With the introduction of urine dipsticks more than 40 yr ago for the rapid detection of glucose and other substances in urine, the benefits of immediate laboratory information became apparent (1). The advantages in the clinical environment include changes to treatment plans while the patient is still in the doctor's office, cost improvements, and the elimination of specimen transportation and additional paperwork (2-3).
By the early 1980s, pregnancy tests were available for near-patient, or point-of-collection use, but required multiple reagent mixing and positive and negative control comparisons. Within a few years, the lateral-flow pregnancy test was introduced. This eliminated the procedure of reagent handling and provided a visual indication of pregnancy by way of a color indicator utilizing colloidal gold. The benefits of this one-step pregnancy test were immediately apparent, and the simplicity of use allowed patients to be use the product in the home. Over time, the sensitivity and specificity of the antibody-P human chorionic gondaotropin (HCG) reaction improved to detect lower levels of PHCG, enabling the detection of pregnancy earlier in the cycle (4-7).
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