IMED License

High-Risk HPV Screening and Genotyping Real-Time PCR Detection Kit

Features:

  • Results obtained in the shortest possible time (90 minutes)
  • Screening of high-risk HPV genotypes and differential detection of genotypes 16, 18, and 31 in two reactions
  • 100% diagnostic sensitivity and specificity

Description

HPV High-Risk Screening/Genotyping Real-Time PCR Kit

Human Papillomavirus (HPV) is a double-stranded DNA virus and is considered one of the most important causes of sexually transmitted diseases and skin and mucosal disorders. The clinical manifestations of this virus vary depending on the anatomical site of the lesion and the type of HPV genotype.

To date, more than 100 different genotypes of HPV have been identified, of which about 40 types can infect the human genital area. Among these genotypes, approximately one-third are directly associated with cervical cancer and anal neoplasia.

Anogenital HPVs are generally classified into two main categories:

1) High-Risk Group (HPV High-Risk)
They have high oncogenic potential and, by disrupting cell division control, can lead to precancerous lesions and invasive cancers such as cervical cancer.

The most common high-risk genotypes include:

HPV 16, HPV 18, HPV 31, HPV 33, HPV 35, HPV 39, HPV 45, HPV 51, HPV 52, HPV 56, HPV 58, HPV 59, HPV 66, and HPV 68.

2) Low-Risk Group (HPV Low-Risk)
These genotypes are typically seen in genital warts or benign lesions and have low oncogenic risk.

The most common low-risk genotypes are:

HPV 6, HPV 11, HPV 40, HPV 42, HPV 43, HPV 44, HPV 54, HPV 55, HPV 61, HPV 67, HPV 74, HPV 81, HPV 83, HPV 84, and HPV 91.

Introduction of the High-Risk HPV Detection Kit from ap-rad

ap-rad has designed and manufactured the HPV High-Risk Screening/Genotyping Real-Time PCR Kit for the rapid, accurate, and specific detection of high-risk human papillomavirus genotypes.

This kit can:

  • Specifically identify 11 high-risk genotypes including 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68.
  • Separately and differentially detect the key genotypes 16, 18, and 31 from other types.

The working method of this kit is based on Real-Time PCR technology, which provides high sensitivity and specificity for the early detection of high-risk HPV.

The use of this kit in molecular diagnostic laboratories helps physicians and healthcare centers perform effective screening for cervical cancer and other HPV-related diseases accurately, quickly, and reliably.

اطلاعات کیت
Description Real-Time Amplification Kit with Viral DNA Extraction of Specimen
Method Real-Time
Type Qualitative
Regulatory Status IVD
Storage & Transfer Condition (˚C) 20-
Number of Reactions 50 & 100
Controls Positive & Negative
Applicable Instruments All Type of Real-Time PCR Machines with FAM, JOE ROX and (Cy5) Channels
Result Display Time 1.5hours
Validated Specimens Thin Prep
Sample Volume 10µL
Analytical Sensitivity (Copy/µL)s 0.57Copy/µL
Analytical Specificity 100%
Clinical Sensitivity 100%
Clinical Specificity 100%
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  • Neisseria gonorrhoeae
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Detection of 10 bacteria including:

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  • Pseudomonas aeruginosa
  • Klebsiella pneumoniae
  • Bordetella pertussis
  • Bordetella parapertussis

and one fungus including:

  • Pneumocystis jirovecii
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6-Plex Bacterial Meningitis-AP6PBMRK1 includes:

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5 Bacterial Pneumonia Detection Real Time PCR Kit
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Detection capability for five pneumonia bacteria including:

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  • Results obtained in the shortest possible time (2 hours)
  • 100% diagnostic sensitivity and specificity
  • Performed in a one-step reaction (no need for cDNA synthesis)
  • Contains internal, positive, and negative controls to confirm the extraction process and PCR test
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  • Results obtained in the shortest possible time (2 hours)
  • 100% diagnostic sensitivity and specificity
  • Performed in a one-step reaction (no need for cDNA synthesis)
  • Contains internal, positive, and negative controls to confirm the extraction process and PCR test