[{"data":1,"prerenderedAt":180},["ShallowReactive",2],{"content-route-/en/research/elvy-aptima-vaginitis-assays-2025":3},{"state":4,"owner":4,"route":5,"locale":6,"template":7,"content":21,"projection":163,"alternates":171},"target","/en/research/elvy-aptima-vaginitis-assays-2025","en-US",{"kind":8,"family":8,"sectionKeys":9},"research-summary",[10,11,12,13,14,15,16,17,18,19,20],"bottom-line","why-source-matters","study-population","tested","results","applicability","limitations","contribution","practical-change","funding-conflicts","source",{"kind":8,"title":22,"description":23,"firstPublished":24,"evidenceAsOf":24,"lastUpdated":24,"changeNote":25,"research":26,"relations":65,"body":69},"Vaginal yeast infection testing: Aptima assay study","Vaginal yeast infection testing: one lab compared Aptima with Gram stain and culture; a positive result alone did not show the cause of symptoms.","2026-10-08","Published a contextual summary of a single-laboratory assay evaluation; no claim or practical action changed.",{"sourceId":27,"studyType":28,"population":29,"sampleScale":30,"contribution":31,"contributionRationale":32,"relatedEvidenceMap":33,"funding":34,"conflicts":35,"paperDate":36,"results":37,"applicability":44,"limitations":51,"practicalChange":64},"elvy-aptima-vaginitis-assays-2025","Single-laboratory diagnostic assay evaluation with a retrospective BV treatment audit","Routine diagnostic vaginal-swab specimens from patients eligible at ages 14–60 years at one laboratory in Dunedin, New Zealand; the 300-specimen cohort was aged 15–58 years (mean 30), and included 16/300 (5%) asymptomatic screening specimens.","300 specimens; paired comparisons included 285 BV results, 271 CV Gram-stain results, 296 CV culture results, and 287 TV results. The separate BV audit contained 25,025 lab results.","contextual","This single-laboratory study adds comparator-specific data on Aptima detection and routine microscopy/culture, but neither its test results nor its retrospective BV prescribing audit establishes patient benefit or whether detected yeast caused symptoms. It does not replace guideline evidence or change practical guidance.","/en/research/evidence/recurrent-vaginal-yeast-symptoms","No specific grant is reported. The acknowledgments state that Hologic supplied study reagents and reviewed the study design; it had no role in performing the study, analyzing results, or writing the manuscript.","The authors declare no conflict of interest.","2024-11-19",[38,39,40,41,42,43],"Among 271 paired results, Aptima CV sensitivity versus consensus Gram stain was 35/35 (100%) and specificity was 197/236 (83.5%); Gram-stain yeast colonization was counted as CV-negative.","Among 296 paired results, sensitivity versus culture was 78/81 (96.3%) and specificity was 196/215 (91.2%); scanty yeast growth was counted as culture-negative.","Aptima CV was positive in 97/296 (32.8%) specimens, compared with CV on consensus Gram stain in 35/271 (12.9%) and positive culture in 81/296 (27.3%). Aptima BV+CV was reported in 38/296 (12.8%), compared with 9/271 (3.3%) by Gram stain and 20/296 (6.8%) by culture.","Of 297 samples with two Nugent readings, 60 (20%) had discordant categories. Among 46 indeterminate Nugent results, Aptima BV was positive in 26/46 (56.5%) and negative in 20/46 (43.5%).","In the retrospective audit, BV-effective antibiotics were prescribed within 30 days to 97/147 (66%) patients sampled after a positive result, 38/147 after an indeterminate result, and 7/147 (5%) after a negative result; this was a prescribing measure, not a patient outcome.","In the retrospective BV audit, 25,025 results were reported. Methods gives the period as 1 June 2021–1 June 2023, while Results gives 1 September 2021–30 August 2023. Results prose reports 78 (27.2%) BV cases, whereas Table 1 and the later comparison report 79/285 (27.7%); the paper does not resolve either discrepancy.",{"appliesTo":45,"doesNotApplyTo":48},[46,47],"Comparing these Aptima assay results with the stated Gram-stain, Nugent-score, and culture methods in this one-laboratory New Zealand setting.","Understanding how the reported CV assay performance changes with the reference method and its classification rules.",[49,50],"Establishing that a positive yeast result caused a person's symptoms; molecular detection and culture do not distinguish colonization from infection.","Predicting patient benefit, choosing treatment, establishing performance in other laboratories or collection methods, or estimating accuracy for individual Candida species or yeasts outside the assay's target set.",[52,55,58,61],{"finding":53,"limitation":54},"The evaluation included 300 routine specimens at one laboratory, with ages 15–58 in the analyzed cohort.","It did not test performance by clinician- versus self-collection, and results may not transfer to other laboratories, populations, or assay workflows.",{"finding":56,"limitation":57},"Aptima detected CV more often than Gram stain or culture, while reported sensitivity and specificity differed by comparator.","CV has no agreed gold-standard comparator; yeast colonization and scanty culture growth were classified as negative, and neither molecular detection nor culture establishes symptomatic infection.",{"finding":59,"limitation":60},"The assay targets a Candida spp group (C. albicans, C. tropicalis, C. parapsilosis, and C. dubliniensis) separately from N. glabrata and T. vaginalis; it does not identify which Candida species within the group is present.","The study did not assess assay accuracy by Candida species. MALDI-TOF identification was not routine except when recurrent or refractory CV was noted on the request form, and the assay does not target every yeast.",{"finding":62,"limitation":63},"The paper reports a retrospective BV prescribing audit alongside the assay evaluation.","It did not prospectively assess symptom outcomes, treatment benefit, adverse outcomes, or the clinical impact of switching methods; the audit period and BV count contain unresolved internal discrepancies.","No practical change. The study adds context about assay performance against specific reference methods but does not establish that a positive result explains symptoms, that one test is universally best, or that clinical outcomes improve.",[66],{"group":67,"route":33,"label":68},"evidence","Recurrent vaginal yeast symptoms evidence map",{"type":70,"value":71,"toc":159},"minimark",[72,80,86,92,98,110,116,122,128,134,140],[73,74,76],"content-section",{"section-key":10,"title":75},"Bottom line",[77,78,79],"p",{},"In this single-laboratory study, Aptima detected yeast more often than Gram stain or culture. A positive test alone cannot show that detected yeast caused someone's symptoms.",[73,81,83],{"section-key":11,"title":82},"Why this source matters",[77,84,85],{},"The study shows that reported performance depends on the comparator and its rules. It also makes the gap between detecting yeast and establishing symptomatic infection important to keep visible.",[73,87,89],{"section-key":12,"title":88},"Study type and population",[77,90,91],{},"This was a diagnostic assay evaluation using 300 anonymized routine vaginal-swab specimens at one laboratory in Dunedin, New Zealand, collected from 10 April to 19 May 2023. Eligibility was ages 14–60 years; the cohort was aged 15–58 years (mean 30). Request forms listed discharge in 218/300 (73%), itch in 67/300 (22%), and pain in 46/300 (15%); 16/300 (5%) were asymptomatic screening before termination of pregnancy and 17/300 (6%) were pregnant. Paired comparisons included 285 BV results, 271 CV Gram-stain results, 296 CV culture results, and 287 TV results.",[73,93,95],{"section-key":13,"title":94},"What was tested",[77,96,97],{},"The Hologic Panther Aptima BV and CV/TV assays were compared with consensus Gram stain and Nugent scoring for BV, consensus Gram stain and yeast culture for CV, and the laboratory's Aptima TV assay for trichomoniasis. The CV/TV assay targets a Candida spp group (C. albicans, C. tropicalis, C. parapsilosis, and C. dubliniensis), N. glabrata, and T. vaginalis; it distinguishes the Candida spp target group from N. glabrata but does not identify which Candida species is present. Yeast colonization counted as CV-negative in the Gram-stain comparison, and scanty culture growth counted as culture-negative. A separate retrospective audit reviewed 25,025 BV results and sampled 150 patients per BV category for prescription records; 3 records per category were unavailable, leaving 147 per group.",[73,99,101,104,107],{"section-key":14,"title":100},"Results",[77,102,103],{},"Against consensus Gram stain, Aptima CV sensitivity was 35/35 (100%) and specificity was 197/236 (83.5%) among 271 paired results. Against culture, sensitivity was 78/81 (96.3%) and specificity was 196/215 (91.2%) among 296 paired results. Aptima CV was positive in 97/296 (32.8%) specimens, compared with 35/271 (12.9%) categorized as CV by Gram stain and 81/296 (27.3%) positive cultures. Aptima BV+CV was reported in 38/296 (12.8%) specimens, compared with 9/271 (3.3%) by Gram stain and 20/296 (6.8%) by culture.",[77,105,106],{},"Of 297 specimens with two Nugent readings, 60 (20%) had different categories. Among 46 indeterminate Nugent results, 26/46 (56.5%) were Aptima BV-positive and 20/46 (43.5%) were negative. In the audit's 147 patients per group, BV-effective antibiotics were prescribed within 30 days for 97/147 (66%) with a positive result, 38/147 with an indeterminate result, and 7/147 (5%) with a negative result; this was a prescribing measure, not a patient outcome.",[77,108,109],{},"The audit period differs within the paper: Methods states 1 June 2021–1 June 2023 and Results states 1 September 2021–30 August 2023. Results prose reports 78 (27.2%) BV cases, while Table 1 and the later comparison report 79/285 (27.7%). Neither discrepancy is resolved in the article.",[73,111,113],{"section-key":15,"title":112},"Applicability",[77,114,115],{},"These data describe the stated Aptima assays compared with these laboratory methods in one New Zealand laboratory. They do not show that a positive Candida result was causing symptoms, identify which test is best in every setting, or establish that changing tests improves patient outcomes.",[73,117,119],{"section-key":16,"title":118},"Limitations",[77,120,121],{},"This was a single-laboratory evaluation of 300 specimens. The study did not compare clinician-collected with self-collected performance, evaluate assay accuracy by individual Candida species, or prospectively measure patient outcomes after a change in testing. MALDI-TOF identification was not routine except when recurrent or refractory CV was noted on the request form. The assay distinguishes the Candida spp target group from N. glabrata but does not identify which Candida species within that group is present, and it does not target every yeast. CV has no agreed gold-standard reference method, and results depend on comparator rules; colonization and scanty growth were counted as negative in the respective comparisons. The authors note that neither culture nor molecular detection distinguishes yeast colonization from infection. The retrospective BV audit measures prescribing, not clinical benefit, and its date range and one BV case count are inconsistent within the paper.",[73,123,125],{"section-key":17,"title":124},"Contribution to the current conclusion",[77,126,127],{},"This study is contextual. It adds comparator-specific diagnostic results and repeat-reading data, but it does not establish patient benefit, a universal testing standard, or whether detected yeast caused symptoms.",[73,129,131],{"section-key":18,"title":130},"Practical change",[77,132,133],{},"No practical change. A molecular result should not be treated on its own as proof that yeast caused symptoms, and this one-laboratory study does not change the existing guidance on confirmation or reassessment.",[73,135,137],{"section-key":19,"title":136},"Funding and conflicts",[77,138,139],{},"No specific grant is reported. The acknowledgments state that Hologic supplied reagents and reviewed the study design; it had no role in performing the study, analyzing results, or writing the manuscript. The authors declare no conflict of interest.",[73,141,143],{"section-key":20,"title":142},"Source",[77,144,145,146,150,151,158],{},"Juliet Elvy and colleagues. “Clinical laboratory evaluation of the Hologic Panther Aptima BV and CV/TV assays for the diagnosis of vaginitis in Dunedin, Aotearoa New Zealand.” ",[147,148,149],"em",{},"Microbiology Spectrum",". 2025;13(1):e01274-24. ",[152,153,157],"a",{"href":154,"rel":155},"https://pmc.ncbi.nlm.nih.gov/articles/PMC11723574/",[156],"nofollow","Read the original article"," (published online 19 November 2024; January 2025 issue; DOI: 10.1128/spectrum.01274-24).",{"title":160,"searchDepth":161,"depth":161,"links":162},"",2,[],{"sources":164,"claims":169,"safety":170},[165],{"sourceId":27,"title":166,"canonicalId":167,"canonicalUrl":154,"publisher":149,"sourceType":168,"publicationDate":36,"lastChecked":24},"Clinical laboratory evaluation of the Hologic Panther Aptima BV and CV/TV assays for the diagnosis of vaginitis in Dunedin, Aotearoa New Zealand","PMID:39560428; DOI:10.1128/spectrum.01274-24","diagnostic-study",[],[],[172,175,178],{"rel":173,"hreflang":6,"href":174},"alternate","https://candipedia.org/en/research/elvy-aptima-vaginitis-assays-2025/",{"rel":173,"hreflang":176,"href":177},"pl-PL","https://candipedia.org/pl/research/testy-aptima-diagnostyka-grzybicy-pochwy-2025/",{"rel":173,"hreflang":179,"href":174},"x-default",1791487498282]