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

Test Number 196125
Test number copied
CPT 87491; 87591; 88175

Test Details

Methodology

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

Result Turnaround Time

3 - 7 days

Turnaround time is defined as the usual number of days from the date of pickup of a specimen for testing to when the result is released to the ordering provider. In some cases, additional time should be allowed for additional confirmatory or additional reflex tests. Testing schedules may vary.

Use

Diagnose primary or metastatic neoplasm; detect Chlamydia trachomatis and Neisseria gonorrhoeae. The high-risk HPV test is used for types 16,18,31,33,35,39,45,51,52,56,58,59, 66, and 68, without differentiation of the individual type. This assay aids in the diagnosis of sexually-transmitted HPV infection and in the triage of patients with an ASCUS Pap test result.

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.)

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.

Specimen Requirements

Specimen

Cervical cells in SurePath™ vial and Aptima® device

Volume

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

Minimum Volume

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

Container

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

Collection Instructions

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 Chlamydiaand Gonococcus: 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

Patient Preparation

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

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 and Gonococcus: Aptima® specimen more than 60 days old; Gen-Probe® Aptima® collection tube with multiple swabs or white-shafted cleaning swab.

LOINC® Map

Order Code Order Code Name Order Loinc Result Code Result Code Name UofM Result LOINC
196125 IGP,CtNg,rfxcobasHPV ASCU 191121 Test ordered: N/A
196125 IGP,CtNg,rfxcobasHPV ASCU 191108 DIAGNOSIS: 47528-5
196125 IGP,CtNg,rfxcobasHPV ASCU 191166 Interpretation 19764-0
196125 IGP,CtNg,rfxcobasHPV ASCU 191170 Category: N/A
196125 IGP,CtNg,rfxcobasHPV ASCU 191173 Recommendation: N/A
196125 IGP,CtNg,rfxcobasHPV ASCU 191169 Infection: N/A
196125 IGP,CtNg,rfxcobasHPV ASCU 191172 Adequacy: N/A
196125 IGP,CtNg,rfxcobasHPV ASCU 191111 Recommendation: 19773-1
196125 IGP,CtNg,rfxcobasHPV ASCU 191109 Specimen adequacy: 19764-0
196125 IGP,CtNg,rfxcobasHPV ASCU 191154 Source: 19763-2
196125 IGP,CtNg,rfxcobasHPV ASCU 191160 Clinician provided ICD9: 52797-8
196125 IGP,CtNg,rfxcobasHPV ASCU 191174 Clinician provided ICD10: 52797-8
196125 IGP,CtNg,rfxcobasHPV ASCU 191107 Clinical history: 22636-5
196125 IGP,CtNg,rfxcobasHPV ASCU 191124 Amended report: N/A
196125 IGP,CtNg,rfxcobasHPV ASCU 191110 Additional comment: 22638-1
196125 IGP,CtNg,rfxcobasHPV ASCU 191125 Addendum: 22639-9
196125 IGP,CtNg,rfxcobasHPV ASCU 191123 Maturation index: N/A
196125 IGP,CtNg,rfxcobasHPV ASCU 191112 Performed by: 19767-3
196125 IGP,CtNg,rfxcobasHPV ASCU 191128 QC reviewed by: N/A
196125 IGP,CtNg,rfxcobasHPV ASCU 191145 Diagnosis provided by: N/A
196125 IGP,CtNg,rfxcobasHPV ASCU 191113 Electronically signed by: 19769-9
196125 IGP,CtNg,rfxcobasHPV ASCU 191139 Special procedure: N/A
196125 IGP,CtNg,rfxcobasHPV ASCU 191129 Cytology history: N/A
196125 IGP,CtNg,rfxcobasHPV ASCU 191179 Previous history: N/A
196125 IGP,CtNg,rfxcobasHPV ASCU 191144 QA comment: N/A
196125 IGP,CtNg,rfxcobasHPV ASCU 019018 . 11546-9
196125 IGP,CtNg,rfxcobasHPV ASCU 191157 Pathologist provided ICD9: 52797-8
196125 IGP,CtNg,rfxcobasHPV ASCU 191175 Pathologist provided ICD10: 52797-8
196125 IGP,CtNg,rfxcobasHPV ASCU 190120 . N/A
196125 IGP,CtNg,rfxcobasHPV ASCU 190109 Note: 8251-1
196125 IGP,CtNg,rfxcobasHPV ASCU 000000 Test Methodology: 47527-7
196125 IGP,CtNg,rfxcobasHPV ASCU 190119 . N/A
196125 IGP,CtNg,rfxcobasHPV ASCU 186114 Chlamydia, Nuc. Acid Amp 50387-0
196125 IGP,CtNg,rfxcobasHPV ASCU 186122 Gonococcus, Nuc. Acid Amp 50388-8
196125 IGP,CtNg,rfxcobasHPV ASCU 191167 Photomicrograph N/A
196125 IGP,CtNg,rfxcobasHPV ASCU 019030 . N/A
196125 IGP,CtNg,rfxcobasHPV ASCU 019031 Patient Counseling Report N/A
Order Code196125
Order Code NameIGP,CtNg,rfxcobasHPV ASCU
Order Loinc
Result Code191121
Result Code NameTest ordered:
UofM
Result LOINCN/A
Order Code196125
Order Code NameIGP,CtNg,rfxcobasHPV ASCU
Order Loinc
Result Code191108
Result Code NameDIAGNOSIS:
UofM
Result LOINC47528-5
Order Code196125
Order Code NameIGP,CtNg,rfxcobasHPV ASCU
Order Loinc
Result Code191166
Result Code NameInterpretation
UofM
Result LOINC19764-0
Order Code196125
Order Code NameIGP,CtNg,rfxcobasHPV ASCU
Order Loinc
Result Code191170
Result Code NameCategory:
UofM
Result LOINCN/A
Order Code196125
Order Code NameIGP,CtNg,rfxcobasHPV ASCU
Order Loinc
Result Code191173
Result Code NameRecommendation:
UofM
Result LOINCN/A
Order Code196125
Order Code NameIGP,CtNg,rfxcobasHPV ASCU
Order Loinc
Result Code191169
Result Code NameInfection:
UofM
Result LOINCN/A
Order Code196125
Order Code NameIGP,CtNg,rfxcobasHPV ASCU
Order Loinc
Result Code191172
Result Code NameAdequacy:
UofM
Result LOINCN/A
Order Code196125
Order Code NameIGP,CtNg,rfxcobasHPV ASCU
Order Loinc
Result Code191111
Result Code NameRecommendation:
UofM
Result LOINC19773-1
Order Code196125
Order Code NameIGP,CtNg,rfxcobasHPV ASCU
Order Loinc
Result Code191109
Result Code NameSpecimen adequacy:
UofM
Result LOINC19764-0
Order Code196125
Order Code NameIGP,CtNg,rfxcobasHPV ASCU
Order Loinc
Result Code191154
Result Code NameSource:
UofM
Result LOINC19763-2
Order Code196125
Order Code NameIGP,CtNg,rfxcobasHPV ASCU
Order Loinc
Result Code191160
Result Code NameClinician provided ICD9:
UofM
Result LOINC52797-8
Order Code196125
Order Code NameIGP,CtNg,rfxcobasHPV ASCU
Order Loinc
Result Code191174
Result Code NameClinician provided ICD10:
UofM
Result LOINC52797-8
Order Code196125
Order Code NameIGP,CtNg,rfxcobasHPV ASCU
Order Loinc
Result Code191107
Result Code NameClinical history:
UofM
Result LOINC22636-5
Order Code196125
Order Code NameIGP,CtNg,rfxcobasHPV ASCU
Order Loinc
Result Code191124
Result Code NameAmended report:
UofM
Result LOINCN/A
Order Code196125
Order Code NameIGP,CtNg,rfxcobasHPV ASCU
Order Loinc
Result Code191110
Result Code NameAdditional comment:
UofM
Result LOINC22638-1
Order Code196125
Order Code NameIGP,CtNg,rfxcobasHPV ASCU
Order Loinc
Result Code191125
Result Code NameAddendum:
UofM
Result LOINC22639-9
Order Code196125
Order Code NameIGP,CtNg,rfxcobasHPV ASCU
Order Loinc
Result Code191123
Result Code NameMaturation index:
UofM
Result LOINCN/A
Order Code196125
Order Code NameIGP,CtNg,rfxcobasHPV ASCU
Order Loinc
Result Code191112
Result Code NamePerformed by:
UofM
Result LOINC19767-3
Order Code196125
Order Code NameIGP,CtNg,rfxcobasHPV ASCU
Order Loinc
Result Code191128
Result Code NameQC reviewed by:
UofM
Result LOINCN/A
Order Code196125
Order Code NameIGP,CtNg,rfxcobasHPV ASCU
Order Loinc
Result Code191145
Result Code NameDiagnosis provided by:
UofM
Result LOINCN/A
Order Code196125
Order Code NameIGP,CtNg,rfxcobasHPV ASCU
Order Loinc
Result Code191113
Result Code NameElectronically signed by:
UofM
Result LOINC19769-9
Order Code196125
Order Code NameIGP,CtNg,rfxcobasHPV ASCU
Order Loinc
Result Code191139
Result Code NameSpecial procedure:
UofM
Result LOINCN/A
Order Code196125
Order Code NameIGP,CtNg,rfxcobasHPV ASCU
Order Loinc
Result Code191129
Result Code NameCytology history:
UofM
Result LOINCN/A
Order Code196125
Order Code NameIGP,CtNg,rfxcobasHPV ASCU
Order Loinc
Result Code191179
Result Code NamePrevious history:
UofM
Result LOINCN/A
Order Code196125
Order Code NameIGP,CtNg,rfxcobasHPV ASCU
Order Loinc
Result Code191144
Result Code NameQA comment:
UofM
Result LOINCN/A
Order Code196125
Order Code NameIGP,CtNg,rfxcobasHPV ASCU
Order Loinc
Result Code019018
Result Code Name.
UofM
Result LOINC11546-9
Order Code196125
Order Code NameIGP,CtNg,rfxcobasHPV ASCU
Order Loinc
Result Code191157
Result Code NamePathologist provided ICD9:
UofM
Result LOINC52797-8
Order Code196125
Order Code NameIGP,CtNg,rfxcobasHPV ASCU
Order Loinc
Result Code191175
Result Code NamePathologist provided ICD10:
UofM
Result LOINC52797-8
Order Code196125
Order Code NameIGP,CtNg,rfxcobasHPV ASCU
Order Loinc
Result Code190120
Result Code Name.
UofM
Result LOINCN/A
Order Code196125
Order Code NameIGP,CtNg,rfxcobasHPV ASCU
Order Loinc
Result Code190109
Result Code NameNote:
UofM
Result LOINC8251-1
Order Code196125
Order Code NameIGP,CtNg,rfxcobasHPV ASCU
Order Loinc
Result Code000000
Result Code NameTest Methodology:
UofM
Result LOINC47527-7
Order Code196125
Order Code NameIGP,CtNg,rfxcobasHPV ASCU
Order Loinc
Result Code190119
Result Code Name.
UofM
Result LOINCN/A
Order Code196125
Order Code NameIGP,CtNg,rfxcobasHPV ASCU
Order Loinc
Result Code186114
Result Code NameChlamydia, Nuc. Acid Amp
UofM
Result LOINC50387-0
Order Code196125
Order Code NameIGP,CtNg,rfxcobasHPV ASCU
Order Loinc
Result Code186122
Result Code NameGonococcus, Nuc. Acid Amp
UofM
Result LOINC50388-8
Order Code196125
Order Code NameIGP,CtNg,rfxcobasHPV ASCU
Order Loinc
Result Code191167
Result Code NamePhotomicrograph
UofM
Result LOINCN/A
Order Code196125
Order Code NameIGP,CtNg,rfxcobasHPV ASCU
Order Loinc
Result Code019030
Result Code Name.
UofM
Result LOINCN/A
Order Code196125
Order Code NameIGP,CtNg,rfxcobasHPV ASCU
Order Loinc
Result Code019031
Result Code NamePatient Counseling Report
UofM
Result LOINCN/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 1
Order Code192555
Order NameChange IG Pap to LB Pap
Result Code000000
Result NameLBP CPT Code Automation
UofM
Result LOINC47527-7
Reflex Table for .
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 507390 HPV, cobas high-risk 507390 HPV, cobas high-risk 59420-0
Reflex 1
Order Code507390
Order NameHPV, cobas high-risk
Result Code507390
Result NameHPV, cobas high-risk
UofM
Result LOINC59420-0