real-time PCR Kit

Product Introduction
Human Papilloma Virus (HPV) is becoming a menace worldwide, especially to the developing world, due to its involve-
ment in a variety of malignancies, with cervical cancer being the most important and prevalent. There are many HPV
types: HPV 16/18 are the most carcinogenic but few others are also characterized as high-risk (HR). This kit is a qualita-
tive in vitro test for the detection of Human Papillomavirus (HPV) nucleic acid in cervical specimens collected by a
health care provider. The device identifies HPV genotypes 6, 11, 16, 18, 31, 33, 35, 39, 45, 51, 52, 53, 56, 58, 59, 66 and
68, while reporting the concurrent detection of the HPV genotypes 26, 73 and 82 at clinically relevant infection levels.

15 high-risk HPV types:


16 18 31 33 35 39 45 51 52 53 56 58 59 66 68
HPV HPV HPV HPV HPV HPV HPV HPV HPV HPV HPV HPV HPV HPV HPV

3 medium-risk HPV types: 2 low-risk HPV types:

26 73 82 6 11
HPV HPV HPV HPV HPV

Product Features
• Simple Operation: From sample processing to detection, results can be completed within 90 minutes.

• Ease of Use: Features a straightforward protocol with minimal hands-on steps, reducing the risk of procedural errors and
improving operational efficiency.

• Strong Specificity: No cross reaction with a variety of other types of HPV and similar pathogens.

• Internal Control Included: Human genome β-Globin gene acted as a non-competitive internal control (IC) to monitor the
entire extraction and detection process, ensuring reliability and quality of the results.
Product Specifications
Sample Type Cervical specimens

Limit of Detection (LoD) 1000 copies/mL


Target Genes L1 region
Internal Control Human genome β-Globin gene

Precision CV 5%
Compatible Platform LineGene 9600 Plus (FQD-96A) , QuantGene 9600 FQD-96C

Validated Collection Kits BSC93 Universal Transport Medium

Validated Extraction Kits BSC57 MagaBio plus Virus DNA/RNA Purification Kit
Detection Time ≈60 min
Storage Condition -25℃ ~ -15℃ away from light

Product Workflow

1 Label the tube with patient


identification information 2 Sampling
3 Primary Tube
4 Transfer to Deep
Well Plate

5 Nucleic Acid
Purification system
6 System setup
7 qPCR analysis
8 Report

Clinical Performance
The positive percent agreement, negative percent agreement and overall percent agreemment were 99.84%
(99.12%-99.995%), 99.64% (97.99%-99.99%), 99.78% (99.21%-99.97%) respectively.

Ordering Information
Product Name Cat. No. Package Storage Condition

BSJ01M1 48 tests/kit
HPV Genotyping Real-time PCR Kit -25℃ ~ -15℃
BSJ01L1 96 tests/kit away from light

For in vitro diagnostic use only.


For professional use only.

Add 1192 BinAn Rd, Binjiang District 310053 Hangzhou, PEOPLE'S REPUBLIC OF CHINA Web: www.bioer.com
Tel +86-571-87774513 Fax +86-571-87774553 E-Mail [email protected] E-Date 2024.09

BIO J01-2409

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