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! > NEWS 8 VIEWS I z New Hepatitis Virus Discovered Researchers recently discovered a virus that is highly associated with acute and chronic hepatitis of unknown origin. The SEN-V virus was discovered by Daniele Primi, PhD, and his research team at the DiaSorin Biomolecular Research Center in Brescia, Italy. DiaSorin is the Medical Systems Division of American Standard Companies (Piscataway, NJ). The name of the virus comes from the initials of the patient in whom the virus was first discovered; the patient was a person with HIV. The newly discovered virus is bloodborne, so patients who undergo transfusions and intravenous drug users are at risk. While no blood screening system for the new virus exists, appropriate screening of blood and blood products may control its spread in the future. The virus appears capable of co-infecting patients who have other types of viral liver disease, raising the possibility that it may aggravate their clinical course, their response to treatment, or both. The SEN-V virus may account for a majority of cases of viral hepatitis of unknown origin. As many as 5.2 million people in the United States are infected with acute or chronic viral hepatitis. Five viruses (A, B, C, D, E) are known to cause 80% to 90% of the hepatitis cases worldwide, but 10% to 20% of cases are of unknown origin (non-A/non-E [NANE] hepatitis). Based on test data from carefully controlled samples, the SEN-V virus may account for approximately 68% of all chronic NANE viral hepatitis cases. Researchers analyzed nearly 600 sera. In 31 cases of NANE hepatitis, the virus was found in 68% of chronic cases and 83% of posttransfusion cases. The prevalence of the virus in the general population is less than 1%, according to the researchers. "These data suggest that this new virus accounts for a significant proportion of transfusion-associated hepatitis of unknown origin," says Harvey Alter, MD, chief of the Infectious Diseases Section, Department of Transfusion Medicine at ! November Is... the Clinical Center, National Institutes of Health (NIH), Bethesda, Md. "Though the data are preliminary, it is striking that such a high percentage of cases demonstrated new SEN-V infection in association with transfusion and that the incidence of infection in various control populations was very low. A great deal of work remains to be done to confirm and expand these findings, but this is the best candidate virus to account for previously unexplained hepatitis that I have observed." Primi and his team have characterized the genomic sequences of the new virus and developed prototype assays. The team is conducting additional research to isolate and characterize the viral particle. Expanded clinical studies are also being conducted in collaboration with the NIH to understand further the dynamics of immune response and the clinical implications of the virus. Initial studies reveal that approximately 30% of patients with HIV are also infected with the new virus.© Diabetic Eye Disease Month — Contact Nancy Antol, Prevent Blindness America, (800) 331-2020. National Alzheimer's Awareness Month — Contact Alzheimer's Disease and Related Disorders Assoc, (800) 272-3900. National Diabetes MonthContact American Diabetes Assoc, (800) 232-3472. National Epilepsy Month — Contact Epilepsy Foundation of America, (800) EFA-1000. Schematic drawing of a damaged liver (lower left) shows a variety of viral cells, including nonspecific enveloped and non-enveloped hepatitis cells. Worldwide 10% to 20% of hepatitis cases are of unknown origin (non-A/non-E) hepatitis. Image courtesy DiaSorin (Stillwater, Minn). NOVEMBER 1999 VOLUME 30. NUMBER 11 LABORATORY MEDICINE 703 Cervical Cancer Update aMtaf ^ H u m a n papillomavirus, which researchers believe causes more than 9 0 % of cervical cancer cases, is characterized by koilocytes, mature s q u a m o u s cells w i t h nuclear dysplasia and cytoplasmic halos. Illustration 35 f r o m DeMay RM. Practical Principles of Cytopathology. Chicago, III: ASCP Press; 1999:12. Electron p h o t o m i c r o g r a p h of h u m a n papillomavirus (HPV) virions in the nucleus of a koilocyte. HPV is an icosahedral non-enveloped virus w i t h a capsid diameter of 55 n m . Using molecular technology, the Digene Hybrid Capture II HPV DNA Test (Digene, Beltsville, Md) detects the DNA of high-risk h u m a n p a p i l l o m a v i r u s in cervical cells.The test was recently approved by the Food and Drug Administration. HPV Testing Women with abnormal Papanicolaou (Pap) smear results may not have to wait the traditional 6 months for a repeat Pap test and possible colposcopy procedure now that the Food and Drug Administration has approved a new test for human papillomavirus (HPV). The Hybrid Capture II HPV Test (Digene, Beltsville, Md) is a DNA-based technology for the detection of HPV, a family of viruses that can produce genetic damage in cells of the cervix. After HPV enters the body, some strains—including HPV-16 and HPV-18—can, over time, trigger cancers of the cervix. Researchers believe HPV causes more than 90% of cervical cancer cases. HPV testing for women with abnormal Pap results accurately identifies women with severe, precancerous cell growth in their cervix. Only 15% to 20% of women with mildly abnormal Pap smears actually have underlying disease requiring treatment, however. Today, these women are subjected to invasive medical procedures and repeat Pap tests even though they may not be at risk for cervical cancer. HPV testing can identify which women are truly at risk, eliminating the need for repeat Pap tests and colposcopy procedures for those who are not high risk. With the HPV test, a swab is used to take a sample specimen from a woman's cervix. This sample can be taken when a Pap smear specimen is taken. The specimen is placed in a transport tube and sent to a laboratory. The HPV test uses molecular technology to detect the DNA of high-risk HPV in cervical cells. The test detects DNA from 13 different types of HPV virus that are most commonly associated with cervical cancer. Cervical cancer is completely treatable if detected early. Nearly 5,000 people die from the disease in the United States each year. Vaccine for Cervical Cancer Several different treatment vaccines for cervical cancer are under development at centers around the world. The National Cancer Institute (NCI) is planning an institute-sponsored, multicenter trial to test a vaccine as adjuvant treatment after radiation therapy or surgery. At least six preventive vaccines are also in development worldwide. One of these, developed at NCI, has succeeded in stimulating the body to produce antibodies to HPV, according to early data. NCI is testing a viruslike particle from HPV-16 in a phase I/II study in people at The Johns Hopkins University, Baltimore. Preliminary results indicate that a low-dose injection of the vaccine induces high levels of protective antibodies against HPV. If further follow-up and analysis confirm these findings, the vaccine will be tested in larger numbers of women, including those at risk for developing HPV infection.© Reported by Terri Yablomky Stat. 704 LABORATORY MEDICINE VOLUME 30, NUMBER 11 NOVEMBER 1999