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
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.
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
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.
Relative Sensitivity: 92.9%
Relative Specificity: 91.2%
Overall Agreement: 92.2%
This product was added to our catalog on Wednesday 07 May, 2014.