Urine hCG Testing

1. Storage and Stability

Store as packaged in the sealed pouch at 2°-30°C. The test device is stable through the expiration date printed on the sealed pouch. The test device must remain in the sealed pouch until use. DO NOT FREEZE. Do not use beyond the expiration date.

2. Quality Control

Internal Procedural Controls

Internal procedural controls are included in the test. A red line appearing in the control region (C) is the internal procedural control. It confirms sufficient specimen volume and correct procedural technique. A clear background is an internal negative background control. If the test is working properly, the background in the result area should be white to light pink and not interfere with the ability to read the test result.

External Quality Control Testing

Two levels of Quantimetrix Controls should be performed when opening a new box of uHCGs. The Level 1 control is to be used as the negative control and Level 2 is to be used for the positive control. The controls should be tested the same as patient samples (see “Procedure”). These results are to be recorded on the uHCG patient log sheet as QC.

Notes:

• Controls should be allowed to come to room temperature (20-25° C), atleast 15 minutes, before using for testing.
• Use the positive and negative controls as if they were patient specimens. Use Standard Precautions!
• Immediately recap the controls and return them to the refrigerator when not in use

Remedial Actions

When correct control results are not obtained, do not report patient results. Contact Technical Services at 800-637-3717 or Point of Care Coordinator at 302-651-4324.

3. Test Procedure

Specimen Collection and Handling

• A urine specimen must be collected in a clean and dry container.
• A first morning urine specimen is preferred since it generally contains the highest concentration of hCG; however, urine specimens collected at any time of the day may be used.
• Urine specimens exhibiting visible precipitates should be centrifuged, filtered, or allowed to settle to obtain a clear specimen for testing.
• Urine specimens may be stored at 2 - 8°C for up to 48 hours prior to testing. For prolonged storage, specimens may be frozen and stored below -20°C. Frozen specimens should be thawed and mixed before testing.

Test Procedure

Allow the test device, urine, and/or controls to equilibrate to room temperature (15-30°C) prior to testing.

1. Bring the pouch to room temperature before opening it. Remove the test device from the sealed pouch and use it as soon as possible.
2. Place the test device on a clean and level surface. Hold the dropper vertically and transfer 3 full drops of urine (approx. 100µl) to the specimen well of the test device, and then start the timer. Avoid trapping air bubbles in the specimen well.
3. Wait for the red line(s) to appear. The result should be read at 3 minutes. It is important that the background is clear before the result is read.

Interpretation of Test Results

POSITIVE*: Two distinct red lines appear. One line should be in the control region (C) and another line should be in the test region (T).

NOTE: The intensity of the red color in the test line region (T) will vary depending on the concentration of hCG present in the specimen. However, neither the quantitative value nor the rate of increase in hCG can be determined by this qualitative test.

NEGATIVE: One red line appears in the control region (C). No apparent red or pink line appears in the test region (T).

INVALID: Control line fails to appear. Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for control line failure. Review the procedure and repeat the test with a new test device. If the problem persists, discontinue using the test kit immediately and contact Technical Support at (800) 637-3717.

Limitations

1. Very dilute urine specimens, as indicated by a low specific gravity, may not contain representative levels of hCG. If pregnancy is still suspected, a first morning urine specimen should be collected 48 hours later and tested.
2. False negative results may occur when the levels of hCG are below the sensitivity level of the test. When pregnancy is still suspected, a first morning urine specimen should be collected 48 hours later and tested.
3. Very low levels of hCG (less than 50 mIU/mL) are present in urine specimen shortly after implantation. However, because a significant number of first trimester pregnancies terminate for natural reasons,⁵ a test result that is weakly positive should be confirmed by retesting with a first morning urine specimen collected 48 hours later.
4. A number of conditions other than pregnancy, including trophoblastic disease and certain non-trophoblastic neoplasms including testicular tumors, prostate cancer, breast cancer, and lung cancer, cause elevated levels of hCG.^6,7 Therefore, the presence of hCG in urine specimen should not be used to diagnose pregnancy unless these conditions have been ruled out.
5. This test provides a presumptive diagnosis for pregnancy. A confirmed pregnancy diagnosis should only be made by a physician after all clinical and laboratory findings have been evaluated.

Expected Values

Negative results are expected in healthy non-pregnant women and healthy men. Healthy pregnant women have hCG present in their urine and serum specimens. The amount of hCG will vary greatly with gestational age and between individuals.

The Sure-Vue Urine hCG has a sensitivity of 25 mIU/mL, and is capable of detecting pregnancy as early as 1 day after the first missed menses