scholarly journals Intra- and inter-cycle variability of anti-Müllerian hormone (AMH) levels in healthy women during non-consecutive menstrual cycles: the BICYCLE study

2021 ◽  
Vol 0 (0) ◽  
Author(s):  
Marieke Biniasch ◽  
Ruediger Paul Laubender ◽  
Martin Hund ◽  
Katharina Buck ◽  
Christian De Geyter
Keyword(s):  
Biological Variability ◽  
Single Cycle ◽  
Serum Samples ◽  
Menstrual Cycles ◽  
Healthy Women ◽  
Analytical Variability ◽  
Coefficients Of Variation ◽  
Periodic Regression ◽  
Roche Diagnostics ◽  
Gonadotropin Dosage

Abstract Objectives Determine variability of serum anti-Müllerian hormone (AMH) levels during ovulatory menstrual cycles between different women (inter-participant), between non-consecutive cycles (inter-cycle) and within a single cycle (intra-cycle) in healthy women. Methods Eligible participants were women aged 18–40 years with regular ovulatory menstrual cycles. Serum samples were collected every second day during two non-consecutive menstrual cycles. AMH levels were measured in triplicate using the Elecsys® AMH Plus immunoassay (Roche Diagnostics). AMH level variability was evaluated using mixed-effects periodic regression models based on Fourier series. The mesor was calculated to evaluate inter-participant and inter-cycle variability. Inter- and intra-cycle variability was evaluated using peak-to-peak amplitudes. Separation of biological and analytical coefficients of variation (CVs) was determined by analysing two remeasured AMH levels (with and without original AMH levels). Results A total of 47 women were included in the analysis (42 assessed over two cycles; five one cycle only). CV of unexplained biological variability was 9.61%; analytical variability was 3.46%. Inter-participant variability, given by time-series plots of AMH levels, was greater than inter-cycle variability. Between individual participants, both mesor and peak-to-peak amplitudes proved variable. In addition, for each participant, intra-cycle variability was higher than inter-cycle variability. Conclusions Inter-participant and intra-cycle variability of AMH levels were greater than inter-cycle variability. Unexplained biological variability was higher than analytical variability using the Elecsys AMH Plus immunoassay. Understanding variability in AMH levels may aid in understanding differences in availability of antral ovarian follicles during the menstrual cycle, which may be beneficial in designing gonadotropin dosage for assisted reproductive technology.

Analytical evaluation of the Dade Behring Dimension RxL automated N-Terminal proBNP (NT-proBNP) method and comparison with the Roche Elecsys 2010

2005 ◽  
Vol 43 (11) ◽  
Author(s):  
Francesca Di Serio ◽  
Vincenzo Ruggieri ◽  
Lucia Varraso ◽  
Rosalisa De Sario ◽  
Angela Mastrorilli ◽  
...  
Keyword(s):  
Detection Limit ◽  
Healthy Subjects ◽  
Effect Of Temperature ◽  
Serum Samples ◽  
Coefficients Of Variation ◽  
Sample Stability ◽  
The Matrix ◽  
Heparin Plasma ◽  
Roche Diagnostics ◽  
Age And Sex

AbstractMethods to quantify B-type natriuretic peptide (BNP) and N-terminal-propeptide (NT-proBNP) in plasma or serum samples are well established. We assessed the analytical performance of the Dimension RxL NT-proBNP method (Dade-Behring). Evaluation of different sample types was carried out. Controls and heparin plasma pools were used to determine the detection limit, precision, and linearity. Sample stability and the effect of interfering substances on the NT-proBNP concentrations were evaluated. Agreement between Dimension RxL and Elecsys 2010 (Roche Diagnostics) NT-proBNP methods was assessed. The influence of age and sex on NT-proBNP concentrations was evaluated in healthy subjects. Heparin plasma should be the matrix of choice. The detection limit was 2.0ng/L. The total imprecision was 2.6–3.6% for concentrations from 231 to 9471ng/L; mean NT-proBNP concentrations of 21 and 15ng/L were associated with coefficients of variation of 9.9% and 14.7%, respectively. The method was linear up to 32,650ng/L. There was no effect of temperature, freeze-thaw cycles and interfering substances. A bias was detected when Dimension RxL and Elecsys 2010 NT-proBNP methods were compared. Age and sex were significantly and independently related to NT-proBNP concentrations. The Dimension RxL NT-proBNP method, like the Elecsys 2010, is suitable for routine use in the diagnosis of heart failure.

scholarly journals Multicenter performance evaluation of a second generation cortisol assay

2017 ◽  
Vol 55 (6) ◽  
pp. 826-835 ◽  
Author(s):  
Michael Vogeser ◽  
Jürgen Kratzsch ◽  
Yoon Ju Bae ◽  
Mathias Bruegel ◽  
Uta Ceglarek ◽  
...  
Keyword(s):  
Second Generation ◽  
Reference Ranges ◽  
Good Precision ◽  
Healthy Individuals ◽  
Serum Samples ◽  
Intermediate Precision ◽  
Coefficients Of Variation ◽  
Liquid Chromatography Tandem Mass ◽  
Cortisol Levels ◽  
Roche Diagnostics

Abstract Background: Untreated disorders of the adrenocortical system, such as Cushing’s or Addison’s disease, can be fatal, and accurate quantification of a patient’s cortisol levels is vital for diagnosis. The objective of this study was to assess the analytical performance of a new fully-automated Elecsys® Cortisol II assay (second generation) to measure cortisol levels in serum and saliva. Methods: Four European investigational sites assessed the intermediate precision and reproducibility of the Cortisol II assay (Roche Diagnostics) under routine conditions. Method comparisons of the Cortisol II assay vs. liquid chromatography-tandem mass spectrometry (LC-MS/MS), the gold standard for cortisol measurement, were performed. Cortisol reference ranges from three US sites were determined using samples from self-reported healthy individuals. Results: The coefficients of variation (CVs) for repeatability, intermediate precision, and reproducibility for serum samples were ≤2.6%, ≤5.8%, and ≤9.5%, respectively, and for saliva were ≤4.4% and ≤10.9%, and ≤11.4%, respectively. Agreement between the Cortisol II assay and LC-MS/MS in serum samples was close, with a slope of 1.02 and an intercept of 4.473 nmol/L. Reference range samples were collected from healthy individuals (n=300) and serum morning cortisol concentrations (5–95th percentile) were 166.1–507 nmol/L and afternoon concentrations were 73.8–291 nmol/L. Morning, afternoon, and midnight saliva concentrations (95th percentile) were 20.3, 6.94, and 7.56 nmol/L, respectively. Conclusions: The Cortisol II assay had good precision over the entire measuring range and had excellent agreement with LC-MS/MS. This test was found suitable for routine diagnostic application and will be valuable for the diagnosis of adrenocortical diseases.

scholarly journals Diurnal rhythm of free estradiol during the menstrual cycle

2003 ◽  
Vol 148 (2) ◽  
pp. 227-232 ◽  
Author(s):  
AM Bao ◽  
RY Liu ◽  
EJ van Someren ◽  
MA Hofman ◽  
YX Cao ◽  
...  
Keyword(s):  
Menstrual Cycle ◽  
Diurnal Rhythm ◽  
Luteal Phase ◽  
Temporal Organization ◽  
Menstrual Phase ◽  
Menstrual Cycles ◽  
Healthy Women ◽  
Reproductive Life ◽  
Periodic Regression ◽  
Free Estradiol

OBJECTIVE: To investigate the diurnal rhythm of estrogens in normally cyclic women during reproductive life. DESIGN: Multiple saliva sampling in normally cyclic healthy women during reproductive life at different phases of their menstrual cycles was carried out. METHODS: Salivary estradiol was measured by radioimmunoassay in samples collected every 2 h for 24 h from 15 normally cyclic healthy women during reproductive life during the menstrual phase, the late follicular/peri-ovulation phase, the early to mid luteal phase and the late luteal phase, respectively, of their menstrual cycles. The levels of salivary estradiol were analyzed by means of periodic regression. RESULTS: A daily biological rhythm of free estradiol was found after quantification with a nonlinear periodic regression model. The observed diurnal free estradiol rhythm consists of two major components: an asymmetrically peaked diurnal cycle and ultradian harmonics in the range of 6 to 12 h. The diurnal and ultradian rhythms were remarkably consistent throughout the menstrual cycle in terms of mesor (24 h mean level), peak width and amplitude. There was a tendency for the 24-h rhythm acrophases to converge in the early morning, while the acrophase of the menstrual phase occurred significantly later than in the late follicular/peri-ovulation phase. CONCLUSIONS: The diurnal rhythm of estradiol has a similar complex temporal organization for different menstrual phases. The menstrual cycle mainly modulates the acrophase of the diurnal rhythm.

scholarly journals COVID-19 Vaccine mRNABNT162b2 Elicits Human Antibody Response in Milk of Breastfeeding Women

Vaccines ◽  
2021 ◽  
Vol 9 (7) ◽  
pp. 785
Author(s):  
Maurizio Guida ◽  
Daniela Terracciano ◽  
Michele Cennamo ◽  
Federica Aiello ◽  
Evelina La Civita ◽  
...  
Keyword(s):  
Breast Milk ◽  
Antibody Response ◽  
Human Milk ◽  
Human Antibody ◽  
Serum Antibodies ◽  
Serum Samples ◽  
Low Concentration ◽  
Milk Samples ◽  
Milk Antibodies ◽  
Roche Diagnostics

Objective: The objective of this research is to demonstrate the release of SARS-CoV-2 Spike (S) antibodies in human milk samples obtained by patients who have been vaccinated with mRNABNT162b2 vaccine. Methods: Milk and serum samples were collected in 10 volunteers 20 days after the first dose and 7 seven days after the second dose of the mRNABNT162b2 vaccine. Anti-SARS-CoV-2 S antibodies were measured by the Elecsys® Anti-SARS-CoV-2 S ECLIA assay (Roche Diagnostics AG, Rotkreuz, Switzerland), a quantitative electrochemiluminescence immunometric method. Results: At first sample, anti-SARS-CoV-2 S antibodies were detected in all serum samples (103.9 ± 54.9 U/mL) and only in two (40%) milk samples with a low concentration (1.2 ± 0.3 U/mL). At the second sample, collected 7 days after the second dose, anti-SARS-CoV-2 S antibodies were detected in all serum samples (3875.7 ± 3504.6 UI/mL) and in all milk samples (41.5 ± 47.5 UI/mL). No correlation was found between the level of serum and milk antibodies; the milk antibodies/serum antibodies ratio was on average 2% (range: 0.2–8.4%). Conclusion: We demonstrated a release of anti-SARS-CoV-2 S antibodies in the breast milk of women vaccinated with mRNABNT162b2. Vaccinating breastfeeding women could be a strategy to protect their infants from COVID-19 infection.

scholarly journals A non-targeted LC–MS metabolic profiling of pregnancy: longitudinal evidence from healthy and pre-eclamptic pregnancies

Metabolomics ◽  
2021 ◽  
Vol 17 (2) ◽  
Author(s):  
Tiina Jääskeläinen ◽  
◽  
Olli Kärkkäinen ◽  
Jenna Jokkala ◽  
Anton Klåvus ◽  
...  
Keyword(s):  
Large Scale ◽  
Scale Effects ◽  
Late Pregnancy ◽  
Metabolite Profile ◽  
Adverse Outcomes ◽  
Liquid Chromatography Mass Spectrometry ◽  
Targeted Metabolomics ◽  
Serum Samples ◽  
Healthy Women ◽  
Maternal Metabolism

Abstract Introduction Maternal metabolism changes substantially during pregnancy. However, few studies have used metabolomics technologies to characterize changes across gestation. Objectives and methods We applied liquid chromatography–mass spectrometry (LC–MS) based non-targeted metabolomics to determine whether the metabolic profile of serum differs throughout the pregnancy between pre-eclamptic and healthy women in the FINNPEC (Finnish Genetics of Preeclampsia Consortium) Study. Serum samples were available from early and late pregnancy. Results Progression of pregnancy had large-scale effects to the serum metabolite profile. Altogether 50 identified metabolites increased and 49 metabolites decreased when samples of early pregnancy were compared to samples of late pregnancy. The metabolic signatures of pregnancy were largely shared in pre-eclamptic and healthy women, only urea, monoacylglyceride 18:1 and glycerophosphocholine were identified to be increased in the pre-eclamptic women when compared to healthy controls. Conclusions Our study highlights the need of large-scale longitudinal metabolomic studies in non-complicated pregnancies before more detailed understanding of metabolism in adverse outcomes could be provided. Our findings are one of the first steps for a broader metabolic understanding of the physiological changes caused by pregnancy per se.

PD-L1 expression in tumor lesions and soluble PD-L1 serum levels in patients with breast cancer: TNBC versus TPBC

2021 ◽  
pp. 1-9
Author(s):  
Parvaneh Yazdanpanah ◽  
Ali Alavianmehr ◽  
Abbas Ghaderi ◽  
Ahmad Monabati ◽  
Mehdi Montazer ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Tumor Cells ◽  
Serum Levels ◽  
Tumor Stage ◽  
Serum Samples ◽  
Healthy Women ◽  
Grade 3 ◽  
Anti Tumor Activity ◽  
Tnbc Subtype ◽  
Cell Death Protein

BACKGROUND: Block of programmed cell death protein 1 (PD-1) interaction with its ligand, PD-L1, enhances anti-tumor activity. OBJECTIVES: We aimed to assess the association between PD-L1 expression in tumor cells and CD8+ tumor infiltrating T cells (TILs) as well as soluble (s)PD-L1 serum levels in patients with triple negative breast cancer (TNBC) compared to triple positive (TPBC). METHODS: A total of 113 tumor sections and 133 serum samples were available from 144 patients with breast cancer (72 TNBC and 72 TPBC). Dual immunohistochemistry staining was applied to determine differential PD-L1 expression in tumor cells and CD8+ TILs. Soluble PD-L1 serum levels were also evaluated in patients compared to 40 healthy women by ELISA method. RESULTS: Despite TPBC patients which were mostly grades 1/2, TNBC patients were grade 3 (72% versus 66.7%, P < 0.001). Most of the TNBC patients were stages I/II, whereas most of the TPBC patients were stages III/IV (57.3% versus 68.3%,P = 0.005). There was no difference in tumor size and metastasis between TNBC and TPBC patients, although the number of involved lymph nodes was significantly more in TPBC patients (P = 0.0012). PD-L1 expression was detected in 11.5% of samples mostly in TNBC subtype and was associated with advanced grades (P = 0.039). There was no relationship between PD-L1 expression and tumor stage. PD-L1 expression in CD8+ TILs was nonsignificantly higher than tumor cells. Serum levels of sPD-L1 showed no difference between patients and healthy women. We found no correlation between PD-L1 expression in tumor lesions and serum levels of sPD-L1 in patients. CONCLUSION: PD-L1 expression was more detected in our patients with TNBC. It seems that, these patients who are resistant to standard chemotherapy regimens may get benefit from PD-L1 inhibition therapy and because of its low serum levels, sPD-L1 cannot interfere with this therapy.

Percentile transformation and recalibration functions allow harmonization of thyroid-stimulating hormone (TSH) immunoassay results

2020 ◽  
Vol 58 (10) ◽  
pp. 1663-1672 ◽  
Author(s):  
Andrea Padoan ◽  
Aldo Clerico ◽  
Martina Zaninotto ◽  
Tommaso Trenti ◽  
Renato Tozzoli ◽  
...  
Keyword(s):  
Robust Regression ◽  
Reference Intervals ◽  
Thyroid Stimulating Hormone ◽  
Validation Dataset ◽  
New Approach ◽  
Coefficients Of Variation ◽  
Significant Difference ◽  
Before And After ◽  
Roche Diagnostics ◽  
Stimulating Hormone

AbstractBackgroundThe comparability of thyroid-stimulating hormone (TSH) results cannot be easily obtained using SI-traceable reference measurement procedures (RPMs) or reference materials, whilst harmonization is more feasible. The aim of this study was to identify and validate a new approach for the harmonization of TSH results.MethodsPercentile normalization was applied to 125,419 TSH results, obtained from seven laboratories using three immunoassays (Access 3rd IS Thyrotropin, Beckman Coulter Diagnostics; Architect System, Abbott Diagnostics and Elecsys, Roche Diagnostics). Recalibration equations (RCAL) were derived by robust regressions using bootstrapped distribution. Two datasets, the first of 119 EQAs, the second of 610, 638 and 639 results from Access, Architect and Elecsys TSH results, respectively, were used to validate RCAL. A dataset of 142,821 TSH values was used to derive reference intervals (RIs) after applying RCAL.ResultsAccess, Abbott and Elecsys TSH distributions were significantly different (p < 0.001). RCAL intercepts and slopes were −0.003 and 0.984 for Access, 0.032 and 1.041 for Architect, −0.031 and 1.003 for Elecsys, respectively. Validation using EQAs showed that before and after RCAL, the coefficients of variation (CVs) or among-assay results decreased from 10.72% to 8.16%. The second validation dataset was used to test RCALs. The median of between-assay differences ranged from −0.0053 to 0.1955 mIU/L of TSH. Elecsys recalibrated to Access (and vice-versa) showed non-significant difference. TSH RI after RCAL resulted in 0.37–5.11 mIU/L overall, 0.49–4.96 mIU/L for females and 0.40–4.92 mIU/L for males. A significant difference across age classes was identified.ConclusionsPercentile normalization and robust regression are valuable tools for deriving RCALs and harmonizing TSH values.

scholarly journals Ribavirin Quantification in Combination Treatment of Chronic Hepatitis C

2003 ◽  
Vol 47 (1) ◽  
pp. 124-129 ◽  
Author(s):  
Sylvie Larrat ◽  
Françoise Stanke-Labesque ◽  
Agnès Plages ◽  
Jean-Pierre Zarski ◽  
Germain Bessard ◽  
...  
Keyword(s):  
Chronic Hepatitis ◽  
Hepatitis C ◽  
Chronic Hepatitis C ◽  
Combination Treatment ◽  
High Performance ◽  
Solid Phase ◽  
Ammonium Phosphate ◽  
Serum Samples ◽  
Coefficients Of Variation ◽  
Immunodeficiency Virus

ABSTRACT Ribavirin in combination with alpha 2 interferon is the consensus treatment for chronic hepatitis C. However, recent preliminary pharmacological studies have suggested that the bioavailability of ribavirin displays great interindividual variability. In order to monitor serum ribavirin levels during combination treatment, we developed and validated a quantitative assay using an approach adaptable for routine hospital laboratories. The method involved solid-phase extraction on phenyl boronic acid cartridges followed by high-performance liquid chromatography with a C18-bonded silica column and a mobile phase containing 10 mM ammonium phosphate buffer (with the pH adjusted to 2.5) and UV detection (207 nm). The sensitivity, recovery, linearity of the calibration curve, intra- and interassay accuracies, precision, and stability at 4°C were consistent with its use in the laboratory routine. In addition, other nucleoside analogues sometimes used with ribavirin in patients coinfected with hepatitis C virus (HCV) and human immunodeficiency virus did not interfere with the quantification of ribavirin levels. The ribavirin concentration was quantified in 24 serum samples from patients with chronic hepatitis C treated with a combination of ribavirin and alpha 2 interferon. The mean serum ribavirin concentration was 2.67 ± 1.06 μg/ml (n = 24) at week 12 of treatment (W12) and 3.24 ± 1.35 μg/ml (n = 24) at week 24 of treatment (W24). In addition, ribavirin concentrations displayed high interindividual variabilities: the coefficients of variation of the serum ribavirin concentrations adjusted to the administered dose were 44 and 48% at W12 and W24, respectively. Moreover, the ribavirin concentration was higher in patients with a sustained virological response (n = 11) than in patients with treatment failure (n = 13), with significant intergroup differences at W12 (P = 0.030) and W24 (P = 0.049). The present study describes a simple analytical method for the quantification of ribavirin in human serum that could be a useful tool for the monitoring of ribavirin concentrations in HCV-infected patients in order to improve the efficacy and safety of therapy with ribavirin plus interferon.

Assessment of choroidal vascularity index during the menstrual cycle

2021 ◽  
pp. 112067212110576
Author(s):  
Nazife Aşikgarip ◽  
Emine Temel ◽  
Kemal Örnek
Keyword(s):  
Optical Coherence Tomography ◽  
Menstrual Cycle ◽  
Prospective Study ◽  
Luteal Phase ◽  
Choroidal Thickness ◽  
Optical Coherence ◽  
Menstrual Cycles ◽  
Healthy Women ◽  
Luminal Area ◽  
Choroidal Structure

Purpose To explore the effect of menstrual cycle on choroidal vascularity index (CVI). Methods Thirty six eyes of 36 healthy women were included in this prospective study. The menstrual cycles were regular and ranged from 28 to 30 days in length. Optical coherence tomography images were obtained in 3 different phases of the menstrual cycle. The choroidal thickness (CT), total choroidal area, luminal area, stromal area, and CVI were quantified. Results Mean subfoveal, nasal and temporal CT were significantly changed in mid-luteal phase in comparison to early follicular (p = 0.018, p = 0.006 and p = 0.001, respectively) and ovulatory phases (p = 0.037, p = 0.037, and p = 0.035, respectively). Mean CVI showed a significant change in mid-luteal phase when compared with early follicular (p = 0.001) and ovulatory phases (p = 0.036). Conclusion CVI seemed to be affected in mid-luteal phase of menstrual cycle. This should be considered while analyzing choroidal structure in otherwise healthy women.

scholarly journals Salivary Afternoon Cortisol and Relationship Status in Healthy Women With Regular Menstrual Cycles

2018 ◽  
Vol 5 (3) ◽  
pp. 170-182 ◽  
Author(s):  
M. Claire Wilson ◽  
Tierney K. Lorenz ◽  
Julia R. Heiman
Keyword(s):  
Relationship Status ◽  
Menstrual Cycles ◽  
Healthy Women
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