Comparison between Aptima Assays (Hologic) and the Allplex STI Essential Assay (Seegene) for the diagnosis of Sexually transmitted infections

Salazar, Adolfo de; Espadafor, Beatriz; Fuentes-López, Ana; Barrientos‐Durán, Antonio; Salvador, L.A.; Alvarez, Marta; García, Féderico

doi:10.1371/journal.pone.0222439

Cited by 26 publications

(10 citation statements)

References 29 publications

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“…The sensitivity and specificity were higher than 95% for the diagnosis of trichomoniasis, in accordance with previous evaluations of T. vaginalis detection in Allplex™ STI Essential Assay (Seegene), which showed 100% agreement with the Aptima Trichomonas Assay (Hologic, San Diego, CA, USA) 18 …”

Section: Discussionsupporting

confidence: 90%

Clinical validation of a new molecular test (Seegene Allplex™ Vaginitis) for the diagnosis of vaginitis: a cross‐sectional study

Vieira‐Baptista

Silva²,

Costa³

et al. 2021

BJOG

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Objective To validate the use of Seegene Allplex™ Vaginitis assay in the diagnosis of candidiasis, bacterial vaginosis (BV) and trichomoniasis. Design Cross‐sectional, prospective study conducted in a single centre. Setting Outpatient clinic of a gynaecology department. Population Consecutive symptomatic and asymptomatic women (18–60 years of age). Methods Comparison of the assay test with the reference standards for the diagnosis of vaginitis (cultures for yeasts, Nugent for BV and nucleic acid amplification test for trichomoniasis). Main outcome measures Performance of the investigational assay, in comparison with the reference standards for the diagnosis of the presence of Candida spp., Trichomonas vaginalis and BV. Secondary objectives are the evaluation of the performance of the test in postmenopausal women and in symptomatic women. Results A diagnosis of vaginitis was established in 14.0%. The global prevalences of BV, Candida spp. and T. vaginalis were 22.3%, 13.2% and 2.4%, respectively. The sensitivity and specificity of the assay test for those three causes of vaginitis were as follows: BV 91.7% and 86.6%; any Candida spp. 91.1% and 95.6%; Candida albicans 88.1% and 98.2%, non‐albicans Candida 100% and 97.5%, and T. vaginalis 94.4 and 99.9%. The performance of the test was identical in the subgroup of women that reported vulvovaginal symptoms. The presence of multiple infections did not interfere with the performance of the test. Conclusions The Seegene Allplex™ Vaginitis assay has an excellent performance in the diagnosis of the BV and presence of Candida; the results were good for trichomoniasis, but the study was underpowered for this outcome. Tweetable abstract Seegene Allplex™ Vaginitis is an excellent option for screening and diagnosis of vaginitis.

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Section: Discussionsupporting

confidence: 90%

Clinical validation of a new molecular test (Seegene Allplex™ Vaginitis) for the diagnosis of vaginitis: a cross‐sectional study

Vieira‐Baptista

Silva²,

Costa³

et al. 2021

BJOG

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“…Most of the studies from the literature review used a research-based MG NAAT, while our study used the Hologic Aptima MG assay (now US FDA-cleared), which 7) 18 (14) has been shown to have a much higher sensitivity than several other research-based MG NAATs. [28][29][30][31][32] Consistent with prior studies on performance of MG NAATs, we found a greater number of MG infections detected in vaginal swabs versus urine. 32 Another important finding from our study was that STIs other than MG were also common in women presenting for evaluation of dysuria.…”

Section: Discussionsupporting

confidence: 88%

Mycoplasma genitalium infection in women reporting dysuria: A pilot study and review of the literature

et al. 2021

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Mycoplasma genitalium (MG) infection, a sexually transmitted infection (STI), causes cervicitis and may cause reproductive sequelae and adverse pregnancy outcomes. Some MG-infected women report dysuria, a symptom frequently attributed to urinary tract infection (UTI). Given potential MG-associated morbidity and the likelihood that UTI treatment would be ineffective in eradicating MG, an improved understanding of MG infection frequency and clinical significance in young women reporting dysuria is needed. We conducted MG testing on stored urogenital specimens collected in a pilot study on frequency of STIs in young women presenting to an emergency department for dysuria evaluation and performed a literature review on MG infection frequency in women reporting dysuria. Among 25 women presenting for dysuria evaluation in our pilot study, 6 (24.0%) had MG detected and one-third had co-infection with chlamydia and one-third with trichomoniasis; half with MG detected did not receive an antibiotic with known efficacy against MG, while the other half received azithromycin. In five studies identified in the literature review, dysuria was reported by 7%–19% of women and MG detected in 5%–22%. MG infection is common in young women with dysuria and empiric UTI treatment may not be effective against MG. Studies evaluating the clinical significance of MG infection in women reporting dysuria are needed.

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“…6 Other Food and Drug Administration (FDA) approved diagnostic tests such as the BD Max GeneXpert, Allplex and Anyplex multiplex assays are expensive and are used to simultaneously test for other STIs in combination with N. gonorrhoeae , whereas the commercially bought TaqMan probe and primer mix is inexpensive and specifically targets N. gonorrhoeae . 17–19 In this study, the TaqMan assay as the comparator assay exhibited the highest specificities ranging from 97% for the 16S rRNA PCR to 100% for both culture and the Opa PCR. However, sensitivities that were obtained (TaqMan as the comparator) demonstrated that culture performed the poorest with a sensitivity of 25% compared to the other PCR assays (Table 1).…”

Section: Discussionmentioning

confidence: 69%

Comparison of methods for the detection of Neisseria gonorrhoeae from South African women attending antenatal care

et al. 2021

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The detection of Neisseria gonorrhoeae using culture assays is challenging. This study aims to compare different assays for the detection of N. gonorrhoeae. This cross-sectional study was conducted at King Edward VIII Hospital and included 307 antenatal attendees, each willing to provide two endocervical swabs. The first swab was used for culture identification of N. gonorrhoeae, and the second swab was processed for the detection of the pathogen by the TaqMan quantitative polymerase chain reaction (qPCR) assay, an in-house 16S ribosomal RNA ( rRNA) PCR and PCR detection of the opa gene. Culture and the nucleic acid amplification assays were each used as comparator tests in the analysis. Sensitivity and specificity were calculated using RS Studio. The prevalence of N. gonorrhoeae was 7.8%. When compared to the TaqMan assay, the 16S rRNA PCR exhibited the highest sensitivity of 62%, with a substantial level of agreement (kappa level of agreement: 0.60), followed by the opa PCR (38%) with a moderate level of agreement (0.52) and culture exhibiting the lowest sensitivity of 25% with a fair level of agreement (0.38). The diagnostic accuracy of all the assays was >90%. The TaqMan qPCR assay has the ability to serve as a future diagnostic assay for the detection of N. gonorrhoeae.

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Comparison between Aptima Assays (Hologic) and the Allplex STI Essential Assay (Seegene) for the diagnosis of Sexually transmitted infections

Cited by 26 publications

References 29 publications

Clinical validation of a new molecular test (Seegene Allplex™ Vaginitis) for the diagnosis of vaginitis: a cross‐sectional study

Clinical validation of a new molecular test (Seegene Allplex™ Vaginitis) for the diagnosis of vaginitis: a cross‐sectional study

Mycoplasma genitalium infection in women reporting dysuria: A pilot study and review of the literature

Comparison of methods for the detection of Neisseria gonorrhoeae from South African women attending antenatal care

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