Gynecologic Pap Test (Image-guided), Liquid-based Preparation and Chlamydia/Gonococcus/Trichomonas and Herpes Simplex Virus (HSV) Types 1 and 2, NAA and Human Papillomavirus (HPV) High-risk DNA Detection With Reflex to HPV Genotypes 16 and 18

CPT: 87491; 87529(x2); 87591; 87624; 87661; 88175
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Test Details

Use

Diagnose primary or metastatic neoplasm; detect Chlamydia trachomatis, Neisseria gonorrhoeae, and Trichomonas vaginalis. Detect and type active HSV shedding. High-risk HPV test is used for types 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, and 68, without differentiation of the individual types. If the Pap evaluation is within normal limits and the initial HPV test is positive, then the residual specimen will be tested individually for high-risk HPV types 16 and 18. This information, together with the physician's assessment of cytology history, other risk factors, and professional guidelines, may be used to guide patient management. The results of this test are not intended to prevent women from proceeding to colposcopy.

Limitations

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.

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.

Methodology

Image-guided liquid-based Pap test; nucleic acid amplification (NAA)

Specimen Requirements

Specimen

Cervical cells collected by one of the methods described below.

Volume

ThinPrep® vial or SurePath™ vial or ThinPrep® vial or SurePath™ vial with optional additional Aptima® swab collection kit (for Chlamydia/Gonococcus/Trichomonas)

Minimum Volume

A minimum volume cannot be determined for the ThinPrep® vial because it varies depending on the cellularity of the specimen. The entire SurePath™ specimen should arrive intact. Specimens collected with the Gen-Probe® Aptima® swab collection kit must arrive intact.

Container

ThinPrep® vial or SurePath™ vial or ThinPrep® vial or SurePath™ vial and Aptima® swab collection kit (for Chlamydia/Gonococcus/Trichomonas)

Patient Preparation

Patient should avoid douches 48 to 72 hours prior to examination. Specimen should not be collected during or shortly after menstrual period.

Collection

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 rotate 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.

Storage Instructions

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 patients; specimen submitted in vial that expired according to the 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 old in SurePath™ vial. 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.

Clinical Information

Special Instructions

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. If the additional assay is performed, testing for HPV genotypes 16 and 18 will not be performed due to volume limitations.

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.

References

American Society for Colposcopy and Cervical Pathology. HPV Genotyping Clinical Update. Hagerstown, Md: ASCCP; 2009:1-3.
Centers for Disease Control and Prevention. Screening test to detect Chlamydia trachomatis and Neisseria gonorrhoeae−2002. MMWR. 2002; 51(RR15). 12418541
Hutchinson ML, Cassin CM, Ball HG 3rd. The efficacy of an automated preparation device for cervical cytology. Am J Clin Pathol. 1991 Sep; 96(3):300-305. 1877527
Hutchinson ML, Isenstein LM, Goodman A, et al, Homogeneous sampling accounts for the increased diagnostic accuracy using the ThinPrep® Processor. Am J Clin Pathol. 1994 Feb; 101(2):215-219. 8116578
Joseph MG, Cragg F, Wright VC, Kontozoglou TE, Downing P, Marks FR. Cyto-histological correlates in a colposcopic clinic: A 1-year prospective study. Diagn Cytopathol. 1991; 7(5):477-481. 1954825
van Der Schee C, van Belkum A, Zwijgers L, et al. Improved diagnosis of Trichomonas vaginalis infection by PCR using vaginal swabs and urine specimens compared to diagnosis by wet mount microscopy, culture, and fluorescent staining. J Clin Microbiol. 1999; 37(12):4127-4130.4562134
Wilbur DC, Cibas ES, Merritt S, James LP, Berger BM, Bonfiglio TA. ThinPrep® Processor. Clinical trials demonstrate an increased detection rate of abnormal cervical cytologic specimens. Am J Clin Pathol. 1994 Feb; 101(2):209-214.8116577

LOINC® Map

Order Code Order Code Name Order Loinc Result Code Result Code Name UofM Result LOINC
198305 PapIG, CtNgTvHSV,HPV,rfx16/18 191121 Test ordered: N/A
198305 PapIG, CtNgTvHSV,HPV,rfx16/18 191158 ****************************** N/A
198305 PapIG, CtNgTvHSV,HPV,rfx16/18 191108 DIAGNOSIS: 22637-3
198305 PapIG, CtNgTvHSV,HPV,rfx16/18 191166 Interpretation N/A
198305 PapIG, CtNgTvHSV,HPV,rfx16/18 191170 Category: N/A
198305 PapIG, CtNgTvHSV,HPV,rfx16/18 191173 Recommendation: N/A
198305 PapIG, CtNgTvHSV,HPV,rfx16/18 191169 Infection: N/A
198305 PapIG, CtNgTvHSV,HPV,rfx16/18 191172 Adequacy: N/A
198305 PapIG, CtNgTvHSV,HPV,rfx16/18 191111 Recommendation: 19773-1
198305 PapIG, CtNgTvHSV,HPV,rfx16/18 191109 Specimen adequacy: 19764-0
198305 PapIG, CtNgTvHSV,HPV,rfx16/18 191159 ****************************** N/A
198305 PapIG, CtNgTvHSV,HPV,rfx16/18 191154 Source: 19763-2
198305 PapIG, CtNgTvHSV,HPV,rfx16/18 191160 Clinician provided ICD9: 52797-8
198305 PapIG, CtNgTvHSV,HPV,rfx16/18 191174 Clinician provided ICD10: 52797-8
198305 PapIG, CtNgTvHSV,HPV,rfx16/18 191107 Clinical history: 22636-5
198305 PapIG, CtNgTvHSV,HPV,rfx16/18 191124 Amended report: N/A
198305 PapIG, CtNgTvHSV,HPV,rfx16/18 191110 Additional comment: 22638-1
198305 PapIG, CtNgTvHSV,HPV,rfx16/18 191125 Addendum: 22639-9
198305 PapIG, CtNgTvHSV,HPV,rfx16/18 191123 Maturation index: N/A
198305 PapIG, CtNgTvHSV,HPV,rfx16/18 191112 Performed by: 19767-3
198305 PapIG, CtNgTvHSV,HPV,rfx16/18 191128 QC reviewed by: N/A
198305 PapIG, CtNgTvHSV,HPV,rfx16/18 191145 Diagnosis provided by: N/A
198305 PapIG, CtNgTvHSV,HPV,rfx16/18 191113 Electronically signed by: 19769-9
198305 PapIG, CtNgTvHSV,HPV,rfx16/18 191139 Special procedure: N/A
198305 PapIG, CtNgTvHSV,HPV,rfx16/18 191129 Cytology history: N/A
198305 PapIG, CtNgTvHSV,HPV,rfx16/18 191179 Previous history: N/A
198305 PapIG, CtNgTvHSV,HPV,rfx16/18 191144 QA comment: N/A
198305 PapIG, CtNgTvHSV,HPV,rfx16/18 019018 . 11546-9
198305 PapIG, CtNgTvHSV,HPV,rfx16/18 191157 Pathologist provided ICD9: 52797-8
198305 PapIG, CtNgTvHSV,HPV,rfx16/18 191175 Pathologist provided ICD10: 52797-8
198305 PapIG, CtNgTvHSV,HPV,rfx16/18 190120 . N/A
198305 PapIG, CtNgTvHSV,HPV,rfx16/18 190109 Note: N/A
198305 PapIG, CtNgTvHSV,HPV,rfx16/18 000000 Test Methodology: 47527-7
198305 PapIG, CtNgTvHSV,HPV,rfx16/18 507303 HPV, high-risk 30167-1
198305 PapIG, CtNgTvHSV,HPV,rfx16/18 186134 Chlamydia, Nuc. Acid Amp 50387-0
198305 PapIG, CtNgTvHSV,HPV,rfx16/18 186135 Gonococcus, Nuc. Acid Amp 50388-8
198305 PapIG, CtNgTvHSV,HPV,rfx16/18 188092 Trich vag by NAA 46154-1
198305 PapIG, CtNgTvHSV,HPV,rfx16/18 188036 HSV 1 NAA 16130-7
198305 PapIG, CtNgTvHSV,HPV,rfx16/18 188037 HSV 2 NAA 16131-5
198305 PapIG, CtNgTvHSV,HPV,rfx16/18 188038 HSV 1 and 2 Tracking N/A
198305 PapIG, CtNgTvHSV,HPV,rfx16/18 191167 Photomicrograph N/A
198305 PapIG, CtNgTvHSV,HPV,rfx16/18 019030 . N/A
198305 PapIG, CtNgTvHSV,HPV,rfx16/18 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
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 HPV, high-risk
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 507405 HPV, low volume rfx 507405 HPV, low volume rfx 59420-0

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