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Digene's molecular diagnostic tests, such as the Digene® HPV Test , are based on the company’s proprietary “Hybrid Capture” technology. The technology uses “probes” that specifically target the DNA of certain bacteria or viruses such as HPV, chlamydia and gonorrhea.

If the bacteria or virus is present in the sample of cells being examined, the probes “hybridize” (bind) to it. The resulting “hybrids” (target DNA bound by the probe) are then “captured” to allow detection through a process called “signal amplification.”

In this process, special antibodies and enzymes are added to the cell sample. When they come into contact with the captured hybrids, light is emitted, which can be measured by a computerized laboratory instrument called a luminometer.
With the Digene HPV Test, if the presence of HPV DNA is detected at significant levels, the patient is considered at risk of cervical cancer and in need of additional monitoring by a physician or nurse. If HPV DNA is not detected, the patient can be reassured that she is not currently at risk of cervical cancer.

Overview of how Hybrid Capture technology works:
Step 1:
Probes find the DNA of targeted bacteria and viruses such as HPV, chlamydia or gonorrhea, if present, and bind to it -- forming a "hybrid" (the probe plus the strand of target DNA).


Step 2:
Special biological chemicals (called antibodies) coat the inside of the testing container and “capture” only the hybrids.


Step 3:
Different antibodies (which produce light in the presence of hybrids) are then added. These bind to the hybrids, resulting in the emission of light that is measured by a specialized laboratory instrument called a luminometer. Using the luminometer, the presence or absence of target DNA is determined from the results of this "chemiluminescent" reaction. The amount of light detected is proportional to the amount of target DNA present in the sample.

For information, visit www.theHPVtest.com