Gynecologic Pap Test (Image-guided), Liquid-based Preparation and Chlamydia/Gonococcus/Trichomonas, NAA and Human Papillomavirus (HPV) DNA With Reflex to HPV E6/E7 (QuantaSURE®)

CPT: 87491; 87591; 87624; 87661; 88175
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Test Details

Use

Diagnose primary or metastatic neoplasm; detect Chlamydia trachomatis, Neisseria gonorrhoeae, and Trichomonas vaginalis by NAA testing. HPV test is used to detect high-risk types 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, and 68, without differentiation of the individual types. If the HPV test is positive, then the residual specimen will be tested for E6/E7. E6/E7 mRNA detects E6/E7 mRNA in sufficient quantity to demonstrate integration and expression in a population of 2% of the ectocervical cells in cervical specimens in which high-risk HPV types have been detected. 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.

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 cells overexpressing E6/E7 mRNA.

Methodology

Image-guided liquid-based Pap test; nucleic acid amplification (NAA); probe hybridization and flow cytometry (E6/E7 QuantaSURE®)

Specimen Requirements

Specimen

Cervical cells in liquid-based cytology transport

Volume

ThinPrep® vial or SurePath™ vial

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.

Container

ThinPrep® vial or SurePath™ vial

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 or Brush/Spatula:

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 then 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.

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.

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.

Storage Instructions

Maintain liquid-based cytology transport specimens at room temperature. Processing must be done within 14 days of collection.

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. Pap processing must occur within 21 days of collection (and therefore it must be received within 21 days to reflex to the HPV test). For Chlamydia/Gonococcus liquid-based cytology specimen more than seven days old. For E6/E7 liquid-based cytology specimen more than 14 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 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.)

References

Cuschieri K, Wentzensen N. Human papillomavirus mRNA and p16 detection as biomarkers for the improved diagnosis of cervical neoplasia. Cancer Epidemiol Biomarkers Prev. 2008 Oct; 17(10):2536-2545.
Ferris DG, Wright TC Jr, Litaker MS, et al. Comparison of two tests for detecting carcinogenic HPV in women with Papanicolaou smear reports of ASCUS and LSIL. J Fam Pract. 1998 Feb; 46(2):136-141. 9487319
Manos MM, Kinney WK, Hurley LB, et al. Identifying women with cervical neoplasia: Using human papillomavirus DNA testing for equivocal Papanicolaou results. JAMA. 1999 May 5; 281(17):1605-1610. 10235153
Schiffman M, Herrero R, Hildesheim A, et al. HPV DNA testing in cervical cancer screening: results from women in a high-risk province of Costa Rica. JAMA. 2000 Jan 5; 283(1):87-93. 10632285
Spathis A, Kottaridi C, Chranioti A, et al. mRNA and DNA detection of human papillomavirus in women of all ages attending two colposcopy clinics. PLoS One. 2012; 7(11): e49205 1-9. 23166611

LOINC® Map

Order Code Order Code Name Order Loinc Result Code Result Code Name UofM Result LOINC
199440 IGP,CtNgTv,HPVrfxE6/E7QSURE 191121 Test ordered: N/A
199440 IGP,CtNgTv,HPVrfxE6/E7QSURE 191158 ****************************** N/A
199440 IGP,CtNgTv,HPVrfxE6/E7QSURE 191108 DIAGNOSIS: 22637-3
199440 IGP,CtNgTv,HPVrfxE6/E7QSURE 191166 Interpretation N/A
199440 IGP,CtNgTv,HPVrfxE6/E7QSURE 191170 Category: N/A
199440 IGP,CtNgTv,HPVrfxE6/E7QSURE 191173 Recommendation: N/A
199440 IGP,CtNgTv,HPVrfxE6/E7QSURE 191169 Infection: N/A
199440 IGP,CtNgTv,HPVrfxE6/E7QSURE 191172 Adequacy: N/A
199440 IGP,CtNgTv,HPVrfxE6/E7QSURE 191111 Recommendation: 19773-1
199440 IGP,CtNgTv,HPVrfxE6/E7QSURE 191109 Specimen adequacy: 19764-0
199440 IGP,CtNgTv,HPVrfxE6/E7QSURE 191159 ****************************** N/A
199440 IGP,CtNgTv,HPVrfxE6/E7QSURE 191154 Source: 19763-2
199440 IGP,CtNgTv,HPVrfxE6/E7QSURE 191160 Clinician provided ICD9: 52797-8
199440 IGP,CtNgTv,HPVrfxE6/E7QSURE 191174 Clinician provided ICD10: 52797-8
199440 IGP,CtNgTv,HPVrfxE6/E7QSURE 191107 Clinical history: 22636-5
199440 IGP,CtNgTv,HPVrfxE6/E7QSURE 191124 Amended report: N/A
199440 IGP,CtNgTv,HPVrfxE6/E7QSURE 191110 Additional comment: 22638-1
199440 IGP,CtNgTv,HPVrfxE6/E7QSURE 191125 Addendum: 22639-9
199440 IGP,CtNgTv,HPVrfxE6/E7QSURE 191123 Maturation index: N/A
199440 IGP,CtNgTv,HPVrfxE6/E7QSURE 191112 Performed by: 19767-3
199440 IGP,CtNgTv,HPVrfxE6/E7QSURE 191128 QC reviewed by: N/A
199440 IGP,CtNgTv,HPVrfxE6/E7QSURE 191145 Diagnosis provided by: N/A
199440 IGP,CtNgTv,HPVrfxE6/E7QSURE 191113 Electronically signed by: 19769-9
199440 IGP,CtNgTv,HPVrfxE6/E7QSURE 191139 Special procedure: N/A
199440 IGP,CtNgTv,HPVrfxE6/E7QSURE 191129 Cytology history: N/A
199440 IGP,CtNgTv,HPVrfxE6/E7QSURE 191179 Previous history: N/A
199440 IGP,CtNgTv,HPVrfxE6/E7QSURE 191144 QA comment: N/A
199440 IGP,CtNgTv,HPVrfxE6/E7QSURE 019018 . 11546-9
199440 IGP,CtNgTv,HPVrfxE6/E7QSURE 191157 Pathologist provided ICD9: 52797-8
199440 IGP,CtNgTv,HPVrfxE6/E7QSURE 191175 Pathologist provided ICD10: 52797-8
199440 IGP,CtNgTv,HPVrfxE6/E7QSURE 190120 . N/A
199440 IGP,CtNgTv,HPVrfxE6/E7QSURE 190109 Note: N/A
199440 IGP,CtNgTv,HPVrfxE6/E7QSURE 000000 Test Methodology: 47527-7
199440 IGP,CtNgTv,HPVrfxE6/E7QSURE 507342 HPV, high-risk 30167-1
199440 IGP,CtNgTv,HPVrfxE6/E7QSURE 186134 Chlamydia, Nuc. Acid Amp 50387-0
199440 IGP,CtNgTv,HPVrfxE6/E7QSURE 186135 Gonococcus, Nuc. Acid Amp 50388-8
199440 IGP,CtNgTv,HPVrfxE6/E7QSURE 188092 Trich vag by NAA 46154-1
199440 IGP,CtNgTv,HPVrfxE6/E7QSURE 191167 Photomicrograph N/A
199440 IGP,CtNgTv,HPVrfxE6/E7QSURE 019030 . N/A
199440 IGP,CtNgTv,HPVrfxE6/E7QSURE 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
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
Reflex Table for HPV, high-risk
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 507905 HPV E6/E7 QuantaSure 507901 HPV QuantaSURE Interpretation 69358-0
Reflex Table for HPV, high-risk
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 507905 HPV E6/E7 QuantaSure 507903 HPV QuantaSURE Percent 76498-5
Reflex Table for HPV, high-risk
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 507905 HPV E6/E7 QuantaSure 507902 HPV E6/E7 QuantaSure Tracking N/A

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The LOINC® codes are copyright © 1994-2017, Regenstrief Institute, Inc. and the Logical Observation Identifiers Names and Codes (LOINC) Committee. Permission is granted in perpetuity, without payment of license fees or royalties, to use, copy, or distribute the LOINC® codes for any commercial or non-commercial purpose, subject to the terms under the license agreement found at https://loinc.org/license/. Additional information regarding LOINC® codes can be found at LOINC.org, including the LOINC Manual, which can be downloaded at LOINC.org/downloads/files/LOINCManual.pdf