HPV 16/18/31
Antigen Rapid Test
No lab needed
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Immediate Results at Point of Care
No lab needed
Point of care triage for immediate colposcopy
HPV-16/18 genotyping or cytological examination has been recommended to triage for immediate colposcopy in many national screening guidelines. This method offers greater sensitivity than cytological examination alone and better specificity than referring all women with HPV for colposcopy.
Referring all women with high-risk HPV to colposcopy would likely lead to overtreatment and incur high healthcare costs.
Women tested
Result
Within
min
How does it work?
The HPV 16/18/31 Antigen Rapid Test is designed to detect HPV 16/18/31 E6 and E7 Oncoproteins through visual interpretation of color development in the internal strip. The membrane on the cassette is immobilized with monoclonal anti-HPV 16/18 antibodies on the test region.
1
Insert the sampler into the vagina
Collect a fluid sample from the cervix in a simple and comfortable way, by releasing a sterile, water based saline solution into the vagina and then drawing the liquid back into the sampler. The round top is smooth and glides easily into the vagina
2
Transfer the fluid to the vile
Transfer the collected fluid from the sampler to the vile
3
Add reaction agents to the vile.
Add 8 drops of Extraction Buffer A to the sample vial and wait 2 minutes. Add 8 drops of Extraction Buffer B to the sample vial and wait for another 1 minute. Using the dropper provided in this kit, transfer 3 drops of extracted sample from the sample vial to the sample well on the test cassette
4
Place drops on the cassette.
The specimen is dropped onto the membrane and is allowed to react with the colored monoclonal anti HPV 16/18 antibodies on the membrane.
5
Results
If there is enough HPV 16/18 E6 & E7 oncoproteins in the specimen, a colored band will appear indicating a positive result. Wait for the colored band(s) to appear. The result should be read in 15 minutes. Do not interpret the result after 20 minutes
1
Insert the sampler into the vagina
Collect a fluid sample from the cervix in a simple and comfortable way, by releasing a sterile, water based saline solution into the vagina and then drawing the liquid back into the sampler. The round top is smooth and glides easily into the vagina
2
Transfer the fluid to the vile
Transfer the collected fluid from the sampler to the vile
3
Add reaction agents to the vile.
Add 8 drops of Extraction Buffer A to the sample vial and wait 2 minutes. Add 8 drops of Extraction Buffer B to the sample vial and wait for another 1 minute. Using the dropper provided in this kit, transfer 3 drops of extracted sample from the sample vial to the sample well on the test cassette
4
![](https://www.mobileodt.com/wp-content/uploads/2023/06/cassette-img.png")
Place drops on the cassette.
The specimen is dropped onto the membrane and is allowed to react with the colored monoclonal anti HPV 16/18 antibodies on the membrane.
5
Results
If there is enough HPV 16/18 E6 & E7 oncoproteins in the specimen, a colored band will appear indicating a positive result. Wait for the colored band(s) to appear. The result should be read in 15 minutes. Do not interpret the result after 20 minutes
Self sampling HPV
screener
Easy to use
Self collected by women
Comfortable
The round top is smooth and glides easily into the vagina reducing the possibility of micro‐lesions and infection. No speculum needed.
Cost effective
No lab needed
Self sampling HPV screener
Easy to use
Self collected by women
Comfortable
The round top is smooth and glides easily into the vagina reducing the possibility of micro‐lesions and infection. No speculum needed.
Cost effective
No lab needed
Clinical Articles
Immuno-chromatographic Analysis forHPV-16 and 18 E7 Proteins as a Biomarker…
Among the more than 120 different types of human papillomavirus (HPV), types 16 and 18 have been known to be…
Comparison of Linear Array and Line Blot Assay for Detection of Human Papill…
We evaluated Linear Array (LA), a newly commercialized PGMY09/11 L1 consensus primer PCR test that detects 37…
Feasibility Study of a Human Papillomavirus E6 Oncoprotein Test for…
In a feasibility study using a prototype, lateral-flow test for human papillomavirus type 16, 18, and/or 45…
Performance of an HPV 16/18 E6 oncoprotein test for detection of cervical…
HPV testing is a better alternative for cervical cancer screening, but additional procedures are required for…
Clinical Articles
Immuno-chromatographic Analysis for HPV-16 and 18 E7 Proteins as a Biomarker of Cervical Cancer Caused by Human Papillomavirus
Comparison of linear array and line blot assay for detection of human papillomavirus and diagnosis of cervical precancer and cancer in the atypical squamous cell of undetermined significance and low-grade squamous intraepithelial lesion triage study
Feasibility study of a human papillomavirus E6 oncoprotein test for diagnosis of cervical precancer and cancer
Performance of an HPV 16/18 E6 oncoprotein test for detection of cervical precancer and cancer
The MobilleODT Single Visit Program
Overcoming loss to follow-up within a single visit
HPV-16/18 genotyping or cytological examination has been recommended to triage for immediate colposcopy in many national screening guidelines. This method offers greater sensitivity than cytological examination alone and better specificity than referring all women with HPV for colposcopy. Referring all women with high-risk HPV to colposcopy would likely lead to overtreatment and incur high healthcare costs.
High proportions of loss to follow-up for cervical cancer patients have been reported in low and mid range income countries, ranging between 41–69%.2,3. The MobileODT screening and treatment solutions reduces loss to follow up and increasing efficacy in diagnosis and treatment programs
