HPV High Risk (16 & 18)

CPT: 87625

Expected Turnaround Time

24 hours

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.

Specimen Requirements

Specimen

Vaginal e Swab or Thin Prep Vial

Volume

1ml

Minimum Volume

200 ul

Container

Liquid Amies Medium or Thinprep vial

Storage Instructions

Room Temp., Refrigerated (2-8 C)

Stability Requirements

5 days both Room Temperature and Refrigerated Temperature

Causes for Rejection

Mislabeled samples, QNS, incorrect container or preservative,

Test Details

Use

This test is used to identify HPV 16 & 18

Methodology

PCR

Reference Interval

Not Detected

Additional Information

Human papillomavirus (HPV) is one of the most common sexually transmitted infections in the world and is strongly linked to the development of cervical cancer. Cervical cancer is the second most common cancer among women in developing countries with an estimated 445,000 new cases in 2012 (84% of the new cases worldwide). Approximately 270,000 women died from cervical cancer in 2012 and more than 85% of these deaths cases occurred in less developed countries. An estimated 14 million persons newly infected every year, resulting in approximately $1.7 billion (estimates range from $800 million to $2.9 billion) in direct medical costs.

HPV is a DNA virus that causes abnormal growth of skin and mucous membrane cells. There are over 100 types of HPV, but about 13 are considered high-risk because they can cause cancer in the cervix, vagina, vulva, anus, and throat. Among these, HPV types 16 and 18 are the most carcinogenic and associated with invasive cervical cancer than other types. They are responsible for about 70% of cervical cancer cases worldwide.

HPV is mainly spread through skin-to-skin contact during vaginal, anal, or oral sex. People at higher risk for HPV-related cancers include smokers, people with weakened immune systems (such as those with HIV or organ transplants), and individuals who have many sexual partners. Although the vast majority of HPV infections cause no symptoms and are self-limited, persistent HPV infection can cause cervical cancer in women as well as other anogenital cancers, oropharyngeal cancer, and genital warts in men and women.

References

Ahmed HG, Bensumaidea SH, Alshammari FD, Alenazi FSH, ALmutlaq BA, Alturkstani MZ, Aladani IA. Prevalence of Human Papillomavirus subtypes 16 and 18 among Yemeni Patients with Cervical Cancer. Asian Pac J Cancer Prev. 2017 Jun 25;18(6):1543-1548. doi: 10.22034/APJCP.2017.18.6.1543. PMID: 28669165; PMCID: PMC6373819.

Powell N, Cuschieri K, Cubie H, Hibbitts S, Rosillon D, De Souza SC, Molijn A, Quint W, Holl K, Fiander A. Cervical cancers associated with human papillomavirus types 16, 18 and 45 are diagnosed in younger women than cancers associated with other types: a cross-sectional observational study in Wales and Scotland (UK). J Clin Virol. 2013 Nov;58(3):571-4. doi: 10.1016/j.jcv.2013.08.020. Epub 2013 Aug 30. PMID: 24051043.

CDC. Retrieved from Chapter 5: Human Papillomavirus | Manual for the Surveillance of Vaccine-Preventable Diseases | CDC

Footnotes

Statement on Medical Necessity
All ordered tests should be medically necessary for the diagnosis or detection of disease, illness, impairment, symptom, syndrome, or disorder and the results should be used in the medical management and treatment decisions for the patient. Solaris requires ICD-10 codes with each order for lab testing and both the tests ordered and the diagnosis should be documented in the provider’s medical record for the patient. The United States Department of Health and Human Services, Office of Inspector General, takes the position that a provider who orders medically unnecessary tests may be subject to civil penalties.

Panels and Profiles
Solaris offers Providers the convenience of ordering test combinations in a group at times with the flexibility to choose appropriate test(s) for individual patients. Providers should only order those tests that he or she believes are medically necessary for each patient, and a lesser inclusive profile or individual tests should be ordered if not all tests in the test combination/profile are medically necessary. All tests offered in a test combination/profile may be ordered separately as individual tests. Solaris encourages clients to contact their Solaris representative if the testing configurations shown do not meet individual needs for any reason, or if some other combination of procedures is needed.

CPT Codes
CPT Codes listed are in accordance with Current Procedural Terminology, a publication of the American Medical Association. CPT codes are the responsibility of the billing party and are listed here for informational purposes. Correct coding may vary from one carrier to another. Solaris may bill specific carriers using codes other than what is shown.

Questions?

For questions or inquiries related to testing please reach out to
customerservice@solarisdx.com or contact us by phone at (844) 550-0308.