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Gynecologic Pap Test (Image-guided), Liquid-based Preparation and Chlamydia/Gonococcus/Trichomonas and Herpes Simplex Virus (HSV) Types 1 and 2, NAA With Reflex to Human Papillomavirus (HPV) High-risk DNA Detection When ASC-U
Diagnose primary or metastatic neoplasm; detect Chlamydia trachomatis, Neisseria gonorrhoeae, and Trichomonas vaginalis. Detect and type active HSV shedding. The high-risk HPV test is used for types 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 68, without differentiation of the individual type. This assay aids in the diagnosis of sexually-transmitted HPV infection and in the triage of patients with an ASCUS Pap smear result.
Failure to obtain adequate ectocervical, endocervical, or vaginal cell population is suboptimal for evaluation. Excessive use of lubricating jelly on the vaginal speculum will interfere with cytologic examination and may lead to unsatisfactory Pap results. The use of the liquid-based cytology specimen for multiple tests may limit the volume available for Pap reprocessing or HPV testing.
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, Neisseria gonorrhoeae, and Trichomonas vaginalis 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, Neisseria gonorrhoeae, and Trichomonas vaginalis testing.
Whenever a transport device used for molecular testing is processed, the chance of cross-specimen contamination increases. Aptima® transports can be placed directly on the analyzer limiting the possibility of cross-specimen contamination. This test is intended for use as an aid in the diagnosis of herpes simplex virus (HSV) infections with active viral shedding; it also differentiates HSV-1 from HSV-2. Negative HSV NAA results indicate lack of viral shedding but do not confirm absence of previous infection.
Image-guided liquid-based Pap test; nucleic acid amplification (NAA)
Cervical cells collected by one of the methods described below.
ThinPrep® vial or SurePath™ vial or ThinPrep® vial or SurePath™ vial with optional additional Aptima® swab collection kit (for Chlamydia/Gonococcus/Trichomonas)
A minimum volume cannot be determined for the ThinPrep® vial because it varies depending on the cellularity of the specimen. Specimens collected with the Gen-Probe® Aptima® swab collection kit must arrive intact.
ThinPrep® vial or SurePath™ vial or ThinPrep® vial or SurePath™ vial and Aptima® swab collection kit (for Chlamydia/Gonococcus/Trichomonas)
Patient should avoid douches 48 to 72 hours prior to examination. Specimen should not be collected during or shortly after menstrual period.
ThinPrep® Vial−Broom Only:
Broom-like collection technique: Obtain a sample from the cervix using a broom-like device by inserting the brush portion into the cervical os and rotating the brush five times. 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 release additional cellular material. Discard the collection device. Tighten the cap on the ThinPrep® vial so that the torque line on the cap passes the torque line on the vial.
SurePath™ Vial: When using the SurePath™ vial, the cervical broom must be used for specimen collection. Insert the broom into the cervical os and rotate five times. Place the broom head into the CytoRich™ preservative fluid in the SurePath™ collection vial. Tightly cap the vial.
Optional Dedicated Specimen for Chlamydia, Gonococcus, and Trichomonas: Use the Gen-Probe® Aptima® swab collection kit. (Note: Do not use the Gen-Probe® PACE DNA probe collection kit.) 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 to 30 seconds to ensure good sampling. Carefully withdraw the blue-shafted swab, avoiding contact with the vaginal mucosa. Remove the cap from the swab specimen transport tube and immediately place the specimen collection swab into the transport tube. Break the swab shaft at the scoreline, using care to avoid splashing contents. Recap the swab specimen transport tube tightly.
Maintain liquid-based cytology and Aptima® swab transport specimens at room temperature. Pap processing must be performed within 21 days of collection. Specimens in ThinPrep® vials must be processed for testing within three months of collection for HPV. SurePath™ vial must be processed for testing within 21 days of collection for HPV. Liquid-based cytology specimens must be tested within seven days for Chlamydia/Gonococcus/Trichomonas and HSV; if the Aptima® swab transport is used it must be tested within 60 days.
Causes for Rejection
Improper collection; inadequate specimen; improper labeling; specimen leaked in transit; quantity not sufficient for analysis; name discrepancies; specimen submitted on male patient; specimen submitted in a vial that expired according to manufacturer's label; frozen specimen. For Pap: liquid-based cytology specimen more than 21 days old. For HPV: specimen more than three months old in ThinPrep® vial; specimen more than 21 days from collection for SurePath™ specimens. For Chlamydia, Gonococcus, and Trichomonas vaginalis: liquid-based cytology specimen more than seven days old, Aptima® specimen more than 60 days old; Gen-Probe® Aptima® collection tube with multiple swabs, white-shafted cleaning swab ,or any swab other than the blue-shafted collection swab. For HSV: liquid-based cytology specimen more than seven days old.
Include date of birth, Social Security number (or other identification number), previous malignancy, drug therapy, radiation therapy, last menstrual period (LMP), postmenopausal patient (PMP), surgery (including surgical biopsies), exogenous hormones, abnormal vaginal bleeding, abnormal Pap results, IUD, and all other pertinent clinical information on the cytology test request form.
Note: In accordance with criteria established by CLIA, Pap smears will be referred for pathologist review if laboratory personnel suspect:
• Reactive or reparative cellular changes
• Atypical squamous or glandular cells of undetermined significance
• 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.)
If ThinPrep® vials are QNS for the hybrid capture assay, then a test requiring a lower input volume will be automatically performed if there is sufficient volume to perform that assay.
HSV NAA is a single test that both detects the presence of HSV DNA and determines which type is present in the positive samples. There is no mechanism, therefore, for testing for HSV-1 without simultaneously testing for HSV-2.
|Order Code||Order Code Name||Order Loinc||Result Code||Result Code Name||UofM||Result LOINC|
|198335||PapIG, CtNgTvHSV rfxHPV ASCU||191121||Test ordered:||N/A|
|198335||PapIG, CtNgTvHSV rfxHPV ASCU||191108||DIAGNOSIS:||22637-3|
|198335||PapIG, CtNgTvHSV rfxHPV ASCU||191166||Interpretation||N/A|
|198335||PapIG, CtNgTvHSV rfxHPV ASCU||191170||Category:||N/A|
|198335||PapIG, CtNgTvHSV rfxHPV ASCU||191173||Recommendation:||N/A|
|198335||PapIG, CtNgTvHSV rfxHPV ASCU||191169||Infection:||N/A|
|198335||PapIG, CtNgTvHSV rfxHPV ASCU||191172||Adequacy:||N/A|
|198335||PapIG, CtNgTvHSV rfxHPV ASCU||191111||Recommendation:||19773-1|
|198335||PapIG, CtNgTvHSV rfxHPV ASCU||191109||Specimen adequacy:||19764-0|
|198335||PapIG, CtNgTvHSV rfxHPV ASCU||191154||Source:||19763-2|
|198335||PapIG, CtNgTvHSV rfxHPV ASCU||191160||Clinician provided ICD9:||52797-8|
|198335||PapIG, CtNgTvHSV rfxHPV ASCU||191174||Clinician provided ICD10:||52797-8|
|198335||PapIG, CtNgTvHSV rfxHPV ASCU||191107||Clinical history:||22636-5|
|198335||PapIG, CtNgTvHSV rfxHPV ASCU||191124||Amended report:||N/A|
|198335||PapIG, CtNgTvHSV rfxHPV ASCU||191110||Additional comment:||22638-1|
|198335||PapIG, CtNgTvHSV rfxHPV ASCU||191125||Addendum:||22639-9|
|198335||PapIG, CtNgTvHSV rfxHPV ASCU||191123||Maturation index:||N/A|
|198335||PapIG, CtNgTvHSV rfxHPV ASCU||191112||Performed by:||19767-3|
|198335||PapIG, CtNgTvHSV rfxHPV ASCU||191128||QC reviewed by:||N/A|
|198335||PapIG, CtNgTvHSV rfxHPV ASCU||191145||Diagnosis provided by:||N/A|
|198335||PapIG, CtNgTvHSV rfxHPV ASCU||191113||Electronically signed by:||19769-9|
|198335||PapIG, CtNgTvHSV rfxHPV ASCU||191139||Special procedure:||N/A|
|198335||PapIG, CtNgTvHSV rfxHPV ASCU||191129||Cytology history:||N/A|
|198335||PapIG, CtNgTvHSV rfxHPV ASCU||191179||Previous history:||N/A|
|198335||PapIG, CtNgTvHSV rfxHPV ASCU||191144||QA comment:||N/A|
|198335||PapIG, CtNgTvHSV rfxHPV ASCU||019018||.||11546-9|
|198335||PapIG, CtNgTvHSV rfxHPV ASCU||191157||Pathologist provided ICD9:||52797-8|
|198335||PapIG, CtNgTvHSV rfxHPV ASCU||191175||Pathologist provided ICD10:||52797-8|
|198335||PapIG, CtNgTvHSV rfxHPV ASCU||190120||.||N/A|
|198335||PapIG, CtNgTvHSV rfxHPV ASCU||190109||Note:||N/A|
|198335||PapIG, CtNgTvHSV rfxHPV ASCU||000000||Test Methodology:||47527-7|
|198335||PapIG, CtNgTvHSV rfxHPV ASCU||190119||.||N/A|
|198335||PapIG, CtNgTvHSV rfxHPV ASCU||186134||Chlamydia, Nuc. Acid Amp||50387-0|
|198335||PapIG, CtNgTvHSV rfxHPV ASCU||186135||Gonococcus, Nuc. Acid Amp||50388-8|
|198335||PapIG, CtNgTvHSV rfxHPV ASCU||188092||Trich vag by NAA||46154-1|
|198335||PapIG, CtNgTvHSV rfxHPV ASCU||188036||HSV 1 NAA||16130-7|
|198335||PapIG, CtNgTvHSV rfxHPV ASCU||188037||HSV 2 NAA||16131-5|
|198335||PapIG, CtNgTvHSV rfxHPV ASCU||188038||HSV 1 and 2 Tracking||N/A|
|198335||PapIG, CtNgTvHSV rfxHPV ASCU||191167||Photomicrograph||N/A|
|198335||PapIG, CtNgTvHSV rfxHPV ASCU||019030||.||N/A|
|198335||PapIG, CtNgTvHSV rfxHPV ASCU||019031||Patient Counseling Report||N/A|
|Reflex Table for Test Methodology:|
|Order Code||Order Name||Result Code||Result Name||UofM||Result LOINC|
|Reflex 1||192555||Change IG Pap to LB Pap||000000||LBP CPT Code Automation||47527-7|
|Reflex Table for .|
|Order Code||Order Name||Result Code||Result Name||UofM||Result LOINC|
|Reflex 1||507301||HPV, high-risk||507303||HPV, high-risk||30167-1|