Use AZO^® UTI Test Strips at the first sign of a UTI:

• Urinary pain
• Burning
• Urgency or frequency to urinate

AZO Test Strips® are used as an aid in the screening of a Urinary Tract Infection (UTI). The UTI test strips are for the detection of Leukocytes (white blood cells) and Nitrite in urine.

WARNINGS AND PRECAUTIONS:

Please read all the information in this package insert before performing the test.

• For urine test only. Do not use for blood testing.
• Do not use after the expiration date.
• Keep out of the reach of children.
• For in-vitro diagnostic use. Not to be taken internally.
• The used test strip, open foil pouch and drying packet should be discarded according to local regulations after testing.

STORAGE AND HANDLING:

• Store in a dry place at room temperature at 59-86° F or 15-30° C. Do not refrigerate. Keep out of direct sunlight.
• The test strip should remain in the foil pouch with the drying packet until use.
• Do not touch the test pads on the strip. Discard any discolored strips that may have deteriorated.

INSTRUCTIONS:

Gently wash the genital area thoroughly with soap and water then rinse well prior to testing.

1. Remove the test strip from the foil pouch and use it as soon as possible. Keep the foil pouch nearby for use in reading results. Do not use if pouch is torn or damaged.
2. Hold the end of the test strip and begin urinating. After 1 or 2 seconds of passing urine, hold the strip downward with the test pads pointing into the urine stream for 1-2 seconds. Make sure the test pads are completely wet. Note: If you prefer, you can urinate into a clean and dry container. Dip the test pads of the test strip completely into the urine for 1-2 seconds and remove immediately. Run the edge of the test strip against the rim of the urine container to remove excess urine.
3. After removing the test strip from your urine, immediately bring the edge of the test strip into contact with an absorbent material (e.g. paper towel) to remove excess urine. Lay the test strip with the test pads facing upwards and begin timing.
4. Read results at 1 minute for Nitrite and 2 minutes for Leukocytes. Compare the test pads to the color blocks on the foil pouch. Hold the test strip close to the color blocks, and carefully match each test pad to the color chart for that test. Note: Ignore any color change after you have read the test pads at three minutes.

READING THE RESULTS

Read the results by comparing the test pads to the color blocks on the foil pouch. Match the color of the test pad to the closest color block on the foil pouch containing the test.

LIMITATIONS OF USE:

There is the possibility that this test may produce false results. Consult your physician before making any medical decisions. Note: The test may be affected by substances that cause abnormal urine color such as riboflavin (Vitamin B2) or products containing dyes as the active ingredient; for example phenazopyridine hydrochloride, the active ingredient in AZO Urinary Pain Relief.® The color development on the test pad may be masked or a color reaction may be produced that could be interpreted as false results. Reading of the results may be affected if you have color vision deficiency (color blindness).

1. Leukocytes: The drug tetracycline may cause a false negative result. High protein or elevated glucose in urine may cause test results to be low. Urine with a pH≥8.0 may cause a false negative leukocyte reading.
2. Nitrite: Any degree of uniform pink color should be read as a positive result. Pink spots or pink edges should not be read as a positive result. High ascorbic acid may cause test results to be low. Note: You may get a negative result if you have a UTI caused by bacteria that does not change nitrate to nitrite, when urine has not been held in the bladder for more than 4 hours, when taking antibiotics, or when your diet does not include nitrates.