Diagnostic accuracy of vaginitis increases

More than 10 million visits by women to their physicians each year are due to vaginitis. The most common type of vaginitis, bacterial vaginosis (BV), has been linked to a growing number of medical conditions, including pregnancy complications, postoperative infection, pelvic inflammatory disease, endometritis, and abnormal cytology.

Because of these complications and the associated costs, an accurate diagnosis is important.

"Vaginitis has historically been considered an unimportant nuisance condition by most physicians," says Sharon L. Hillier, PhD, director of reproductive infectious disease research at Magee-Women's Hospital in Pittsburgh. "The number of severe complications that are now linked to bacterial vaginosis have made diagnosis and treatment more important," she explains.

The four steps taken to diagnose BV are:

1. Evaluate appearance of discharge.

2. Read the pH level of vaginal discharge.

3. Check vaginal fluid for fishy odor.

4. Look at fluid under microscope.

Three out of the four tests must be positive for bacterial vaginitis before treatment for BV is recommended.

"Unfortunately, two of the four steps have always been difficult to accomplish and rely upon subjective interpretation," says Hillier. For these reasons, an estimated 80% of physicians do not perform these tests and start by treating for yeast infection, says Hillier. This guess results in repeat visits by the woman and medication changes when the symptoms don't go away.

New products may simplify diagnosis

Two products that are now on the market make the diagnosis less complicated and less subjective.

"Checking pH is difficult because most physicians use regular pH strips that are difficult to use in this instance," says Hillier. The physician has to be careful not to get cervical mucus on the pH strip because it will distort the reading. To add to the difficulty, the nurse or physician has to compare the color of the pH paper to a chart that is often on a box somewhere else in the office.

PhemAlert, manufactured by Imagyn Medical Technology in Newport Beach, CA, makes pH testing easier by simply having the pH paper mounted on an 8-inch swab. "PhemAlert makes it easy to work around the speculum, and our color chart is on the package for each swab," explains Cassie Hoag, president of the gynecology division of Imagyn.

PhemAlert is more expensive than pH strips, admits Hoag. PH strips might cost about nine cents per strip while PhemAlert costs $3.30. Reimbursement by Medicare for vaginal pH tests is $4.95, and in Southern California, the average private payer reimbursement is $12.80, says Hoag. The advantage of the product is the ease with which the test can be performed to garner a more accurate diagnosis.

Amines test eliminates subjectivity

FemExam pH and Amines TestCard (CooperSurgical, Shelton, CT) address the pH test as well as the amines test. "Checking for the presence of amines means taking a drop of vaginal fluid, putting it on a slide, adding a drop of potassium hydroxide, and sniffing the slide to detect a fishy odor."

Many people don't like to sniff vaginal fluid because of safety concerns, and most people are not comfortable doing it, says Hillier. "This test is not very reliable because so many factors can affect the provider's ability to smell," says Hillier. "Allergies, poor sense of smell, or even colds can make a subjective test even less reliable."

The TestCard is a credit-card sized, disposable device that enables the provider to rub a swab that contains unprocessed vaginal fluid across two test areas. The area for pH and for amines displays a plus or minus sign to show levels that indicate bacterial vaginosis. Used with the appearance and microscopic tests, the provider can make an accurate diagnosis.

"The TestCard doesn't give you the diagnosis, but it gives you two of the four pieces of information you need for diagnosis," explains Hillier. The TestCard costs about $5.25, and reimbursement levels differ throughout the country.

The financial savings of diagnosing BV correctly is the elimination of repeat office visits and additional medications. "Although BV is not considered a life-threatening condition on its own, misdiagnosis can be costly in terms of additional therapy and multiple visits," explains Hillier. "If you are going to treat women for vaginitis, then you need to diagnose and treat them right the first time."