This test should be regarded as 'Research Use Only'. This test has not been cleared or approved by the U.S. Food and Drug Administration. It may not be covered by insurance and providers need to inform all patients of this prior to ordering.
For Medicare patients, an Advanced Beneficiary notice (ABN) is required; for Medicaid patients, a Noncovered Services Waiver is required, and for commercial payers, prior authorization should be obtained.
Human herpesvirus-8 (HHV-8) infections are limited in the general population. The virus was first discovered in Kaposi's sarcoma (KS) lesions and also is known as Kaposi's sarcoma herpesvirus.
Endemic KS is common in sub-Saharan equatorial Africa, accounting for 10% to 17% of all adult malignancies. Elsewhere KS is rare, occurring primarily in Mediterranean and Eastern European adults. In the United States, KS primarily affects acquired immunodeficiency syndrome (AIDS) patients. Approximately 90% of KS tissues from AIDS patients contain HHV-8 DNA sequences. Sexual transmission of human herpesvirus-8 (HHV-8) may be possible since HHV-8 DNA sequences have been found in the semen of AIDS patients.
HHV-8 also is associated with transplantation-associated KS, which occurs in up to 5% of kidney transplant patients. Transmission of HHV-8 through renal allografts has been shown to be a risk factor for transplantation-associated KS.(3,6) Patients who are negative for antibodies to HHV-8 and receive transplanted organs from a donor who has antibodies to HHV-8 are at increased risk for the development of KS post transplantation.
HHV-8 also is associated with Bowen’s disease, a malignant squamous cell carcinoma; primary effusion lymphoma; Castleman's disease; and multiple myeloma.