Please login to order a test.
Gynecologic Pap Test (Image-guided), Liquid-based Preparation and Chlamydia/Gonococcus/Trichomonas, NAA and High-risk HPV (Cobas®) With HPV Genotypes 16 and 18
Diagnose primary or metastatic neoplasm; detect Chlamydia trachomatis, Neisseria gonorrhoeae, and Trichomonas vaginalis. The HPV test specifically identifies types HPV16 and HPV18 while concurrently detecting the rest of the high-risk types: 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68 without further specific differentiation.
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 processing or HPV testing. Detection of high-risk HPV is dependent on the number of copies present in the specimen and may be affected by specimen collection methods, patient factors, stage of infection and the presence of interfering substances.
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.
Any time 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.
Image-guided liquid-based Pap test; nucleic acid amplification (NAA) for Chlamydia/Gonococcus/Trichomonas and HPV
Cervical cells collected by one of the methods described below.
ThinPrep® vial or ThinPrep® 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 ThinPrep® vial with optional 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. Excessive use of lubricating jelly will interfere with cytologic examination.
Brush/spatula technique: Insert the brush into the endocervical canal until only the bottommost fibers are exposed. Slowly rotate the brush 1/4 to 1/2 turn in one direction. Do not over-rotate the brush. Then, rotate the brush in the PreservCyt® solution 10 times while pushing against the wall of the ThinPrep® vial. Swirl the brush vigorously to release additional material. Discard the brush. Obtain an adequate sample from the ectocervix using a plastic spatula. Swirl vigorously in the ThinPrep® vial 10 times and discard the spatula. Tighten the cap on the ThinPrep® container so that the torque line on the cap passes the torque line on 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 specimens at room temperature. Pap processing must be performed within 21 days of collection. ThinPrep® vial may be stored for six months after the date of collection prior to performing the Cobas® HPV test. Liquid-based cytology specimens must be tested within seven days for Chlamydia/Gonococcus/Trichomonas; if the Aptima® swab transport is used, it must be tested within 60 days. ThinPrep® specimens should not be frozen.
Causes for Rejection
Improper collection; inadequate specimen; improper labeling; frozen specimen; specimen leaked in transit; quantity not sufficient for analysis; name discrepancies; specimen submitted on male patients. For Pap: liquid-based cytology specimen more than 21 days old. For HPV: specimen more than six months old in ThinPrep® vial; excessively bloody specimens. For Chlamydia, Gonococcus, and Trichomonas: 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.
Include date of birth, Social Security number (or other identification number), previous malignancy, drug therapy, radiation therapy, last menstrual period (LMP), postmenopausal patient
Note: In accordance with criteria established by CLIA, Pap tests 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.)
|Order Code||Order Code Name||Order Loinc||Result Code||Result Code Name||UofM||Result LOINC|
|196220||IGP, CtNgTv, cobasHPV16/18||191121||Test ordered:||N/A|
|196220||IGP, CtNgTv, cobasHPV16/18||191108||DIAGNOSIS:||22637-3|
|196220||IGP, CtNgTv, cobasHPV16/18||191166||Interpretation||N/A|
|196220||IGP, CtNgTv, cobasHPV16/18||191170||Category:||N/A|
|196220||IGP, CtNgTv, cobasHPV16/18||191173||Recommendation:||N/A|
|196220||IGP, CtNgTv, cobasHPV16/18||191169||Infection:||N/A|
|196220||IGP, CtNgTv, cobasHPV16/18||191172||Adequacy:||N/A|
|196220||IGP, CtNgTv, cobasHPV16/18||191111||Recommendation:||19773-1|
|196220||IGP, CtNgTv, cobasHPV16/18||191109||Specimen adequacy:||19764-0|
|196220||IGP, CtNgTv, cobasHPV16/18||191154||Source:||19763-2|
|196220||IGP, CtNgTv, cobasHPV16/18||191160||Clinician provided ICD9:||52797-8|
|196220||IGP, CtNgTv, cobasHPV16/18||191174||Clinician provided ICD10:||52797-8|
|196220||IGP, CtNgTv, cobasHPV16/18||191107||Clinical history:||22636-5|
|196220||IGP, CtNgTv, cobasHPV16/18||191124||Amended report:||N/A|
|196220||IGP, CtNgTv, cobasHPV16/18||191110||Additional comment:||22638-1|
|196220||IGP, CtNgTv, cobasHPV16/18||191125||Addendum:||22639-9|
|196220||IGP, CtNgTv, cobasHPV16/18||191123||Maturation index:||N/A|
|196220||IGP, CtNgTv, cobasHPV16/18||191112||Performed by:||19767-3|
|196220||IGP, CtNgTv, cobasHPV16/18||191128||QC reviewed by:||N/A|
|196220||IGP, CtNgTv, cobasHPV16/18||191145||Diagnosis provided by:||N/A|
|196220||IGP, CtNgTv, cobasHPV16/18||191113||Electronically signed by:||19769-9|
|196220||IGP, CtNgTv, cobasHPV16/18||191139||Special procedure:||N/A|
|196220||IGP, CtNgTv, cobasHPV16/18||191129||Cytology history:||N/A|
|196220||IGP, CtNgTv, cobasHPV16/18||191179||Previous history:||N/A|
|196220||IGP, CtNgTv, cobasHPV16/18||191144||QA comment:||N/A|
|196220||IGP, CtNgTv, cobasHPV16/18||019018||.||11546-9|
|196220||IGP, CtNgTv, cobasHPV16/18||191157||Pathologist provided ICD9:||52797-8|
|196220||IGP, CtNgTv, cobasHPV16/18||191175||Pathologist provided ICD10:||52797-8|
|196220||IGP, CtNgTv, cobasHPV16/18||190120||.||N/A|
|196220||IGP, CtNgTv, cobasHPV16/18||190109||Note:||N/A|
|196220||IGP, CtNgTv, cobasHPV16/18||000000||Test Methodology:||47527-7|
|196220||IGP, CtNgTv, cobasHPV16/18||507386||HPV other hr types||71431-1|
|196220||IGP, CtNgTv, cobasHPV16/18||507387||HPV 16||61372-9|
|196220||IGP, CtNgTv, cobasHPV16/18||507388||HPV 18||61373-7|
|196220||IGP, CtNgTv, cobasHPV16/18||186134||Chlamydia, Nuc. Acid Amp||50387-0|
|196220||IGP, CtNgTv, cobasHPV16/18||186135||Gonococcus, Nuc. Acid Amp||50388-8|
|196220||IGP, CtNgTv, cobasHPV16/18||188092||Trich vag by NAA||46154-1|
|196220||IGP, CtNgTv, cobasHPV16/18||191167||Photomicrograph||N/A|
|196220||IGP, CtNgTv, cobasHPV16/18||019030||.||N/A|
|196220||IGP, CtNgTv, cobasHPV16/18||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|