ABSTRACT
OBJECTIVES: Anti-Müllenria hormone (AMH) is an established biomarker for assessing ovarian reserve and predicting response to controlled ovarian stimulation. Its routine clinical use is hampered by the variability and low-throughput of available enzyme-linked immunosorbent assays (ELISA). The presented study examined if a fully automated AMH electrochemiluminescence assay (ECLIA; Elecsys® AMH assay, Roche Diagnostics) was suitable for measuring AMH levels in healthy women and in those diagnosed with polycystic ovary syndrome (PCOS). DESIGN AND METHODS: Five European laboratories evaluated the Elecsys® AMH assay independently under routine conditions over eight months. Within-run imprecision, repeatability, intermediate precision, linearity and functional sensitivity were assessed. The Elecsys® AMH assay was compared to a manual ELISA microtiter plate format test (AMH Gen II ELISA, modified version; Beckman Coulter Inc.) using 1729 routine serum samples. AMH reference intervals were determined in 887 healthy women with regular menstrual cycle aged 2050 years, and 149 women diagnosed with PCOS. RESULTS: The fully automated Elecsys® AMH assay showed excellent precision, linearity, and functional sensitivity. The coefficient of variation was 1.8% for repeatability and 4.4% for intermediate precision. Values measured with the Elecsys® AMH assay were highly correlated with the manual ELISA method (modified version) but 2428% lower. Reference intervals showed the expected AMH decline with age in healthy women and increased AMH levels in women with PCOS. CONCLUSIONS: The Elecsys® AMH assay demonstrated good precision under routine conditions, and is suitable for determining AMH levels in serum and lithium-heparin plasma.
Subject(s)
Anti-Mullerian Hormone/analysis , Enzyme-Linked Immunosorbent Assay/methods , Luminescent Measurements/methods , Adolescent , Adult , Anti-Mullerian Hormone/blood , Automation, Laboratory/instrumentation , Automation, Laboratory/methods , Biomarkers/blood , Enzyme-Linked Immunosorbent Assay/standards , Female , Humans , Laboratories , Luminescent Measurements/standards , Menstrual Cycle/metabolism , Middle Aged , Polycystic Ovary Syndrome/blood , Reference Values , Reproducibility of Results , Sensitivity and SpecificityABSTRACT
BACKGROUND: Genital Chlamydia trachomatis infection is a worldwide public health burden. A screening program for C. trachomatis was therefore initiated by the public health insurers in Germany ("Gemeinsamer Bundesausschuss", GBA) in April 2008. OBJECTIVES: To estimate C. trachomatis prevalence from screening 115,766 asymptomatic females and 20,033 female patients with unspecific abdominal pain. STUDY DESIGN: Urine samples (pooled by five for the asymptomatic screening subjects) and cervical swabs were analyzed using semi-automated real-time PCR. Infection prevalence was determined separately in four categories of women, defined by health status (asymptomatic screening vs. non-screening with unspecified symptoms) and test material used. Comparative analyses were stratified by age and pregnancy status. RESULTS: Experimental evaluation of the assay used revealed a detection limit of 379 genome copies/ml urine. For pooled urine samples, the positive predictive value was 100% whereas the negative predictive value equaled 98.1%. The observed infection prevalence was higher for cervical swabs than for urine samples. Prevalence estimates also differed significantly between pregnant and non-pregnant adolescents (< or = 20 years), irrespective of the test material used (10.2% vs. 7.3% for cervical swabs, 10.9% vs. 6.1% for pooled urine samples). CONCLUSIONS: Our retrospective study, based upon a very large number of females from all parts of Germany, revealed a high infection prevalence in adolescents, particularly in pregnant adolescents, thereby justifying the screening directive of the German GBA.
Subject(s)
Chlamydia Infections/epidemiology , Chlamydia trachomatis , Mass Screening , Adolescent , Adult , Age Factors , Automation, Laboratory , Chlamydia Infections/microbiology , Chlamydia Infections/urine , Chlamydia trachomatis/genetics , Chlamydia trachomatis/isolation & purification , DNA, Bacterial/genetics , DNA, Bacterial/urine , Female , Germany/epidemiology , Humans , Limit of Detection , Middle Aged , Predictive Value of Tests , Pregnancy , Pregnancy Complications, Infectious/epidemiology , Pregnancy Complications, Infectious/microbiology , Pregnancy Complications, Infectious/urine , Prevalence , Retrospective Studies , Reverse Transcriptase Polymerase Chain Reaction , Vaginal SmearsABSTRACT
Previous studies had shown that binding of TGF-beta to the small proteoglycan decorin results in its inactivation. Indeed, in osteosarcoma cells the addition of decorin prevented the TGF-beta 1-mediated up-regulation of biglycan synthesis. However, the down-regulation of proteoglycan-100 remained unaltered. Even in the presence of a 100,000-fold molar excess of decorin, TGF-beta 1 was fully active in U937 monocytes with respect to the inhibition of cell proliferation. There was no inhibition of the TGF-beta-mediated stimulation of the retraction of fibroblast-populated collagen lattices. Thus, the formation of TGF-beta/decorin complexes leads to the neutralization of distinct effects only.
