HPV Genital Warts Test

This is a rapid at home test for detection of genital human papilovirus 6, and genital human papillovirus 11, the two most common types of HPV that are the cause of genital warts.

The area to be tested is swabbed, and the swab is then dipped in the provided buffer solution A, then mixed with buffer solution B, then a few drops of of the buffer  are dropped into the rapid test cassette.  Test results show within minutes.

Intended Use
The DiagLineTM Screening Test for Genital Warts is a rapid visual immunoassay for the qualitative presumptive detection of HPV 6/11 antigens in skin or cutaneous swab specimens. This kit is intended to be used as an aid in the diagnosis of clinical or subclinical genital warts.

Introduction
Human papillomavirus (HPV) belongs to papillomaviruses, a diverse group of DNA-based viruses that infect the skin and mucous membranes of humans and a variety of animals.  Over 100 different human papillomavirus(HPV) types have been identified on the basis of difference in the virus genome nucleotide sequences. Today genital HPV infection is one of the most widespread sexually transmitted diseases. Approximately 20 million people around the world are currently infected with HPV. At least 50 percent of sexually active men and women acquir genital HPV infection at some point in their lives.

All HPVs are transmitted by skin-to-skin contact. A group of “low-risk” HPVs is typically transmitted through sexual contact and infect the anogenital region, may cause genital warts or venereal warts (condylomata acuminata). Most genital warts are caused by HPV type 6 and to a lesser extent HPV type 11 and other HPV types.

Persistent infection with a subset of “high-risk” sexually transmitted HPVs, mainly including types 16,18, may lead to the development of cervical intraepithelial neoplasia (CIN). These are precancerous lesions and can progress to invasive cancer. HPV infection is a necessary factor in the development of nearly all cases of cervical cancer.

Most HPV infections of the genital tract are subclinical and asymptomatic. Subclinical HPV infections may be 10-30 times more common than overt infections. Asymptotic HPV infections may cause the transmission of HPV and post-treatment recurrences of genital warts.

The diagnosis of genital warts now is usually by visual inspection, biopsy, aceto-white application or DNA testing, The sensitivity and specificity of aceto-white application and other clinical diagnoses of HPV infection is much lower than the diagnoses based on detection of HPV DNA. But HPV DNA testing needs skilled operator and expensive machine which limited its use.  A simple, rapid, and cost-effective screening test of HPV 6 and 11 antigen aids in the differential diagnosis for genital warts, discovery of subclinical HPV infections, and evaluation the risk factors for genital warts post-treatment recurrences.

Performance Characteristics
Relative Sensitivity: 92.9%
Relative Specificity: 91.2%
Overall Agreement: 92.2%