scholarly journals Comparison of three serum androstenedione assays: the Siemens Immulite immunoassay, the Roche Elecsys immunoassay, and an LC-MS/MS assay

2021 ◽  
Vol 156 (Supplement_1) ◽  
pp. S10-S11
Author(s):  
Ruhan Wei ◽  
Kathleen Bowers ◽  
Grace Kroner ◽  
Drew Payto ◽  
Jessica Colón-Franco
Keyword(s):  
Clinical Performance ◽  
Polycystic Ovary ◽  
Method Comparison ◽  
Clinical Information ◽  
Reference Intervals ◽  
Female Group ◽  
Healthy Children ◽  
Oral Contraceptive Pills ◽  
Contraceptive Pills ◽  
Healthy Female

Abstract Introduction Serum androstenedione (ASD) is a useful biomarker in the diagnostic workup of hyperandrogenism, congenital adrenal hyperplasia, premature adrenarche, and polycystic ovary syndrome (PCOS). Recently, the Elecsys ASD assay (Roche Diagnostics), a competitive electrochemiluminescence immunoassay, became available in the US. Herein, the analytical and clinical performance of the Elecsys ASD assay was tested and compared with the Immulite assay (our current assay) and an LC-MS/MS assay (the gold standard) using deidentified residual patient specimens. Method In this study, the linearity, analytical measuring range (AMR), precision, and accuracy of the Elecsys ASD assay (cobas e602 analyzer) were tested. ASD from 40 deidentified residual serum/plasma samples was measured and compared between the Elecsys assay, the Immulite assay, and an LC-MS/MS assay. The reference intervals (RIs) provided by Roche for healthy male (0.280-1.52 ng/mL), healthy female (0.490-1.31 ng/mL), postmenopausal female (0.187-1.07 ng/mL), healthy children (<0.519 ng/mL), and patients with PCOS (0.645-3.47 ng/mL) were tested with at least 20 specimens, according to CLSI C28A3. Statistical analysis was performed using EP evaluator and R program. Result and conclusion The assay had a linear response across the AMR (0.3-10.0 ng/mL). The inter- and intra-assay coefficients of variation measured at multiple concentrations were less than 4.5% and 2.0%, respectively. The Elecsys ASD assay had an excellent correlation with the LC-MS/MS assay with a mean bias of -0.0542 ng/mL (-2%). The Immulite assay had a mean bias of 1.15 ng/mL (44%) and 1.22 ng/mL (32%) compared to the LC-MS/MS and Elecsys ASD assays, respectively. The Roche recommended RIs for healthy males and postmenopausal females were successfully verified in our patient population. However, the ASD concentrations for the healthy children were outside of the suggested RI, with concentrations up to 1.41 ng/mL. Therefore, the RIs for healthy children were adopted from RIs established using the same LC-MS/MS method used for method comparison. RI verification for the healthy female group also failed since many low ASD values were observed. Instead, a RI of < 1.30 ng/mL was established using 60 deidentified residual serum/plasma specimens. Finally, a separate RI for the PCOS group was not established since it may not provide useful clinical information due to the heterogeneity of the group. Unlike some published studies, hormone therapies such as oral contraceptive pills did not cause a significant decrease in ASD in patient specimens (p=0.4967). Overall, the Elecsys ASD assay has superior comparability to the LC-MS/MS assay than the Immulite assay. We were unable to verify the applicability of the RIs recommended by Roche for healthy females and children, warranting the need to establish or transfer them. When RI verification is challenging due to limited qualified specimens, transferring from an LC-MS/MS established RI is possible as long as the methods are comparable.

scholarly journals Cross-Method Comparison of Serum Androstenedione Measurement Using Three Different Assays: The Siemens Immulite Immunoassay, the Roche Elecsys Immunoassay, and an LC/MS-MS Assay

2021 ◽  
Vol 5 (Supplement_1) ◽  
pp. A730-A731
Author(s):  
Ruhan Wei ◽  
Kathleen Bowers ◽  
Grace M Kroner ◽  
Drew Payto ◽  
Jessica Colon Franco
Keyword(s):  
Clinical Performance ◽  
Polycystic Ovary ◽  
Pediatric Population ◽  
Method Comparison ◽  
Reference Intervals ◽  
Healthy Children ◽  
Healthy Male ◽  
Serum Samples ◽  
Female Sex Hormones ◽  
Deming Regression

Abstract Introduction: Androstenedione is a common precursor of male and female sex hormones produced by the adrenal glands and gonads. Serum androstenedione is a helpful biomarker in the diagnostic workup of a subset of patients with polycystic ovary syndrome (PCOS), the investigation of virilizing endocrinopathies, and for monitoring pediatric patients with congenital adrenal hyperplasia. The gold standard for the measurement of androstenedione is LC-MS/MS. A newly developed androstenedione competitive immunoassay is now available in the US, the Roche Elecsys Androstenedione (ASD) immunoassay. Until recently, the Siemens Immulite assay was the only non-radioimmunologic immunoassay available. We characterized the analytical and clinical performance of the ASD across different patient populations and in comparison to the Immulite and an LC-MS/MS assay. Methods and materials: The experiments performed were: linearity and analytical measuring range (AMR), precision (intra- and inter-assay), and accuracy. Androstenedione was measured on de-identified residual serum samples (n=40) using the ASD and Immulite immunoassays and an LC-MS/MS assay. The reference intervals (RIs) provided by Roche for healthy male (0.280-1.52 ng/mL), healthy female (0.490-1.31 ng/mL), postmenopausal women (0.187-1.07 ng/mL), healthy children (<0.519 ng/mL), and patients with PCOS (0.645-3.47 ng/mL) were verified with at least 20 specimens, according to CLSI C28A3. Statistical analysis was performed using EP Evaluator and R program. Results: The ASD had a linear response across the AMR of 0.3 to 10.0 ng/mL. The inter- and intra-assay coefficients of variation were 4.5% and 2.0% or lower, at concentrations 0.5-6.7 ng/mL, respectively. The ASD and LC-MS/MS assays had a mean bias of -0.0542 ng/mL (-2%), Deming regression of y = 1.000 [0.961; 1.039] x - 0.0548 [-0.1806; 0.0709], and r = 0.9930. The Immulite assay had a mean bias of 1.15 ng/mL (44%) and 1.22 ng/mL (32%) compared to the LC-MS/MS and ASD assays, respectively. The recommended RIs from Roche for healthy male, female, and postmenopausal female groups were successfully verified in our patient population. However, the androstenedione concentrations for the healthy children and PCOS groups were outside of the suggested RIs, with concentrations up to 1.41 ng/mL and 0.527-2.24 ng/mL, respectively. Unlike published elsewhere, hormone therapies such as contraceptive pills and steroid treatments did not significantly affect serum androstenedione concentrations in healthy females and patients with PCOS. Conclusion: The ASD is superior to the Immulite immunoassay, and it has excellent comparability with the LC-MS/MS for serum androstenedione measurement. The RIs published by Roche may not be universally transferable; verification is recommended, and establishing RIs for the pediatric population may be necessary.

Antiticiombin III Deficiency In A Large Family with 41 Affected Members

1981 ◽  
Author(s):  
J Stibbe ◽  
S Adhin ◽  
G L Ong ◽  
R S Panday ◽  
S H Peters ◽  
...  
Keyword(s):  
Autosomal Dominant ◽  
Large Family ◽  
Clinical Information ◽  
Impedance Plethysmography ◽  
Age Group ◽  
Oral Contraceptive Pills ◽  
Contraceptive Pills ◽  
At Iii ◽  
L 51 ◽  
First Time

Hereditary Antithrombin III (AT III) deficiency was found in a large Hindustani family, living partly in the Netherlands, partly in Suriname. Of 201 members investigated 35 were found to affected: AT III activity (chromogenic substrate) and AT III antigen (immuno-electrophoresis according to Laurell) were about 45 %. Analysis of this fanily clearly demonstrated the autosomal dominant inheritance of the condition. Six non-investigated members (1 living, 5 non-living) were diagnosed as being affected on the basis of affected offspring.Seventeen affected members had no signs of thrombo-embolic(TE) processes (age group 0-10 years old, n=2; 11-20, n=5; 21-30, n=4; 31-40, n=4; 41-50, n=2). Thirteen showed clinical or proven signs of TE processes (first time in age group 0-10 years old, n=0; 11-20, n=l; 21-30, n=G; 31-40, n=4; 41-50,n=l; 51-60, n=0; 61-70, n=l). No clinical information is yet available on the remaining affected members. Deep venous thrombosis (DVT) occurred in 9 patients (age group 21-30, n=5; 31-40, n=3; 61-70, n=l). Triggering factors were none 4, surgery 1, oral contraceptives and preg- nancy4. Pulmonary embolism occurred in 6 patients (2 clinical, 4 proven) and was fatal in 4; ages were 19, 21, 26, 37, 48 and 68 years old. Pregnancy was uncomplicated in 3 women (total of 4 pregnancies), one of these women was treated prophylactically with anticoagulants during pregnancy (1 pregnancy). Two women (9 pregnancies) had a thrombotic episode (1st and 3rd pregnancy respectively) and 1 woman died suddenly 7 days after her 7th childbirth. DVT occurred in 2 of 4 women who used oral contraceptive pills.In some symptomless patients (age 22, 26, 32, 33, 40 years old) impedance plethysmography (n=5), 125I-fibrinogen leg scanning (n=3), 125I-fibrinogen T½(n=3) and 51C-platelet survival (n=l) were normal

scholarly journals Cardiovascular profile of pharmacological agents used for the management of polycystic ovary syndrome

2018 ◽  
Vol 10 ◽  
pp. 204201881880567
Author(s):  
Huda Alalami ◽  
Thozhukat Sathyapalan ◽  
Stephen L. Atkin
Keyword(s):  
Polycystic Ovary Syndrome ◽  
Polycystic Ovary ◽  
Ovary Syndrome ◽  
Pharmacological Agents ◽  
Oral Contraceptive Pills ◽  
Contraceptive Pills ◽  
Increased Risk ◽  
Dipeptidyl Peptidase Iv Inhibitors ◽  
Onset Of Diabetes ◽  
Glucagon Like Peptide 1

Women with polycystic ovary syndrome (PCOS) have an adverse metabolic profile with an increased risk of prediabetes and type 2 diabetes (T2DM); however, it is unclear if PCOS is associated with increased cardiovascular events in later years independent of the presence of T2DM. Many therapies have been used to treat the differing facets of PCOS, including those for menstrual irregularity, hirsutism, acne and anovulatory infertility. The aim of this review was to evaluate the cardiovascular profiles associated with the medications used in the management of PCOS and evaluate whether they have cardiovascular benefit, detriment or are neutral. The medications reviewed include oral contraceptive pills, antiandrogens, clomiphene and drugs specifically used in diabetes therapy; metformin, glitazones, dipeptidyl peptidase IV inhibitors and glucagon-like peptide-1 receptor agonists. This review concludes that therapies that are used to treat these patients appear not to add to the cardiovascular risk and that there is no evidence that any interventional medical therapy may prevent the onset of diabetes in patients with PCOS, though in the case of metformin, this agent may be beneficial in preventing development of gestational diabetes.

scholarly journals Myo-Inositol in the Treatment of Teenagers Affected by PCOS

2016 ◽  
Vol 2016 ◽  
pp. 1-6 ◽  
Author(s):  
Lali Pkhaladze ◽  
Ludmila Barbakadze ◽  
Nana Kvashilava
Keyword(s):  
Adolescent Girls ◽  
Ethinyl Estradiol ◽  
Negative Impact ◽  
Polycystic Ovary ◽  
Open Label ◽  
Ovary Syndrome ◽  
Open Label Study ◽  
C Peptide ◽  
Oral Contraceptive Pills ◽  
Contraceptive Pills

Objective. To compare the effectiveness of myo-inositol (MI) and oral contraceptive pills (OCPs) in monotherapy and MI in combination with OCPs in the treatment of teenagers affected by polycystic ovary syndrome (PCOS).Methods. 61 adolescent girls aged 13–19 years, with PCOS, were involved in the prospective, open-label study. Patients were randomized into three groups: I group, 20 patients receiving drospirenone 3 mg/ethinyl estradiol 30 μg; II group, 20 patients receiving 4 g myo-inositol plus 400 mg folic acid; III group, 21 patients receiving both medications.Results. After receiving MI significant reduction in weight, BMI, glucose, C-peptide, insulin, HOMA-IR, FT, and LH was detected. The levels of SHBG, TT, FAI, DHEA-S, and AMH did not change statistically significantly. After receiving OCPs weight and BMI slightly increased, but metabolic parameters did not change. Combination of MI and OCPs did not change weight and BMI, but reduction in C-peptide, insulin, and HOMA-IR was detected. TT, FT, FAI, DHEA-S, LH, and AMH levels decreased and SHBG increased.Conclusions. Administration of MI is a safe and effective method to prevent and correct metabolic disorders in teenagers affected by PCOS. With combination of MI and OCPs antiandrogenic effects are enhanced, negative impact of OCPs on weight gain is balanced, and metabolic profile is improved.

Persistence with Oral Contraceptive Pills Versus Metformin in Women with Polycystic Ovary Syndrome

2012 ◽  
Vol 21 (6) ◽  
pp. 690-694 ◽  
Author(s):  
Nicole W. Karjane ◽  
Kai I. Cheang ◽  
Gabriela A. Mandolesi ◽  
Dale W. Stovall
Keyword(s):  
Oral Contraceptive ◽  
Polycystic Ovary Syndrome ◽  
Polycystic Ovary ◽  
Ovary Syndrome ◽  
Oral Contraceptive Pills ◽  
Contraceptive Pills
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