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Test ID NBLD0665 Primary HPV: HPV screen with reflex to PAP for HPV-positive samples

Important Note

This test is for Primary HPV which reflexes to a Pap ONLY when the HPV result is Positive.
 

If wanting both Pap and HPV (aka co-testing), order Liquid-Based Pap Test (PATH1021).
 

Specimen Type/Requirements

ThinPrep Vial – Cervical/Endocervical sample obtained via brush, spatula, or combo device. Submit fluid only, not collection device.

 

NOTE: Specimens that are macroscopically bloody and/or dark brown will be rejected. Recommended to not collect sample during menses.

*Lubricants interfere with processing and should be avoided during specimen collection. If necessary, use a minimal amount of carbomer-free lubricant (e.g., KY Jelly, Surgilube Surgical Lubricating Helly, HR Lubricating Jelly) making sure to only place on outside of speculum.

Specimen Volume

Submit entire ThinPrep vial (contains 20mL).

Stability/Transport

 Room Temperature     3 weeks     Preferred transport   
Refrigerated                3 weeks   
Frozen                         NA  

Performing Lab

Sanford Laboratories Sioux Falls – HPV only

Reflexed to pap (if applicable) - pap will be sent to originating region for processing and sign out.

Report Available

1-2 days – HPV only

Reflexed to pap (if applicable) – 5 days from receipt of vial into performing laboratory (NOTE: Vial not sent until HPV is resulted)

Performed Test Frequency

Sunday through Saturday – HPV only

Reflexed to pap (if applicable) – Monday through Friday

Methodology

Nucleic Acid Detection

CPT

87624

Additional Information

  • Primary HPV Screen will have the molecular HPV test performed first. Test will reflex to a PAP smear only when HPV Nucleic Acid Detection with 16 and 18 Genotyping is positive or detected
  • HPV-negative samples will not reflex to a PAP smear. If co-testing is desired, place Liquid-Based Pap order (PATH1021)
  • Add-on PAP smear requests for HPV-negative samples must be placed within 21 days of collection.
  • Not for use with Vaginal samples.

 

The cobas HPV assay is a qualitative real-time PCR test performed on the Roche cobas 6800 platform which detects viral DNA from HPV High Risk genotypes 16, 18 and 12 other high-risk genotypes (31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, 68).