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The modified Fact PLUS Pregnancy Test (Cup and Dropper) is an over-the counter in vitro diagnostic immunoassav intended for the qualitative detection of human chorionic gonadotropin (hCG), in urine. A labeling modification to the currently marketed Fact PLUS® Pregnancy Test enables the test results to be read in three minutes or less without altering the accuracy, sensitivity or specificity of the test. The Fact PLUS Pregnancy Test is indicated for consumer use to detect pregnancy as early as first day of a missed period, any time of the day. Negative test results are confirmed after three minutes, some positives results can be read as soon as one minute.

The modified Fact PLUS Pregnancy Test is a disk-shaped ("Test Disk") device constructed of two pieces of molded plastic. The test chemistries are coated on a test strip housed within the test disk. The test strip contains three reactive sites: a conjugate site, an antibody site and a control site. Three openings on the upper surface of the test disk correspond to these sites: "Urine Well," "Result Window," "Control Window" (CW) respectively. When urine is added via the Urine Well it wets the conjugate (anti-α hCG antibody) mobilizing it. If hCG molecules are present in the urine specimen, an hCG/conjugate complex is formed. This complex and any remaining unbound coniuqate migrate along the strip attaching to the anti-8 hCG antibody contained on the vertical bar (positive) and also to the polyclonal antibodies on the intersecting horizontal bar (negative) causing a pink reaction. The appearance of pink color on the horizontal and vertical bars forms the "plus" sign or positive "pregnant" result. When no hCG molecules are present in the urine specimen, the conjugate remains unbound and attaches only to the horizontal or "minus" bar causing it to turn pink. The appearance of only one pink horizontal bar constitutes the negative or ("not pregnant") result. The urine flow continues on to the Control Window where it activates a special dye causing a red color to appear. The red color in the CW tells the user the that enough urine was added. It is can also play an important role in helping the Consumer Service representatives on our toll free number to evaluate consumer reported problems. It takes approximately five minutes for the urine to reach the Control Window. The appearance of a "plus" or a "minus" in the Result Window however, appears sooner usually within three minutes or less. Some positive results can appear as soon as one minute. The appearance of a plus or minus in the Result Window and red color in the Control Window are the built-in controls which indicate the test chemistries worked properly and that a sufficient volume of urine was added.

The FactPLUS® One Step Pregnancy Test is an over-the-counter in vitro diagnostic immunoassay intended for the qualitative detection of human chorionic gonadotropin (hCG) in urine. This device is the same device as ADVANCE® Pregnancy Test, with a labeling modification that provides for reading the test in three minutes without affecting the accuracy, sensitivity or specificity of the test. FactPLUS Cne Step Pregnancy Test is indicated for consumer use to detect pregnancy as early as first day of a missed period, using a direct urine stream sampling mode. Test results can be read after three minutes. Some positives appear as soon as one minute, neaative results are confirmed in three minutes.

The FactPLUS One Step Pregnancy Test is an elongated "Test Stick" constructed of two pieces of molded plastic which house the internal chemistry strip. The chemistry strip contains a conjugate site, an antibody reaction site and a test control site. There are three openings on the upper surface of the Test Stick: - "Urine Well" . - "Result Window" . - "Control Window" . Urine is absorbed through the Urine Well and travels along the test membrane to the Result Window (reaction site) and finally to the Control Window. The conjugate (anti-α hCG antibody) present on the membrane is mobilized by the urine flow. If hCG molecules are present in the urine, an hCG/conjugate/complex is formed. The mobilized hCG/conjugate/ complex continues to migrate along the strip to the reaction site where it binds with the anti-ß hCG antibody present on the vertical bar and the polyclonal antibody present on the horizontal bar causing both bars to turn pink. The appearance of pink color on both intersecting bars create the plus sign or "pregnant" result. This reaction generally appears within three minutes. Some positives appear as soon as one minute; however, negative results are confirmed in three minutes. In the absence of hCG molecules, the conjugate remains unbound and attaches only to the antibody present on the horizontal bar, causing it to turn pink. The appearance of only one reaction bar constitutes the minus or ("not pregnant") result. The urine continues to migrate until it reaches the Control Window where it reacts with a special dye causing a red color to appear. The red color in the CW is an indication that enough urine was added to the device. It takes approximately five minutes after the addition of urine for the Control Window to turn red. A labeling modification and optimization of the test antibodies, enable the results to be read sooner than previous versions of the test and eliminates the restriction of waiting for red color in the Control Window before reading the results.