Gynecologic Pap Test (Image-guided), Liquid-based Preparation and Chlamydia/Gonococcus/Trichomonas, NAA With Reflex to High-risk HPV (Cobas®) With HPV Genotypes 16 and 18 When ASC-U using SurePath™ specimen

CPT: 87491; 87591; 87661; 88175
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Test Details

Use

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.

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.

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.

Methodology

Image-guided liquid-based Pap test; nucleic acid amplification (NAA; for Chlamydia/Gonococcus/Trichomonas and HPV)

Specimen Requirements

Specimen

Cervical cells in SurePath™ vial and Aptima® device

Volume

Entire SurePath™ vial and Aptima® device (for Chlamydia/Gonococcus/Trichomonas)

Minimum Volume

Entire SurePath™ vial and Aptima® device (for Chlamydia/Gonococcus/Trichomonas)

Container

SurePath™ vial and Aptima® device (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

SurePath™ vial - Using a cervical broom: 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.

Required Dedicated Specimen for Chlamydia/Gonococcus/Trichomonas: Aptima® vaginal swab or unisex swab collection kit.

Vaginal Swab Kit: Collect vaginal fluid sample using the Gen-Probe® Aptima® swab by contacting the swab to the lower third of the vaginal wall and rotating the swab for 10 to 30 seconds to absorb fluid. Immediately place the swab into the transport tube and carefully break the swab shaft against the side of the tube. Tightly screw on the cap.

Unisex Swab 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

Room temperature

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 four weeks old in SurePath™ vial; excessively bloody specimens. For Chlamydia/Gonococcus/Trichomonas: Aptima® specimen more than 60 days old; Gen-Probe® Aptima® collection tube with multiple swabs or white-shafted cleaning swab.

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

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.)

LOINC® Map

Order Code Order Code Name Order Loinc Result Code Result Code Name UofM Result LOINC
196115 IGP,CtNgTvrfxcobasHPV16/18ASCU 191121 Test ordered: N/A
196115 IGP,CtNgTvrfxcobasHPV16/18ASCU 191158 ****************************** N/A
196115 IGP,CtNgTvrfxcobasHPV16/18ASCU 191108 DIAGNOSIS: 22637-3
196115 IGP,CtNgTvrfxcobasHPV16/18ASCU 191166 Interpretation N/A
196115 IGP,CtNgTvrfxcobasHPV16/18ASCU 191170 Category: N/A
196115 IGP,CtNgTvrfxcobasHPV16/18ASCU 191173 Recommendation: N/A
196115 IGP,CtNgTvrfxcobasHPV16/18ASCU 191169 Infection: N/A
196115 IGP,CtNgTvrfxcobasHPV16/18ASCU 191172 Adequacy: N/A
196115 IGP,CtNgTvrfxcobasHPV16/18ASCU 191111 Recommendation: 19773-1
196115 IGP,CtNgTvrfxcobasHPV16/18ASCU 191109 Specimen adequacy: 19764-0
196115 IGP,CtNgTvrfxcobasHPV16/18ASCU 191159 ****************************** N/A
196115 IGP,CtNgTvrfxcobasHPV16/18ASCU 191154 Source: 19763-2
196115 IGP,CtNgTvrfxcobasHPV16/18ASCU 191160 Clinician provided ICD9: 52797-8
196115 IGP,CtNgTvrfxcobasHPV16/18ASCU 191174 Clinician provided ICD10: 52797-8
196115 IGP,CtNgTvrfxcobasHPV16/18ASCU 191107 Clinical history: 22636-5
196115 IGP,CtNgTvrfxcobasHPV16/18ASCU 191124 Amended report: N/A
196115 IGP,CtNgTvrfxcobasHPV16/18ASCU 191110 Additional comment: 22638-1
196115 IGP,CtNgTvrfxcobasHPV16/18ASCU 191125 Addendum: 22639-9
196115 IGP,CtNgTvrfxcobasHPV16/18ASCU 191123 Maturation index: N/A
196115 IGP,CtNgTvrfxcobasHPV16/18ASCU 191112 Performed by: 19767-3
196115 IGP,CtNgTvrfxcobasHPV16/18ASCU 191128 QC reviewed by: N/A
196115 IGP,CtNgTvrfxcobasHPV16/18ASCU 191145 Diagnosis provided by: N/A
196115 IGP,CtNgTvrfxcobasHPV16/18ASCU 191113 Electronically signed by: 19769-9
196115 IGP,CtNgTvrfxcobasHPV16/18ASCU 191139 Special procedure: N/A
196115 IGP,CtNgTvrfxcobasHPV16/18ASCU 191129 Cytology history: N/A
196115 IGP,CtNgTvrfxcobasHPV16/18ASCU 191179 Previous history: N/A
196115 IGP,CtNgTvrfxcobasHPV16/18ASCU 191144 QA comment: N/A
196115 IGP,CtNgTvrfxcobasHPV16/18ASCU 019018 . 11546-9
196115 IGP,CtNgTvrfxcobasHPV16/18ASCU 191157 Pathologist provided ICD9: 52797-8
196115 IGP,CtNgTvrfxcobasHPV16/18ASCU 191175 Pathologist provided ICD10: 52797-8
196115 IGP,CtNgTvrfxcobasHPV16/18ASCU 190120 . N/A
196115 IGP,CtNgTvrfxcobasHPV16/18ASCU 190109 Note: N/A
196115 IGP,CtNgTvrfxcobasHPV16/18ASCU 000000 Test Methodology: 47527-7
196115 IGP,CtNgTvrfxcobasHPV16/18ASCU 190119 . N/A
196115 IGP,CtNgTvrfxcobasHPV16/18ASCU 186134 Chlamydia, Nuc. Acid Amp 50387-0
196115 IGP,CtNgTvrfxcobasHPV16/18ASCU 186135 Gonococcus, Nuc. Acid Amp 50388-8
196115 IGP,CtNgTvrfxcobasHPV16/18ASCU 188092 Trich vag by NAA 46154-1
196115 IGP,CtNgTvrfxcobasHPV16/18ASCU 191167 Photomicrograph N/A
196115 IGP,CtNgTvrfxcobasHPV16/18ASCU 019030 . N/A
196115 IGP,CtNgTvrfxcobasHPV16/18ASCU 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 .
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 507301 HPV, high-risk 507303 HPV, high-risk 30167-1
Reflex 2 000000 507405 000000 59420-0
Reflex Table for .
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 507385 HPV, cobas high-risk/16/18 507386 HPV other hr types 71431-1
Reflex Table for .
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 507385 HPV, cobas high-risk/16/18 507387 HPV 16 61372-9
Reflex Table for .
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 507385 HPV, cobas high-risk/16/18 507388 HPV 18 61373-7

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