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1.
J Immunoassay Immunochem ; 40(6): 642-652, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-31556778

RESUMO

The objectives of this study were to investigate the usability and performance of seven visual home pregnancy tests, available in Europe. Part one of the study was home-based and involved volunteers testing a selection of four home pregnancy tests. The tests used and order of use were randomized. Part two, performed at a study site, involved volunteers reading and interpreting the results of the same selection of home pregnancy tests used in part one, but using urine standards representing early pregnancy (25 mIU/mL human chorionic gonadotropin) or a 'not pregnant' (0 mIU/mL human chorionic gonadotropin) sample. The volunteers completed a questionnaire after each test in both parts. Three of the seven tests met their accuracy/reliability claims: tests A (99.8%), B (100%), and F (97.6%) (not statistically different from the claimed 99% accuracy). The remaining four tests had accuracies/reliabilities of <99% at 81.6% (C), 89.0% (E), 92.5% (D), and 95.9% (G), respectively. Test A was the highest-rated test for each attribute tested in both settings. Test D was ranked the lowest in part one and test C was ranked lowest overall for part two. Home pregnancy tests vary in performance and usability, therefore requiring better standardization and performance evaluation in Europe.Clinical Trials Reference Number: NCT03589534.


Assuntos
Gonadotropina Coriônica/urina , Testes de Gravidez , Adulto , Europa (Continente) , Feminino , Humanos , Pessoa de Meia-Idade , Gravidez , Reprodutibilidade dos Testes , Adulto Jovem
2.
Gynecol Oncol ; 155(1): 8-12, 2019 10.
Artigo em Inglês | MEDLINE | ID: mdl-31375268

RESUMO

OBJECTIVE: To determine the optimal duration of human chorionic gonadotrophin (hCG) surveillance following treatment for low and high risk gestational trophoblastic neoplasia (GTN) and establish whether the current surveillance protocol that recommends life-long hCG monitoring requires revision. METHODS: A population-based cohort study was undertaken using a national registry, comprising patients from both tertiary trophoblastic disease treatment units in the UK (London and Sheffield). All patients who received chemotherapy for low or high risk GTN in the UK between 1958 and 2014 in London and 1973 and 2015 in Sheffield (n = 4201) were included in the study. Patients with placental site trophoblastic tumours and epithelioid trophoblastic tumours were excluded due to their distinct clinical behavior, treatment and follow-up requirements. The risk of recurrence with time following completion of chemotherapy for low or high risk GTN was measured. RESULTS: The overall risk of relapse in this national cohort of 4201 patients was 4.7% (198/4201) with a median time to recurrence of 117.5 days (range 9 days to 6.54 years). The greatest risk of recurrence occurred in the first year after completing treatment for either low or high risk GTN measuring 72.7% (n = 112) or 86.4% (n = 38), respectively. The subsequent recurrence risk reduced over time with none observed beyond 7 years. CONCLUSIONS: The absence of any recurrences beyond seven years following completion of chemotherapy for GTN indicates that the UK policy of life-long hCG surveillance is unnecessary. Our revised conservative protocol recommends stopping after 10 years.


Assuntos
Gonadotropina Coriônica/sangue , Gonadotropina Coriônica/urina , Doença Trofoblástica Gestacional/tratamento farmacológico , Doença Trofoblástica Gestacional/metabolismo , Adulto , Estudos de Coortes , Feminino , Doença Trofoblástica Gestacional/sangue , Doença Trofoblástica Gestacional/urina , Humanos , Recidiva Local de Neoplasia/sangue , Recidiva Local de Neoplasia/urina , Gravidez , Estudos Retrospectivos , Fatores de Risco
3.
J Pharm Biomed Anal ; 174: 495-499, 2019 Sep 10.
Artigo em Inglês | MEDLINE | ID: mdl-31234040

RESUMO

The study of glycoproteins is a rapidly growing field, which is not surprising considering that approximately 70% of human proteins are glycosylated and that numerous biological functions are associated to the glycosylation. In this work, our interest focused on the heterodimeric human Chorionic Gonadotropin (hCG) glycoprotein that is the specific hormone of the human pregnancy, consisting of an α and a ß subunit, so-called hCGα and hCGß, respectively. This protein possesses a very high structural heterogeneity, essentially due to the presence of 8 glycosylation sites, but also other types of post-translational modifications. In this study, for the first time, the potential of hydrophilic interaction liquid chromatography (HILIC) was investigated to separate the intact hCG isoforms. Three different HILIC stationary phases were tested using an hCG-based drug as standard, a recombinant hCG. For each stationary phase, the effect of the initial mobile phase composition based on ACN/H2O mixture, the slope of the gradient, the content and nature of the acidic additive (formic acid and trifluoroacetic acid (TFA)), and the addition of a volatile salt (ammonium formate) on the retention and the resolution were studied. The best HILIC separation was obtained with the amide column and a mobile phase composed of water/ACN containing 0.1% of TFA. The repeatability in terms of retention times and peak areas was then assessed. Finally, the method was applied to the analysis of a second hCG-based drug obtained from urine of pregnant women. Both drugs gave chromatograms with more than 10 peaks. However, they were significantly different, which demonstrated the potential of HILIC method for hCG isoform fingerprinting.


Assuntos
Gonadotropina Coriônica/química , Cromatografia Líquida/métodos , Gonadotropina Coriônica/urina , Feminino , Formiatos/química , Glicoproteínas/química , Glicosilação , Humanos , Interações Hidrofóbicas e Hidrofílicas , Gravidez , Isoformas de Proteínas/química , Multimerização Proteica , Proteínas Recombinantes , Espectrofotometria Ultravioleta , Ácido Trifluoracético/química
4.
Electrophoresis ; 40(11): 1622-1629, 2019 06.
Artigo em Inglês | MEDLINE | ID: mdl-30883802

RESUMO

To determine whether there is a measurable protein background in different formulations of urinary and recombinant human chorionic gonadotropin (hCG). Primary outcome measures: identification of contaminant proteins in urinary-derived formulations of hCG; secondary outcome measures: quantitative values of contaminant proteins in different batches of urinary -derived hCG formulations. It was found that urinary-derived batches have high presence of contaminant proteins beside the active substance. The relative amount of contaminant proteins and hCG differs strongly between different batches.


Assuntos
Gonadotropina Coriônica , Composição de Medicamentos/métodos , Contaminação de Medicamentos , Proteômica/métodos , Gonadotropina Coriônica/urina , Composição de Medicamentos/normas , Feminino , Humanos , Proteínas/análise
6.
Trop Doct ; 49(2): 129-132, 2019 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-30526377

RESUMO

In Masanga, Sierra Leone, a multigravid woman presented with a urine pregnancy test negative molar pregnancy. This can be explained by the 'hook-effect'. In resource-poor settings where quantitative serum hCG cannot be determined, it is of paramount importance to remain vigilant of the diagnosis of molar pregnancy. Clinical judgement and sonography remain key in diagnosing molar pregnancy in district hospitals in low- and middle-income countries (LMICs), especially since their occurrence is much more common in these countries.


Assuntos
Gonadotropina Coriônica/urina , Mola Hidatiforme/diagnóstico , Neoplasias Uterinas/diagnóstico , Adulto , Reações Falso-Negativas , Feminino , Humanos , Mola Hidatiforme/epidemiologia , Mola Hidatiforme/patologia , Mola Hidatiforme/urina , Gravidez , Serra Leoa/epidemiologia , Ultrassonografia , Neoplasias Uterinas/epidemiologia , Neoplasias Uterinas/patologia , Neoplasias Uterinas/urina
7.
J Immunoassay Immunochem ; 39(6): 672-686, 2018.
Artigo em Inglês | MEDLINE | ID: mdl-30346873

RESUMO

The Ultra Micro Analytical System (SUMA) is an ELISA-based analytical platform, developed andmanufactured by the Cuban Immunoassay Center (IC), which is primarily used in clinical medicine applications. In this article, we describe the validation of the UMELISA HCG kits, which are based on SUMA, as a pre-screening procedure for the detection of human Chorionic Gonadotrophin (hCG) in urine for anti-doping purposes. Validation of assay performance parameters showed satisfactory results, in accordance with the criteria established by the World Anti-Doping Agency (WADA): intra-assay repeatability (6.7-9.7%), inter-assay reproducibility (7.8-10.5%), accuracy (91-98%), limit of detection (2.7 IU/L), and linearity. Relative sensitivity and specificity and Predictive Positive and Negative Values were used to evaluate the Efficacy showing a value of 97.6%. A Kappa Index analysis was applied to check agreement with the commercially available, reference assay COBASe411 (Roche), which is often applied in WADA-accredited anti-doping laboratories for measurement of intact (heterodimeric) hCG in urine. UMELISA HCG kits are considered as fit for anti-doping control purposes.


Assuntos
Gonadotropina Coriônica/urina , Doping nos Esportes/métodos , Doping nos Esportes/prevenção & controle , Ensaio de Imunoadsorção Enzimática , Detecção do Abuso de Substâncias/métodos , Anticorpos Monoclonais/imunologia , Complexo Antígeno-Anticorpo/imunologia , Gonadotropina Coriônica/imunologia , Humanos
8.
PLoS One ; 13(9): e0202474, 2018.
Artigo em Inglês | MEDLINE | ID: mdl-30208049

RESUMO

Most clinical trials exclude pregnant women in order to avoid the possibility of adverse embryonic and/or fetal effects. Currently, there are no evidence-based guidelines regarding appropriate methods for identifying early pregnancy among research subjects. This lack of guidance results in wide variation in pregnancy testing plans, leading to the potential for inadequate protection against embryonic or fetal exposure in some cases and unnecessary burdens on research participants in others, as well as inefficiencies caused by disagreements among sponsors, investigators, and regulators. To address this issue, the Clinical Trials Transformation Initiative convened content experts and stakeholders to develop recommendations for pregnancy testing in clinical research based on currently available evidence. Recommendations included: 1) the study protocol should clearly state the rationale for pregnancy testing and the plan for handling positive and indeterminate tests; 2) protocols should include an assessment of the pregnancy testing plan advantages (reduced risk of embryo/fetal exposure) versus the burdens (participant burden, study team workload, costs); 3) protocols should assess the participant burdens regarding the likelihood of false negative and false positive results; 4) participant administered home pregnancy testing should be avoided in clinical trials; and 5) the consent process should describe the extent of knowledge about the study intervention's potential risk to the embryo/fetus and the limitations and consequences of pregnancy testing. CTTI has also developed an online tool to help implement these recommendations.


Assuntos
Prática Clínica Baseada em Evidências/métodos , Testes de Gravidez/métodos , Gonadotropina Coriônica/análise , Gonadotropina Coriônica/sangue , Gonadotropina Coriônica/urina , Reações Falso-Negativas , Feminino , Guias como Assunto , Humanos , Internet , Gravidez , Inquéritos e Questionários
9.
J Clin Endocrinol Metab ; 103(12): 4501-4510, 2018 12 01.
Artigo em Inglês | MEDLINE | ID: mdl-30124893

RESUMO

Context: Fatty acids (FAs) are important for reproductive processes, including steroidogenesis, though associations with fecundability, as measured by time to pregnancy (TTP), are unclear. Objective: To investigate the relationship between preconception plasma phospholipid FA (PPFA) levels and time to human chorionic gonadotropin-pregnancy among women with prior pregnancy loss. Design, Setting, and Participants: Prospective cohort of 1228 women attempting pregnancy (aged 18 to 40 years, with one or two prior pregnancy losses) followed for up to six cycles at four US university medical centers during 2006 to 2012. PPFA levels were measured at baseline. Main Outcome Measures: Associations with fecundability overall and by body mass index (BMI) group after adjusting for confounders were estimated using fecundability odds ratios (FORs) and 95% CIs. False discovery rate (FDR) was used to account for multiple comparisons. Results: Monounsaturated fatty acids (MUFAs) were associated with increased fecundability or shorter TTP [FOR, 1.08 (95% CI, 1.01 to 1.16) per unit increase in percentage of total FAs], whereas polyunsaturated fatty acids (PUFAs) were associated with decreased fecundability or longer TTP [FOR, 0.95 (95% CI, 0.91 to 1.00) per 1% change], though associations only remained significant after FDR adjustment among women with BMI <25 kg/m2. Saturated FA and trans FA were not associated with fecundability. Omega-3 FAs and omega-6 linoleic acid were not associated with fecundability. Conclusion: We observed associations between preconception MUFA and PUFA levels and fecundability among women with normal BMI, highlighting the importance of FA composition among normal-weight women with prior pregnancy loss.


Assuntos
Ácidos Graxos Insaturados/sangue , Fosfolipídeos/sangue , Tempo para Engravidar/fisiologia , Adulto , Índice de Massa Corporal , Gonadotropina Coriônica/urina , Ácidos Graxos Insaturados/fisiologia , Feminino , Humanos , Fosfolipídeos/fisiologia , Gravidez , Estudos Prospectivos , Adulto Jovem
10.
Clin Biochem ; 53: 168-170, 2018 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-29395091

RESUMO

Biotin is commonly used as a dietary supplement for the claimed benefits of promoting healthy hair and nail growth and is available without a prescription at doses up to 10mg/capsule. Biotin-mediated interference in immunoassay testing is an emerging issue for clinical laboratories and previous studies have indicated that biotin at regularly encountered doses may interfere with these assays. In this study, we evaluated the effect of supplemental biotin on seven POC urine hCG test devices using purified biotin and urine collected from four volunteers consuming 10mg biotin/day. Six of the seven devices showed no evidence of biotin interference as each device's control line remained clearly detectable at all biotin concentrations tested. However, the QuickVue device control line demonstrated a marked decrease in intensity when used to test solutions containing >5µg/mL biotin. The absence of a control line during patient testing has the potential to delay care due to the generation of an invalid test result and lead to additional unnecessary testing. It is not realistic to measure urinary biotin concentrations in every patient undergoing qualitative urine hCG testing but biotin supplementation should be considered if repeat testing on a patient sample generates an invalid test result.


Assuntos
Biotina/urina , Gonadotropina Coriônica/urina , Sistemas Automatizados de Assistência Junto ao Leito , Feminino , Humanos
11.
Drug Test Anal ; 10(6): 956-960, 2018 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-29098788

RESUMO

Human chorionic gonadotropin (hCG) stimulates testosterone production by the testicles and can normalize suppressed testosterone concentrations in males following prolonged anabolic steroid use. Because of the potential for abuse by males, hCG is on the World Anti-Doping Agency (WADA) list of prohibited substances. The majority of WADA-accredited laboratories measure urinary hCG using an automated immunoassay. Only immunoassays that recognize the intact alpha and beta heterodimer of hCG (intact hCG) should be used to measure urinary hCG for doping control purposes since intact hCG is the only biologically active molecule. WADA further requires that confirmation testing is performed using an intact hCG immunoassay that is different from the one used in the initial testing procedure or by liquid chromatography-tandem mass spectrometry (LC-MS/MS). In this study we measured the concentration of intact hCG, free ß-subunit (hCGß) and ß-subunit core fragment (hCGßcf) in 570, 275, and 256 male urine samples, respectively, by an immunoextraction LC-MS/MS method. Mean concentrations of intact hCG, hCGß and hCGßcf were 0.04 IU/L, 0.47 pmol/L and 0.16 pmol/L, respectively. The upper reference limits (97.5th percentile) for intact hCG, hCGß and hCGßcf were 0.21 IU/L, 0.40 pmol/L, and 1.86 pmol/L, respectively. Based on these data, we recommend a threshold of 1.0 IU/L for intact hCG (false positive rate of <1 in 10 000) for detecting male athletes that dope with hCG.


Assuntos
Gonadotropina Coriônica/isolamento & purificação , Gonadotropina Coriônica/urina , Detecção do Abuso de Substâncias/métodos , Adolescente , Adulto , Gonadotropina Coriônica/administração & dosagem , Cromatografia Líquida , Humanos , Masculino , Isoformas de Proteínas/urina , Valores de Referência , Espectrometria de Massas em Tandem , Adulto Jovem
12.
J Assist Reprod Genet ; 34(10): 1341-1351, 2017 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-28710674

RESUMO

PURPOSE: The purpose of the present study is to study what is the best predictor of severe ovarian hyperstimulation syndrome (OHSS) in IVF. METHODS: This is a retrospective analysis of all consecutive IVF/intracytoplasmic injection cycles performed during a 5-year period (2009-2014) in a single university fertility centre. All fresh IVF cycles where ovarian stimulation was performed with gonadotrophins and GnRH agonists or antagonists and triggering of final oocyte maturation was induced with the administration of urinary or recombinant hCG were analyzed (2982 patients undergoing 5493 cycles). Because some patients contributed more than one cycle, the analysis of the data was performed with the use of generalized estimating equation (GEE). RESULTS: Severe OHSS was diagnosed in 20 cycles (0.36%, 95% CI 0.20-0.52). The number of follicles ≥10 mm on the day of triggering final oocyte maturation represents the best predictor of severe OHSS in IVF cycles. The cutoff in the number of follicles ≥10 mm with the best capacity to discriminate between women that will and will not develop severe OHSS was ≥15. CONCLUSION: The presence of more than 15 follicles ≥10 mm on the day of triggering final oocyte maturation represents the best predictor of severe OHSS in IVF cycles.


Assuntos
Biomarcadores/análise , Síndrome de Hiperestimulação Ovariana/etiologia , Indução da Ovulação/efeitos adversos , Indução da Ovulação/métodos , Adulto , Gonadotropina Coriônica/urina , Estudos de Coortes , Estradiol/sangue , Feminino , Fertilização In Vitro/efeitos adversos , Hormônio Foliculoestimulante/farmacologia , Hormônio Liberador de Gonadotropina/análogos & derivados , Humanos , Técnicas de Maturação in Vitro de Oócitos/métodos , Modelos Logísticos , Hormônio Luteinizante/sangue , Folículo Ovariano/efeitos dos fármacos
13.
J Immunoassay Immunochem ; 38(4): 449-455, 2017.
Artigo em Inglês | MEDLINE | ID: mdl-28521601

RESUMO

Very high levels of ß-core fragment human chorionic gonadotrophin (ßcf-hCG) are reported to potentially cause false negative results in point-of-care (POC)/over-the-counter (OTC) pregnancy tests. To investigate this further, women's daily early morning urine samples, collected prior to conception and during pregnancy, were analysed for intact, free ß-, and ßcf-hCG. The proportion of ßcf-hCG was found to be related to that of hCG produced and in circulation. Therefore, best practice for accuracy testing of POC/OTC pregnancy tests would be to test devices against clinical samples containing high levels of ßcf-hCG as well as standards spiked with biologically relevant ratios.


Assuntos
Gonadotropina Coriônica/urina , Testes de Gravidez , Reações Falso-Negativas , Feminino , Humanos , Sistemas Automatizados de Assistência Junto ao Leito , Gravidez
14.
Int J Hyg Environ Health ; 220(5): 799-809, 2017 07.
Artigo em Inglês | MEDLINE | ID: mdl-28392401

RESUMO

Phthalates are a class of plasticizing chemicals produced in high volume and widely found in consumer products. Evidence suggests that phthalates may have non-monotonic effects on reproductive hormone activity. With exposure to phthalates virtually ubiquitous among industrialized populations, identifying unexposed and/or minimally exposed human populations is essential for understanding the effects of low level exposures. Our primary objective was to quantify urinary phthalate metabolite concentrations in the Tsimane', a remote population of Bolivian forager-horticulturalists. Our secondary objectives were to determine if phthalate metabolite concentrations vary in relation to access to market goods; and to explore relationships between phthalate and reproductive hormone metabolite concentrations. Given that phthalate exposure is of particular concern during fetal development, we focused on reproductive age women in the current analyses. Phthalate metabolites were assayed in urine samples from 59 naturally cycling, reproductive age Tsimane' women. Market access was assessed as: (1) distance from residence to the largest nearby town (San Borja, Bolivia) and (2) Spanish fluency. Urinary reproductive hormone metabolite concentrations were quantified using enzyme immunoassays. We fit linear models to examine: (1) predictors of phthalate exposure; and (2) relationships between urinary phthalate and reproductive hormone metabolite concentrations. Eight phthalate metabolites were detectable in at least 75% of samples. Median concentrations were up to an order of magnitude lower than industrialized populations. Proximity to San Borja and Spanish fluency were strong predictors of exposure. In exploratory analyses, the sum of the di-2-ethylhexyl phthalate metabolites (∑DEHP) and Mono-isobutyl phthalate (MiBP) were significantly associated with altered concentrations of urinary reproductive hormone metabolites. Remote, subsistence populations, like the Tsimane', offer a unique window into the health effects of endocrine active compounds because: (1) exposures are low and likely to be first generation; (2) a natural fertility lifestyle allows for exploration of reproductive effects; and (3) ever-increasing globalization will result in increasing exposure in the next decade.


Assuntos
Poluentes Ambientais/urina , Ácidos Ftálicos/urina , Plastificantes/análise , Adolescente , Adulto , Agricultura , Bolívia , Gonadotropina Coriônica/urina , Monitoramento Ambiental , Estrona/análogos & derivados , Estrona/urina , Feminino , Hormônio Foliculoestimulante/urina , Humanos , Pregnanodiol/análogos & derivados , Pregnanodiol/urina , Adulto Jovem
15.
Chirurgia (Bucur) ; 112(1): 68-71, 2017.
Artigo em Inglês | MEDLINE | ID: mdl-28266296

RESUMO

Tubal abortion is characterized by the extrusion of an ectopic product of conception implanted in the fallopian tube through the abdominal ostium into the peritoneal cavity. It can be either complete or incomplete and may lead to severe bleeding. Recognition of a complete tubal abortion may be challenging but is essential because it allows conservative management which make possible preservation of tubal function and fertility without the need for further cytostatic therapy. A case of a 30 years-old woman admitted for lower abdominal pain is reported.The level of hCG was 659.2 mU/mL and transvaginal ultrasound reveled a fluid collection in the pouch of Douglas. Laparoscopy was subsequently performed for the suspicion of ectopic pregnancy with hemoperitoneum. Corroborating the hCG dynamics with the laparoscopic findings, the diagnosis of complete tubal abortion was established. The histopathological examination confirmed the presence of intermediate trophoblastic cells in the tissue collected during laparoscopy. Ultrasound examination helps recognition of hemoperitoneum but adds little value to the diagnosis of tubal abortion. Laparoscopic findings alone are only suggestive for complete tubal abortion but in combination with hCG dynamics, the diagnosis can be established. Conservative management might be sufficient in complete tubal abortion and ensures preservation of tubal function and fertility.


Assuntos
Aborto Espontâneo/diagnóstico , Aborto Espontâneo/terapia , Hemoperitônio/terapia , Gravidez Tubária/diagnóstico , Gravidez Tubária/terapia , Adulto , Gonadotropina Coriônica/sangue , Gonadotropina Coriônica/urina , Feminino , Hemoperitônio/etiologia , Humanos , Laparoscopia , Gravidez , Gravidez Ectópica/terapia , Gravidez Tubária/sangue , Gravidez Tubária/urina , Resultado do Tratamento , Ultrassonografia Pré-Natal/métodos
16.
Lab Chip ; 17(6): 1051-1059, 2017 03 14.
Artigo em Inglês | MEDLINE | ID: mdl-28154873

RESUMO

Through their computational power and connectivity, smartphones are poised to rapidly expand telemedicine and transform healthcare by enabling better personal health monitoring and rapid diagnostics. Recently, a variety of platforms have been developed to enable smartphone-based point-of-care testing using imaging-based readout with the smartphone camera as the detector. Fluorescent reporters have been shown to improve the sensitivity of assays over colorimetric labels, but fluorescence readout necessitates incorporating optical hardware into the detection system, adding to the cost and complexity of the device. Here we present a simple, low-cost smartphone-based detection platform for highly sensitive luminescence imaging readout of point-of-care tests run with persistent luminescent phosphors as reporters. The extremely bright and long-lived emission of persistent phosphors allows sensitive analyte detection with a smartphone by a facile time-gated imaging strategy. Phosphors are first briefly excited with the phone's camera flash, followed by switching off the flash, and subsequent imaging of phosphor luminescence with the camera. Using this approach, we demonstrate detection of human chorionic gonadotropin using a lateral flow assay and the smartphone platform with strontium aluminate nanoparticles as reporters, giving a detection limit of ≈45 pg mL-1 (1.2 pM) in buffer. Time-gated imaging on a smartphone can be readily adapted for sensitive and potentially quantitative testing using other point-of-care formats, and is workable with a variety of persistent luminescent materials.


Assuntos
Processamento de Imagem Assistida por Computador/instrumentação , Substâncias Luminescentes/química , Medições Luminescentes , Smartphone , Gonadotropina Coriônica/urina , Desenho de Equipamento , Humanos , Limite de Detecção , Substâncias Luminescentes/análise , Medições Luminescentes/economia , Medições Luminescentes/instrumentação , Medições Luminescentes/métodos , Testes Imediatos
17.
Contraception ; 95(5): 442-448, 2017 May.
Artigo em Inglês | MEDLINE | ID: mdl-28041991

RESUMO

OBJECTIVES: To summarize data on the accuracy of a strategy designed to exclude ongoing pregnancy after medical abortion treatment by observing a decline in urine human chorionic gonadotropin (hCG) concentration as estimated by multilevel urine pregnancy tests (MLPTs) performed before and after treatment. STUDY DESIGN: We collated original data from seven studies performed by our organization that evaluated the accuracy of the MLPT strategy for assessment of outcome of medical abortion. Our first analysis included data from the five studies in which each participant was evaluated both with the MLPT strategy and with ultrasound or other clinical assessment. Our second analysis combined data from two randomized trials that compared the MLPT strategy to assessment by ultrasound. Both analyses included only participants treated at ≤63 days of gestation. RESULTS: In the first analysis, 1482 (93%) of 1599 participants had a decline in hCG concentration after treatment. Twenty-one (1.3%) had an ongoing pregnancy, none of whom had a decline (predictive value 100%, 95% CI 93.3%, 100%). The remaining 96 women (6.0%) had no decline without an ongoing pregnancy. The second analysis, which included 3762 participants with follow-up, found no significant difference in the rates of ongoing pregnancy ascertained in the randomized groups (RR 0.88; 95% CI 0.50, 1.54). Nearly all of the post-treatment MLPTs in the seven studies (3484/3535; 99%) were performed by the participants themselves. CONCLUSIONS: Serial multilevel urine pregnancy testing is a highly reliable and efficient strategy for excluding ongoing pregnancy after medical abortion at≤63 days of gestation. IMPLICATIONS STATEMENT: Serial urine testing using MLPTs can obviate the need for routine ultrasound or examination after medical abortion treatment and can allow most women to avoid an in-person follow-up visit to the abortion facility.


Assuntos
Aborto Induzido/métodos , Gonadotropina Coriônica/urina , Testes de Gravidez/métodos , Resultado do Tratamento , Abortivos não Esteroides , Abortivos Esteroides , Feminino , Humanos , Mifepristona/administração & dosagem , Misoprostol/administração & dosagem , Gravidez , Sensibilidade e Especificidade , Fatores de Tempo
18.
Drug Test Anal ; 9(5): 699-712, 2017 May.
Artigo em Inglês | MEDLINE | ID: mdl-27497113

RESUMO

Urine collection containers used in the doping control collection procedure do not provide a protective environment for urine, against degradation by microorganisms and proteolytic enzymes. An in-house chemical stabilization mixture was developed to tackle urine degradation problems encountered in human sport samples, in cases of microbial contamination or proteolytic activity. The mixture consists of antimicrobial substances and protease inhibitors for the simultaneous inactivation of a wide range of proteolytic enzymes. It has already been tested in lab-scale, as part of World Anti-Doping Agency's (WADA) funded research project, in terms of efficiency against microbial and proteolytic activity. The present work, funded also by WADA, is a follow-up study on the improvement of chemical stabilization mixture composition, application mode and limitation of interferences, using pilot urine collection containers, spray-coated in their internal surface with the chemical stabilization mixture. Urine in plastic stabilized collection containers have been gone through various incubation cycles to test for stabilization efficiency and analytical matrix interferences by three WADA accredited Laboratories (Athens, Ghent, and Rome). The spray-coated chemical stabilization mixture was tested against microorganism elimination and steroid glucuronide degradation, as well as enzymatic breakdown of proteins, such as intact hCG, recombinant erythropoietin and small peptides (GHRPs, ipamorelin), induced by proteolytic enzymes. Potential analytical interferences, observed in the presence of spray-coated chemical stabilization mixture, were recorded using routine screening procedures. The results of the current study support the application of the spray-coated plastic urine container, in the doping control collection procedure. Copyright © 2016 John Wiley & Sons, Ltd.


Assuntos
Manejo de Espécimes/métodos , Detecção do Abuso de Substâncias/métodos , Urinálise/métodos , Urina/química , Gonadotropina Coriônica/urina , DNA/urina , Doping nos Esportes , Eritropoetina/urina , Seguimentos , Humanos , Peptídeos/urina , Projetos Piloto , Proteólise , Proteínas Recombinantes/urina , Manejo de Espécimes/instrumentação , Esteroides/urina , Detecção do Abuso de Substâncias/instrumentação , Urinálise/instrumentação , Urina/microbiologia
19.
Ann Clin Biochem ; 54(5): 548-557, 2017 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-27629911

RESUMO

Background Human chorionic gonadotrophin is a marker of early pregnancy. This study sought to determine the possibility of being able to distinguish between healthy and failing pregnancies by utilizing patient-associated risk factors and daily urinary human chorionic gonadotrophin concentrations. Methods Data were from a study that collected daily early morning urine samples from women trying to conceive (n = 1505); 250 of whom became pregnant. Data from 129 women who became pregnant (including 44 miscarriages) were included in these analyses. A longitudinal model was used to profile human chorionic gonadotrophin, a Cox proportional hazards model to assess demographic/menstrual history data on the time to failed pregnancy, and a two-stage model to combine these two models. Results The profile for log human chorionic gonadotrophin concentrations in women suffering miscarriage differs to that of viable pregnancies; rate of human chorionic gonadotrophin rise is slower in those suffering a biochemical loss (loss before six weeks, recognized by a rise and fall of human chorionic gonadotrophin) and tends to plateau at a lower log human chorionic gonadotrophin in women suffering an early miscarriage (loss six weeks or later), compared with viable pregnancies. Maternal age, longest cycle length and time from luteinizing hormone surge to human chorionic gonadotrophin reaching 25 mIU/mL were found to be significantly associated with miscarriage risk. The two-stage model found that for an increase of one day in the time from luteinizing hormone surge to human chorionic gonadotrophin reaching 25 mIU/mL, there is a 30% increase in miscarriage risk (hazard ratio: 1.30; 95% confidence interval: 1.04, 1.62). Conclusion Rise of human chorionic gonadotrophin in early pregnancy could be useful to predict pregnancy viability. Daily tracking of urinary human chorionic gonadotrophin may enable early identification of some pregnancies at risk of miscarriage.


Assuntos
Aborto Espontâneo/urina , Gonadotropina Coriônica/urina , Modelos Estatísticos , Urinálise , Adolescente , Adulto , Feminino , Humanos , Estudos Longitudinais , Gravidez , Modelos de Riscos Proporcionais , Medição de Risco , Adulto Jovem
20.
Drug Test Anal ; 8(11-12): 1147-1151, 2016 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-27594536

RESUMO

Anti-doping laboratories routinely use immunoassays to measure urinary concentrations of human chorionic gonadotropin (hCG). To minimize immunoassay differences and false positive screen results from inactive isoforms (free ß-subunit (hCGß), ß-subunit core fragment (hCGßcf)) laboratories now use intact hCG instead of total hCG immunoassays to measure hCG. To determine the distribution of hCG isoforms in urine, we determined the concentrations of intact hCG, hCGß, and hCGßcf in male urine samples based on immunoassay total hCG concentrations using a sequential immunoextraction and a liquid chromatography-tandem mass spectrometry (LC-MS/MS) method. hCG was isolated using antibody-conjugated magnetic beads and unique tryptic peptides were quantified by LC-MS/MS. Negative samples with detectable but low total hCG concentrations (1.2-3.5 pmol/L) had intact and hCGß concentrations <1.2 pmol/L, and hCGßcf concentrations <2.3 pmol/L by LC-MS/MS. Urine samples from an athlete receiving hCG had intact hCG concentrations ranging from 18.8 to 57.6 pmol/L, hCGß concentrations <0.7 pmol/L, and hCGßcf concentrations ranging from 94 to 243% of the intact hCG concentration. In 27 atypical samples with total hCG concentrations ranging from 16.7 to 412.7 pmol/L with intact hCG <2.7 pmol/L by immunoassay, all samples had intact hCG concentrations <3.8 pmol/L and hCGß concentrations <6.2 pmol/L by LC-MS/MS. hCGßcf concentrations by LC-MS/MS varied widely and ranged from 1.03 to 21.9 pmol/L. In summary, total hCG immunoassays significantly overestimate hCG concentrations and can produce false positive results. Although the intact hCG immunoassay slightly overestimates hCG concentrations compared to LC-MS/MS, it can distinguish between cases of hCG use and atypical cases with elevated total hCG concentrations. Copyright © 2016 John Wiley & Sons, Ltd.


Assuntos
Gonadotropina Coriônica Humana Subunidade beta/química , Gonadotropina Coriônica/urina , Imunoensaio/métodos , Fragmentos de Peptídeos/química , Espectrometria de Massas em Tandem/métodos , Gonadotropina Coriônica/química , Gonadotropina Coriônica Humana Subunidade beta/análise , Doping nos Esportes , Humanos , Fragmentos de Peptídeos/análise
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