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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.

 

STI Collection Guide - Carbomer Containing Products

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

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).

 

  1. 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.
  2. Prevalence of HPV infection in a population may affect performance. Positive predictive values decrease when testing populations with low prevalence or individuals with no risk of infection.
  3. Infection with HPV is not an indicator of cytologic high-grade squamous intraepithelial lesion (HSIL) or underlying high-grade cervical intraepithelial neoplasia (CIN), nor does it imply that CIN2-3 or cancer will develop. Most women infected with 1 or more high-risk (HR) HPV types do not develop CIN2-3 or cancer.
  4. A negative-HR-HPV result does not exclude the possibility of future cytologic HSIL or underlying CIN2-3 or cancer.
  5. This is a screening test, and results from this test should only be interpreted in conjunction with information available from clinical evaluation of the patient and patient history.

This is intended as educational information to providers for compliance with CAP regulation CYP.07582:

 

“There is a mechanism to educate providers that cervical cancer screening tests, including primary HPV and pap tests, are screening tests with inherent false negative results.

 

NOTE: The preferred mechanism is an educational note on all negative Pap test reports and all primary HPV screening tests. Other mechanisms include sending periodic educational information to providers, conference presentations, specimen collection manual, etc.”

Methodology

Nucleic Acid Detection

CPT

87626