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The median age of the HR-HPV–positive patients was approximately 11 years younger than the HPV-negative group, and pregnant patients were also more apt to be HPV positive. In cases diagnosed as ASCUS, there are certain cytologic features and patient types that are more likely to be associated with HR-HPV positivity. In 2001, the ALTS trial demonstrated the effectiveness of high-risk human papillomavirus (HR- HPV) testing in the triage of patients with a cytologic diagnosis of atypical squamous cells of undetermined significance (ASCUS).
Certain behavioral, clinical and socioeconomic risk factors have been identified in association with HR-HPV infection and the development of cervical neoplasia.
The ALTS trial showed that the cytologic features associated with LSIL had a high correlation with HR-HPV positivity (83%).
The correlation between HPV and the development of cervical neoplasia has been well established. Several studies have investigated additional methods of resolving ASCUS, but none have been met with widespread acceptance. Certain nonclassical cytomorphologic characteristics are associated with positive HR-HPV–DNA status. Shew ML, Fortenberry JD, Tu W, Juliar BE, Batteiger BE, Qadadri B, Brown DR: Association of condom use, sexual behaviors, and sexually transmitted infections with the duration of genital human papillomaviral infection among adolescent women. Smith EM, Johnson SR, Jiang D, Zaleski S, Lynch CF, Brundage S, Anderson RD, Turek LP: The association between pregnancy and human papilloma virus prevalence. Lu DW, Pirog EC, Zhu X, Wang HL, Pinto KR: Prevalence and typing of HPV DNA in atypical squamous cells in pregnant women. Schneider A, Meinhardt G, De-Villiers EM, Gissmann L: Sensitivity of the cytologic diagnosis of cervical condyloma in comparison with HPV-DNA hybridization studies. Bollmann M, Bánkfalvi A, Trosic A, Speich N, Schmitt C, Bollmann R: Can we detect cervical human papillomavirus (HPV) infection by cytomorphology alone?
Zhao FH, Forman MR, Belinson J, Shen YH, Graubard BI, Patel AC, Rong SD, Pretorius RG, Qiao YL: Risk factors for HPV infection and cervical cancer among unscreened women in a high-risk rural area of China. Viikki M, Pukkala E, Nieminen P, Hakama M: Gynaecological infections as risk determinants of subsequent cervical neoplasia. Saccomanno G, Saunders RP, Ellis H, Archer VE, Wood BG, Beckler PA: Concentrations of carcinoma or atypical cells in sputum. Presented as a poster at the 53rd Annual Meeting of the American Society of Cytopathology, San Diego, California, November 6, 2005. Financial Disclosure: The authors have no connection to any companies or products mentioned in this article.
Most people “shed” virus asymptomatically, which actually accounts for the majority (~70%) of transmission events.5 HSV-2 shedding can be readily monitored by measuring the amount of viral DNA from genital swabs using a validated PCR assay, such as the widely-used assay developed at the University of Washington. A high unmet medical need exists for treatments that reduce HSV-2 genital herpes recurrences and viral transmission, because no licensed therapeutic vaccine exists for this indication.
Therapeutic vaccines represent a new treatment modality against herpes viruses, especially HSV-2. The plasmid DNA vaccine technology developed at Vical is an attractive vaccine strategy against HSV-2 because induction of robust T-cell responses is a hallmark of this platform.9 Furthermore, plasmid DNA vaccines are noninfectious and can be repeatedly used for vaccine boosting without generating antivector responses (as frequently occur with adenovirus, poxvirus, and other vaccine vectors).
Several considerations were of importance in the design and testing of Vical's HSV-2 therapeutic vaccine candidate.
The use of Vaxfectin® as an adjuvant to potentiate the performance of the HSV-2-encoding plasmids is a critical component of Vical’s vaccine. The trial consists of a dose escalation component to assess the safety of ? dose, ? dose, and a full dose of vaccines in a small number of subjects prior to dosing additional subjects at the full dose. Each subject in the efficacy cohort will perform daily swabbing to measure HSV shedding rates both before vaccination and again after vaccination. With approximately 60 subjects per each vaccine group, the study is powered to show at least a 30% decrease in the shedding rate. 4 Looker KJ, Garnett GP, Schmid GP.An estimate of the global prevalence and incidence of herpes simplex virus type 2 infection. STD testing for herpes measures the amount of antibodies present in the blood for herpes simplex virus 1 and 2. STD testing for chlamydia is ideally performed using a nucleic acid amplification (NAA) test on a urine sample. STD testing for gonorrhoeae is performed using the same nucleic acid amplification urine test used to detect chlamydia.
STD testing for HIV can be done using a few different blood tests depending upon your needs and concerns. The material on this page is educational and does not constitute medical advice, diagnosis or treatment. I teach Business full time at the Nova Scotia Community College and part time at Dalhousie, Mount St. The HSV 2 blood test is used to determine if there is a type 2 genital herpes infection in specific situations: if someone has genital symptoms that could be related to herpes or if someone has had a sexual partner who has symptomatic herpes at the time. If someone wants to know if they have genital herpes because of their sexual history, then the HSV 2 blood test can provide conclusive information about whether or not they have been infected.
There may also be flu-like symptoms experienced with the first outbreak of symptoms after the initial infection. Although HSV 2 is the most common infection that causes genital herpes, the HSV 1 virus can also cause the same signs and symptoms. If an individual with an active HSV 1 infection of the mouth performs oral sex on their partner, then this can create an active genital herpes infection. The HSV 2 blood test has also been known to create false positive results from time to time. Sometimes genital herpes is mistaken for other health conditions, such as a bacterial, bladder, or yeast infection. There is no cure for genital herpes, but there are treatments available that can help to lessen the symptoms that are experienced. Fisher’s Exact test (2-tailed) was used to calculate the exact probability of obtaining results by chance. Atypical cells in greater numbers and in groups as opposed to single cells correlated more often with HR-HPV–positive individuals.
Although certain criteria have been established for making this diagnosis, this determination remains very subjective and hence problematic.
Additionally, this study assessed the utility of retrospective HPV-DNA testing on Pap test specimens as a method of evaluating individual and laboratory ASCUS reporting rates and performance improvement. Cytology slides were retrospectively reviewed by 5 cytotechnologists (CTs) as part of a site-specific quality improvement indicator in the laboratory, and an information grid was completed on each case. Seventy-three cases (49%) were HR-HPV positive, 75 (51%) were negative; 2 were equivocal and excluded from the study. The average age of patients with a positive HR-HPV result was 28 years and of those with a negative result was 39 years. The significant cytoplasmic changes in the HR-HPV–positive cases were koilocytelike changes and parakeratosis, as shown in Figures 5 and 6, respectively.
Some evidence exists that atypical cells deserve even closer scrutiny in pregnancy as the risk of HPV infection may actually be increased. ASCUS cases were positive for HR-HPV approximately 50% of the time.1 Various studies, including ours, suggest that it may be possible to further define the cytologic characteristics found in ASCUS that are most strongly associated with HR-HPV.

A study by Schneider et al9 showed that the most significant correlation was with mild koilocytosis, mild hyperkeratosis, hyperchromatic nuclei, binucleation or multinucleation, and cleared cytoplasm. Many studies have suggested that other infections, especially those involving the female reproductive tract, are also involved in the development of cervical neoplasia.
A study utilizing this method found an association with increased DNA content and HR-DNA–positive ASCUS having similar biologic features as HSIL. These findings demonstrate acceptable individual and laboratory reporting rates and show that HR-HPV DNA testing can serve as a reliable tool for retrospective assessment of laboratory and individual reporting practices.
In particular, koilocytelike changes, parakeratosis and increased numbers of cells with these and other mildly atypical findings are most significant. Diagnostic value of non-classic cytological signs of HPV effect in minimally abnormal Pap tests. Steinman was Fellow in Cytopathology, and currently is Staff Pathologist, Department of Laboratory Medicine, UPMC Mercy Hospital, Pittsburgh, Pennsylvania.
Mody is Medical Director of Cytopathology, The Methodist Hospital, and Professor, Department of Pathology and Laboratory Medicine, Weill Medical College of Cornell University, Houston, Texas.
DNA vaccines offer the potential benefits of live-attenuated virus vaccines in stimulating T-cell responses but do not inherently possess the attendant safety concerns of live virus vaccines.
From the program’s inception, key collaborations were established with the laboratories of leading HSV experts Dr.
This trial is designed to be a proof-of-concept study that would capitalize on their lab’s expertise in conducting viral shedding studies that have contributed towards understanding the natural course of HSV-2 infection in humans. All enrolled subjects must be HSV-2 seropositive, as established using the University of Washington’s Western blot assay.
Regardless of dose, all subjects will receive the vaccine or a placebo on days 0, 28, and 56. Importantly, sampling periods of 60 days for swab collections were designed for this study to generate robust shedding data to compare the pre-vaccination to the post-vaccination periods.
Seroprevalence of Herpes Simplex Virus Type 2 Among Persons Aged 14–49 Years — United States, 2005–2008. Genital shedding of herpes simplex virus among symptomatic and asymptomatic persons with HSV-2 infection. Mucosal host immune response predicts the severity and duration of herpes simplex virus-2 genital tract shedding episodes. A novel therapeutic cytomegalovirus DNA vaccine in allogeneic haemopoietic stem-cell transplantation: a randomised, double-blind, placebo-controlled, phase 2 trial. Vaxfectin-adjuvanted plasmid DNA vaccine improves protection in a murine model of genital herpes infection.
Phase 1 clinical trials of the safety and immunogenicity of adjuvanted plasmid DNA vaccines encoding influenza A virus H5 hemagglutinin. A Vaxfectin-adjuvanted HSV-2 plasmid DNA vaccine is effective for prophylactic and therapeutic use in the guinea pig model of genital herpes. Vical assumes no responsibility for content not provided by Vical, or for practices or standards of any non-Vical websites. Most of the time HSV 1 presents itself as an active infection by the presence of cold sores or fever blisters around the mouth.
If this happens, then the HSV 2 blood test could be negative because a different herpes virus has caused the bothersome symptoms. If this blood test is positive, but you do not have any known genital herpes outbreaks, did not have a positive culture test, and did not have a positive PCR result, then an immunoblot test may be necessary to confirm a diagnosis. If there are persistent symptoms that do not go away or are accompanied by tingling feelings around the genital region, then the HSV 2 blood test may help to provide confirmation of the health issue. Antivral medications can help with discomfort and some people may benefit from taking a daily medication that suppresses the virus.
Once a person tests positive, however, then this blood test will always be positive because the antibodies never go away.
Koilocytelike changes and parakeratosis were more frequently associated with HR-HPV, but the presence of Trichomonas was usually a negative predictor.
Monitoring individual and laboratory ASCUS rates with HR-HPV positivity can be an important quality improvement indicator.
First, the many variations in cellular abnormalities associated with ASCUS allows great differences in opinion between pathologists. In the negative cases, the significant changes were cell enlargement (both nuclear and cytoplasmic) and small halos (Figure 4). However, at the time of interpretation, the background information is limited to the patient age, menstrual status, significant past gynecologic history and hormonal status. Smith et al5 compared 69 pregnant and 54 nonpregnant age-frequency–matched women for the presence of HR-HPV DNA.
In our study, the most significant cytologic characteristics associated with HR-HPV–positive ASCUS were the presence of parakeratosis and koilocytelike changes (Figures 5 and 6). This study also stressed that the total number of features was an important factor in distinguishing HPV-positive cases from HPV-negative cases. Samoff et al12 reported a relationship with HPV persistence and Chlamydia trachomatis infection, but not with Neisseria gonorrhoeae or Trichomonas vaginalis. Additional disposable items would be required such as glass slides, test tubes, disposable pipettes, fixative vials and necessary reagents.
The benefit of this particular method is in sorting HR-positive cases that may progress to invasive carcinoma from those that may resolve. Based on the deviation from the laboratory mean, certain thresholds could be set up and the rates monitored.
Our study suggests that screening for these characteristics in the initial cytologic examination coupled with patient profiling can help select those cases needing a further workup. Therefore, an unmet need remains for additional treatment options such as a therapeutic HSV-2 vaccine.
T cells induced to recognize important herpes antigens following therapeutic vaccination are likely to be key participants as antiviral mediators. Vical has already established the precedent of a therapeutic DNA vaccine against a related herpes virus, cytomegalovirus (CMV). In addition, these subjects are required to have a history of symptomatic genital herpes with 2 to 9 lesion recurrences per year; higher herpes shedding rates are observed in symptomatic compared to asymptomatic subjects6 and also permit the opportunity to explore potential reductions in lesions after vaccination.
The trial is currently enrolling subjects who will be receiving the full doses of vaccine or placebo to assess the effectiveness of the vaccines for the primary endpoint of the change in HSV-2 shedding rate from baseline. Essentially the amount of viral shedding will be measured for each subject at baseline (pre-vaccination) and then again after the intervention (completion of 3 vaccination series, the post-vaccination period). Vical expects the trial to be fully enrolled in the fourth quarter of 2014, and topline data are projected to be available in mid-2015. Health screening lab tests may or may not alert you and your doctor to serious medical conditions and are not intended to be a substitute for a physician's examination. It may also be recommend for individuals who have multiple sexual partners within a short period of time. Once someone tests positive for this virus, then they will always test positive for herpes. It is also useful to confirm a herpes diagnosis if someone is suffering from the symptoms of an active infection.

If there are active symptoms, however, they will typically involve the presence of a small blister that will eventually break and ooze fluid. The herpes virus can also make people 2x more susceptible to other STD infections, particularly HIV.
These will last for about 10-14 days in most individuals and created crusted sores in the corner of the mouth that can make it very painful to eat. If the immunoblot test is given, a test result that is higher than 1.1 is generally considered to be a strong indication of the presence of herpes. It can be present on any skin that remains uncovered while having intercourse and then spread. Second, the current criteria do not distinguish cellular abnormalities that are more suggestive of HPV infection from those that are not. Seven different PTs signed out these cases, and the HR-HPV positivity rates of 6 were within 10% of the laboratory average HR-HPV rate, with 1 who was 20% higher. The focus of our study was to identify the cytologic characteristics and pertinent background information available at the time of interpretation, which would maximize the screening power of the Pap test in the most cost-effective and time-efficient manner.
Additionally, many atypical cells, whether singly or in groups, and increased numbers of atypical groups of cells were also associated with increased incidence of HR-HPV (Table I). Another study, by Zhao et al,13 found no relationship between trichomoniasis and cervical neoplasia but did find a possible correlation with tuberculosis infection.
While this technique is reportedly successful at sorting 60% of cases diagnosed as ASCUS into either LSIL or HSIL, it does involve additional cost, time and manpower. This technique may be useful after the diagnosis of HR DNA–positive ASCUS has been rendered, but with the additional cost incurred for this procedure, it is less desirable as a universal screening option.
Individuals with significant departure from the laboratory mean or laboratories with significant departure from national reporting rates could trigger closer examination of their interpretive and reporting rates.
Obtaining more patient information, such as smoking history, may be additional data to be used for future studies.
Larry Corey at the University of Washington to leverage their experience in selecting key HSV-2 antigens and in conducting numerous murine studies under a multi-year NIH grant. Because the virus is not believed to spread unless there is symptomatic genital herpes present during sexual intercourse, however, routine testing is generally considered unnecessary unless the risk factors are in place. This is because small, unnoticeable cracks in the skin can occur around the genital region to allow the virus to have access to the body. Speak to a medical provider today about your risk factors, take preventative measures to prevent transmission during sex, and avoid sexual contact with active symptoms.
And finally, although reflex HR-HPV DNA testing is the preferred management option in the diagnosis of ASCUS, it does add an extra cost for the patient.
The grid consisted of patient information: age, pregnancy status as available on the requisition, cell morphology, cell patterns, original cytologic diagnosis by pathologist (PT) and CT, and quality control review diagnosis. The average age of the pregnant patients was 31 years, with an age range of 16–35 years. Therefore, we used patient age and pregnancy status in our patient profiles because this information could be obtained from the specimen requisition form as it is a required field. Although increased numbers of atypical cells correlated with an increased incidence of HR-HPV infection, the converse did not prove to be true. In contrast to these findings, a longitudinal cohort study performed by Viikki et al14 involving several different infectious agents showed that both T vaginalis and Herpes simplex were possible additional predictors of cervical neoplasia. No information is given concerning cost-effectiveness as compared to reflex HR-HPV DNA testing. Our study also affirms that HR-HPV DNA testing results can be used for retrospective analysis of laboratory and individual reporting practices and could be incorporated into the laboratory quality improvement program.
If the criteria used in the initial diagnosis of ASCUS could be better defined and made more specific, the Pap test might be a more powerful tool. For the 5 CTs who screened these cases, the original laboratory statistics for 4 were within 10% of the laboratory average, with the exception of 1 CT, who was 20% lower on the positive HR-HPV rate. These findings suggest that hormonal or other effects of pregnancy may be associated with an increased risk of HPV infection. A study by Cecchini et al10 evaluated these same nonclassical findings and also found a significant association with HPV infections.
Surprisingly, our study not only showed a lack of correlation but also a lower incidence of trichomoniasis in the HPV-positive group as compared with the HPV-negative group. Nuclear enlargement was defined as a nucleus 2–3 times the size of an intermediate cell nucleus. The review done by CTs as part of this project would have upgraded 32% of the cases to low grade squamous intraepithelial lesions (LSIL) or ASC-H (ASC, cannot rule out HSIL) and downgraded 24% to NILM (negative for intraepithelial lesion or malignancy).
In our study, the 25 pregnant patients (16%) were found to have a higher percentage of positive HR-HPV results than the other women in the study (75% and 25%, respectively, Table I). This suggests that while increased numbers of atypical cells or groups of cells may increase suspicion for HR-HPV infection, fewer numbers of cells are not a reliable negative indicator. In summary, the body of evidence for the correlation of specific infectious agents, particularly T vaginalis, and the development of cervical neoplasia is inconclusive at this point. Food and Drug Administration–approved method of processing cervical cytology specimens. Koilocytelike changes were defined as changes in cells that had some cytoplasmic and nuclear features suggestive of koilocytes but were qualitatively short of a diagnosis of koilocyte. Finally, 7 cases sent for HR-HPV testing were from the negative quality control rescreens as mandated under CLIA ’88. Hyperchromasia and nuclear enlargement were nonspecific findings in our study, while cells that demonstrated both nuclear and cytoplasmic enlargement were most often associated with HPV-negative cases. They may represent an actual increase in infection, but the possibility that this is an age-related finding cannot be dismissed.
Fishers’s Exact test (2-tailed) was used to calculate the exact probability of obtaining results by chance. Our study differed from these other studies in that we did not separate cytomorphologic characteristics according to HR vs.
However, even in this study, the pregnant population had a 4.8% higher HPV-positive rate, but whether this increase is significant is not known.
We also evaluated total number of cells with changes rather than total number of features present. Subsequent reporting rates and HR-HPV positivity rates continue to be monitored as part of the laboratory’s quality improvement program. In contrast to the Bollmann study, we did not find that fewer cells or minimally abnormal Pap tests were reliable in ruling out a case for further triage. Conclusive results is currently several fda-approved, gg-based blood test gynocologist appointment weeks.

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