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Alavi M.,University of New South Wales | Grebely J.,University of New South Wales | Matthews G.V.,University of New South Wales | Petoumenos K.,University of New South Wales | And 47 more authors.
Journal of Gastroenterology and Hepatology (Australia) | Year: 2012

Background and Aim: Pegylated interferon (PEG-IFN) treatment for hepatitis C virus (HCV) infection has neuropsychiatric side effects. Data on the effect of HCV treatment on mental health among injecting drug users (IDUs) are limited. We assessed mental health during treatment of recently acquired HCV, within a predominantly IDU population. Methods: Participants with HCV received PEG-IFN-α-2a (180μg/week) for 24weeks; HCV/HIV received PEG-IFN with ribavirin. Depression was assessed using the Mini-International Neuropsychiatric Interview (MINI). Logistic regression was used to identify factors associated with depression at enrolment and during treatment. Also, the effect of depression prior to and during treatment on sustained virological response (SVR) was assessed. Results: Of 163 participants, 111 received treatment (HCV, n=74; HCV/HIV, n=37), with 76% ever reporting IDU. At enrolment, 16% had depression (n=25). In adjusted analysis, depression at enrolment occurred less often in participants full-/part-time employed (adjusted odds ratio [AOR] 0.23; 95% confidence interval [CI]: 0.06, 0.82, P=0.023) and more often in recent IDUs (AOR 3.04; 95% CI: 1.19, 7.72, P=0.019). During treatment, 35% (n=31) developed new-onset depression. In adjusted analysis, poorer social functioning (higher score) was associated with new-onset depression (score≤9 vs score≥17; OR 5.69; 95% CI: 1.61, 20.14, P=0.007). SVR was similar among participants with and without depression at enrolment (60% vs 61%, P=0.951) and in those with and without new-onset depression (74% vs 63%, P=0.293). Conclusions: Although depression at enrolment and during treatment was common among participants with recent HCV, neither influenced SVR. Participants with poor social functioning may be most at risk of developing depression during HCV therapy. © 2011 Journal of Gastroenterology and Hepatology Foundation and Blackwell Publishing Asia Pty Ltd.

Han X.,SEALS | McShane M.,SEALS | Sahertian R.,SEALS | White C.,SEALS | Ledger W.,University of New South Wales
Human Reproduction | Year: 2014

STUDY QUESTION: Does pre-mixing stored serum samples with assay buffer improve the reproducibility of the Beckman Gen II assay for anti-Müllerian hormone (AMH)? SUMMARY ANSWER: Pre-mixing serum samples with assay buffer is a prerequisite for reproducible measurement of AMH in serum using the Beckman Coulter Gen II assay. WHAT IS KNOWN ALREADY: Discrepancies in the results obtained from AMH assays have raised doubts concerning the clinical utility of measuring AMH. Sample storage conditions may be responsible for the lack of reproducibility of results obtained from the Gen II kit. STUDY DESIGN, SIZE, DURATION: This was a prospective study in which serum samples were stored at three different temperatures and assayed for AMH at times 0, 4, 8, 12, 24, 48 h and 1 or 2 weeks after collection. Volunteers (n = 28) were healthy non-pregnant and early pregnant women aged 22-41 years. Anonymized long-term stored samples (n = 42, stored at-20° for 2 weeks) from fertility clinic attendees were also included. For determining the reference range, 179 samples from healthy pregnant women presenting for first trimester screening were used. PARTICIPANTS/MATERIALS, SETTING, METHODS: Thirty separate assays were performed by two operators using four different Gen II kit lots with both kit and in-house quality controls (QCs) included in each assay. In addition to the standard protocol, a modified protocol (pre-mixing samples with assay buffer) was used for selected sample groups. MAIN RESULTS AND THE ROLE OF CHANCE: In non-pregnant women, AMH concentrations remained unchanged in serum stored for up to 8 h at room temperature,-20 and-80°C. At room temperature, levels started to rise by 24 h, increasing by up to 29% of the time 0 h value by 48 h and 26% after 1 week. Significant changes versus baseline (time 0 h) in measured AMH concentration were also observed after storage at-20 and-80°C (only at the 12 h time point). In the pregnant group, there was a 50% increase above baseline in samples stored for 48 h at room temperature. When samples were pre-mixed with assay buffer, AMH concentrations showed a consistent increase versus the standard assay in both non-pregnant (29%) and pregnant (280%) groups, regardless of storage conditions and duration, but concentrations remained constant during long-term storage (2 weeks). Stored fertility clinic patient samples also exhibited stability of AMH values after a consistent 2-fold increase following pre-mixing. Kit QCs were consistent over 30 weeks using either standard or modified protocols while the in-house pooled serum QC rose over time unless using the modified protocol. Overall, there was a 2-fold increase in medians in the pre-mixed reference range, with the biggest increase observed in the oldest age bracket (41-45 years, 3.4-fold). LIMITATIONS, REASONS FOR CAUTIONT: he cause of the observed instability of AMH in stored serum samples requires further investigation, which is outside the scope of this publication. A larger and wider population study is necessary for a more reliable and clinically relevant reference range. WIDER IMPLICATIONS OF THE FINDINGS: Our study has confirmed previous findings of lack of consistency in AMH concentrations when measured with the Gen II assay. Pre-mixing serum samples with assay buffer gave higher but also the most consistent results regardless of storage conditions; therefore, we propose that all serum samples for AMH assay should be pre-mixed with assay buffer. Furthermore, clinical laboratories that offer AMH measurement as part of the assessment of endocrinopathies, such as polycystic ovary syndrome or premature ovarian failure, or for management of ovulation induction as part of assisted reproduction, must re-establish their own normal ranges using the modified method. © 2014 The Author.

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