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Introduction
Product Features
Specification
Q&A
PRIMARY SCREENING HPV TEST KIT
Primary Screening of Cervical Cancer
This kit is intended to qualitatively detect the deoxyribonucleic acid (DNA) of 24 types of human papillomavirus (HPV) in women's cervical shedding cell samples, and identify the HPVs as Group 1 (6, 11, 42, 43, 44 or 81), Group 2 (16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59 or 68) or Group 3 (26, 53, 66, 73 or 82).
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Introduction
Product Features
Specification
Q&A
Introduction

Why do we test HPV? 


Cervical cancer is a leading cause of mortality among women. In 2020, an estimated 604 000 women were diagnosed with cervical cancer worldwide and about 342 000 women died from the disease. In the new WHO guideline for screening and treatment of cervical pre-cancer lesions for cervical cancer prevention, WHO suggests among the general population of women at the age of 30 years screening HPV every 5 to 10 years. 


WHO suggests using an HPV DNA primary screening test either with triage or without triage to prevent cervical cancer among the general population of women. 

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Product Features
Specification
Product Name
PRIMARY SCREENING HPV TEST KIT
Package Specification
24 Tests/Kit | 48 Tests/Kit
Storage Condition

The shelf life of this kit is 12 months when stored at – (20±5) oC. It is suggested to transport the kits in a sealed foam box with ice packs. Never leave the kit for more than 7 days at 2-8 oC under light avoidance. Never leave the kit for more than 5 days at 37 oC. Never repeat freeze-thaw more than 5 times for this kit, the effects beyond 12 times haven't been verified.


Performance

Coincidence of References

By using the China national reference for L1 genotyping of Human Papillomavirus genome to evaluate this kit, the results were consistent with both positive references and negative references. For enterprise references, the coincidence rates of 14 negative references and 24 positive references are both 100%.

The limit of Detection (LoD)

The limit of detection for all targeted HPV genotypes are 1×104 copies?mL-1.

Precision

The coefficient of variation of Ct values of precision references is not higher than 5% within-batch and inter-batch.

Specificity

  • The kit identified Group 1 (6, 11, 42, 43, 44 or 81), Group 2 (16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59 or 68) and Group 3 (26, 53, 66, 73 or 82). No cross-reactivity was found among Group 1, Group 2 and Group 3.

  • The kit did not show any cross-reactivity with any other microorganisms parasitized in human urinary and reproductive tract or sexually transmitted pathogens, including Herpes simplex virus type II, Treponema pallidum, Ureaplasma urealyticum, Mycoplasma genitalium, Gonorrhea Naysayorbacteria (Gonorrhea), Candida albicans, Trichomonas vaginalis, Chlamydia trachomatis. No cross-reactivity was found with other non-targeted HPV types such as 40, 54, 61, 67, 69, 70, 71, 72 and 83. (The tested concentration of the above  with the pipette to avoid aerosol, and finally centrifuging the reaction mixture solution for a few second. Use the kit before the expiration date and do not combinate the reagents with different batch numbers.


Q & A
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