Abbott CLEARVIEW HCG Pregnacy Test Cassette (1 Test)

THE Abbott CLEARVIEW® HCG PREGNANCY TEST

The Abbott Clearview® hCG pregnancy test is the one-step test for high sensitivity detection of hCG in urine. It provides rapid, reliable results in 3 minutes.

It has the ability to detect pregnancy on the day of a missed period and has an inbuilt procedural control for confirmation that the test has been performed correctly.

The test can be stored at room temperature so it is ready to use and leaves valuable refrigerator space free. It also has a long shelf life so small volume users need not worry that the product will expire before use.

Features

• Results in 3 minutes
• Sensitive to 25ml U/ml
• One step - no additional reagents, training or equipment required
• Proven accuracy of > 99%
• Inbuilt procedural control
• Room temperature storage
• Long shelf lfie
• ‘One shot’ pipette for exact specimen volume
• CE marked

Test Procedure

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

1. Remove the test cassette from the sealed pouch and use it as soon as possible.
2. Place the test cassette on a clean and level surface. Hold the pipette vertically and transfer 3 full drops of urine (approx. 100 μL) to the specimen well (x3) of the test cassette, and then start the timer. Avoid trapping air bubbles in the specimen well.  See the illustration.
3. Wait for the red line(s) to appear. Read the result at 3-4 minutes.  Do not interpret results after the appropriate read time.  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:  A sample hCG concentration below the cut-off level of this test might result in a weak line appearing in the test region (T) after an extended period of time.  A line in the test region (T) seen after the read time could be indicative of a low hCG in the sample.  If such results are seen, it is recommended that the test be repeated with a new sample in 48-72 hours or that an alternate confirmation method is used.

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 cassette. If the problem persists, discontinue using the test kit immediately and contact Alere Technical Support at 866-216-0094.

*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.