Diagnostic devices and methods are provided. The diagnostic devices
preferably comprise a test strip with a test area. The sample to be
analyzed contacts the test area, which comprises a specific binding
partner for the analyte of interest. Analyte, if present in the sample,
binds to the immobilized binding partner in the test area and is
subsequently contacted with a conjugate. The conjugate specifically binds
the analyte and provides a visual indication of the presence of the
analyte. The devices may be used for the diagnosis of particular diseases
or disorders in a patient, such as HIV or hepatitis. They may also be
used to determine if an individual is pregnant.