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Wunder Pregnancy Test is a rapid chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in human urine. The device is visually read as an aid for the early detection of pregnancy and intended for in vitro single use. This test is intended for prescription use including at point-of-care sites.

Wunder Pregnancy Test is a single-use qualitative immunochromatic lateral flow device intended to detect human chorionic gonadotropin (hCG) in urine to help in the early detection of pregnancy. The device is visually read and intended for prescription use. Wunder Pregnancy Test is provided in a cassette format. A pipette is included for use with the device. The operator utilizes the included pipette to collect a sample of urine specimen to be tested from a sample cup. The operator then dispenses the urine specimen into the round sample well of the device. An absorbent, nitrocellulose membrane strip is incorporated in the sample well into the rectangular window where the results are read. In the results window, there are two band regions on the membrane strip, a test band and a control band. The test band region is pre-coated with Goat anti-a hCG antibodies. Goat anti-β monoclonal antibodies are placed on the membrane between the test band and the sample well. During the test, the urine sample is allowed to migrate upward and hydrate the anti-β monoclonal antibodies. The mixture then migrates along the membrane by capillary action to the immobilized Goat anti-α hCG antibodies in the test band region. In the presence of hCG in the urine, the anti-ß monoclonal antibodies bind with the hCG ß unit antigen and moves with the sample urine fluid by capillary action along the membrane. As the solution reaches the test band, the antibody hCG ß-unit antigen complex becomes linked to the pre-coated Goat anti-a hCG antibodies to form a visible precipitate that can be seen as a color line at the test band. Therefore, the formation of a visible color line on the test band region indicates the urine sample has tested positive for hCG. In the absence of hCG in the urine, the anti-ß monoclonal antibodies bypass the pre-coated Goat anti-q hCG antibodies in the test region without forming a visible precipitate. As a result, the absence of a visible color line in the test band region indicates the urine sample tested is negative for hCG. The distal control band region is pre-coated with Goat anti Mouse IgG. If there is sufficient urine volume, the anti-ß antibodies will migrate by capillary action to the control region. The anti-ß antibodies will bind with the Goat anti Mouse IgG and precipitate to form a color line. This antigen-antibody reaction at the control line ensures that the test is performed properly and should always be seen as a visible line duringtesting. The presence of this color band in the control region serves as verification that sufficient urine volume has been added and that proper flow was obtained. In conclusion, a valid positive urine sample produces two distinct color bands. A valid negative sample produces only one color band in the control zone.