Research Article
Comparison of the Effectiveness of VGTest™ and Standard Microbiological Tests in the Diagnosis of the Vaginal Infections
Abstract
Aim: To determine the effectiveness of the VGTest™ by comparing it with standard microbiological tests in patients clinically diagnosed with vaginitis.
Material and method: One hundred sixty-five patients who were admitted to the gynaecology outpatient clinic with symptoms of vaginitis and clinically diagnosed to have vaginitis were included in the study. The presence of blastospore-pseudohyphae formation on Gram stain for vaginal candidiasis, Nugent score for bacterial vaginosis, and direct microscopy for trichomonas vaginalis were used as laboratory tests in diagnosing vaginitis. A point-of-care VGTest™ was concurrently performed with the standard laboratory tests during patients' vaginal examinations. Symptoms and clinical diagnosis of vaginitis were considered as the gold standard method, and the effectiveness of the VGTest™ was evaluated in determining vaginitis causes by comparing with the standard microbiological laboratory tests.
Results: According to causing factors of vaginitis, 77 out of 165 patients (46.7%) had clinical vaginal candidiasis, 126 patients (76,4%) had bacterial vaginosis, and 16 (9.7%) patients had trichomonas vaginalis. The sensitivity and specificity of standard laboratory tests for bacterial vaginosis were 39.7% and 76.9%, for vaginal candidiasis 68.8% and 94.3%, and for trichomonas vaginalis 25.0% and 100%, respectively. The sensitivity and specificity of the VGTest™ for bacterial vaginosis were 66.7% and 74.4%, for vaginal candidiasis 29.9% and 85,2%, and for trichomonas vaginalis 62.5% and 93.3%, respectively.
Conclusion: VGTest ™, which is a-point-of-care diagnostic method, is a highly sensitive method especially in the diagnosis of bacterial vaginosis and trichomonas vaginalis, in order to make a rapid diagnosis and to be able to treat the agent promptly.
Keywords
Vaginal infections VGTest™ efficiency bacterial vaginosis trichomonas vaginalis vaginal candidiasis
References
- Diseases Characterized by Vaginal Discharge, 2015 Sexually Transmitted Diseases Treatment Guidelines, Available from: http://www.cdc.gov/std/tg2015/vaginal-discharge.htm (Erişim: 15.06.2020)
- Sobel JD. Vulvovaginitis in healthy women. Compr Ther 1999; 25:335-46.
- Livengood CH. Bacterial vaginosis: an overview for 2009. Rev Obstet Gynecol 2009; 2:28-37.
- Atashili J, Poole C, Ndumbe PM, Adimora AA, Smith JS. Bacterial vaginosis and HIV acquisition: A meta-analysis of published studies. AIDS 2008; 22:1493-1501.
- Karpas Z, Chaim W, Gdalevsky R, Tilman B, Lorber A. Novel application for ion mobility spectrometry: diagnosing vaginal infections through measurement of biogenic amines. Anal Chim Acta 2002; 474:115–1123.
- Wolrath H, Forsum U, Larsson PG, Boren H. Analysis of bacterial vaginosis related amines in vaginal fluid by gas chromatography and mass spectrometry. J Clin Microbiol 2001; 39:4026-4031.
- Fredricks DN, Fiedler TL, Marrazzo JM. Molecular identification of bacteria associated with bacterial vaginosis. N Engl J Med 2005; 353:1899-1911.
- Sobel JD, Karpas Z, Lorber A. Diagnosing vaginal infections through measurement of biogenic amines by ion mobility spectrometry. Eur J Obstet Gynecol Reprod Biol 2012; 163:81-84.
- Blankenstein T, Lytton SD, Leidl B, Atweh E, Friese K, Mylonas I. Point-of-care (POC) diagnosis of bacterial vaginosis (BV) using VGTestTM ion mobility spectrometry (IMS) in a routine ambulatory care gynecology clinic. Arch Gynecol Obstet 2015; 292:355-62.
- Workowski KA, Bolan GA, Centers for Disease Control and Prevention. Sexually transmitted diseases treatment guidelines, 2015. MMWR Recomm Rep 2015; 64:1-137.
- No authors listed. National Guideline for the Management of Vulvovaginal Candidiasis. Clinical Effectiveness Group (Association of Genitourinary Medicine and the Medical Society for the study of venereal diseases) Sex Transm Infect 1999; 75 Suppl 1:S19-20.
- Sobel JD. Epidemiology and pathogenesis of recurrent vulvovaginal candidiasis. Am J Obstet Gynecol 1985; 152:924-935.
- Dan M, Leshem Y, Yeshaya A. Performance of a rapid yeast test in detecting Candida spp. in the vagina. Diagn Microbiol Infect Dis 2010;67:52-55.
- Chatwani AJ, Mehta R, Hassan S, Rahimi S, Jeronis S, Dandolu V. Rapid testing for vaginal yeast detection: A prospective study. Am J Obstet Gynecol 2007; 196:309.e1-4.
- Marot-Leblond A, Nail-Billaud S, Pilon F, Beucher B,, Poulain D, Robert R. Efficient diagnosis of vulvovaginal candidiasis by use of a new rapid immunochromatography test. J Clin Microbiol 2009; 47:3821-3825.
- Tabrizi SN, Pirotta MV, Rudland E, Garland SM. Detection of Candida species by PCR in self-collected vaginal swabs of women after taking antibiotics. Mycoses 2006; 49:523-524.
- Gratacós E, Figueras F, Barranco M, et al. Prevalence of bacterial vaginosis and correlation of clinical to Gram stain diagnostic criteria in low risk pregnant women. Eur J Epidemiol 1999; 15:913-6.
- Eschenbach DA, Hillier S, Critchlow C, Stevens C, DeRouen T, Holmes KK. Diagnosis and clinical manifestations of bacterial vaginosis. Am J Obstet Gynecol 1988; 158:819-828.
- Mohammadzadeh F, Dolatian M, Jorjani M, Alavi Majd H. Diagnostic value of Amsel's clinical criteria for diagnosis of bacterial vaginosis. Glob J Health Sci 2014; 7:8-14.
- Cauci S, Driussi S, De Santo D et al. Prevalence of bacterial vaginosis and vaginal flora changes in peri- and post-menopausal women. J Clin Microbiol 2002; 40:2147-2152.
- Tamrakar R, Yamada T, Furuta I et al. Association between Lactobacillus Species and Bacterial Vaginosis-related bacteria, and Bacterial Vaginosis scores in pregnant Japanese women. BMC Infect Dis 2007; 7:128.
- Sheiness D, Dix K, Watanabe S, Hillier SL. High levels of Gardnerella vaginalis detected with an oligonucleotide probe combined with elevated pH as a diagnostic indicator of bacterial vaginosis. J Clin Microbiol 1992; 30:642-648.
- Myziuk L, Romanowski B, Johnson SC. BVBlue test for diagnosis of bacterial vaginosis. J Clin Microbiol 2003; 41:1925-8.
- Sumeksri P, Koprasert C, Panichkul S. BVBLUE test for diagnosis of bacterial vaginosis in pregnant women attending antenatal care at Phramongkutklao Hospital. J Med Assoc Thai 2005; 88 Suppl 3:S7-13.
- Briselden AM, Hillier SL. Evaluation of affirm VP Microbial Identification Test for Gardnerella vaginalis and Trichomonas vaginalis. J Clin Microbiol 1994; 32:148-152.
- Evaluation of Automatic Class III Designation for BD MAX Vaginal Panel. Decison Summary. US Food and Drug Administration. Available on: www.accessdata.fda.gov/cdrh_docs/reviews/DEN160001.pdf (Erişim: 15.06.2020).
- Chen KCS, Forsyth PS, Buchanan TM, Holmes KK. Amine content of vaginal fluid from untreated and treated patients with non-specific vaginitis. J Clin Invest 1979; 63:828-835.
- Sanderson BE, White E, Baldson MJ. Amine content of vaginal fluid from patients with Trichomoniasis and Gardnerella associated non-specific vaginitis. Br J Vener Dis 1983; 59:302-305.
- Jones BM, aI-Fattani M, Gooch H. The determination of amines in the vaginal secretions of women in health and disease. Int J STD AIDS 1994; 5:52-55.
- Nelson TM, Borgogna JLC, Brotman RM, Ravel J, Walk ST, Yeoman CJ. Vaginal biogenic amines: Biomarkers of bacterial vaginosis or precursors to vaginal dysbiosis? Front Physiol 2015; 6:253.
- Nye MB, Schwebke JR, Body BA. Comparison of APTIMA Trichomonas vaginalis transcription-mediated amplification to wet mount microscopy, culture, and polymerase chain reaction for diagnosis of trichomoniasis in men and women. Am J Obstet Gynecol 2009; 200:188.e1-7.
- Krieger JN, Tam MR, Stevens CE, et al. Diagnosis of Trichomoniasis. Comparison of conventional wet-mount examination with cytologic studies, cultures, and monoclonal antibody staining of direct specimens. JAMA 1988; 259:1223-1227.
- Stoner KA, Rabe LK, Meyn LA, Hillier SL. Survival of Trichomonas vaginalis in wet preparation and on wet mount. Sex Transm Infect 2013;89:485-488.
- Sutton M, Sternberg M, Koumans EH, McQuillan G, Berman S, Markowitz L. The prevalence of Trichomonas vaginalis infection among reproductive-age women in the United States, 2001-2004. Clin Infect Dis 2007; 45:1319-1326.
- Ginocchio CC, Chapin K, Smith JS, et al. Prevalence of Trichomonas vaginalis and coinfection with Chlamydia Trachomatis and neisseria gonorrhoeae in the United States as determined by the Aptima Trichomonas vaginalis nucleic acid amplification assay. J Clin Microbiol 2012; 50:2601-2608.
- Schwebke J, Merriweather A, Massingale S, Scisney M, Hill C, Getman D. Screening for Trichomonas vaginalis in a large high-risk population: Prevalence among men and women determined by nucleic acid amplification testing. Sex Transm Dis 2018; 45:e23-e24.
- Kalkancı A, Çiftçi B, Biri A, Kuştimur S, Güner H. Vajinit ön tanısı almış olgularda vajinal kültür sonuçlarının etkenlerine göre dağılımı. Turkiye Klinikleri J Gynecol Obst 2005; 15:137-139.
- Değerli S, Şalk S, Malatyalı E. Sivas'ta vajinit ön tanılı hastalarda Trichomonas vaginalis sıklığı. Turkiye Parazitol Derg 2011; 35:145-147. doi: 10.5152/tpd.2011.36
Vajinal Enfeksiyonların Tanısında VGTest™ ve Standart Mikrobiyolojik Testlerin Etkinliğinin Karşılaştırılması
Abstract
Amaç: Klinik olarak vajinit tanısı almış hastalarda VGTest™'in standart mikrobiyolojik tanı testleri ile karşılaştırılarak vajinite neden olan mikroorganizmaları belirlemesindeki etkinliğinin saptanması.
Gereç ve Yöntem: Hastanemiz Jinekoloji Poliklinikleri’ne vajinit semptomları ile başvuran ve klinik olarak vajinit tanısı almış 165 hasta çalışmaya dahil edildi. Standart mikrobiyolojik laboratuvar değerlendirmelerinde; vajinal kandidiazis için gram boyamada blastospor-pseudöhif yapılarının varlığı, bakteriyel vajinozis için Nugent skoru, trikomonas vajinalis için fresh preparatta direkt mikroskopi kullanıldı. Hastaların hepsine muayeneleri sırasında standart laboratuvar değerlendirmeleri ile eş zamanlı olarak hasta başı VGTest™ değerlendirmesi yapıldı. Altın standart olarak semptom ve klinik tanı pozitifliği alındı ve standart mikrobiyolojik laboratuvar değerlendirmeleri ile VGTest™’in vajinit etkenini belirlemedeki etkinliği kıyaslanarak değerlendirildi.
Bulgular: Hastalar vajinit etkenlerine göre gruplara ayrıldığında 165 hastanın 77'sinde (%46,7) klinik olarak vajinal kandidiazis, 126'sında (%76,4) bakteriyel vajinozis, 16 hastada ise (%9,7) trikomonas vajinalis saptandı. Standart mikrobiyolojik laboratuvar testlerinin bakteriyel vajinozis için duyarlılığı %39,7, özgüllüğü %76,9, vajinal kandidiazis için duyarlılığı %68,8, özgüllüğü %94,3, trikomonas vajinalis için duyarlılığı %25,0, özgüllüğü %100 olarak saptanırken VGTest™’in bakteriyel vajinozis için duyarlılığı %66,7, özgüllüğü %74,4, vajinal kandidiazis için duyarlılığı %29,9, özgüllüğü %85,2, trikomonas vajinalis için duyarlılığı %62,5, özgüllüğü %93,3 olarak belirlendi.
Sonuç: Hızlı tanı koyulabilmesi ve etkene yönelik tedavinin ivedilikle yapılabilmesi açısından hasta başı tanı yöntemi olan VGTest™ özellikle bakteriyel vajinozis ve trikomonas vajinalis'in tanısında yüksek duyarlılığa sahip bir yöntemdir.
References
- Diseases Characterized by Vaginal Discharge, 2015 Sexually Transmitted Diseases Treatment Guidelines, Available from: http://www.cdc.gov/std/tg2015/vaginal-discharge.htm (Erişim: 15.06.2020)
- Sobel JD. Vulvovaginitis in healthy women. Compr Ther 1999; 25:335-46.
- Livengood CH. Bacterial vaginosis: an overview for 2009. Rev Obstet Gynecol 2009; 2:28-37.
- Atashili J, Poole C, Ndumbe PM, Adimora AA, Smith JS. Bacterial vaginosis and HIV acquisition: A meta-analysis of published studies. AIDS 2008; 22:1493-1501.
- Karpas Z, Chaim W, Gdalevsky R, Tilman B, Lorber A. Novel application for ion mobility spectrometry: diagnosing vaginal infections through measurement of biogenic amines. Anal Chim Acta 2002; 474:115–1123.
- Wolrath H, Forsum U, Larsson PG, Boren H. Analysis of bacterial vaginosis related amines in vaginal fluid by gas chromatography and mass spectrometry. J Clin Microbiol 2001; 39:4026-4031.
- Fredricks DN, Fiedler TL, Marrazzo JM. Molecular identification of bacteria associated with bacterial vaginosis. N Engl J Med 2005; 353:1899-1911.
- Sobel JD, Karpas Z, Lorber A. Diagnosing vaginal infections through measurement of biogenic amines by ion mobility spectrometry. Eur J Obstet Gynecol Reprod Biol 2012; 163:81-84.
- Blankenstein T, Lytton SD, Leidl B, Atweh E, Friese K, Mylonas I. Point-of-care (POC) diagnosis of bacterial vaginosis (BV) using VGTestTM ion mobility spectrometry (IMS) in a routine ambulatory care gynecology clinic. Arch Gynecol Obstet 2015; 292:355-62.
- Workowski KA, Bolan GA, Centers for Disease Control and Prevention. Sexually transmitted diseases treatment guidelines, 2015. MMWR Recomm Rep 2015; 64:1-137.
- No authors listed. National Guideline for the Management of Vulvovaginal Candidiasis. Clinical Effectiveness Group (Association of Genitourinary Medicine and the Medical Society for the study of venereal diseases) Sex Transm Infect 1999; 75 Suppl 1:S19-20.
- Sobel JD. Epidemiology and pathogenesis of recurrent vulvovaginal candidiasis. Am J Obstet Gynecol 1985; 152:924-935.
- Dan M, Leshem Y, Yeshaya A. Performance of a rapid yeast test in detecting Candida spp. in the vagina. Diagn Microbiol Infect Dis 2010;67:52-55.
- Chatwani AJ, Mehta R, Hassan S, Rahimi S, Jeronis S, Dandolu V. Rapid testing for vaginal yeast detection: A prospective study. Am J Obstet Gynecol 2007; 196:309.e1-4.
- Marot-Leblond A, Nail-Billaud S, Pilon F, Beucher B,, Poulain D, Robert R. Efficient diagnosis of vulvovaginal candidiasis by use of a new rapid immunochromatography test. J Clin Microbiol 2009; 47:3821-3825.
- Tabrizi SN, Pirotta MV, Rudland E, Garland SM. Detection of Candida species by PCR in self-collected vaginal swabs of women after taking antibiotics. Mycoses 2006; 49:523-524.
- Gratacós E, Figueras F, Barranco M, et al. Prevalence of bacterial vaginosis and correlation of clinical to Gram stain diagnostic criteria in low risk pregnant women. Eur J Epidemiol 1999; 15:913-6.
- Eschenbach DA, Hillier S, Critchlow C, Stevens C, DeRouen T, Holmes KK. Diagnosis and clinical manifestations of bacterial vaginosis. Am J Obstet Gynecol 1988; 158:819-828.
- Mohammadzadeh F, Dolatian M, Jorjani M, Alavi Majd H. Diagnostic value of Amsel's clinical criteria for diagnosis of bacterial vaginosis. Glob J Health Sci 2014; 7:8-14.
- Cauci S, Driussi S, De Santo D et al. Prevalence of bacterial vaginosis and vaginal flora changes in peri- and post-menopausal women. J Clin Microbiol 2002; 40:2147-2152.
- Tamrakar R, Yamada T, Furuta I et al. Association between Lactobacillus Species and Bacterial Vaginosis-related bacteria, and Bacterial Vaginosis scores in pregnant Japanese women. BMC Infect Dis 2007; 7:128.
- Sheiness D, Dix K, Watanabe S, Hillier SL. High levels of Gardnerella vaginalis detected with an oligonucleotide probe combined with elevated pH as a diagnostic indicator of bacterial vaginosis. J Clin Microbiol 1992; 30:642-648.
- Myziuk L, Romanowski B, Johnson SC. BVBlue test for diagnosis of bacterial vaginosis. J Clin Microbiol 2003; 41:1925-8.
- Sumeksri P, Koprasert C, Panichkul S. BVBLUE test for diagnosis of bacterial vaginosis in pregnant women attending antenatal care at Phramongkutklao Hospital. J Med Assoc Thai 2005; 88 Suppl 3:S7-13.
- Briselden AM, Hillier SL. Evaluation of affirm VP Microbial Identification Test for Gardnerella vaginalis and Trichomonas vaginalis. J Clin Microbiol 1994; 32:148-152.
- Evaluation of Automatic Class III Designation for BD MAX Vaginal Panel. Decison Summary. US Food and Drug Administration. Available on: www.accessdata.fda.gov/cdrh_docs/reviews/DEN160001.pdf (Erişim: 15.06.2020).
- Chen KCS, Forsyth PS, Buchanan TM, Holmes KK. Amine content of vaginal fluid from untreated and treated patients with non-specific vaginitis. J Clin Invest 1979; 63:828-835.
- Sanderson BE, White E, Baldson MJ. Amine content of vaginal fluid from patients with Trichomoniasis and Gardnerella associated non-specific vaginitis. Br J Vener Dis 1983; 59:302-305.
- Jones BM, aI-Fattani M, Gooch H. The determination of amines in the vaginal secretions of women in health and disease. Int J STD AIDS 1994; 5:52-55.
- Nelson TM, Borgogna JLC, Brotman RM, Ravel J, Walk ST, Yeoman CJ. Vaginal biogenic amines: Biomarkers of bacterial vaginosis or precursors to vaginal dysbiosis? Front Physiol 2015; 6:253.
- Nye MB, Schwebke JR, Body BA. Comparison of APTIMA Trichomonas vaginalis transcription-mediated amplification to wet mount microscopy, culture, and polymerase chain reaction for diagnosis of trichomoniasis in men and women. Am J Obstet Gynecol 2009; 200:188.e1-7.
- Krieger JN, Tam MR, Stevens CE, et al. Diagnosis of Trichomoniasis. Comparison of conventional wet-mount examination with cytologic studies, cultures, and monoclonal antibody staining of direct specimens. JAMA 1988; 259:1223-1227.
- Stoner KA, Rabe LK, Meyn LA, Hillier SL. Survival of Trichomonas vaginalis in wet preparation and on wet mount. Sex Transm Infect 2013;89:485-488.
- Sutton M, Sternberg M, Koumans EH, McQuillan G, Berman S, Markowitz L. The prevalence of Trichomonas vaginalis infection among reproductive-age women in the United States, 2001-2004. Clin Infect Dis 2007; 45:1319-1326.
- Ginocchio CC, Chapin K, Smith JS, et al. Prevalence of Trichomonas vaginalis and coinfection with Chlamydia Trachomatis and neisseria gonorrhoeae in the United States as determined by the Aptima Trichomonas vaginalis nucleic acid amplification assay. J Clin Microbiol 2012; 50:2601-2608.
- Schwebke J, Merriweather A, Massingale S, Scisney M, Hill C, Getman D. Screening for Trichomonas vaginalis in a large high-risk population: Prevalence among men and women determined by nucleic acid amplification testing. Sex Transm Dis 2018; 45:e23-e24.
- Kalkancı A, Çiftçi B, Biri A, Kuştimur S, Güner H. Vajinit ön tanısı almış olgularda vajinal kültür sonuçlarının etkenlerine göre dağılımı. Turkiye Klinikleri J Gynecol Obst 2005; 15:137-139.
- Değerli S, Şalk S, Malatyalı E. Sivas'ta vajinit ön tanılı hastalarda Trichomonas vaginalis sıklığı. Turkiye Parazitol Derg 2011; 35:145-147. doi: 10.5152/tpd.2011.36
There are 38 citations in total.
Details
| Primary Language | Turkish |
|---|---|
| Subjects | Obstetrics and Gynaecology |
| Journal Section | Research Article |
| Authors | |
| Publication Date | June 29, 2020 |
| Acceptance Date | June 15, 2020 |
| Published in Issue | Year 2020 Volume: 2 Issue: 2 |
