1232 Kingston Road, Scarborough, Ontario, Canada, M1N 1P3

Tel: 416-691-4167 Fax: 416-691-8112

E-mail: Web: www.viaguardinc.com

Accu-Cervical Cancer Test Instructions

This precision test uses exclusive DNAffirm antigen-antibody technology

For complete information visit our website at www.viaguardinc.com

Please read this instruction sheet completely before using this test.

The same instructions are used for both the Primary and Confirmatory test. Use the Primary test kit first.

Do not eat, drink, or smoke in the area where the test is being performed.

Test should be done at room temperature.

Step One: Collect Specimen

For female cervical specimens:

Before specimen collection, remove excess mucus from the endocervical area (just inside the vagina) with a cotton ball and discard. The swab should be inserted into the endocervical canal. This will permit acquisition of columnar and squamos epithelial cells. Firmly rotate the swab for 15-20 seconds. Smoothly withdraw the swab while trying to minimize contact between the swab and other parts of the body. Be sure the swab is inserted to a sufficient depth to contact the cervical area.

Place the swab in the unlabelled, clear extraction tube.

Step Two: Preparing the Specimens

Unscrew the cap from the Extraction Buffer Bottle. Add 15 drops of Extraction Buffer to the extraction tube. Immerse the swab in the buffer solution for 2 minutes, while using a circular motion to roll the swab against the side of the tube so that the liquid is squeezed and expressed 4-6 times.

Close the extraction tube by pushing the cap firmly into the top.

Step Three: Performing the Test

Remove the test cassette from the sealed foil pouch and place on a clear, level surface. Squeeze 3 drops of the specimen from the extraction tube into the small, circular specimen well.

Do not drip any fluid into the rectangular observation window.

Wait for the coloured bands to appear. Result should be read after 15 minutes. Do not interpret results more than 20 minutes after adding specimen to cassette. Interpretation guidelines are on the back of this page.

Interpretation of Results

Positive Result: If both C and T bands are developed, the result is positive.

Negative Result: If only the C band is developed, the result is negative.

Invalid: If no C band is developed, the assay is invalid regardless of colour development on the T band as indicated below.

* Note: The intensity of the colour in the test line region (T) may vary depending on the concentration of analytes present in the specimen. Therefore, any shade of colour in the test region (T) should be considered positive.

The Confirmatory Test

The initial test you completed is a primary test. The second confirmatory test is needed to ensure a definitive result. If the primary test indicated a negative result, the confirmatory test is repeated in 20-25 days and if a second negative result is obtained you are negative for HPV unless you have contracted the disease in the last two weeks and anti-bodies have not yet formed.

If the initial test result was positive, the confirmatory test should be done in 3-6 days. If the second test is positive you should immediately consult a medical professional since you have tested positive for Human Papillomavirus, linked to pre-cervical and cervical cancer.

If the initial test result is positive, you should presume that you have an HPV infection and should act accordingly.

There is a social responsibility to have the disease treated immediately, inform sexual partners, and use condoms until you are confirmed disease free.

Important Notes

Blood can interfere with the results of this test. Females should not perform this test during menstrual period.

Used test supplies should be handled as though they were potentially infectious, and disposed of appropriately.