Pregnancy testing with hCG--future prospects.

Pregnancy tests for human chorionic gonadotrophin (hCG) are used widely in hospital and home settings. Assays measuring hCG also have uses in prenatal screening and oncology. The output from three recent international workshops provides a framework for reliable measurement of hCG. Requirements for future hCG assays include use of clear descriptive nomenclature, informed selection of antibodies of well-defined epitope specificities, and design of robust methods. Tests will be precisely characterized and calibrated in SI units using six International Reference Reagents (IRR) for hCG and variants, and the Fifth International Standard for hCG 07/364, making it possible to report clinical results in molar units. These measures will help to increase patient safety by reducing the risk of erroneous or misleading hCG results.

Should the qualitative serum pregnancy test be considered obsolete?

Qualitative and quantitative serum human chorionic gonadotropin (hCG) tests are used to diagnose pregnancy. We assessed physicians' perceptions and compared turnaround times (TATs) and performance characteristics of both tests. We surveyed 1,058 physicians about their perceptions of hCG tests. Seven months of TAT data were analyzed. hCG was measured in all qualitative samples. Pregnancy status was determined by chart review. Of the physicians surveyed, 183 responded. Forty-nine percent preferred qualitative over quantitative serum tests for determining pregnancy status. Physicians were willing to wait 45 minutes for results from either test. Qualitative tests are performed faster than quantitative tests, but TATs were not significantly different when sample transport time was considered. The negative predictive value of both tests was 99.9%. Qualitative serum hCG testing could be replaced by quantitative hCG tests, but there is no clear advantage to doing so.

[Trends in the incidence of positive pregnancy tests in adolescents seen in an emergency department]. / Evolución de la incidencia de test de embarazo positivo en adolescentes atendidas en un servicio de urgencias.

INTRODUCTION: The current debate on induced abortion and the age when a young woman is considered mature to have this without parental consent, shows the need to know the real importance of adolescent pregnancy in the Emergency Department. OBJECTIVES: a) To determine the adolescent pregnancy rate variation in the Emergency Department during last 12 years; b) to determine the characteristics of the pregnant adolescent and the outcome of their pregnancies. MATERIAL AND METHODS: Retrospective study of pregnant adolescents diagnosed in the Emergency Department between July 1, 1997 and June 30, 2009. Pregnancy rates were calculated per 1000 annual female adolescent consultations. Two periods were considered: 1/from July 1, 1997 to June 30, 2003 and 2/from July 1, 2003 to June 30, 2009. RESULTS: Eighty-three pregnancies were diagnosed in adolescents. Pregnancy rates varied from 0.5 to 2.0 per 1000 females; an increased trend in adolescent pregnancy rate was observed in the second period. Metrorrhagia, abdominal pain and vomiting were the most frequent complaints. There were 62 on-going pregnancies, 20 abortions and one ectopic pregnancy. Only 35 of the outcomes of the 62 on-going pregnancies were known: 19 ended in live birth, 11 in induced abortion and 4 in stillbirth. CONCLUSIONS: The adolescent pregnancy rate is low; nevertheless an increased trend is being observed in the last few years. Many adolescents diagnosed with pregnancy had nonspecific complaints, so it is important to ask about sexual habits in all adolescents. A high percentage of diagnosed pregnancies end in abortion.

Uso adecuado del ensayo de gonadotrofina coriónica humana en el diagnóstico de embarazo. ¿Sangre u orina? / Adequate use of the human chorionic gonadotropin in the pregnancy diagnosis. Blood or urine?

Introducción: Los niveles de Gonadotrofina Coriónica humana (hCG) pueden detectarse en suero o en orina con métodos de distinta sensibilidad y permiten no solamente el diagnóstico del embarazo, sino también su seguimiento, la posibilidad de detección de embarazos ectópicos y las amenazas de aborto. Objetivos: 1) Demostrar la concordancia entre las pruebas para diagnóstico precoz de embarazo en muestras simultáneas de sangre y orina a niveles iguales o superiores a 25 mUI/ml. 2) Estimar el grado de sobreutilización del enzimoinmunoensayo en sangre y su repercusión sobre los costos. Material y métodos: Sesenta muestras consecutivasde suero y sus correspondientes de orina recolectadas el mismo día de la extracción de sangre. La determinación cuantitativa de hCG b total en sangre se efectuó por el método ELISA (MEIA) (Abbott. AXSYM System). En orina se utilizó un inmunoensayo cromatográfico cualitativo en un solo paso (Acon).

Uso adecuado del ensayo de gonadotrofina coriónica humana en el diagnóstico de embarazo. ¿Sangre u orina? / Adequate use of the human chorionic gonadotropin in the pregnancy diagnosis. Blood or urine?

Introducción: Los niveles de Gonadotrofina Coriónica humana (hCG) pueden detectarse en suero o en orina con métodos de distinta sensibilidad y permiten no solamente el diagnóstico del embarazo, sino también su seguimiento, la posibilidad de detección de embarazos ectópicos y las amenazas de aborto. Objetivos: 1) Demostrar la concordancia entre las pruebas para diagnóstico precoz de embarazo en muestras simultáneas de sangre y orina a niveles iguales o superiores a 25 mUI/ml. 2) Estimar el grado de sobreutilización del enzimoinmunoensayo en sangre y su repercusión sobre los costos. Material y métodos: Sesenta muestras consecutivasde suero y sus correspondientes de orina recolectadas el mismo día de la extracción de sangre. La determinación cuantitativa de hCG b total en sangre se efectuó por el método ELISA (MEIA) (Abbott. AXSYM System). En orina se utilizó un inmunoensayo cromatográfico cualitativo en un solo paso (Acon).(AU)

Trends in adherence to a revised risk management program designed to decrease or eliminate isotretinoin-exposed pregnancies: evaluation of the accutane SMART program.

OBJECTIVE: To review adherence to selected procedures outlined in the System to Manage Accutane-Related Teratogenicity (SMART) program during the first year of implementation vs the procedures in effect in the year prior to initiation of the SMART program. DESIGN: Observational. SETTING: A novel pharmacy compliance survey and an ongoing, voluntary survey. PATIENTS: Female recipients of isotretinoin. INTERVENTION: In April 2002, Hoffmann-La Roche Inc, Nutley, NJ, manufacturer of Accutane brand isotretinoin and at that time the sole source of isotretinoin, revised earlier guidelines and instituted the SMART risk management program, which included the use of qualification stickers to affix to all prescriptions for Accutane to indicate, among other things, a negative pregnancy test just before the prescription was written. The goal of the SMART program was to decrease or eliminate isotretinoin-exposed pregnancies. MAIN OUTCOME MEASURES: Use and completion of prescription qualification stickers; changes in pretherapy pregnancy testing and birth control use. RESULTS: The results of the pharmacy compliance survey indicated high (>90%) use of prescription qualification stickers. Results of the patient survey suggested that 9% of prescription qualification stickers within the observed user cohort were issued without a pregnancy test. Furthermore, the pregnancy rate for patients participating in the survey was similar to that reported for cohorts recruited before the SMART program. CONCLUSIONS: The usefulness of the results derived from 2 surveys designed to evaluate the SMART program is limited by the lack of reliability and validity of the survey instruments and by questionable generalizability to all female recipients of isotretinoin. The presence of a qualification sticker may not have an impact on pregnancy testing or compliance with effective birth control behavior as outlined in the SMART program.

Pruebas de embarazo

Se hace una revisión bibliográfica de las pruebas de embarazo disponibles en el medio para la práctica médica, haciendo énfasis en las pruebas inmunológicas. Se analizan las causas de resultados falsos positivos y falsos negativos, así como el comportamiento de la prueba en las principales situaciones anormales del embarazo, especialmente el embarazo ectópico. Se concluye que, a la luz de los conocimientos actuales, la ®mejor prueba de embarazo¼ está representada por la tecnología del radioinmunoanálisis, y que una prueba cualitativa con esta tecnología - con sensibilidad por debajo de 25 mUl/mL- es lo suficientemente sensible para detectar todos los embarazos normales a partir del momento enque se presenta la amenorrea.