PRIMA LH Ovulation Urine Test Cassettes, 5 Tests

PRIMA LH Ovulation Urine Test Cassettes are rapid immunochromatographic tests for the qualitative detection of human luteinizing hormone (LH) in urine. The product is intended for self-testing and in vitro diagnostic use. It detects an increase in urinary LH associated with probable ovulation within the following 24 to 36 hours. The pack contains 5 cassette-format tests, with results displayed as coloured lines in the test and control regions.

The assay uses a lateral flow immunological mechanism. The urine sample moves through the membrane by capillary action, and LH present in the sample reacts with labelled anti-hLH antibodies. The intensity of the line in the test region T is compared with the line in the control region C to interpret the result. The stated detection threshold is 40 mIU/mL, and the result is read 5 minutes after applying the sample.

Characteristics:
• Product type: rapid LH ovulation test in cassette format.
• Test method: lateral flow immunochromatographic assay.
• Sample type: human urine.
• Qualitative detection of LH at concentrations of 40 mIU/mL or higher.
• Sample volume: 3 drops of urine per test.
• Reading time: 5 minutes; results must not be interpreted after 10 minutes.
• Internal procedural control indicated by a line in region C.
• Single-use tests intended for self-testing and in vitro diagnostic use.
• Storage temperature: 2 to 30 °C in a dry place; do not freeze.

Applications:
• Qualitative detection of an increase in luteinizing hormone in urine samples.
• Daily testing during the testing period determined by menstrual cycle length.
• Identification of a positive result associated with probable ovulation within the following 24 to 36 hours.
• Self-testing through visual comparison of the lines in regions T and C; the product is not intended for use as a contraceptive method.

Instructions for use:
• Determine the starting day for testing according to menstrual cycle length, using the table in the package leaflet. Consult a doctor if the cycle is shorter than 21 days or longer than 38 days.
• Perform testing at approximately the same time each day. Do not use the first morning urine, and reduce fluid intake approximately 2 hours before testing.
• Allow the test and urine sample to reach room temperature, between 15 and 30 °C. Open the sealed pouch only when ready to test and use the cassette within one hour of opening.
• Place the cassette on a clean, level surface. Hold the pipette vertically, transfer 3 drops of urine into the sample well marked S, and start the timer. Avoid introducing air bubbles into the sample well.
• Read the result at 5 minutes. The result is positive when the T line is as dark as or darker than the C line. The result is negative when the T line is lighter than the C line or does not appear.
• Treat the result as invalid if the C line does not appear, and repeat the procedure with a new test. Do not interpret the result after 10 minutes or reuse the cassette.
• A timer and a urine collection container are required for testing and are not listed among the supplied materials.

Package contents:
• PRIMA pack containing 5 rapid LH ovulation test cassettes, a pipette and a package leaflet with instructions for use.

PRIMA test cassettes qualitatively detect an increase in urinary LH through a cassette-based procedure and visual interpretation of the result according to the package leaflet.