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

CPT: 87491; 87591; 87624; 88175
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Test Details


Diagnose primary or metastatic neoplasm; detect Chlamydia trachomatis and Neisseria gonorrhoeae 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.


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 detects cells overexpressing E6/E7 mRNA..


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

Specimen Requirements


Cervical cells in liquid-based cytology transport


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.


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.


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.)


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


Order Code Order Code Name Order Loinc Result Code Result Code Name UofM Result LOINC
199435 IGP,CtNg,HPV rfxE6/E7QSURE 019018 . 11546-9
199435 IGP,CtNg,HPV rfxE6/E7QSURE 019030 . N/A
199435 IGP,CtNg,HPV rfxE6/E7QSURE 019031 Patient Counseling Report N/A
199435 IGP,CtNg,HPV rfxE6/E7QSURE 186114 Chlamydia, Nuc. Acid Amp 50387-0
199435 IGP,CtNg,HPV rfxE6/E7QSURE 186122 Gonococcus, Nuc. Acid Amp 50388-8
199435 IGP,CtNg,HPV rfxE6/E7QSURE 190109 Note: N/A
199435 IGP,CtNg,HPV rfxE6/E7QSURE 190120 . N/A
199435 IGP,CtNg,HPV rfxE6/E7QSURE 191107 Clinical history: 22636-5
199435 IGP,CtNg,HPV rfxE6/E7QSURE 191108 DIAGNOSIS: 22637-3
199435 IGP,CtNg,HPV rfxE6/E7QSURE 191109 Specimen adequacy: 19764-0
199435 IGP,CtNg,HPV rfxE6/E7QSURE 191110 Additional comment: 22638-1
199435 IGP,CtNg,HPV rfxE6/E7QSURE 191111 Recommendation: 19773-1
199435 IGP,CtNg,HPV rfxE6/E7QSURE 191112 Performed by: 19767-3
199435 IGP,CtNg,HPV rfxE6/E7QSURE 191113 Electronically signed by: 19769-9
199435 IGP,CtNg,HPV rfxE6/E7QSURE 191121 Test ordered: N/A
199435 IGP,CtNg,HPV rfxE6/E7QSURE 191123 Maturation index: N/A
199435 IGP,CtNg,HPV rfxE6/E7QSURE 191124 Amended report: N/A
199435 IGP,CtNg,HPV rfxE6/E7QSURE 191125 Addendum: 22639-9
199435 IGP,CtNg,HPV rfxE6/E7QSURE 191128 QC reviewed by: N/A
199435 IGP,CtNg,HPV rfxE6/E7QSURE 191129 Cytology history: N/A
199435 IGP,CtNg,HPV rfxE6/E7QSURE 191139 Special procedure: N/A
199435 IGP,CtNg,HPV rfxE6/E7QSURE 191144 QA comment: N/A
199435 IGP,CtNg,HPV rfxE6/E7QSURE 191145 Diagnosis provided by: N/A
199435 IGP,CtNg,HPV rfxE6/E7QSURE 191154 Source: 19763-2
199435 IGP,CtNg,HPV rfxE6/E7QSURE 191157 Pathologist provided ICD9: 52797-8
199435 IGP,CtNg,HPV rfxE6/E7QSURE 191160 Clinician provided ICD9: 52797-8
199435 IGP,CtNg,HPV rfxE6/E7QSURE 191166 Interpretation N/A
199435 IGP,CtNg,HPV rfxE6/E7QSURE 191167 Photomicrograph N/A
199435 IGP,CtNg,HPV rfxE6/E7QSURE 191169 Infection: N/A
199435 IGP,CtNg,HPV rfxE6/E7QSURE 191170 Category: N/A
199435 IGP,CtNg,HPV rfxE6/E7QSURE 191172 Adequacy: N/A
199435 IGP,CtNg,HPV rfxE6/E7QSURE 191173 Recommendation: N/A
199435 IGP,CtNg,HPV rfxE6/E7QSURE 191174 Clinician provided ICD10: 52797-8
199435 IGP,CtNg,HPV rfxE6/E7QSURE 191175 Pathologist provided ICD10: 52797-8
199435 IGP,CtNg,HPV rfxE6/E7QSURE 191179 Previous history: N/A
199435 IGP,CtNg,HPV rfxE6/E7QSURE 507342 HPV, high-risk 30167-1
199435 IGP,CtNg,HPV rfxE6/E7QSURE 000000 Test Methodology: 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 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 507902 HPV E6/E7 QuantaSure Tracking N/A
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 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

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