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Human Papilloma Virus High-Risk DNA Types without Reflex HPV 16/18

Item Value
Approval req'd? No
Available Stat? No
Test code HPVNO
Performed by Immunology
In House Availability Twice a week (Monday and Thursday, day shift)
Method Invader¨ chemistry signal amplification
Collection Instructions Place the cervical brush in the Cytyc ThinPrep PreservCyt solution.
Container type
Sample type Cervical brush sample in preservative
Preferred volume Sample in 10 mL preservative
Min. Volume Sample in 6 mL preservative
UCSF Rejection Criteria Specimen not received in required preservative
Processing notes Store at room temperature until processed. Do not centrifuge the sample. Forward to Immunology at room temperature.
Normal range Not detected
Synonyms HPV; Cervical cancer; Pap smear; Papanicolaou smear
Turn around times 1-5 days
Reflex? lab will not automatically perform HPV Genotyping 16/18 on positive specimens when this test is ordered. To have test automatically reflex to test for HPV 16/18 order HPVHR
Additional information According to 2012 guidelines from the American College of Obstetricians and Gynecologists, high-risk HPV testing is appropriate in the following settings:

- Screening in conjunction with cervical cytology for all women aged 30-65 years.
- Initial management of women 25 years or older with ASC-US cytology result.
- Initial management of women 30 years or older with LSIL cytology result.
- Post-colposcopy at 12 months and possibly 24 months depending on cytology and histology results.
- Repeat testing is indicated in patients with prior positive results after 12 months.
- Repeat testing is indicated in patients with prior negative results after 3 years or 5 years depending on cytology results.
- Testing may also be indicated outside of the above guidelines when clinical management may be affected.

At this time, no clear guidelines are available regarding HPV genotyping. However, this testing can be performed on positive samples.
LOINC code 21440-3
LDT or Mod FDA? No
Last Updated 3/19/2014 12:28:50 PM
Entry Number 538
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