Assay device for determining and indicating time since conception by comparing a measured hCG level to two stored threshold levels

摘要

589488 Disclosed is an assay result reader when used with an assay or assay device (50) adapted to calculate a quantitative estimate of the length of time since conception in a female human subject. The assay result reader is comprised of: a) a first stored analyte threshold corresponding to 14 days since conception; b) a second stored analyte threshold corresponding to 21 days since conception; c) a stored minimum pregnancy threshold (PTDmin); d) a measurement means adapted to measure an analyte signal value; and e) a display means (53) adapted to display a time since conception. The analyte signal value measured by the measurement means corresponds to the level of hCG in a urine sample obtained from the subject. The measurement means is also adapted to compare the analyte signal value to the minimum pregnancy threshold and the first and second stored analyte thresholds. The measurement means provides a quantitative estimate of the length of time since conception based upon this comparison. The time since conception is defined relative to the date of LH surge. The results displayed by the reader are as follows: "not pregnant" if the analyte signal is less than the minimum pregnancy threshold; 1-2 weeks if the analyte signal is less than the first analyte threshold but greater than the minimum pregnancy threshold; 2-3 weeks if the analyte signal is greater than or equal to the first threshold but less than or equal to the second threshold; and 3+ weeks if the analyte signal is greater than the second threshold.