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Human Papillomavirus (HPV) (Aptima®) With Reflex to HPV Genotypes 16 and 18,45

CPT

87624

Test Details

Methodology

Nucleic acid amplification (NAA)

Result Turnaround Time

2 - 5 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

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. If the initial high-risk test is positive, then the residual specimen will be tested for HPV types 16 and 18,45; type 18 cannot be differentiated from type 45.

Limitations

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.

Specimen Requirements

Specimen

Cervical cells in liquid-based cytology transport

Volume

ThinPrep® vial

Minimum Volume

A minimum volume cannot be determined for the ThinPrep® vial because it varies depending on the cellularity of the specimen.

Container

ThinPrep® vial

Collection Instructions

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 ¼ to ½ 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.

Storage Instructions

Maintain specimen at room temperature. Specimens in ThinPrep® vials must be processed within 21 days of collection for HPV.

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; specimen leaked in transit; quantity not sufficient for analysis; name discrepancies; specimen submitted on male patient; specimen submitted in vial that expired according to manufacturer's label; frozen specimen; SurePath™ vial. For HPV: specimen more than 21 days old in ThinPrep® vial.

LOINC® Map

Order Code Order Code Name Order Loinc Result Code Result Code Name UofM Result LOINC
507805 HPV, Aptima High 16/18,45 507801 HPV Aptima 59420-0
507805 HPV, Aptima High 16/18,45 019054 PDF 11502-2
Order Code507805
Order Code NameHPV, Aptima High 16/18,45
Order Loinc
Result Code507801
Result Code NameHPV Aptima
UofM
Result LOINC59420-0
Order Code507805
Order Code NameHPV, Aptima High 16/18,45
Order Loinc
Result Code019054
Result Code NamePDF
UofM
Result LOINC11502-2
Reflex Table for HPV Aptima
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 507825 HPV Genotypes 16/18,45 507811 HPV Genotype 16 59263-4
Reflex 1
Order Code507825
Order NameHPV Genotypes 16/18,45
Result Code507811
Result NameHPV Genotype 16
UofM
Result LOINC59263-4
Reflex Table for HPV Aptima
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 507825 HPV Genotypes 16/18,45 507812 HPV Genotype 18,45 75694-0
Reflex 1
Order Code507825
Order NameHPV Genotypes 16/18,45
Result Code507812
Result NameHPV Genotype 18,45
UofM
Result LOINC75694-0
Reflex Table for HPV Aptima
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 507825 HPV Genotypes 16/18,45 507813 HPV Genotype 16/18,45 Tracking N/A
Reflex 1
Order Code507825
Order NameHPV Genotypes 16/18,45
Result Code507813
Result NameHPV Genotype 16/18,45 Tracking
UofM
Result LOINCN/A
Reflex Table for HPV Aptima
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 507825 HPV Genotypes 16/18,45 019054 PDF 11502-2
Reflex 1
Order Code507825
Order NameHPV Genotypes 16/18,45
Result Code019054
Result NamePDF
UofM
Result LOINC11502-2