A profile of the FDA-approved and CE/IVD-marked Aptima<i>Mycoplasma genitalium</i>assay (Hologic) and key priorities in the management of<i>M. genitalium</i>infections

Shipitsyna, Elena; Unemo, Magnus

doi:10.1080/14737159.2020.1842198

Cited by 9 publications

(11 citation statements)

References 73 publications

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“…genitalium ‐specific nucleic acid (DNA or RNA) in clinical specimens are the only useful methods for diagnosis. Some commercially available NAATs have been evaluated up to the US Food and Drug Administration (FDA) approval standard 43 . However, currently, none include detection of macrolide resistance mutations and some of the tests on the market which have been Conformité Europëenne (CE) marked to document conformity according the European Union (EU) legislation suffer from limited validation.…”

Section: Laboratory Diagnosticsmentioning

confidence: 99%

“…Some commercially available NAATs have been evaluated up to the US Food and Drug Administration (FDA) approval standard. 43 With the widespread macrolide resistance in Europe, all M. genitalium-positive tests must be followed up with an assay capable of detecting macrolide resistance mutations (Grade 1B). A variety of laboratory developed tests are available for this purpose, 34,44-49, and CE-marked, commercially available methods have also become available.…”

Section: Recommended Diagnostic Assaysmentioning

confidence: 99%

See 1 more Smart Citation

2021 European guideline on the management of Mycoplasma genitalium infections

Jensen

Cusini

Gomberg

et al. 2022

Acad Dermatol Venereol

115

139

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Mycoplasma genitalium infection contributes to 10–35% of non‐chlamydial non‐gonococcal urethritis in men. In women, M. genitalium is associated with cervicitis and pelvic inflammatory disease (PID) in 10–25%. Transmission of M. genitalium occurs through direct mucosal contact. Clinical features and diagnostic tests Asymptomatic infections are frequent. In men, urethritis, dysuria and discharge predominate. In women, symptoms include vaginal discharge, dysuria or symptoms of PID – abdominal pain and dyspareunia. Symptoms are the main indication for diagnostic testing. Diagnosis is achievable only through nucleic acid amplification testing and must include investigation for macrolide resistance mutations. Therapy Therapy for M .genitalium is indicated if M. genitalium is detected. Doxycycline has a cure rate of 30–40%, but resistance is not increasing. Azithromycin has a cure rate of 85–95% in macrolide‐susceptible infections. An extended course of azithromycin appears to have a higher cure rate, and pre‐treatment with doxycycline may decrease organism load and the risk of macrolide resistance selection. Moxifloxacin can be used as second‐line therapy but resistance is increasing. Recommended treatment Uncomplicated M. genitalium infection without macrolide resistance mutations or resistance testing:Azithromycin 500 mg on day one, then 250 mg on days 2–5 (oral). Second‐line treatment and treatment for uncomplicated macrolide‐resistant M. genitalium infection:Moxifloxacin 400 mg od for 7 days (oral). Third‐line treatment for persistent M. genitalium infection after azithromycin and moxifloxacin:Doxycycline or minocycline 100 mg bid for 14 days (oral) may cure 40–70%.Pristinamycin 1 g qid for 10 days (oral) has a cure rate of around 75%. Complicated M. genitalium infection (PID, epididymitis):Moxifloxacin 400 mg od for 14 days. Main changes from the 2016 European M. genitalium guideline Due to increasing antimicrobial resistance and warnings against moxifloxacin use, indications for testing and treatment have been narrowed to primarily involve symptomatic patients. The importance of macrolide resistance‐guided therapy is emphasised.

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Section: Laboratory Diagnosticsmentioning

confidence: 99%

Section: Recommended Diagnostic Assaysmentioning

confidence: 99%

2021 European guideline on the management of Mycoplasma genitalium infections

Jensen

Cusini

Gomberg

et al. 2022

Acad Dermatol Venereol

115

139

View full text Add to dashboard Cite

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“…As a bacterial culture of M. genitalium can take months to grow, NAAT of urine or vaginal/endocervical samples is recommended in symptomatic individuals. The U.S. Food and Drug Administration (FDA) approved such testing in early 2019 [51][52][53]. Unfortunately, recent research has identified various genetic mutations in M. genitalium that result in antimicrobial resistance (AMR) [54][55][56][57].…”

Section: Mycoplasma Genitaliummentioning

confidence: 99%

2021 CDC Update: Treatment and Complications of Sexually Transmitted Infections (STIs)

et al. 2022

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The Centers for Disease Control and Prevention (CDC) recently updated their Sexually-Transmitted Infection (STI) Treatment Guidelines with a revision to the approach to gonococcal infections in December 2020 and other STIs in July 2021. This article reviews the new recommendations and highlights important updates from the 2015 iteration that are crucial for primary care and community health practice.

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“…Большинство тест-систем для детекции M. genitalium в биологических образцах базируется на методе полимеразной цепной реакции (ПЦР) [56].…”

Section: полимеразная цепная реакцияunclassified

Molecular epidemiology and antimicrobials resistance mechanism of Mycoplasma genitlaium

Shedko

Дмитриевна²,

Головешкина

et al. 2021

Vestnik dermatologii i venerologii

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Currently, infections caused by Mycoplasma genitalium are ones the most common sexually transmitted infections. Their prevalence is varied from 1.3% to 15.9%. Infections caused by M.genitalium may lead to urethritis in men and a wide spectrum of diseases in women. Antibiotic resistance now is one of the most emerging problems both in the scientific and in the healthcare fields. The usage of antimicrobials inhibiting cell wall synthesis for the treatment of M.genitalium is ineffective, and resistance to macrolides and fluoroquinolones is increasing rapidly. M.genitalium infections diagnostics is complicated due to specific conditions and duration of culture methods. The usage of nucleic acid amplification techniques is the most relevant for laboratory diagnostics, and is used in existing assays. This review compiles current data on the prevalence, molecular mechanisms of pathogenesis and antibiotic resistance, as well as diagnostics methods of M.genitalium.

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A profile of the FDA-approved and CE/IVD-marked AptimaMycoplasma genitaliumassay (Hologic) and key priorities in the management ofM. genitaliuminfections

Cited by 9 publications

References 73 publications

2021 European guideline on the management of Mycoplasma genitalium infections

2021 European guideline on the management of Mycoplasma genitalium infections

2021 CDC Update: Treatment and Complications of Sexually Transmitted Infections (STIs)

Molecular epidemiology and antimicrobials resistance mechanism of Mycoplasma genitlaium

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