Munson, Erik

Munson, Kimber L.

Napierala, Maureen

Journal of Clinical Microbiology

English

PubMed

epublications@Marquette

Marquette Universitye-Publications@MarquetteClinical Lab Sciences Faculty Research andPublications Health Sciences, College of2-1-2016Suboptimal Trichomonas vaginalis Antigen TestPerformance in a Low-Prevalence SexuallyTransmitted Infection CommunityKimber L. MunsonWheaton Franciscan LaboratoryMaureen NapieralaWheaton Franciscan LaboratoryErik MunsonMarquette University, erik.munson@marquette.eduPublished version. Journal of Clinical Microbiology, Vol. 54, No. 2 (February 2016): 500-501. DOI. ©2016, American Society for Microbiology. Used with permission.Suboptimal Trichomonas vaginalis Antigen Test Performance in aLow-Prevalence Sexually Transmitted Infection CommunityKimber L. Munson,a Maureen Napieralaa Erik Munsona,bWheaton Franciscan Laboratory, Milwaukee, Wisconsin, USAa; College of Health Sciences, Marquette University, Milwaukee, Wisconsin, USAbTrichomonas vaginalis is the most common nonviral etiology ofsexually transmitted infection (STI) worldwide (1). TheOSOM Trichomonas rapid test (OSOM; Sekisui Diagnostics, SanDiego, CA) is a rapid surrogate to microscopic analysis in symp-tomatic patients (2), but its performance in low-prevalence STIpopulations has been assessed on a limited basis in the literature(3). OSOM has widespread usage, as accreditation data from theCollege of American Pathologists report that over 300 participantlaboratories utilize this assay on an annual basis (4). We sought tocharacterize the analytical and clinical performance of OSOM in alow-prevalence STI population on the basis of a commercial tran-scription-mediated amplification (TMA) reference.Results from the performance of OSOM with 1,421 consecu-tive vaginal saline suspensions were audited from a 4-month in-terval in a low-prevalence southeasternWisconsin STI population(5). The concomitant Aptima specimen transport tube from thehealth care encounter (98.7% endocervical, 1.3% vaginal), previ-ously subjected to Chlamydia trachomatis and Neisseria gonor-rhoeae TMA (Aptima Combo 2 assay; Hologic, San Diego, CA),was forwarded for retrospective T. vaginalis TMA (AptimaTrichomonas vaginalis assay; Hologic) evaluation on a TIGRISdirect tube sampling (DTS) system per the manufacturer’s speci-fications (6). A previous assessment of T. vaginalis TMA showed100% molecular concordance between the data from vaginal sa-line suspension aliquots and endocervical specimens maintainedin Aptima specimen transport tubes (7). In addition, Napierala etal. (8) have shown equivalent T. vaginalis TMA detection ratesfrom endocervical swabs and vaginal swabs in our population.This study was governed by the Wheaton Franciscan HealthcareInstitutional Review Board.The low-prevalence STI population exhibited TMA detectionrates of 6.4% and 0.6% for C. trachomatis and N. gonorrhoeae,respectively, while the T. vaginalis TMA detection rate was 4.0%.On the basis of a T. vaginalis TMA reference standard, the sensi-tivity and specificity of OSOM were 35.1% and 99.9%, respec-tively (Table 1). The kappa value for this data set was 0.502 (95%confidence interval, 0.346 to 0.658), and agreement was 0.973(95% confidence interval, 0.963 to 0.981).In an analogous fashion, 98 consecutive tandem vaginal salinesuspensions and endocervical swabs from an increased-preva-lence STI setting (C. trachomatis TMA detection rate, 11.2%; N.gonorrhoeae TMA detection rate, 6.1%; setting characterized pre-viously [7, 9]) were retrospectively analyzed via OSOM and T.vaginalis TMA, respectively, per the manufacturer’s guidelines (2,6). Improved concordance between OSOM and T. vaginalis TMAwas observed within this study set, with a 21.4% T. vaginalis TMAdetection rate (Table 2). An increased kappa value of 0.904 (95%confidence interval, 0.797 to 1.000) was calculated, with agree-ment of 0.969 (95% confidence interval, 0.907 to 0.992).Campbell et al. (3) reported 94.7% sensitivity for OSOM com-pared to microscopy in a population with a 1.9% T. vaginalisdetection rate. Molecular diagnostics did not factor into the de-termination of the overall T. vaginalis incidence. For a high-prev-alence population, Huppert and colleagues (10, 11) reported 83 to90% sensitivity for OSOM. One can hypothesize that the signifi-cant T. vaginalis TMA/T. vaginalis antigen discordance frequencyin our low-prevalence population is related to organism burden(12) or to T. vaginalis TMA detection in asymptomatic patients.However, 56.8% of OSOM-negative/T. vaginalis TMA-positivedata in the low-prevalence population were derived from symp-tomatic patients (determined by chart review to have pelvic pain,abdominal pain, vaginal discharge, irritation, or itching). This rateof symptom incidence did not differ from that for patients yield-Accepted manuscript posted online 9 December 2015CitationMunson KL, Napierala M, Munson E. 2016. Suboptimal Trichomonasvaginalis antigen test performance in a low-prevalence sexually transmittedinfection community. J Clin Microbiol 54:500–501. doi:10.1128/JCM.02949-15.Editor:M. J. LoeffelholzAddress correspondence to Erik Munson, Erik.Munson@wfhc.org.Copyright © 2016, American Society for Microbiology. All Rights Reserved.TABLE 1 Performance of OSOM Trichomonas rapid test and AptimaTrichomonas vaginalis assay in a low-prevalence STI communityOSOM Trichomonasrapid test resultNo. of specimens withindicated result byAptima Trichomonasvaginalis assayTotal no. ofspecimensPositive NegativePositive 20 1a 21Negative 37 1,363 1,400Total 57 1,364 1,421a Repeat Aptima Trichomonas vaginalis assay testing yielded a negative result.TABLE 2 Performance of OSOM Trichomonas rapid test and AptimaTrichomonas vaginalis assay in an increased-prevalence STI communityOSOM Trichomonasrapid test resultNo. of specimens withindicated result byAptima Trichomonasvaginalis assayTotal no. ofspecimensPositive NegativePositive 18 0 18Negative 3 77 80Total 21 77 98LETTER TO THE EDITORcrossmark500 jcm.asm.org February 2016 Volume 54 Number 2Journal of Clinical Microbiology on July 12, 2016 by Marquette University Librarieshttp://jcm.asm.org/Downloaded from ing positive OSOM and T. vaginalis TMA results (P 0.17; Table3). Moreover, symptomatic status did not impact concordant anddiscordant OSOM/T. vaginalis TMA frequencies in the increased-prevalence population (P 0.54).It has been documented that up to 70% of infections with T.vaginalis are asymptomatic (13). Detection of subclinicaltrichomoniasis is important, as studies have demonstrated persis-tent indolent infection via laboratory detection of the agent fol-lowing previously negative results in the face of sexual abstinence(14, 15). In further support of this paradigm, 27% of the 37 pa-tients with OSOM-negative/retrospective T. vaginalis TMA-posi-tive results in our low-prevalence population returned for clinicalevaluation of an STI (data not shown). In conclusion, poor reli-ability of OSOM in a low-prevalence population combined withthe inability to detect the organism in a significant proportion ofsymptomatic patients may warrant consideration of T. vaginalisTMA for accurate laboratory diagnosis of this protozoan.FUNDING INFORMATIONFunding was not provided by any external source.REFERENCES1. Cates W, Jr. 1999. Estimates of the incidence and prevalence of sexuallytransmitted diseases in the United States. The American Social HealthAssociation Panel. Sex Transm Dis 26(Suppl 4): S2–S7.2. Sekisui Diagnostics. 2013. OSOMTrichomonas rapid test package insert.Sekisui Diagnostics, San Diego, CA.3. Campbell L, Woods V, Lloyd T, Elsayed S, Church DL. 2008. Evaluationof the OSOM Trichomonas rapid test versus wet preparation examinationfor detection ofTrichomonas vaginalis vaginitis in specimens fromwomenwith a low prevalence of infection. J Clin Microbiol 46:3467–3469. http://dx.doi.org/10.1128/JCM.00671-08.4. College of American Pathologists. 2014. Vaginitis screen participant sum-mary, VS-A and VS-B. College of American Pathologists, Northfield, IL.5. Munson E, Bykowski H, Munson KL, Napierala M, Reiss PJ, Schell RF,Hryciuk JE. 2016. Clinical laboratory assessment of Mycoplasma genita-lium transcription-mediated amplification using primary female urogen-ital specimens. J Clin Microbiol 54:432–438. http://dx.doi.org/10.1128/JCM.02463-15.6. Hologic. 2012. APTIMATrichomonas vaginalis assay package insert. Ho-logic, San Diego, CA.7. Munson E, Napierala M, Basile J, Miller C, Burtch J, Hryciuk JE, SchellRF. 2010. Trichomonas vaginalis transcription-mediated amplification-based analyte-specific reagent and alternative target testing of primaryclinical vaginal saline suspensions. Diagn Microbiol Infect Dis 68:66–72.http://dx.doi.org/10.1016/j.diagmicrobio.2010.05.002.8. Napierala M, Munson E, Munson KL, Kramme T, Miller C, Burtch J,Olson R, Hryciuk JE. 2011. Three-year history of transcription-mediatedamplification-basedTrichomonas vaginalis analyte-specific reagent testingin a subacute care patient population. J Clin Microbiol 49:4190–4194.http://dx.doi.org/10.1128/JCM.05632-11.9. Munson E, Napierala M, Olson R, Endes T, Block T, Hryciuk JE, SchellRF. 2008. Impact of Trichomonas vaginalis transcription-mediated ampli-fication-based analyte-specific reagent testing in a metropolitan setting ofhigh sexually transmitted disease prevalence. J Clin Microbiol 46:3368–3374. http://dx.doi.org/10.1128/JCM.00564-08.10. Huppert JS, Batteiger BE, Braslins P, Feldman JA, Hobbs MM, SankeyHZ, Sena AC, Wendel KA. 2005. Use of an immunochromatographicassay for rapid detection of Trichomonas vaginalis in vaginal specimens. JClinMicrobiol 43:684–687. http://dx.doi.org/10.1128/JCM.43.2.684-687.2005.11. Huppert JS, Mortensen JE, Reed JL, Kahn JA, Rich KD, Miller WC,Hobbs MM. 2007. Rapid antigen testing compares favorably with tran-scription-mediated amplification assay for the detection of Trichomonasvaginalis in young women. Clin Infect Dis 45:194–198. http://dx.doi.org/10.1086/518851.12. Kurth A, Whittington WLH, Golden MR, Thomas KK, Holmes KK,Schwebke JR. 2004. Performance of a new, rapid assay for detection ofTrichomonas vaginalis. J Clin Microbiol 42:2940–2943. http://dx.doi.org/10.1128/JCM.42.7.2940-2943.2004.13. Sutton M, Sternberg M, Koumans EH, McQuillan G, Berman S,Markowitz L. 2007. The prevalence of Trichomonas vaginalis infectionamong reproductive-age women in the United States, 2001-2004. ClinInfect Dis 45:1319–1326. http://dx.doi.org/10.1086/522532.14. Peterman TA, Tian LH, Metcalf CA, Malotte CK, Paul SM, Douglas JM,Jr, RESPECT-2 Study Group. 2009. Persistent, undetected Trichomonasvaginalis infections? Clin Infect Dis 48: 259–260. http://dx.doi.org/10.1086/595706.15. Gatski M, Kissinger P. 2010. Observation of probable persistent, unde-tected Trichomonas vaginalis infection among HIV-positive women. ClinInfect Dis 51:114–115. http://dx.doi.org/10.1086/653443.TABLE 3 Symptomatic status of Aptima Trichomonas vaginalis assay-positive patients from low- and increased-prevalence STI communitiesstratified by OSOM Trichomonas rapid test resultOSOM Trichomonasrapid test resultNo. (%) of patients positive by AptimaTrichomonas vaginalis assay exhibitingsymptomsLow-prevalencecommunityIncreased-prevalencecommunityPositive 15 (75.0) 16 (88.9)Negative 21 (56.8)a 3 (100.0)ba P 0.17, versus those with positive OSOM result; significance test of proportions.b P 0.54, versus those with positive OSOM result; significance test of proportions.Letter to the EditorFebruary 2016 Volume 54 Number 2 jcm.asm.org 501Journal of Clinical Microbiology on July 12, 2016 by Marquette University Librarieshttp://jcm.asm.org/Downloaded from 

Suboptimal Trichomonas vaginalis Antigen Test Performance in a Low-Prevalence Sexually Transmitted Infection Community

Kimber L. Munson

Maureen Napierala

Erik Munson

Crossref

Suboptimal Trichomonas vaginalis Antigen Test Performance in a Low-Prevalence Sexually Transmitted Infection Community

Abstract

Similar works

Full text

Available Versions

epublications@Marquette

Crossref