Note: In accordance with criteria established by CLIA, Pap smears will be referred for pathologist's review if laboratory personnel suspect:

1) reactive or reparative cellular changes
2) atypical squamous or glandular cells of undetermined significance
3) cells in the premalignant or malignant category

In these cases, LabCorp will charge for the associated service. (Slides that are routinely reviewed by a pathologist for quality control purposes are not included.)

1. Obtain a sample from the cervix using a broom-like device by inserting the brush portion into the cervical os and rotate the brush 5 times.
2. Rinse the collection device in the PreservCyt® solution by pushing the brush into the bottom of the vial 10 times, forcing the bristles to bend apart to release the cervical material. As a final step, twirl the brush between the thumb and forefinger vigorously to further release cellular material. Discard the collection device.
3. Tighten the cap on the ThinPrep® vial so that the torque line on the cap passes the torque line on the vial.

1. Insert the broom into the cervical os and rotate 5 times.
2. Place the broom head into the CytoRich® preservative fluid in the SurePath® collection vial.
3. Tightly cap the vial.

1. First remove excess mucus from the cervical os and surrounding ectocervix using a cotton or polyester swab. Discard this swab.
2. To obtain specimen, insert the Digene Cervical Sampling Brush 1.0-1.5 centimeters into the cervical os until the largest bristles touch the ectocervix. Do not insert brush completely into the cervical canal. Rotate brush 3 full turns in a counterclockwise direction, remove from the canal.
3. Insert brush into the transport tube. Snap off shaft at scored line, leaving brush end inside tube, and recap securely by snapping in place.

1. Clean the cervix using the larger, white-shafted swab supplied in the Gen-Probe® Aptima® swab collection kit and discard. Insert the smaller, blue-shafted swab into the cervix and rotate for 10-30 seconds to ensure good sampling.
2. Carefully withdraw the blue-shafted swab, avoiding contact with the vaginal mucosa.
3. Remove the cap from the swab specimen transport tube and immediately place the specimen collection swab into the transport tube.
4. Break the swab shaft at the scoreline, using care to avoid splashing contents.
5. Recap the swab specimen transport tube tightly.

A negative result does not exclude the possibility of an HPV infection since very low levels of infection or sampling error may produce a false-negative result. This test detects only the 13 most common high-risk HPV types and cannot determine the specific HPV type present.

Testing for Chlamydia trachomatis and Neisseria gonorrhoeae requires special procedures to be used in the processing of the cytology specimen, therefore testing for these organisms cannot be added on after the specimen has been submitted. The liquid-based cytology specimen must be processed for Chlamydia trachomatis and Neisseria gonorrhoeae testing. Any time a transport device used for molecular testing is processed, the chance of cross specimen contamination increases. Aptima(R) transports can be placed directly on the analyzer limiting the possibility of cross specimen contamination.

Because nucleic acid amplification (NAA) tests are more sensitive than conventional culture methods and nonculture tests, the CDC recommendations stressed the potential for false-positives and the impact of low incidence on the positive predictive value of a test. For this reason, they recommended that all non-culture methods should be considered as 'presumptively' positive. In those cases where a positive result is thought to be incorrect, they suggested that treatment should be offered while awaiting the results of additional testing. Only another NAA test was recommended as follow up testing after an initial suspect positive test and a test with an alternate target was the first choice for additional testing. Culture continued to be the method recommended for all medicolegal cases. Testing of children was actively discouraged because of the potentially low positive predictive value of the tests in low incidence populations.

Chlamydia trachomatis is recognized as the leading agent of sexually transmitted disease worldwide. Although only 30% of states designate Chlamydia a reportable disease, in the United States more than 4 million new cases of Chlamydia infection are reported annually. The asymptomatic nature of a large proportion of chlamydia infections leads to underdiagnosis of chlamydial infection and consequent health problems. Approximately 75% of infections in the female and approximately 50% of male infections are asymptomatic.^3,4 Women are most severely affected due to the correlation between untreated Chlamydia infection and ectopic pregnancy and infertility.⁵ Rapid detection and diagnosis of chlamydial infection is critical in controlling not only the spread of disease but also the devastating sequelae. Partner evaluation to prevent reinfection is also an important aspect of controlling spread of the disease.

The diagnosis of Chlamydia trachomatis infections has traditionally relied on culture technology; however, the time-consuming nature of culture techniques catalyzed the development of direct antigen and nucleic acid detection methods. Conventional techniques such as culture and fluorescent antibody staining have demonstrated limited sensitivity.^1,6 The development of targeted nucleic acid amplification techniques provide the means by which direct detection methodologies could achieve requisite sensitivity while maintaining excellent specificity.¹ Clinical studies have shown that amplified methods detect about 15% more chlamydial infections than other non-culture with a specificity >99%.¹

Gonorrhea manifests as acute urethritis in males and as cervicitis in females.⁷ N. gonorrhoeae can be detected from asymptomatic females. Detection and treatment of these individuals is critical because if it is left untreated, gonorrhea can result in serious complications, including pelvic inflammatory disease, sterility, and ectopic pregnancy.^8,9 It is very important to control the spread of this disease between sexual partners; thus, the use of a quick reliable test system is essential.

The current definitive method of detection for N. gonorrhoeae is the culture of the microorganism; however, this organism is especially fastidious. It can be difficult to grow in culture. Negative cultures due to overgrowth of contaminating microorganisms occur or due to the organism rendered nonviable during transport due to the incorrect transport being used or the correct transport used incorrectly. At least one study has demonstrated that a significant proportion of negative cultures received in a public health lab had evidence of N. gonorrhoeae by nucleic acid testing but were negative by culture.¹⁰ The nucleic acid amplification test for the presence of N. gonorrhoeae provides the sensitivity and a specificity equal to traditional methods of organism isolation and identification.¹ The major disadvantage at the present time is that antibiotic sensitivity testing cannot be done on these specimens. Guidelines for antibiotic susceptibility testing of N. gonorrhoeae have been published;¹¹ however, this microorganism is not routinely tested for antibiotic sensitivities.