Affirm VPIII Research Articles

Patterns of Use and Barriers to STI Point-of-care Tests for Military Obstetrician Gynecologists.

Sexually transmitted infections (STIs) are commonly reported in military populations. Point-of-care tests (POCTs) are commercially available, but their use is variable in the civilian sector. Their use among military providers has not been evaluated. We sought to identify the pattern of use and barriers to using STI POCTs for military obstetrician/gynecologists (OBGYNs). We adapted a survey of civilian OBGYNs on patterns of use and barriers to STI POCTs for military OBGYNs. We sent an online questionnaire to 479 military OBGYNs via Army, Air Force, and Navy specialty leaders in May 2023. The questionnaire included 14 demographic questions and up to 52 questions regarding availability, use, and barriers to STI POCTs. The USU Institutional Review Board deemed the study exempt from Institutional Review Board review. Of the 479 solicited, 117 participated in the survey (24.4%). Of respondents, 64.1% were women and 79.5% non-Hispanic white. Sexually transmitted infections were detected once to twice weekly by 13.0% of respondents and once or twice monthly by 52.8%. The most available STI-related POCTs were wet mount prep (68.7%), rapid HIV (43.3%), and urine dipstick (38.6%). Gram stain was available for 30.3%, the Affirm VPIII (Becton, Dickinson and Company, Franklin Lakes, NJ) for 24.5%, and stat RPR for 16.3%. Economic barriers to using POCTs included cost of the test from manufacturer/distributor (57.9%) and military funding/stocking decisions (10.3%). The greatest barriers to use were the purchasing of an instrument (60.8%) and the interruption to workflow in clinic (57.8%). Military OBGYNs rely on several STI-related POCTs. Economic factors and interruption to workflow were cited as the most significant barriers to using POCTs for military OBGYNs. Test cost and impact on workflow should be considered in future development and procurement of POCTs for the Military Health System.

Diagnostic evaluation of the BD Affirm VPIII assay as a point-of-care test for the diagnosis of bacterial vaginosis, trichomoniasis and candidiasis.

Untreated sexually transmitted infections and bacterial vaginosis (BV) pose a serious health risk to mother and child. Limited data exist on the use of the BD Affirm™ VPIII assay as a point-of-care test (POCT). The performance of the BD Affirm™ VPIII assay was compared with the BD Max™ vaginal assay for the diagnosis of BV, Trichomonas vaginalis (TV) and Candida spp. A total of 273 pregnant women were enrolled in this study and had provided two self-collected vaginal swabs. Sensitivity, specificity, positive predictive value, negative predictive value and prevalence were calculated. The prevalence of BV, candidiasis and trichomoniasis was 49.4, 57.2 and 10.3%, respectively. The BD Affirm™ VPIII assay showed a moderate sensitivity (79.8%) and a moderate specificity (80.3%) for diagnosing BV in all participants. The BD Affirm™ VPIII assay had an excellent specificity for Candida spp. and TV of 97.4 and 100%, respectively; however, the assay exhibited poor sensitivities of 52.9 and 46.4%, respectively. This study was the first to report on the performance of the BD Affirm™ VPIII assay as a POCT in an antenatal population. The assay was found to be unsuitable as a screening test for vaginal infections in pregnancy.

Estudio prospectivo de la incidencia de patógenos genitales oportunistas y estrictos que crecen en medios de cultivo artificiales

Background and objectivePurulent or exudative genitourinary infections are a frequent reason for consultation in primary and specialized health care. The objective of this study was to determine the incidence of the microorganisms most commonly involved in the development of bacterial vaginosis, cervicitis, urethritis, vulvovaginitis, and balanitis in a general population attending 2tertiary level hospitals in the province of Granada (Spain). Patients and methodsAll the samples received for the microbiological diagnosis of acute lower genital tract infection between February and May 2015 were analysed following a standard protocol. Detection of the microorganisms in the samples was performed by cultivation in artificial media or nucleic acid hybridisation techniques (Affirm VPIII). ResultsThe analysis included a total of 2,017 samples, obtained from 1,722 different patients (1626 women and 96 men).. The presence of at least one microorganism with clinical significance was detected in 772 patients (44.8%; 745 women and 27 men). Among the women, the most frequent microorganism more found was Gardnerella vaginalis, present in the 26.7%, followed by Candida albicans (20.0%), Trichomonas. vaginalis (1.0%), and Ureaplasma urealyticum (0.4%). Neisseria gonorrhoeae and Haemophilus spp. were detected in 10.4% and 6.3% of samples of male origin, respectively. ConclusionsIn the studied population, bacterial vaginosis by G. vaginalis, vulvovaginitis by Candida spp., trichomoniasis, gonorrhea, and urethritis by Ureaplasma spp. and Haemophilus spp., were the most frequent exudative genital infections.

Patterns of point-of-care test use among obstetricians and gynaecologists in the US.

Between June and August 2016, 1000 members of the American College of Obstetricians and Gynecologists were randomly selected and invited to complete a Qualtrics (222 West river Park Drive, Provo, Utah 84604, USA) survey; 600 of these were members of the Collaborative Ambulatory Research Network. Respondents who completed at least 60% of the survey were included in the analysis. Of the 1000 selected members, 749 had valid emails and 288 (38%) of these participated in and completed the survey. Of the respondents, 70% were male with a mean of 18 years in practice. Detection of sexually transmissible infections (STIs) once or twice a week was reported by 30%, whereas 45% reported detecting STIs once or twice a month. POCTs used included pregnancy tests (83%), urine dipstick (83%), wet mount tests (79%) and the vagina pH test (54.8%). Few used Gram stain (5%) and stat rapid plasma regain tests (4%). Relatively newer US Food and Drug Administration-approved POCTs were used less frequently, with 25% of respondents reporting using the Affirm VPIII (Becton, Dickinson and Company, 1 Becton Drive, Franklin Lakes, NJ 07471, USA) test use and only 10% using a rapid HIV test. The most common perceived barriers to testing were the amount of reimbursement received for performing the test (61.9%) and the payment coverage from the patient (61.3%). US obstetricians and gynaecologists rely on laboratory test results and traditional POCTs to diagnosis STIs. Future development and marketing of POCTs should consider not only ease and time of test performance, but also the cost of the tests to the practice and the patient, as well as reimbursement.

Affirm VPIII microbial identification test can be used to detect gardnerella vaginalis, Candida albicans and trichomonas vaginalis microbial infections in Korean women.

The aim of this study was to compare Affirm VPIII Microbial Identification Test results for Korean women to those obtained for Gardnerella vaginalis through Nugent score, Candida albicans based on vaginal culture and Trichomonas vaginalis based on wet smear diagnostic standards. Study participants included 195 women with symptomatic or asymptomatic vulvovaginitis under hospital obstetric or gynecologic care. A definite diagnosis was made based on Nugent score for Gardnerella, vaginal culture for Candida and wet prep for Trichomonas vaginalis. Affirm VPIII Microbial Identification Test results were then compared to diagnostic standard results. Of the 195 participants, 152 were symptomatic, while 43 were asymptomatic. Final diagnosis revealed 68 (37.87%) cases of Gardnerella, 29 (14.87%) cases of Candida, one (0.51%) case of Trichomonas, and 10 (5.10%) cases of mixed infections. The detection rates achieved by each detection method (Affirm assay vs diagnostic standard) for Gardnerella and Candida were not significantly different (33.33% vs 34.8% for Gardnerella, 13.33% vs 14.87% for Candida, respectively). The sensitivity and specificity of the Affirm test for Gardnerella compared to the diagnostic standard were 75.0% and 88.98%, respectively. For Candida, the sensitivity and specificity of the Affirm test compared to the diagnostic standard were 82.76% and 98.80%, respectively. The number of Trichomonas cases was too small (1 case) to be statistically analyzed. The Affirm test is a quick tool that can help physicians diagnose and treat patients with infectious vaginitis at the point of care.

ESwab as an Optional Collection Device for Use with the Affirm VPIII Microbial Test System

The ESwab collection device was compared to the collection swab provided as part of the Affirm VPIII microbial identification test kit for testing vaginal specimens with the Affirm test system. There was excellent agreement between the two sampling devices for Candida spp., Gardnerella vaginalis, and Trichomonas vaginalis.

Comparison of Nucleic Acid Amplification Assays with BD Affirm VPIII for Diagnosis of Vaginitis in Symptomatic Women

A commercially available, nonamplified, nucleic acid probe-based test system (BD Affirm VPIII) was compared with nucleic acid amplification (NAA)-based assays for determining the etiology of vaginitis in a cohort of 323 symptomatic women. First, a semiquantitative, multiplexed PCR assay (BV-PCR) and the Affirm VPIII Gardnerellavaginalis test were compared with a unified bacterial-vaginosis (BV) reference standard incorporating both Nugent Gram stain scores and Amsel clinical criteria. In the evaluable population of 305 patients, BV-PCR was 96.9% (191/197) sensitive and 92.6% specific (100/108) for BV, while Affirm VPIII was 90.1% sensitive (179/197) and 67.6% specific (73/108). Second, a multiplexed PCR assay detecting Candida albicans and Candida glabrata (CAN-PCR) was compared with the Affirm VPIII Candida test using a reference standard for vulvovaginal candidiasis (VVC) of yeast culture plus exclusion of alternate vaginitis etiologies. In the population evaluated (n = 102), CAN-PCR was 97.7% sensitive (42/43) and 93.2% specific (55/59) and Affirm VP III was 58.1% sensitive (25/43) and 100% specific (59/59) for VVC. Finally, the results of a commercial NAA test (GenProbe Aptima Trichomonas vaginalis assay; ATV) for T. vaginalis were compared with the Affirm VPIII Trichomonas vaginalis test. In the absence of an independent reference standard for trichomonal vaginitis (TV), a positive result in either assay was deemed to represent true infection. In the evaluable cohort of 388 patients, the sensitivity of ATV was 98.1% (53/54) versus 46.3% (25/54) for Affirm VPIII. The diagnostic accuracy of the combined NAA-based test construct was approximately 20 to 25% higher than that of the Affirm VPIII when modeled in populations with various prevalences of infectious vaginitis.

Detection ofTrichomonas vaginalis,Gardnerella vaginalis, andCandidaSpecies in Affirm VPIII, Papanicolaou Smear Test and Gram Stain

Background: Infectious vaginitis is caused primarily by three different groups of microbial pathogens (Trichomonas vaginalis, Candida spp., and Gardnerella vaginalis). The objective of this study was to compare the Affirm VPIII assay using a DNA hybridization technique with the Papanicolaou (Pap) smear test and the Gram stain in the detection and identification of these three organisms. Methods: A total of 300 vaginal samples were collected from women that were either symptomatic for vaginitis or asymptomatic women that were being seen for routine obstetric or gynecological care. The presence of T. vaginalis, Candida spp., and G. vaginalis was evaluated by using the Affirm VIII assay (Becton Dickinson, USA), Pap smear test, and Gram stain method, respectively. Results: With the Affirm VPIII assay, 1 (0.3%) patient tested positive for T. vaginalis, 99 (33.0%) patients were positive for G vaginalis, and 18 (6.0%) were positive for Candida spp. The detection rates of Trichomonas infection, bacterial vaginosis and candidiasis by the Pap smear test and Gram stain method were 0.7% versus 0%, 16.3% versus 35.7%, and 1.7% versus 9.7%, respectively. The differences between the detection rates of the above three organisms between the Pap smear test and the Gram stain method were statistically significant (P<0.05). Conclusion: The Affirm VPIII assay was more sensitive than the Pap smear test and more specific than the Gram stain method for the detection and identification of these three organisms. In addition, the results of the Affirm VPIII assay are quick to obtain and are simple and easy to interpret. (Korean J Clin Microbiol 2012;15:104-109)

P3-S7.13 Evaluation of the Affirm VPIII microbial identifications test for the diagnosis of vaginitis and bacterial vaginosis

BackgroundVaginitis and bacterial vaginosis (BV) are the most prevalent causes of vaginal symptoms among women of childbearing age. Diagnosis is based on clinical signs and symptoms, microscopy, pH and the...

Comparison of the BD Affirm VPIII Test to Primary Care and Clinical Laboratory Methods for the Diagnosis of Bacterial Vaginosis and Yeast Vaginitis

Background: Diagnosis of bacterial vaginosis (BV) or yeast vaginitis (YV) in the primary care physician's (PCP's) office has relied on patient symptoms, clinical findings during vaginal examination, and analysis of vaginal fluid. These approaches support PCP decisions when selecting patient treatment regimens for these conditions. Alternatively, vaginal specimens may be tested at a clinical or hospital-based laboratory where other diagnostic methods are used including the Nugent Gram stain (NGS), culture, or molecular methods. This study compared these methods and the BD Affirm VPIII (AFF) test to the diagnosis provided by the PCP. Methods: Eighty-four patients were enrolled at 3 primary care sites. Each site used routine Amsel criteria for BV and wet mount for YV. Three additional vaginal swabs were collected: the first was used to perform a NGS for BV; the second was used for yeast culture; and the third for testing with the AFF, a DNA probe-based method. Primary care physicians diagnosed and treated 36 patients for BV and 30 patients for YV. Results: Using a NGS score indicative of BV (>6), the sensitivity and specificity of Amsel criteria, AFF, and Nugent GS for BV was 95% and 57%, 100% and 71%, and 50% and 100%, respectively. For YV, the sensitivity and specificity of the wet mount, AFF, and yeast culture was 100% and 11%, 86% and 100%, and 100% and 100%, respectively. Several patients were misdiagnosed and treated inappropriately for BV and YV. Conclusions: The AFF outperformed and provided a faster result than traditional testing done in the PCP or clinical laboratory setting.

Saccharomyces cerevisiae Vaginitis: Microbiology and In Vitro Antifungal Susceptibility

Genitourinary infections by Saccharomyces cerevisiae are rare. Here, we describe eight S. cerevisiae vulvovaginitis episodes where molecular (Affirm VPIII) and conventional microbiological methods (culture and carbohydrate assimilation) have proven to be inadequate for diagnostic purposes. DNA sequencing allowed the correct identification of the pathogen. All isolates were susceptible to most antifungal agents, with two of them also found to be susceptible-dose-dependent to itraconazole.

Comparison of Affirm VPIII and Papanicolaou Tests in the Detection of Infectious Vaginitis

To compare the Affirm VPIII molecular test (Becton Dickinson, Burlington, NC) with morphologic identification used in routine Papanicolaou (Pap) test screening in the detection and identification of Candida species, Trichomonas vaginalis, and Gardnerella vaginalis, we identified 431 cases with a concomitant Pap test and Affirm VPIII assay performed from the archives of a large academic institution. The study population consisted of women ranging in age from 17 to 79 years (mean and median ages, 33 and 31 years, respectively). With a routine Pap test, 60 patients (13.9%) were found to have bacterial vaginosis, 60 (13.9%) candidiasis, and 3 (0.7%) Trichomonas infection. With the Affirm VPIII assay, 183 (42.5%) patients tested positive for G vaginalis, 70 (16.2%) positive for Candida species, and 10 (2.3%) positive for T vaginalis. The differences were statistically significant. The results demonstrate that our patient population had a high incidence of bacterial vaginosis/Candida vaginitis; however, the Affirm VPIII was a more sensitive diagnostic test for the detection and identification of all 3 organisms compared with the Pap test.

Comparison of Aptima Trichomonas vaginalis Transcription-Mediated Amplification Assay and BD Affirm VPIII for Detection of T. vaginalis in Symptomatic Women: Performance Parameters and Epidemiological Implications

Trichomonas vaginalis is an underestimated sexually transmitted infection (STI) associated with numerous clinical sequelae. The true prevalence and clinical impact of trichomoniasis are unknown, as current methods of detection exhibit poor sensitivity compared to molecular amplification methods. Limited data exist comparing the BD Affirm VPIII hybridization assay to the Gen-Probe Aptima T. vaginalis (ATV) transcription-mediated amplification (TMA) assay for detection of T. vaginalis. In this study, specimens from 766 patients were evaluated. Specimens were retrieved consecutively from patients with vaginal complaints and/or with histories suggestive of STI. Study inclusion was dependent upon the request for and collection of both a vaginal swab for Affirm and a specimen for Aptima Combo 2 by the health care provider during the same office visit. Affirm was performed using the specific collection swab and the transport provided for the test. The ATV assay was performed on remnant Aptima Combo 2 specimens. A second ATV TMA assay, utilizing an alternate T. vaginalis primer and probe set, was performed on all specimens positive by the initial TMA and/or the Affirm assay. Infected-patient status was defined as positive T. vaginalis test results by at least 2 assays. Overall, 5.1% of subjects were positive for T. vaginalis. T. vaginalis was most prevalent in women who were 36 to 45 (11.9%), 51 to 60 (7.7%), and 16 to 25 (4.2%) years of age. The ATV assay was statistically more sensitive than the Affirm assay (100% versus 63.4%, P < 0.0001), identifying 36.6% more positive patients.

Utilidad del sistema Affirm VPIII y de la prueba L-Pap para el diagnóstico de vaginosis bacteriana

Bacterial vaginosis is a syndrome occurring in women of reproductive age, characterized by abnormal vaginal discharge and associated with gynecological and obstetric problems during pregnancy.This study assesses the value of proline aminopeptidase (L-Pap) detection and DNA hybridization with the Affirm VPIII microbial identification test, as analytical tools for the diagnosis of bacterial vaginosis.Vaginal secretions from 406 women were collected and analyzed to investigate bacterial vaginosis with the Affirm VPIII commercial kit and the L-Pap reaction. The criteria of Nugent et al, and Amsel et al. were used to characterize patients with bacterial vaginosis syndrome. Results were analyzed with a 2 x 2 contingency table and evaluated by the chi-square test, at a significance level of P < 0.05.L-Pap showed a sensitivity of 92.2%, specificity of 93.4%, PPV of 91.7% and NPV of 93.8%. The Affirm VPIII method had a sensitivity of 91.1%, specificity of 94.7%, PPV of 93.1% and NPV of 93.8%. The diagnostic performance of the two tests showed no statistical differences. CONCLUSION. L-Pap and Affirm VPIII are both suitable tests for fast, accurate diagnosis of bacterial vaginosis.

Use of DNA hybridization test for diagnosing bacterial vaginosis in women with symptoms suggestive of infection

The purpose of this study was to evaluate a DNA hybridization test (Affirm VPIII) as an alternative to Gram stain for the rapid diagnosis of bacterial vaginosis in women with clinical signs of vaginal infection. Vaginal specimens were collected from 321 symptomatic women, and analyzed for bacterial vaginosis by both Gram stain using Nugent criteria and DNA hybridization test. Sensitivity, specificity, positive predictive value, and negative predictive value of the DNA hybridization test were determined using the Gram staining as the standard for diagnosis of bacterial vaginosis. Of the 321 patients, 115 (35.8%) were Gram positive for bacterial vaginosis and 126 (39.2%) were negative. 80 patients (25.0%) demonstrated intermediate Gram staining that was also considered negative. The Affirm system detected G. vaginalis in 107 (93.0%) of 115 vaginal specimens positive for bacterial vaginosis diagnosed by Gram stain. Compared to the Gram stain, DNA hybridization test had a sensitivity of 87.7% and a specificity of 96.0%. Positive and negative predictive values of the DNA hybridization test were 93.0% and 92.7%, respectively. In conclusion, Affirm VPIII hybridization test correlated well with Gram stain and may be used as a rapid diagnostic tool to exclude bacterial vaginosis in women with genital complaints.

Throwing the dice for the diagnosis of vaginal complaints?

BackroundVaginitis is among the most common conditions women are seeking medical care for. Although these infections can easily be treated, the relapse rate is high. This may be due to inadequate use of the diagnostic potential.MethodsWe evaluated the misjudgement rate of the aetiology of vaginal complaints. A total of 220 vaginal samples from women with a vaginal complaint were obtained and analysed for numbers of total lactobacilli, H2O2-producing lactobacilli, total aerobic cell counts and total anaerobic cell counts including bifidobacteria, Bacteroides spp., Prevotella spp. Additionally, the presence of Atopobium vaginae, Gardnerella vaginalis, Candida spp. and Trichomonas vaginalis was evaluated by DNA-hybridisation using the PCR and Affirm VPIII Microbial Identification Test, respectively.ResultsThe participating physicians diagnosed Bacterial vaginosis (BV) as origin of discomfort in 80 cases, candidiasis in 109 cases and mixed infections in 8 cases. However, a present BV, defined as lack of H2O2-lactobacilli, presence of marker organisms, such as G. vaginalis, Bacteroides spp. or Atopobium vaginae, and an elevated pH were identified in only 45 cases of the women examined. Candida spp. were detected in 46 cases. Interestingly, an elevated pH corresponded solely to the presence of Atopobium vaginae, which was detected in 11 cases.ConclusionErrors in the diagnosis of BV and candida vulvovaginitis (CV) were high. Interestingly, the cases of misjudgement of CV (77%) were more numerous than that of BV (61%). The use of Amsel criteria or microscopy did not reduce the number of misinterpretations. The study reveals that the misdiagnosis of vaginal complaints is rather high.