Fertility and sterility · 2014
Human chorionic gonadotropin discriminatory zone in ectopic pregnancy: does assay harmonization matter?
Сравнительное исследованиеСтатьяМногоцентровое исследованиеНазвание и аннотация: Перевод в очереди
Обработка статьи · этапы, ошибки и управление
Загрузка состояния…
Ошибки и ограничения
История · было → стало
Состояние обновляется каждые 5 секунд, пока блок открыт. Процент показывается только там, где известен объём работы. Пауза останавливает продолжение этапа; текущий запрос к источнику может завершиться.
Desai Diana, Lu Jun, Wyness Sara P, Greene Dina N, Olson Kalen N, Wiley Carmen L, Grenache David G
Аннотация
OBJECTIVE: To determine the effect that lack of hCG assay harmonization has on the interpretation of a serum hCG concentration with regards to the hCG discriminatory zone.
DESIGN: A multisite method comparison study.
SETTING: Clinical laboratories.
PATIENT(S): Eighty serum samples containing various concentrations of hCG.
INTERVENTION(S): None.
MAIN OUTCOME MEASURE(S): Concentrations of hCG obtained from seven hCG reagent platforms.
RESULT(S): The hCG concentrations were significantly different across hCG reagent platforms. Seventy-one percent of assay pairs showed significant differences with samples selected based on hCG concentrations between 1,500 and 3,500 IU/L as determined by a comparative method. Relative to the comparative method, the calculated hCG discriminatory zones for five assays were within 9%, and one assay was within 40% of the target concentrations of 1,500 and 3,500 IU/L.
CONCLUSION(S): Despite significant differences in hCG concentrations across hCG immunoassays, an hCG concentration within a discriminatory zone of 1,500-3,500 IU/L can be used for all but one commonly used hCG reagent platform.
DESIGN: A multisite method comparison study.
SETTING: Clinical laboratories.
PATIENT(S): Eighty serum samples containing various concentrations of hCG.
INTERVENTION(S): None.
MAIN OUTCOME MEASURE(S): Concentrations of hCG obtained from seven hCG reagent platforms.
RESULT(S): The hCG concentrations were significantly different across hCG reagent platforms. Seventy-one percent of assay pairs showed significant differences with samples selected based on hCG concentrations between 1,500 and 3,500 IU/L as determined by a comparative method. Relative to the comparative method, the calculated hCG discriminatory zones for five assays were within 9%, and one assay was within 40% of the target concentrations of 1,500 and 3,500 IU/L.
CONCLUSION(S): Despite significant differences in hCG concentrations across hCG immunoassays, an hCG concentration within a discriminatory zone of 1,500-3,500 IU/L can be used for all but one commonly used hCG reagent platform.