2017 Article - "Does azithromycin given to women in labour decrease ocular bacterial infection in neonates? A double-blind, randomized trial" (pdf, 365KB)

Background: Vertical transmission can result in neonatal infection and disease. Reducing the transmission of bacterial pathogens from mother to infant may be an effective means of preventing neonatal infection, including bacterial conjunctivitis.

Methods: In a double-blind, randomized trial, we assessed the effect of administering a single dose of oral azithromycin to women in labour on bacterial colonization of the neonate. A reduction in purulent neonatal conjunctivitis was a secondary objective of the trial. Ocular samples were collected from the lower fornix of infants presenting with clinical signs of purulent conjunctivitis during the first eight weeks of life. Incidence of purulent conjunctivitis was compared between trial arms. Bacterial infection was assessed using PCR and incidence of purulent conjunctivitis due to bacteria was also compared between arms.

Results: Forty of 843 infants (4.7%) presented clinical signs of purulent conjunctivitis. No significant difference in incidence of purulent conjunctivitis was seen between azithromycin and placebo arms [4.3% (18/419) versus 5.2% (22/424), OR = 0.82,95% CI (0.44,1.54), p=0.628]. S. aureus was the most commonly identified pathogen, detected in 38% of cases. Incidence of purulent-conjunctivitis due to bacterial infection was lower in the azithromycin arm [1.2% (5/419) versus 3.8% (16/424), OR = 0.31, 95% CI (0.12–0.82), p = 0.025)]. The incidence of gram-positive bacteria was also lower in the azithromycin arm [1.0% (4/419) versus 3.3% (14/424), OR = 0.28, 95%CI (0.10–0.82), p = 0.029].

Conclusions: Oral azithromycin given to women during labour may have the potential to reduce the incidence of bacterial neonatal conjunctivitis.

Kit used: FTD SPn/Staph/MC/Hi
FTD Vaginal Swab

2016 Article - "Clinical and magnetic resonance imaging features in survivors of acute encephalitis syndrome in Uttar Pradesh, India" (pdf, 262KB)

Summary: Acute Encephalitis like illness (AES) is a public health problem in Uttar Pradesh. A major cause was Japanese Encephalitis (JE) but this is less frequent now. The objective of this article is to compare clinical and neuroimaging features in children having JE and non-JE AES. Next to testing for JEV, patients were also tested for HSV-1.

Kit used: FTD Herpes simplex virus

2016 Article - "Bacterial Load in Daily Urine Samples of Patients Infected with Mycoplasma genitalium" (pdf, 1MB)

Summary: Increasing macrolide resistant strains of Mycoplasma genitalium is a challenge, and to differentiate between treatment failure and reinfection a timely test of cure (TOC) is warranted. The aim of this study was to evaluate the best time for TOC after five days’ treatment of Mycoplasma genitalium infection with azithromycin. Methods. Nineteen patients with positive PCR for Mycoplasma genitalium in urine provided urine samples daily for 2 weeks and on days 21, 28, and 35. Samples were tested by a commercial qPCR and by sequencing of the 23S rRNA gene. Results. Eight patients with a wild type of Mycoplasma genitalium responded successfully within four days after treatment initiation. Eleven patients had a mutation in the 23S rRNA gene. These samples exhibited high variations in bacterial load, and some patients tested negative at several time points during the observation period. Conclusions. Day-to-day fluctuations in the mutation samples allow for false negative TOC during the first 5 weeks after start of treatment. Due to increasing macrolide resistance of Mycoplasma genitalium, pretreatment mutation analysis is recommended. When a wild type is verified, TOC performed one week after initiation of treatment is suggested.

Kit used: FTD Urethritis basic

2016 Article - "A novel SimpleProbe PCR for detection of mutations in the 23S rRNA gene associated with macrolide resistance in Mycoplasma genitalium in clinical samples" (pdf, 595KB)

Summary: Macrolide resistant strains of Mycoplasma genitalium is an increasing problem throughout the world, and the implementation of a rapid and sensitive assay for mutation detection to guide treatment is needed. Macrolide resistant strains have been shown to contain base substitutions in positions 2058 and 2059 (E. coli numbering) in region V of the 23S rRNA gene. In this study we present a SimpleProbe PCR followed by melting curve analysis to differentiate between macrolide resistant mutants and wild types. The assay was performed on 159 Mycoplasma genitalium positive samples, and the results were compared with DNA sequencing. We also looked at the prevalence of macrolide resistant strains in a Norwegian population. Of 139 samples characterized successfully by sequencing, 54 (39%) were wild types and 85 (61%) were mutants, consisting of 59 (42%) A2059G, 24 (17%) A2058G, 1 (1%) A2058T and 1 (1%) A2059C mutations. The melting curve analysis correctly differentiated between wild types and mutant strains in all cases, but it could not identify the different mutant types. The SimpleProbe PCR proved to be a simple, rapid and reliable method for the detection of macrolide resistant isolates of Mycoplasma genitalium in a clinical setting.

Kit used: FTD Urethritis basic

2016 Article - "The prevalence of Chlamydia trachomatis and Mycoplasma genitalium tubal infections and their effects on the expression of interleukin-6 and leukaemia inhibitory factor in Fallopian tubes with and without an ectopic pregnancy" (limited access)

Summary: This was a prospective case-control study that measured the prevalence of Chlamydia trachomatis (CT), Neisseria gonorrhoeae (NG) and Mycoplasma genitalium (MG) by an IVD CE multiplex PCR kit in fresh Fallopian tubes (FT) obtained from 96 ectopic pregnancies (EP) and 61 controls in the midluteal phase of the cycle. We later measured the expression profile of interleukin (IL)-6, leukaemia inhibitory factor (LIF) and their signalling molecules, in respect to the type and number of infections, by immunohistochemistry, ELISA and quantitative RT-PCR. The frequencies of Innate Immunity CT, MG mono- and co-infections were significantly higher in EP. IL-6, LIF, their receptors and intracellular mediators were significantly (P < 0.05) upregulated at the gene and protein levels in positive compared with negative FTs within each group. EP tubal samples with co-infections showed the highest significant expression (P < 0.05) of the candidate cytokines by all techniques. In conclusion, CT and MG are frequent in EP and up-regulate the tubal expression of IL-6, LIF and their signaling molecules. Both cytokines could be involved in the tubal immune response against bacterial infections as well as the pathogenesis of EP. Further studies are needed to explore the roles of IL-6 family in infection induced tubal inflammation and EP.

Kits used: FTD Urethritis basic and FTD Gonorrhoeae confirmation
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2015 Article - "Prevalence of 7 sexually transmitted organisms by multiplex real-time PCR in Fallopian tube specimens collected from Saudi women with and without ectopic pregnancy" (pdf, 543KB)

Summary: Ectopic pregnancy (EP) is associated with maternal morbidity and occasionally mortality during the first trimester. A history of sexually transmitted infection (STI) and pelvic inflammatory disease have been implicated as major risk factors for EP. Our aim was to measure the prevalence of Chlamydia trachomatis (CT), Neisseria gonorrhoeae, Mycoplasma genitalium (MG), Ureaplasma parvum/urealyticum, Gardnerella vaginalis, Trichomonas vaginalis and herpes simplex virus (HSV)-1&2 in Fallopian tubes collected from EP and the results were compared with those obtained from total abdominal hysterectomy (TAH) and tubal ligation.

Kits used: FTD STD9 and FTD Gonorrhoeae confirmation

2015 Poster - "Prevalence of 7 sexually transmitted organisms detected simultaneously in Fallopian tube bearing an ectopic pregnancy: The significance of multiplex Taqman real-time PCR in infertility workup" (pdf, 161KB)

Summary: The aim of this study was to measure the prevalence of Chlamydia Trachomatis (CT), Neisseria Gonorrhoeae, Mycoplasma Genitalium (MG), Ureaplasma Parvum/Urealyticum, Gardnerella Vaginalis, Trichomonas Vaginalis and herpes simplex virus (HSV)-1&2 in Fallopian tubes collected from EP and the results were compared with those obtained from total abdominal hysterectomy (TAH) or tubal ligation.

Kit used: FTD STD9

2014 Article - "QCMD - Most but not all laboratories can detect the recently emerged Neisseria gonorrhoeae porA mutants – results from the QCMD 2013 N. gonorrhoeae external quality assessment programme" (pdf, 209KB)

Summary: This article shows that most but not all laboratories can detect the recently emerged Neisseria gonorrhoeae porA mutants. This report describes the results of the Quality Control for Molecular Diagnostics (QCMD) 2013 N. gonorrhoeae External Quality Assessment (EQA) programme. It included an N. gonorrhoeae strain containing an N. meningitidis porA gene which gives rise to falsenegative results in molecular diagnostic assays targeting the gonococcal porA pseudogene. The article it shows that FTD successfully detected 100% of mutant samples.

Kits used: FTD STD9, FTD Urethritis, FTD Urethritis basic, FTD Urethritis plus and FTD Vaginal swab

2013 Poster - "Clinical validation of the FTD Urethritis plus panel in collaboration with Laboratoires Reunis, Luxembourg" (pdf, 295KB)

Summary: In this validation it was found that the FTD Urethritis Plus showed, in comparison to reference methods, high sensitivities and specificities for all tested pathogens. The use of Real-time multiplex PCR in the detection STD causing agents saves time and enzyme compared to singleplex PCRs or culture growth.The detection limits (not shown here) for all pathogens were determined to be as low as 0.1-1.0 target copies/µl.

Kit used: FTD Urethritis Plus