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Biomedical subjects

William C Miller

Publications and source records attributed to William C Miller.

At least 19 recordsLinked to original sources

Psychometric properties of the Activities-specific Balance Confidence Scale among individuals with a lower-limb amputation.

OBJECTIVE: To evaluate the internal consistency, test-retest reliability, and construct validity of the Activities-specific Balance Confidence (ABC) Scale among people who have a lower-limb amputation. DESIGN: Retest design. SETTING: A university-affiliated outpatient amputee clinic in Ontario. PARTICIPANTS: Two samples of individuals who have unilateral transtibial and transfemoral amputation. Sample 1 (n=54) was a consecutive and sample 2 (n=329) a convenience sample of all members of the clinic population. INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: Repeated application of the ABC Scale, a 16-item questionnaire that assesses confidence in performing various mobility-related tasks. Correlation to test hypothesized relationships between the ABC Scale and the 2-minute walk (2MWT) and the timed up-and-go (TUG) tests; and assessment of the ability of the ABC Scale to discriminate among groups based on amputation cause, amputation level, mobility device use, automatic stepping ability, wearing time, stair climbing ability, and walking distance. RESULTS: Test-retest reliability (intraclass correlation coefficient) of the ABC Scale was .91 (95% confidence interval [CI], .84-.95) with individual item test-retest coefficients ranging from .53 to .87. Internal consistency, measured by Cronbach alpha, was .95. Hypothesized associations with the 2MWT and TUG test were observed with correlations of .72 (95% CI, .56-.84) and -.70 (95% CI, -.82 to -.53), respectively. The ABC Scale discriminated between all groups except those based on amputation level. CONCLUSIONS: Balance confidence, as measured by the ABC Scale, is a construct that provides unique information potentially useful to clinicians who provide amputee rehabilitation. The ABC Scale is reliable, with strong support for validity. Study of the scale's responsiveness is recommended.

Accidental Falls↗

Bacterial vaginosis, vaginal fluid neutrophil defensins, and preterm birth.

OBJECTIVE: To examine the association between bacterial vaginosis, vaginal fluid neutrophil defensins, and preterm birth. METHODS: Vaginal fluid specimens were obtained at 24-29 weeks' gestation from 242 cases with preterm birth and 507 noncases sampled using a case-cohort study design. We tested for bacterial vaginosis by Gram staining and Nugent scores and assayed for neutrophil defensins by enzyme-linked immunosorbent assay. Bacterial vaginosis was studied as a categoric variable (negative, intermediate, and positive), whereas defensins were studied as a continuous, categoric (based on percentiles), and dichotomous measure (presence versus absence). Three gestational age cut points were used to define preterm birth. Modified Cox proportional hazard models were used to evaluate the associations between bacterial vaginosis, defensins, and degree (less than 32, less than 34, and less than 37 weeks) and type (premature rupture of membranes, preterm labor) of preterm birth. RESULTS: Elevated vaginal fluid neutrophil defensins were not associated with birth before 37 weeks. Compared with women who did not have measurable vaginal fluid defensins, women with higher defensin levels (0-2.8 micro g/mL, 2.8-8.2 micro g/mL, and greater than 8.2 micro g/mL) had a greater risk of delivering before 32 weeks. Hazard ratios adjusted for maternal race and vaginal bleeding during pregnancy and 95% confidence intervals for these defensin levels were 1.7 (0.4, 6.9), 2.4 (0.7, 7.9), and 3.1 (1.0, 9.8), respectively. Bacterial vaginosis status did not influence the association between defensins and preterm birth. CONCLUSION: Elevated concentrations of vaginal fluid neutrophil defensins at 24-29 weeks' gestation might predict preterm birth before 32 weeks.

Adult↗

Addition of treatment for trichomoniasis to syndromic management of urethritis in Malawi: a randomized clinical trial.

BACKGROUND: Male urethritis is generally treated syndromically, but failure of empirical treatment is common. GOAL: The study goal was to evaluate the addition of metronidazole to the syndromic management of urethritis in Malawi in a randomized clinical trial. STUDY DESIGN: Men with urethritis were randomized to receive either 2 g of metronidazole by mouth or placebo, in addition to standard care for urethritis (i.e., a single intramuscular dose of 240 mg gentamicin and 100 mg doxycycline twice daily for 7 days). The primary endpoints of the study included measurement of the effects of treatment on Trichomonas vaginalis, signs and symptoms of urethritis, and the concentration of HIV RNA in semen in dually infected subjects. RESULTS: The overall prevalence of T vaginalis was 17.3% (71/411), and treatment with metronidazole cleared 95% of culture-positive infections, compared with 54% clearance among men receiving placebo (P = 0.006). Prevalence of persistent urethritis was observed in approximately 16% of both groups at the end of 1 week (29/179 of those receiving metronidazole versus 29/187 in the placebo group; P = 0.86). For a subset of HIV-infected men with trichomoniasis, the seminal plasma HIV RNA concentration was higher than in a group of HIV-positive control subjects (median copies/mL:35,000 vs. 1800 P = 0.06) [correction]. CONCLUSION: In areas with a high prevalence of trichomoniasis, the addition of metronidazole to the syndromic management of male urethritis can eliminate infection with T vaginalis and may help to reduce the transmission of HIV. Such treatment should be strongly considered as part of empirical therapy for urethritis in men in Malawi and places where T vaginalis infection in men is common.

Administration, Oral↗

Validation of a urine-based PCR-enzyme-linked immunosorbent assay for use in clinical research settings to detect Trichomonas vaginalis in men.

Trichomonas vaginalis infection is highly prevalent worldwide and is associated with urethritis, prostatitis, and urethral strictures in men. However, the natural history and importance of T. vaginalis in men are poorly understood, in part because of difficulties in diagnosing infection. Traditional detection methods rely on culture and wet-mount microscopy, which can be insensitive and time consuming. Urethral swabs are commonly used to detect T. vaginalis in men, but discomfort from specimen collection is a barrier to large studies. One thousand two hundred twenty-five Malawian men attending sexually transmitted disease and dermatology clinics were enrolled in this cross-sectional study to validate detection by urine-based PCR-enzyme-linked immunosorbent assay (ELISA) with urine and urethral swab culture as the reference standard. This assay for detection of amplified T. vaginalis DNA in first-catch urine (< or = 30 ml) performed with a sensitivity of 92.7%, a specificity of 88.6%, and an adjusted specificity of 95.2% compared to culture of urethral swabs or urine sediment. For clinical research settings in which urethral swabs are not available and culture is not feasible, the urine-based PCR-ELISA may be useful for detection of trichomoniasis in men.

Adolescent↗

Assessment by meta-analysis of PCR for diagnosis of smear-negative pulmonary tuberculosis.

We conducted a meta-analysis to assess the performance of PCR for the diagnosis of smear-negative pulmonary tuberculosis (SPT) and to identify factors that account for differences in the diagnostic accuracy of different studies. Studies published before February 2002 were included if sensitivity and specificity of PCR in smear-negative respiratory or gastric-aspirate specimens could be calculated. Analysis was conducted by using summary receiver operating characteristics models. Sensitivity and specificity ranged from 9 to 100% and from 25 to 100%, respectively. Fewer than 40% of the 50 studies reported results by number of patients, reported clinical characteristics of patients, or used as a reference standard combined culture and clinical criteria. Studies that included bronchial specimens showed higher accuracy than studies that evaluated only sputum specimens or included gastric aspirates. Studies that did not report that tests were applied blindly showed higher accuracy than those reporting blind testing. Increased sensitivity due to the use of DNA purification methods was associated with decreased specificity. Studies published after 1995, using Amplicor or dUTP-UNG, were associated with an increase in specificity at the expense of lower sensitivity. We concluded that PCR is not consistently accurate enough to be routinely recommended for the diagnosis of SPT. However, PCR of bronchial specimens could be useful in highly suspicious SPT cases. Studies not reporting blind testing are likely to overestimate accuracy of PCR. Future evaluation of PCR accuracy should be conducted by patient and type of respiratory specimen, blindly, by using a reference standard that combines culture and clinical criteria and addresses the issue of how patient characteristics affect PCR accuracy.

Humans↗

Failure to return for HIV posttest counseling in an STD clinic population.

This study assessed the extent of and characteristics associated with FTR for HIV posttest counseling in persons undergoing an HIV test during their visit to a sexually transmitted disease (STD) clinic. The study population included all 101 newly diagnosed HIV-infected subjects and 411 matched HIV-uninfected subjects, identified over a 5-year period in a publicly funded STD clinic in the southeastern United States. Overall, 55% of subjects failed to return for their test results. HIV testing history, demographic characteristics, and STD diagnosis were associated with FTR. Of clients testing HIV-positive, 58% failed to return. A median of 12 days was required for disease intervention specialists (DIS) to locate HIV-infected subjects who failed to return. The proportion of persons returning for HIV antibody test results is low among patients tested while seeking STD services. Considerable time and effort is required to find and notify those subjects testing HIV-positive who fail to return. To maximize the potential benefit of counseling and testing, interventions need to be designed to target those at highest risk of not returning.

Adolescent↗

Who should be screened for postpartum anemia? An evaluation of current recommendations.

The authors evaluated the utility of selective screening criteria for postpartum anemia developed by the Centers for Disease Control and Prevention (CDC) versus criteria developed among low-income women using prevalence-based screening principles. Pregnant women in Raleigh, North Carolina, were followed up to the postpartum visit in 1997-1999 (n = 345). Prevalence of postpartum anemia was 19.1%. Independent risk markers, arrived at through multivariate logistic regression, were multiparity (odds ratio (OR) = 1.5, 95% confidence interval (CI): 0.8, 2.9), obesity (OR = 3.0, 95% CI: 1.6, 5.5), anemia at 24-29 weeks' gestation (OR = 2.3, 95% CI: 1.2, 4.4), anemia before delivery (OR = 3.4, 95% CI: 1.8, 6.7), and not exclusively breastfeeding (OR = 2.8, 95% CI: 1.0, 7.7). Risk scores were calculated by counting risk markers present. Likelihood ratios were determined for all possible risk scores of our algorithm and CDC's algorithm. Anemia screening decisions differed depending on clinic anemia prevalence. For example, if low test thresholds are assumed, when clinic prevalence is 10%, women with risk scores >3 on the authors' algorithm and >0 on CDC's algorithm should be screened. The authors' algorithm, in combination with prevalence information, can save clinics more money than CDC's current algorithm because a broader range of likelihood ratios was obtained, indicating a better ability to distinguish high- from low-risk women. However, if resources are available, universal screening should be considered in high-prevalence settings.

Adult↗

Spectrum bias or spectrum effect? Subgroup variation in diagnostic test evaluation.

Diagnostic tests must be evaluated in a clinically relevant population. However, test performance often varies across population subgroups. Spectrum bias, a term commonly used to describe this heterogeneity, is typically thought to occur when diagnostic test performance varies across patient subgroups and a study of that test's performance does not adequately represent all subgroups. Yet subgroup variation is not a bias if appropriate analyses are conducted. Failure to recognize and address heterogeneity will lead to estimates of test performance that are not generalizable to the relevant clinical populations. Heterogeneity can be addressed with relatively simple stratification procedures, limited primarily by the sample size and the precision of the estimates. This paper proposes the use of the term spectrum effect, rather than spectrum bias, and outlines strategies for using stratified sensitivity and specificity estimates, likelihood ratios, and receiver-operating characteristic curves. Investigators of diagnostic tests should consider the potential for spectrum effect seriously and should address heterogeneity in their analyses. Furthermore, clinicians should consider study samples carefully to determine whether results are generalizable to their specific patient population.

Adult↗

Untreated gonococcal and chlamydial infection in a probability sample of adults.

CONTEXT: The prevalence and distribution of gonococcal and chlamydial infections in the general population are poorly understood. Development of nucleic acid amplification tests, such as the ligase chain reaction assay, provides new opportunities to estimate the prevalence of untreated infections in the population. OBJECTIVE: To estimate the overall prevalence of untreated gonococcal and chlamydial infections and to describe patterns of infection within specific demographic subgroups of the young adult population in Baltimore, Md. DESIGN AND SETTING: Cross-sectional behavioral survey based on a probability sample of Baltimore households with collection of urine specimens between January 1997 and September 1998. PARTICIPANTS: A total of 728 adults aged 18 to 35 years completed the interview portion of the study, and 579 of these respondents also provided a urine specimen adequate for testing. MAIN OUTCOME MEASURE: Prevalence of untreated infection, as measured by the percentage of specimens testing positive for gonococcal and chlamydial infection by ligase chain reaction, weighted to reflect variations in probabilities of sample selection from the population. Alternate estimates of the prevalence of recent treated infection were derived from clinically diagnosed cases reported to the Baltimore City Health Department and by diagnoses reported by participants in the survey. RESULTS: An estimated 5.3% (SE, 1.4%) of the population aged 18 to 35 years has an untreated gonococcal infection, and 3.0% (SE, 0.8%) is estimated to have an untreated chlamydial infection. While 7.9% (SE, 1.6%) of the population is estimated to have either an untreated gonococcal or chlamydial infection, estimated prevalence is substantially higher among black women (15.0%; SE, 3.7%). Few participants with untreated infections reported dysuria or discharge during the 6 months preceding testing. The estimated number of untreated gonococcal infections in the population (9241; SE, 2441) substantially exceeds both the number of such infections diagnosed among Baltimore adults aged 18 to 35 years and reported to the Baltimore City Health Department during 1998 (4566), and the estimated number of diagnoses derived using participants' reports for the 12 months prior to the survey (4708 [SE, 1918] to 5231 [SE, 2092]). The estimated number of untreated chlamydial infections (5231; SE, 1395) is also greater than the number of cases reported to the health department in 1998 (3664) but is slightly less than the estimated number of diagnoses derived using participants' reports of chlamydial infections diagnosed during the 12 months prior to the survey (5580 [SE, 1918] to 6975 [SE, 2441]). CONCLUSION: In 1997-1998, the estimated number of undiagnosed gonococcal and chlamydial infections prevalent in the population of Baltimore adults aged 18 to 35 years approached or exceeded the number of infections that were diagnosed and treated annually.

Adult↗

Goal attainment scaling in the rehabilitation of patients with lower-extremity amputations: a pilot study.

OBJECTIVE: To assess the interrater reliability, construct validity, and responsiveness of Goal Attainment Scaling (GAS) among patients who have had lower-extremity amputations. DESIGN: Pilot study comparing GAS with 2 functional measures with established reliability, validity, and responsiveness values. SETTING: Regional amputee program in southwestern Ontario. PARTICIPANTS: Ten patients (6 women, 4 men; mean age +/- standard deviation, 72.3+/-10.7 y) with unilateral lower-extremity amputations who were consecutively admitted to a regional amputee program. The ratio of transtibial to transfemoral amputations was 6:4. INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: Subjects were assessed by using GAS, the Barthel Index, and the Locomotor Capabilities Index (LCI) of the Prosthetic Profile of the Amputee. RESULTS: The interrater reliability of GAS was r=.67, and 63% of goals developed were identified independently by both investigators. The construct validity between GAS and the Barthel Index and the LCI was r=.44 and r=.35, respectively. GAS was more responsive than both the Barthel Index and the LCI, as indicated by the calculation of effect sizes and relative efficiencies. CONCLUSION: This pilot study suggests that GAS is a promising outcome measure for the rehabilitation of patients with lower-extremity amputations.

Activities of Daily Living↗

The status of outcome measurement in amputee rehabilitation in Canada.

OBJECTIVE: To describe how centers of amputee care in Canada evaluate program and patient outcome. DESIGN: National postal survey. SETTING: Amputee rehabilitation centers across Canada. PARTICIPANTS: Forty-four medical directors. INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: Type and frequency of use of program evaluation, formal and informal patient outcome measures data, and how collected data was used. RESULTS: Forty-four clinics responded (response rate, 72%). Program evaluation was conducted in some format by at least 18 centers. Twelve centers conducted regular chart audits, whereas 15 indicated their intention to submit an annual program report. The majority of centers collected information on patient outcomes; however, most used informal measures. Thirty-nine clinics used part or all of a checklist of informal measures of skill attainment. The most common standardized outcome measure was the FIM instrument (18 centers). Eighteen centers used a form of mobility performance such as walking speed or timed walk test. Eighteen of 39 centers that responded to this section did not collect any formal patient outcome measures. The most frequently used outcome measures were the nonstandardized informal measures of independence. CONCLUSION: A diverse selection of program- and patient-related outcome measures were used by Canadian amputee centers. Outcomes could be better compared if all centers used similar outcome measures.

Amputees↗

Effect of fenfluramine-derivative diet pills on cardiac valves: a meta-analysis of observational studies.

BACKGROUND: Fenfluramine-derivative diet pills were withdrawn from the market in 1997 because of an association with valvular regurgitation, but subsequent estimates of the prevalence of this condition have varied widely. We systematically reviewed evidence regarding the prevalence of valvular disease after fenfluramine exposure. METHODS: We searched multiple databases with multiple search terms. Conference proceedings from 1997 onward were searched by index. Authors of eligible studies were contacted to identify unpublished works. Selection criteria were liberally determined. Ten of the identified 11 articles met these criteria. Reviewers assessed the studies' methodologic quality by use of a standard form to evaluate selection, attrition, performance, and detection bias. The studies were analyzed in 2 groups on the basis of length of exposure (<90 days or >90 days). The Mantel-Haenszel method was used to summarize data. Quantitative and qualitative tests for heterogeneity were performed. Tests for publication bias were also done. RESULTS: Tests for heterogeneity were nonsignificant after removing 1 outlier trial. The pooled prevalence of valvular regurgitation meeting Food and Drug Administration criteria (at least mild aortic regurgitation or at least moderate mitral regurgitation) among patients treated for >90 days was 12.0% compared with 5.9% for the unexposed group (prevalence odds ratio 2.2, 95% CI 1.7-2.7). The combined analyses also identified a small but statistically significant increase in mitral regurgitation not previously identified by individual studies (exposed 3.5%, unexposed 1.8%, prevalence odds ratio 1.6, 95% CI 1.05-2.3). Among patients exposed for <90 days, a trend toward more regurgitation was not statistically significant by either combined Food and Drug Administration criteria (exposed 6.8%, unexposed 5.8%, prevalence odds ratio 1.4, 95% CI 0.8-2.4) or by individual valve. CONCLUSIONS: These data indicate that fenfluramine-associated valvular regurgitation is less common than initially reported, but still present in 1 of 8 patients treated for >90 days.

Aortic Valve Insufficiency↗

Hospital primary cesarean delivery rates and the risk of poor neonatal outcomes.

OBJECTIVE: The purpose of this study was to determine whether risk-adjusted hospital primary cesarean delivery rates are associated with poor neonatal outcomes. STUDY DESIGN: The Washington State Birth Events Records for 1995 and 1996 were used. Predicted primary cesarean delivery rates were calculated for each hospital. Women were divided by whether the hospital had an actual primary cesarean delivery rate below, within, or greater than the predicted CI. Asphyxia (a lack of oxygen that leads to organ damage) was used as a marker of poor neonatal outcome. Risk of neonatal asphyxia was compared for each of the 3 cesarean rating groups. RESULTS: The risk for asphyxia among infants who were born to women who delivered at hospitals that had more, within, or fewer cesarean deliveries than predicted were 0.58%, 0.17%, and 0.33%, respectively (P <.0001). CONCLUSION: Infants born to women who delivered at hospitals that had more than or fewer than the predicted number of primary cesarean deliveries experienced a greater risk of neonatal asphyxia.

Adolescent↗

Bacterial vaginosis and vaginal fluid defensins during pregnancy.

OBJECTIVE: The purpose of this study was to examine the association between Gram stain findings of vaginal fluid and the concentration of vaginal fluid neutrophil defensins. STUDY DESIGN: Vaginal fluid specimens obtained from 749 women at 24 to 29 weeks of gestation were tested for bacterial vaginosis and assayed for neutrophil defensins. Bacterial vaginosis was studied as a categoric variable (negative, intermediate, and positive), whereas defensins were examined as a continuous measure and dichotomized on the basis of presence versus absence and at the 90th percentile. Multiple linear and logistic regression models were used to assess the relationship between bacterial vaginosis and defensins. RESULTS: Women with intermediate bacterial vaginosis were more likely to have elevated vaginal fluid neutrophil defensins (>90th percentile) than women with normal vaginal flora (adjusted odds ratio, 2.3; 95% CI, 1.3, 4.2), whereas women with frank bacterial vaginosis were not (adjusted odds ratio, 1.3; 95% CI, 0.7, 2.6). Among women with any detectable defensin (69.5% of the study population), intermediate bacterial vaginosis was associated positively with defensin concentrations in multiple linear regression models (P =.007). Women with intermediate and frank bacterial vaginosis had 5.9 microg/mL and 2.2 microg/mL higher defensin concentrations, respectively, than women who did not have bacterial vaginosis. The presence of leukocytes in vaginal fluids was associated positively with defensin concentrations (P <.0001). CONCLUSION: Changes in vaginal microflora during mid pregnancy are associated with an increased concentration of vaginal fluid neutrophil defensins.

Adolescent↗

Infections diagnosed in the first year after pediatric stem cell transplantation.

BACKGROUND: Cumulative incidence of infections in the first year posttransplantation in adult patients has been well-described. Such description is less than complete for pediatric stem cell transplantation (SCT) patients. Further among those patients who have been infected, analysis of risk factors for infection has not been well-described for a large cohort of pediatric SCT patients. METHODS: We conducted a retrospective cohort study of infections in the first year after SCT at Duke University Medical Center. We recorded all infections in the first year after transplantation. We determined incidences for 6 categories of infection: gram-negative rods; gram-positive cocci; yeast species; Aspergillus sp.; adenovirus; and cytomegalovirus. We determined incidences based on type of transplant and days post transplantation. We also completed bivariable and multivariable analysis of risk factors [neutropenia, graft vs. host disease (GVHD) and GVHD treatment] for infection type among those children who were infected. RESULTS: We evaluated 510 transplants in 485 children. There were 584 infections in the first year after transplantation. During the first 30 days posttransplantation, type of transplantation did not predict incidence of infection or type of infection. After 30 days children who received unrelated cord blood transplant and matched unrelated donor transplant were at much higher risk of infection than were patients who received autologous, matched sibling or haploidentical transplant (P < 0.001). Patients who received unrelated cord blood or matched unrelated donor transplantation were at higher risk of aspergillosis (P = 0.002), candidiasis (P = 0.005) and adenovirus (P < 0.0001) but not cytomegalovirus (P = 0.18). In analysis of risk factors among those infected, patients with aspergillosis were more likely to have severe GVHD: multivariable 1 year risk ratio, 7.5; 95% confidence interval, 3.0, 18.4. Neutropenia was more strongly associated with gram-negative rod infection than any other type of infection. CONCLUSIONS: The incidence of infection immediately after transplantation did not differ significantly by type of transplant in this pediatric population. Type of transplant predicted increased incidence of infection 30 days posttransplantation and increased incidence of infection with several organisms traditionally associated with a high mortality rate in the transplant population.

Adolescent↗

NAAT-identified and self-reported gonorrhea and chlamydial infections: different at-risk population subgroups?

BACKGROUND: Information on the characteristics and behaviors of persons at high risk for gonorrhea and chlamydial infection has typically been derived from studies of sexually transmitted disease (STD) clinic populations. The Baltimore STD and Behavior Survey (BSBS) used urine-based nucleic acid amplification testing (NAAT) to assess the prevalence and behavioral correlates of gonorrhea and chlamydial infection in a population-based cross-sectional survey of adults in Baltimore, Maryland. GOAL: The goal of this study was to examine the demographic characteristics and behavioral markers of gonorrhea and chlamydial infection as reported by adults with a self-reported history of gonorrhea and chlamydial infection and to compare these to the characteristics and behaviors of individuals with current NAAT-identified gonorrhea and/or chlamydial infection. STUDY DESIGN: A probability sample of adults aged 18 to 35 years residing in Baltimore was evaluated with collection of urine specimens and administration of a health and behavior survey. Data and specimens were collected between January 1997 and September 1998. RESULTS: Respondents with NAAT-detected gonorrhea and/or chlamydial infection (7.9%) did not report a history of high-risk behaviors or more recent occurrences of those behaviors, and the majority were asymptomatic. However, adults in our study who self-reported a history of infection (26.0%) were more likely than those with no history of infection to report multiple partners, paid sex, partners with prior STDs, and STD symptoms-a pattern consistent with findings described in previous clinic-based reports. CONCLUSION: The risk profile generated from studies of clinic populations, with a focus on symptomatic disease, may not characterize the broader population with current, untreated, largely asymptomatic infection.

Adolescent↗

Development and validation of a PCR-based enzyme-linked immunosorbent assay with urine for use in clinical research settings to detect Trichomonas vaginalis in women.

Trichomonas vaginalis infection is highly prevalent worldwide and is associated with poor birth outcomes and enhanced human immunodeficiency virus transmission. Traditional detection methods rely on microscopic examination of vaginal specimens (wet mount) and culture, which can be insensitive and time-consuming. More than 3,000 women attending two sexually transmitted disease clinics were enrolled in this cross-sectional study to evaluate urine-based PCR for detection of T. vaginalis using a combined reference standard of wet mount and culture from vaginal swab. The prevalence of trichomoniasis in the population was 16.7% (502 of 3,009 women) using the reference standard. PCR with urine combined with agarose gel-based detection was 66.9% sensitive and 98.3% specific compared to the reference standard. Detection of PCR products using an unlabeled enzyme-linked immunosorbent assay (ELISA) improved the sensitivity to 86.4%, but specificity fell to 86.1%. Using a digoxigenin-labeled ELISA for detection of amplified T. vaginalis DNA from urine, the sensitivity and specificity of the PCR improved to 90.8 and 93.4%, respectively, compared to wet mount or culture from vaginal swabs. For clinical research settings in which vaginal specimens are not available and culture conditions are not feasible, urine-based PCR-ELISA may be useful for the detection of trichomoniasis in women.

Adolescent↗