Unilever Patent Holdings B.v.

Inverness Medical Switzerland Gmbh

John Coley

Paul James Davis

Michael Catt

Ronald Smith

Anthony Blake

Philip Porter

Lorraine D Butlin

Mohamed M Gani

Stephen J Eida

Stephanie J Senior

A method and test device for differentiating between states of an analyte that can exist in different forms, such as follicle stimulating hormone (FSH). The method or test device uses a pair of specific binding agents, especially monoclonal antibodies, in two assays for the same analyte. The assays, applied to contemporaneous samples, differ from one another in format, one being a two step assay and the other being one step. A novel pair of anti-FSH monoclonal antibodies that can be used together in two such assays to differentiate pre-menopausal and post-menopausal FSH samples is disclosed.

Test methods and devices

A method and test kit for providing contraceptive advice during the human ovulation cycle, involving simply the measurement of urinary lutenising hormone (LH) concentration on a daily basis during the early phase of the cycle until the LH surge indicative of ovulation is detected, together with calender means to advise the user to abstain from unprotected intercourse during a time interval commencing not later than a predetermined first day of LH testing and ending at least 2 days following the day of LH surge detection.

Advisory method

A method of monitoring the status of a current ovulation cycle of an individual human female subject, involving testing of the body fluid concentration of an analyte of significance in relation to the status of the ovulation cycle, such as urinary E3G, during at least part of the pre-ovulation phase of the current ovulation cycle of the individual subject, and identification from the results of such testing an analyte concentration change indicative of imminent ovulation, relative to an analyte concentration reference value that has been adapted to the individual human subject on the basis of analyte concentration test data obtained from the individual human subject during one or more previous ovulation cycles.

Monitoring method

A method of monitoring the status of a current ovulation cycle of an individual human female subject, involving testing of the body fluid concentration of an analyte of significance in relation to the status of the ovulation cycle, such as urinary E3G, during at least part of the pre-ovulation phase of the current ovulation cycle of the individual subject, and identification from the results of such testing an analyte concentration change indicative of imminent ovulation, relative to an analyte concentration reference value that has been adapted to the individual human subject on the basis of analyte concentration test data obtained from the individual human subject during one or more previous ovulation cycles. Preferably testing for said analyte concentration during the current ovulation cycle is commenced a plurality of days (preferably at least 5) following the onset of menses but at least 2 numerical days in advance of the earliest numerical day on which actual ovulation has occurred in one or more previous ovulation cycles in the same individual subject.

Method for monitoring ovulation

A device for carrying out chemical or clinical testing of a liquid sample, for example a urine sample, by a specific binding assay, said device comprising a test compoenent (2) which has a sensitised solid surface (2a) carrying an immobilized component of a specific binding pair relevant to the essay, and a handling piece (1), and characterized in that the test component (2) bearing the sensitized surface (2a) is removably mounted in spaced relationship with a removably mounted accessory component (4) carrying an accessory solid surface (5), and in that there is a space (4a) between the sensitized surface (2a) and the removable accessory component (4) to act as a container for sample liquid, so that when the device is contacted with a sample liquid source or immersed in liquid which is to provide the test sample, liquid of the sample can enter the space (4a) to contact the sensitized surface (2a), and the accessory surface (5) acts to retain and contain sample liquid in contact with the sensitized surface (2a) even after removal of the device from further contact with or immersion in the source of sample liquid, and in that the test component (2) is so formed that after removal of the removable accessory component (4) the sensitized surface (2a) is left exposed and accessible to further treatment liquid such as washing liquid and/or reagents.

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Stanwick, United Kingdom

John Coley