[show abstract][hide abstract] ABSTRACT: Abstract. Background: Clinicians and developers identify sensitivity as an important quality in a point-of-care test (POCT) for sexually transmissible infections (STIs). Little information exists regarding what patients want for STI POCTs. Methods: A qualitative study, encompassing five focus groups among attendees of STI and adolescent health centres in Baltimore, Maryland, and Cincinnati, Ohio, were conducted between March 2008 and April 2009. Discussion topics included advantages and disadvantages of having a POCT, perceived barriers to using POCTs in the clinic setting and at home, priorities for the development of new POCTs for STIs, and envisioned characteristics of an ideal POCT. All discussions were recorded and transcribed. A qualitative content analysis was performed to examine frequencies or patterns of recurring codes, which were regrouped and indexed to identify salient themes. Results: Patients attending STI and adolescent outpatient clinics are in favour of diagnostic tests that are rapid, easy to read and simple to use. Home testing
options for POCTs were acceptable and provided better confidentiality, privacy and convenience, but clinic-based POCTs were also acceptable because they offer definitive results and ensure immediate treatment. Barriers to home POCTs centred on cost and the ability to read and perform the test correctly at home. Opinions did not differ by patient ethnicity, except that Hispanic participants questioned the reliability of home test results, wanted high sensitivity and desired bilingual instructions. Conclusions: Patients attending STI and adolescent medical centres are in favour of STI POCTs if they are affordable, rapid, easy to read and simple to use.
[show abstract][hide abstract] ABSTRACT: Unintended pregnancy rates are high in the United States. It is important to know whether improving males' access to emergency contraceptive pills may help prevent unintended pregnancy, especially in cases of -condom failure.
A search of the PubMed, PsycINFO and Cumulative Index of Nursing and Allied Health Literature databases was conducted to identify studies published from January 1980 to April 2011 concerning males and emergency contraception. Forty-three studies met the specified criteria and examined relevant knowledge, attitudes, beliefs, intentions or behaviors, from the perspectives of males, clinicians or pharmacists.
The proportion of males who were familiar with emergency contraception ranged from 38% among teenagers to 65-100% among adults. Small proportions reported that they and their partner had used or discussed using emergency contraceptive pills (13-30%) or that they themselves had ever purchased them (11%). Most providers (77-85%) reported general knowledge about emergency contraceptives, but the proportions who knew the time frame within which the pills can be prescribed were smaller (28-63%). Most males approved of emergency contraceptive use following contraceptive failure (74-82%) or unprotected sex (59-65%), or in cases of rape (85-91%), but both pharmacists and college students reported concerns that females might feel pressured to use the method. No study examined clinicians' attitudes and behaviors (e.g., counseling or advance provision) regarding males and emergency contraception.
Studies are needed to determine whether male involvement in emergency contraception can reduce rates of unintended pregnancy and to assess health professionals' ability to counsel males about the method.
Perspectives on Sexual and Reproductive Health 09/2012; 44(3):184-93. · 1.41 Impact Factor
[show abstract][hide abstract] ABSTRACT: OBJECTIVES: To determine if a gap exists between sexually transmitted infection (STI) clinicians and industry professionals regarding perceptions of the ideal types and characteristics of STI point-of-care tests (POCTs). METHODS: Our online survey design contained sections on demographics; barriers of use for available STI POCTs; characteristics of an ideal POCT, including prioritizing pathogens for targets; and "building your own POCT". Practicing clinicians and academic experts from two venues, STI-related international conference attendees and U.S. STD clinic clinicians, were invited to participate in the clinician survey. Professionals from industry in the STI diagnostic field were invited to participate in the industry survey. Chi-square test and conditional logistical regression were used for data analysis. RESULTS: Clinician survey participants (n=218) identified "the time frame required" (39.9%), "complexity" (31.2%), and "interruption of work flow" (30.3%) as the top three barriers making it difficult to use STI POCTs, while the industry survey participants (n=107) identified "complexity" (65.4%), "unreliability" (53.3%), and "difficulty in reading results" (34.6%) as the top three barriers (all p values <0.05). Sensitivity was always the most important attribute to be considered for a new STI POCT by both participant groups. Participants of the clinician group chose cost as the second priority attribute, while those of the industry group chose specificity as the second priority. CONCLUSION: We identified differences in the perceptions regarding barriers and ideal attributes for STI POCTs between frontline clinical providers and industry personnel. Tailored training is warranted to inform scientists, biomedical engineers, and other industry experts about characteristics that clinicians desire for STI POCTs.
Point of Care The Journal of Near-Patient Testing & Technology 06/2012; 11(2):126-129.
[show abstract][hide abstract] ABSTRACT: INTRODUCTION: A point of care test (POCT) for Chlamydia trachomatis detection is an urgent public health need. Technology advances in diagnostics have made solutions possible. Yet no reliable POCT exist. Our goal was to address the gap between chlamydia POCT needs and successful POCT development by determining which characteristics of POCT tests are most critical and if any flexibility in the attributes assigned those characteristics exist between technology developer and end user. METHODS: We employed a process known as WALEX (Warfare Analysis Laboratory Exercise) in combination with Design of Experiment (DOE) methodology using discrete choice experiments (DCE), to describe the attributes of the most realistic, rather than the most ideal POCT. The WALEX was conducted as interactive oral and simultaneous electronic discussion among experts with differing expertise, but linked by a common interest in development of a chlamydia POCT. RESULTS: Our studies demonstrated which features of the ideal chlamydia POCT were considered critical to test acceptance by users and which were open to negotiation. In particular, end users were more lenient on the requirement for the fastest ideal test and the lowest one time instrument costs, if the requirement for higher throughput, lowest cost and vaginal sample source collection were preserved. DOE methods used in forced choice question design provided confirmation of opinions derived from oral and electronic WALEX comments CONCLUSIONS: The WALEX in combination with DCE helped us achieve our goal in identifying the gaps in the chlamydia POCT and determining the most realistic solutions to bridge those gaps.
Point of Care The Journal of Near-Patient Testing & Technology 06/2012; 11(2):130-139.
[show abstract][hide abstract] ABSTRACT: Most entrepreneurial ventures fail long before the core technology can be brought to the marketplace because of disconnects in performance and usability measures such as accuracy, cost, complexity, assay stability, and time requirements between technology developers' specifications and needs of the end-users. By going through a clinical needs assessment (CNA) process, developers will gain vital information and a clear focus that will help minimize the risks associated with the development of new technologies available for use within the health care system. This article summarizes best practices of the principal investigators of the National Institute of Biomedical Imaging and Bioengineering point-of-care (POC) centers within the National Institute of Biomedical Imaging and Bioengineering POC Technologies Research Network. Clinical needs assessments are particularly important for product development areas that do not sufficiently benefit from traditional market research, such as grant-funded research and development, new product lines using cutting-edge technologies developed in start-up companies, and products developed through product development partnerships for low-resource settings. The objectives of this article were to (1) highlight the importance of CNAs for development of POC devices, (2) discuss methods applied by POC Technologies Research Network for assessing clinical needs, and (3) provide a road map for future CNAs.
Point of Care The Journal of Near-Patient Testing & Technology 06/2012; 11(2):108-113.
[show abstract][hide abstract] ABSTRACT: Chlamydia trachomatis (CT), Mycoplasma genitalium (MG), and Trichomonas vaginalis (TV) are sexually transmitted infections (STIs) associated with nongonococcal urethritis (NGU). We assessed their predictors and persistence after treatment.
We analyzed data from an NGU treatment trial among symptomatic heterosexual men aged 16-45 years from STI clinics. Nucleic acid amplification tests detected CT, MG, and TV at baseline and at 1 and 4 weeks after therapy. Associations between variables and STI detection were investigated.
Among 293 participants, 44% had CT, 31% had MG, and 13% had TV at baseline. In multivariate analysis, CT infection was associated with young age and STI contact. Young age was also associated with MG, and having ≥ 1 new partner was negatively associated with TV. We detected persistent CT in 12% and MG in 44% of participants at 4 weeks after therapy, which were associated with signs and symptoms of NGU. Persistent CT was detected in 23% of participants after azithromycin treatment vs 5% after doxycycline treatment (P = .011); persistent MG was detected in 68% of participants after doxycycline vs 33% after azithromycin (P = .001). All but 1 TV infection cleared after tinidazole.
Persistent CT and MG after treatment of NGU are common, and were associated with clinical findings and drug regimen.
The Journal of Infectious Diseases 05/2012; 206(3):357-65. · 5.85 Impact Factor
[show abstract][hide abstract] ABSTRACT: An analysis of data from a prospective study of 1257 high-risk women revealed 7 predictors of discordance between self-reported lack of recent exposure to semen and detection of spermatozoa on Gram stain, suggesting that inaccuracies in the reporting of sexual behaviors cannot be assumed to be distributed randomly.
[show abstract][hide abstract] ABSTRACT: Multi-state modeling is often employed to describe the progression of a disease process. In epidemiological studies of certain diseases, the disease state is typically only observed at periodic clinical visits, producing incomplete longitudinal data. In this paper we consider fitting semi-Markov models to estimate the persistence of human papillomavirus (HPV) type-specific infection in studies where the status of HPV type(s) is assessed periodically. Simulation study results are presented indicating that the semi-Markov estimator is more accurate than an estimator currently used in the HPV literature. The methods are illustrated using data from the HIV Epidemiology Research Study.
Statistics in Medicine 05/2011; 30(17):2160-70. · 2.04 Impact Factor
[show abstract][hide abstract] ABSTRACT: Many studies have chronicled the "epidemiologic synergy" between human immunodeficiency virus (HIV) and herpes simplex virus type 2 (HSV-2). HIV adversely affects the natural history of HSV-2 and results in more frequent and severe HSV-2 reactivation. Few longitudinal studies, however, have examined whether HSV-2 is associated with increased HIV plasma viral loads or decreased CD4 counts. The authors estimated the effect of HSV-2 seropositivity on HIV RNA viral load and on CD4 count over time among 777 HIV-seropositive US women not receiving suppressive HSV-2 therapy in the HIV Epidemiology Research Study (1993-2000). Linear mixed models were used to assess the effect of HSV-2 on log HIV viral load and CD4 count/mm(3) prior to widespread initiation of highly active antiretroviral therapy. Coinfection with HSV-2 was not associated with HIV RNA plasma viral loads during study follow-up. There was a statistically significant association between HSV-2 seropositivity and CD4 count over time, but this difference was small and counterintuitive at an increase of 8 cells/mm(3) (95% confidence interval: 2, 14) per year among HSV-2-seropositive women compared with HSV-2-seronegative women. These data do not support a clinically meaningful effect of baseline HSV-2 seropositivity on the trajectories of HIV plasma viral loads or CD4 counts.
American journal of epidemiology 03/2011; 173(7):837-44. · 5.59 Impact Factor
[show abstract][hide abstract] ABSTRACT: Cytomegalovirus (CMV) enters latency following primary infection and can subsequently reactivate. Reinfection with a different viral strain can also occur. During these events, CMV is shed in bodily fluids. This study examined correlates of CMV shedding in specimens obtained from the HIV Epidemiology Research Study, a multicenter cohort study of US women with or at high risk for human immunodeficiency virus (HIV) infection. Among the women studied, 91.4 % (911/997) were CMV IgG seropositive. Of these women, 2.7 % (25/911) were CMV IgM seropositive. CMV DNA was detected via real-time PCR more frequently in cervicovaginal lavage (CVL) specimens (55/764, 7.2 %) than in peripheral blood mononuclear cells (PBMCs) (26/897, 2.9 %). CMV viral loads in 1 ml CVL (median 534; mean 2598; range = 40-74, 844) were higher than in 10⁶ PBMCs (median 264; mean 1287; range = 35-13 ,250). CMV DNA in PBMCs was associated with HIV seropositivity [odds ratio (OR) 13.5; 95 % confidence interval (CI) 1.8-100], increasing HIV viral load (P<0.001 for trend), decreasing CD4 cell counts (P<0.001 for trend) and CMV DNA in CVL (OR 26; 95 % CI 10.7-64). CMV DNA in CVL specimens was associated with CMV IgM seropositivity (OR 4.3; 95 % CI 1.5-12.3), HIV seropositivity (OR 7.3; 95 % CI 2.6-20), increasing HIV viral load (P<0.001 for trend) and decreasing CD4 cell counts (P<0.001 for trend). The positive predictive value of CMV IgM seropositivity for CMV DNA shedding in either PBMCs or CVL was 20 %. In summary, CMV shedding in CVL and PBMCs was highly correlated with each other and with markers of immune suppression.
Journal of Medical Microbiology 03/2011; 60(Pt 6):768-74. · 2.30 Impact Factor
[show abstract][hide abstract] ABSTRACT: To investigate the possible effects of different levels of attributes of a point-of-care test (POCT) on sexually transmitted infection (STI) professionals' decisions regarding an ideal POCT for STI(s).
An online survey was designed based on a large-scale in-depth focus discussion study among STI experts and professionals. The last section of the survey "build your own POCT" was designed by employing the discrete choice experiment approach. Practicing clinicians from two venues, STI-related international conference attendees and U.S. STD clinic clinicians were invited to participate in the survey. Conditional logistical regression modeling was used for data analysis.
Overall, 256 subjects took the online survey with 218 (85%) completing it. Most of the participants were STD clinic clinicians who already used some POCTs in their practice. "The time frame required" was identified as a major barrier that currently made it difficult to use STI POCTs. Chlamydia trachomatis was the organism chosen as the top priority for a new POCT, followed by a test that would diagnose early seroconversion for HIV, and a syphilis POCT. Without regard to organism type selected, sensitivity of 90-99% was always the most important attribute to be considered, followed by a cost of $20. However, when the test platform was prioritized for early HIV seroconversion or syphilis, sensitivity was still ranked as most important, but specificity was rated second most important.
STI professionals preferred C. trachomatis as the top priority for a new POCT with sensitivity over 90%, low cost, and a very short completion time.
PLoS ONE 01/2011; 6(4):e19263. · 3.73 Impact Factor
[show abstract][hide abstract] ABSTRACT: Populations of African ancestry continue to account for a disproportionate burden of the human immunodeficiency virus type 1 (HIV-1) epidemic in the United States. We investigated the effects of human leukocyte antigen (HLA) class I markers in association with virologic and immunologic control of HIV-1 infection among 338 HIV-1 subtype B-infected African Americans in 2 cohorts: Reaching for Excellence in Adolescent Care and Health (REACH) and HIV Epidemiology Research Study (HERS). One-year treatment-free interval measurements of HIV-1 RNA viral loads and CD4(+) T cells were examined both separately and combined to represent 3 categories of HIV-1 disease control (76 controllers, 169 intermediates, and 93 noncontrollers). Certain previously or newly implicated HLA class I alleles (A*32, A*36, A*74, B*14, B*1510, B*3501, B*45, B*53, B*57, Cw*04, Cw*08, Cw*12, and Cw*18) were associated with 1 or more of the endpoints in univariate analyses. After multivariable adjustments for other genetic and nongenetic risk factors of HIV-1 progression, the subset of alleles more strongly or consistently associated with HIV-1 disease control included A*32, A*74, B*14, B*45, B*53, B*57, and Cw*08. Carriage of infrequent HLA-B but not HLA-A alleles was associated with more favorable disease outcomes. Certain HLA class I associations with control of HIV-1 infection cross the boundaries of race and viral subtype, whereas others appear confined within one or the other of those boundaries.
Human immunology 01/2011; 72(4):312-8. · 2.55 Impact Factor
[show abstract][hide abstract] ABSTRACT: To evaluate associations between common vaginal infections and human papillomavirus (HPV).
Data from up to 15 visits on 756 HIV-infected women and 380 high-risk HIV-uninfected women enrolled in the HIV Epidemiology Research Study (HERS) were evaluated for associations of bacterial vaginosis, trichomoniasis, and vaginal Candida colonization with prevalent HPV, incident HPV, and clearance of HPV in multivariate analysis.
Bacterial vaginosis (BV) was associated with increased odds for prevalent (aOR = 1.14, 95% CI: 1.04, 1.26) and incident (aOR = 1.24, 95% CI: 1.04, 1.47) HPV and with delayed clearance of infection (aHR = 0.84, 95% CI: 0.72, 0.97). Whereas BV at the preceding or current visit was associated with incident HPV, in an alternate model for the outcome of incident BV, HPV at the current, but not preceding, visit was associated with incident BV.
These findings underscore the importance of prevention and successful treatment of bacterial vaginosis.
Infectious Diseases in Obstetrics and Gynecology 01/2011; 2011:319460.
[show abstract][hide abstract] ABSTRACT: Nongonococcal urethritis (NGU) is a common chlamydia-associated syndrome in men; however, Trichomonas vaginalis and Mycoplasma genitalium are associated with its etiology and should be considered in approaches to therapy. We sought to determine whether the addition of tinidazole, an anti-trichomonal agent, to the treatment regimen would result in higher cure rates than those achieved with treatment with doxycycline or azithromycin alone. A secondary aim was to compare the efficacy of doxycycline therapy and with that of azithromycin therapy.
Randomized, controlled, double-blinded phase IIB trial of men with NGU. Participants were randomized to receive doxycycline plus or minus tinidazole or azithromycin plus or minus tinidazole and were observed for up to 45 days.
The prevalences of Chlamydia trachomatis, M. genitalium, and T. vaginalis were 43%, 31%, and 13%, respectively. No pathogens were identified in 29% of participants. Clinical cure rates at the first follow-up visit were 74.5% (111 of 149 patients) for doxycycline-containing regimens and 68.6% (107 of 156 patients) for azithromycin-containing regimens. By the final visit, cure rates were 49% (73 of 149 patients) for doxycycline-containing regimens and 43.6% (68 of 156 patients) for azithromycin-containing regimens. There were no significant differences in clinical response rates among the treatment arms. However, the chlamydia clearance rate was 94.8% (55 of 58 patients) for the doxycycline arm and 77.4% (41 of 53 patients) for the azithromycin arm (P = .011), and the M. genitalium clearance rate was 30.8% (12 of 39 patients) for the doxycycline arm and 66.7% (30 of 45 patients) for the azithromycin arm (P = .002).
Addition of tinidazole to the treatment regimen did not result in higher cure rates but effectively eradicated trichomonas. Clinical cure rates were not significantly different between patients treated with doxycycline and those treated with azithromycin; however, doxycycline had significantly better efficacy against Chlamydia, whereas azithromycin was superior to doxycycline for the treatment of M. genitalium.
[show abstract][hide abstract] ABSTRACT: OBJECTIVE. To identify correlates of incident bacterial vaginosis (BV) diagnosed with Nugent scoring among high-risk women. STUDY DESIGN. We conducted both cohort and case-crossover analyses, stratified by HIV infection status, based on 871 HIV-infected and 439 HIV-uninfected participants in the HIV Epidemiology Research Study, conducted in 4 US sites in 1993-2000. RESULTS. BV incidence was 21% and 19% among HIV-infected and -uninfected women, respectively. Fewer correlates of BV were found with case-crossover than with cohort design. Reporting frequent coitus (regardless of consistency of condom use) was correlated with BV in cohort analyses but not in case-crossover analyses. The sole correlate of BV in both types of analyses was the detection of spermatozoa on Gram stain, which is a marker of semen exposure. CONCLUSION. The inconsistent association between condom use and BV in prior studies could be from reporting bias. We found evidence of a relationship between semen exposure and incident BV.
Infectious Diseases in Obstetrics and Gynecology 01/2011; 2011:842652.
[show abstract][hide abstract] ABSTRACT: To assess the accuracy of clinical diagnosis of bacterial vaginosis (BV) by using Amsel criteria, overall and by human immunodeficiency virus (HIV) infection status.
Women with HIV, or at risk for HIV, participated in the HIV Epidemiology Research Study, a prospective study conducted in 4 US sites. At enrollment and follow-up visits, scheduled at 6-month intervals for ≤ 5 years, participants received gynecologic examinations, had specimens collected, and underwent standardized interviews. We used McNemar test statistic to evaluate agreement between Amsel criteria and Nugent scoring. Using Nugent scoring as the reference standard, we calculated sensitivity and specificity for Amsel criteria and for 3 other classifications of clinical BV. Our results are based on data collected from 9140 study visits by 862 HIV-infected women and 421 HIV-uninfected women.
Amsel criteria and Nugent scoring did not agree in the classification of BV cases (P < 0.01). Amsel criteria had poor sensitivity (60%; 95% confidence interval, 58%-61%) and specificity (90%; 95% confidence interval, 89%-91%) with wide differences in test properties by study site. We found no differences in diagnosing BV by HIV infection status.
The under- and overdiagnosing of BV clinically suggests that the accuracy of Amsel criteria for routine screening of asymptomatic women might be lower than previous estimates; that clinicians need more rigorous training to apply subjective Amsel criteria accurately; or that wide heterogeneity in cases might prevent agreement between clinical and laboratory diagnoses, with future research needed to better understand the criteria or morphotypes associated with specific adverse outcomes.
[show abstract][hide abstract] ABSTRACT: The optimal antimicrobial regimen to treat syphilis in HIV-infected subjects remains controversial.
To systematically assess the literature for studies evaluating syphilis treatment regimens in this population.
Two reviewers independently assessed studies published between 1980 and June 2008 in electronic databases, trial registries and bibliographies (with no language restrictions) for content and quality. Studies that included 10 or more people, with documented HIV status, type and duration of syphilis treatment and at least 6 months of follow-up were included. The primary outcome was syphilis serological or clinical failure stratified by syphilis stage.
Of 1380 unique citations, 23 studies (22 published papers and 1 conference abstract) were included in the systematic review. Owing to the significant heterogeneity among studies, pooled summary statistics could not be generated. The range of probabilities for serological failure with 2.4 million units (MU) of intramuscular benzathine penicillin G (BPG) was 6.9% (95% CI 2.6% to 14.4%) to 22.4% (11.7% to 36.6%); that of 7.2 MU of BPG in late latent syphilis was 19.4% (11.9% to 28.9%) to 31.1% (22.3% to 40.9%) and failure estimates with 18-24 MU of aqueous penicillin for the treatment of neurosyphilis were 27.3% (6.0% to 61.0%) to 27.8% (14.2% to 45.2%).
The optimal antimicrobial regimen to treat syphilis in HIV-infected subjects is unknown; guideline recommendations in this population are based on little objective data.
[show abstract][hide abstract] ABSTRACT: The role of human leukocyte antigen (HLA) class I supertypes in controlling human immunodeficiency virus type 1 (HIV-1) infection in African Americans has not been established. We examined the effects of the HLA-A and HLA-B alleles and supertypes on the outcomes of HIV-1 clade B infection among 338 African American women and adolescents. HLA-B58 and -B62 supertypes (B58s and B62s) were associated with favorable HIV-1 disease control (proportional odds ratio [POR] of 0.33 and 95% confidence interval [95% CI] of 0.21 to 0.52 for the former and POR of 0.26 and 95% CI of 0.09 to 0.73 for the latter); B7s and B44s were associated with unfavorable disease control (POR of 2.39 and 95% CI of 1.54 to 3.73 for the former and POR of 1.63 and 95% CI of 1.08 to 2.47 for the latter). In general, individual alleles within specific B supertypes exerted relatively homogeneous effects. A notable exception was B27s, whose protective influence (POR, 0.58; 95% CI, 0.35 to 0.94) was masked by the opposing effect of its member allele B*1510. The associations of most B supertypes (e.g., B58s and B7s) were largely explained either by well-known effects of constituent B alleles or by effects of previously unimplicated B alleles aggregated into a particular supertype (e.g., B44s and B62s). A higher frequency of HLA-B genotypic supertypes correlated with a higher mean viral load (VL) and lower mean CD4 count (Pearson's r = 0.63 and 0.62, respectively; P = 0.03). Among the genotypic supertypes, B58s and its member allele B*57 contributed disproportionately to the explainable VL variation. The study demonstrated the dominant role of HLA-B supertypes in HIV-1 clade B-infected African Americans and further dissected the contributions of individual class I alleles and their population frequencies to the supertype effects.
Journal of Virology 03/2010; 84(5):2610-7. · 5.08 Impact Factor
[show abstract][hide abstract] ABSTRACT: A point-of-care test (POCT) for sexually transmitted infections (STIs), which offers immediate diagnosis resulting in patients receiving diagnosis and treatment in a single visit, has the ability to address some of the STI control needs. However, needs assessment from STI experts and end users about currently available STI POCTs and their future new development has not been evaluated since World Health Organization Sexually Transmitted Diseases Diagnostics Initiative was formed over 15 years ago. Therefore, our objective was to explore the perceptions of the ideal types of STI POCT for use in health care settings.
A qualitative study, encompassing eight focus groups, was conducted from March 2008 through April 2009. Participants included 6 STD clinic directors, 63 clinicians, and 7 public health/laboratory/epidemiology professionals in the STI field. Discussion topics included currently available POCT, perceived barriers to using POCT in clinics, priority STI for the development of new POCT, and characteristics of the ideal POCT. All discussions were recorded and transcribed verbatim. Themes raised as barriers for current POCT included complexity, long time frames of the so-called "rapid" test, multiple time-driven steps, requiring laboratory technician, difficulty in reading result, interruption of workflow, unreliability, and invasiveness. Chlamydia trachomatis was identified as the priority organism for development of a new STI POCT. Themes indicated for the ideal POCT included rapid turnaround (up to 20 minutes), ease of use, non-invasive, accurate (preferred sensitivity and specificity in the range of high 90s), Clinical Laboratory Improvement Amendments (CLIA)-waived, user-friendly (for both patients and staff), compact, durable, and sturdy.
Focus group discussions with STI experts and professionals highlighted chlamydia as the top priority pathogen for POCT development, and identified the qualities of new POCT for STIs. Participants endorsed ease of use, rapid turnaround and high accuracy as essential characteristics of an ideal POCT.
PLoS ONE 01/2010; 5(11):e14144. · 3.73 Impact Factor