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Test Code LAB263 HPV High Risk Reflex to 16 and 18/45 Genotyping

Useful For

The detection of high-risk genotypes associated with the development of cervical cancer.  This can be used as an aid to triaging women with abnormal Pap smear results. A positive HPV HR result will automatically reflex to 16 and 18 genotyping.

Methodology

Nucleic Acid Amplification and Detection (NAD)

  

Reflex Testing

Test Code Test Name

Available

Separately

Always

Performed
LAB1365

Cytology, Human Papillomavirus (HPV) Genotypes 16 & 18/45

 No No

 

The detection of specific high-risk HPV genotypes 16 and 18/45 associated with the development of cervical cancer.  This test differentiates between genotypes 16 and 18/45.  This test does not differentiate between genotypes 18 and 45.

Performing Laboratory

Bozeman Health Laboratory Services

Specimen Requirements

Call Bozeman Health Laboratory Services (Cytology) at 406-414-5057 or fax a request to 406-414-5117 to obtain collection materials.

 

Specimen Type: Exocervix

Container/Tube: ThinPrep vial

Specimen Volume: Adequate amount

Collection Instructions:

  1. Label ThinPrep vial with patient’s name (first and last).
  2. Do not use lubricant on speculum.
  3. Visualize cervix with a speculum.
  4. To collect specimen from exocervix, select contoured end of plastic spatula and rotate it 360° around entire exocervix while maintaining tight contact with exocervical surface. Remove spatula.
  5. Rinse contoured end of plastic spatula into PreservCyt Solution vial by swirling spatula vigorously in vial 10 times. Discard spatula. Place cap on vial.
  6. Obtain an adequate sampling from endocervix using an endocervical brush device. Insert brush into cervix until only bottom-most fibers are exposed. Slowly rotate one quarter or one half turn in 1 direction. Do not over-rotate. Additional rotation may cause bleeding and contaminate specimen.  Note: A cervical “broom” (e.g. Rovers Cervex Brush or Combi, Wallach Papette) may be used in lieu of spatula/cervical brush if desired. It is extremely important to immediately dislodge cellular material and not allow collection devices to sit in fixative or cells will become trapped to/in collection device.
  7. Rinse brush in PreservCyt Solution vial by rotating device in solution 10 times while pushing against PreservCyt vial wall. Swirl brush VIGOROUSLY to further release material.
  8. Discard collection device after depositing cellular material in vial. Do not send collection device in vial.
  9. Tighten cap so torque line on cap passes torque line on vial.
  10. Place specimen in plastic specimen bag with completed cytology test requisition inserted into pocket separate from specimen, and, if possible, deliver specimen to Cytology Laboratory.

Specimen Rejection:

1. No request form

2. Frozen samples

3. Unlabeled specimen

4. Fixed in formalin

Specimen Transport Temperature

Ambient/Refrigerated

Specimen Stability

 

Specimen Type Temperature Time
ThinPrep Vial Ambient 30 days
  Refrigerated 30 days
APTIMA Specimen Transfer Tube Ambient 60 days
  Refrigerated 60 days

 

Reference Values

Results are reported as positive, negative, or Inconclusive

 

Negative:  HPV E6/E7 mRNA  for genotypes 16, 18, 31, 33, 35, 39, 45, 51, 52 , 56 , 58, 59, 66, or 68 were NOT detected

 

Positive:  A positive result indicates the presence of HPV E6/E7 mRNA of any one or more of the high-risk genotypes 16, 18, 31, 33, 35, 39, 45, 51, 52 , 56 , 58, 59, 66, or 68.

 

Inconclusive: A result of Inconclusive reflects low patient genomic DNA from cervical cells. This is a quality control indicator built in the test methodology, to ensure an adequate cervical sample has been collected, and that a negative result is not due to insufficient specimen sample. High risk HPV status is unknown and repeat collection is indicated.

Additional Information

Current Consensus guideline recommendations for High risk HPV testing include:

  • Testing women age 21 and above who have an ASC-US Pap smear result.
  • Pap smear co-testing with HR HPV for women 30 and over.

Day(s) Test Set Up

HPV testing is performed on Tuesdays and Thursdays. GT reflex testing, on Fridays. No STAT testing available.

Test Classification and CPT Coding

87624

88142 (if appropriate)