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In pregnancy testing, our new ICON® 25 hCG test will reshape your thinking. It gives you fast, accurate results, plus Beckman Coulter confidence. For the physician's office, ICON® 25 hCG offers CLIA waived simplicity for urine and a "moderately complex" catergorization for serum. For the hospital, it's the perfect complement to our ICON II HCG test, the gold standard in pregnancy testing.
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Product Features
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Simple, one-step process for reliability
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3-minute result with urine; 5-minute result with serum
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Requires just 3 drops of specimen
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25 mIU/mL sensitivity with > 99 percent specificity
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Room temperature storage, long shelf life
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More Info
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Frequently Asked Questions (FAQs)
1. Specimen
Q: How can specimens be stored prior to testing?
A: Both urine and serum specimens can be stored in a clean, dry container at room temperature for up to 8 hours prior to testing. Both may also be stored refrigerated at 2 to 8° C for up to 48 hours. For prolonged storage (no longer than 1 year), specimens may be frozen below –20° C and thawed and mixed before testing.
Q: Can preservatives be added to urine specimens?
A: Though not required, 0.01% NaN3 (sodium azide) may be added to urine prior to the appropriate storage. It should not affect the test result.
Q: Can “cloudy” urine samples be used for testing?
A: Urine specimens exhibiting visible precipitates should be centrifuged, filtered, or allowed to settle to obtain a clear specimen for testing.
2. Test Procedure
Q: At what point in a woman’s cycle can the test be used?
A: In normal pregnancy, hCG can be detected 7 to 10 days after conception. Usually, the test can be used as early as the first day of a missed period. If the menstrual cycle length is irregular, the test time can be based on the longest cycle length that occurred in the past few months. If a negative result is obtained and pregnancy is still suspected, the test can be repeated in 2-4 days, and/or supplemental tests can be performed.
Q: Is there any “hook” effect? If so, at what level of hCG? If not, what is the highest level of hCG tested?
A: The product provides the correct result up to 500,000 mIU hCG/mL.
Q: What part of the molecule is detected?
A: The product detects intact hCG.
Q: When is the best time of day to obtain a urine specimen for testing?
A: Urine specimens collected at any time of day may be used on ICON® 25 hCG tests. However, a first morning urine specimen is preferred if possible as it usually contains the highest concentration of hCG.
Q: If the test is used prior to the equilibration of the specimen and test to room temperature, is the result reliable?
A: No. The test and the specimen must equilibrate to room temperature (15 to 30° C) prior to testing.
Q: If too much or not enough of the specimen sample was added, is the result still reliable?
A: No, an incorrect amount of specimen sample can affect the test result. It should be repeated with a new test and the appropriate amount of sample.
Q: Occasionally, the drops of specimen may appear as air bubbles; are these counted as true drops on the test device?
A: No. It is important that when using a dropper, the full amount of drops is dispensed onto the test and air bubbles are not trapped in the specimen well.
Q: If the hCG test was dropped on the floor prior to using it, will it still work?
A: If the test is intact and the exposed membrane in the “reaction window” was not damaged, it can still be used and expected to function properly.
Q: Liquid/specimen sample/water was inadvertently dropped onto the “reaction window” of the test. Will it still work?
A: No. Addition of any type of liquid into any other location other than the test’s designated sample port renders the test invalid. Use a new test.
Q: How many tests is it possible to run at a time?
A: It depends on the proficiency of the user. However, even in experienced hands, we do not recommend running more than 10 tests at a time.
3. Interpretation
Q: When the sample is added to the test, pink fluid can be seen migrating up the membrane. Is this normal?
A: A pink background is normal as the sample flows up the test strip and will not affect the test result. As long as it does not interfere with the interpretation of the line(s), the background can be disregarded.
Q: How does one know that the test has been performed properly?
A: As an internal procedural control, a red/purple line appearing in the control (C) region confirms the addition of sufficient specimen volume and the performance of correct procedural technique.
Q: A positive result is read when two distinct red/purple lines appear, one in the control region (C) and another in the test region (T). Do the two lines need to be of the same intensity?
A: No. The intensity of the color in the test line region (T) will vary. Any trace of a line in the test (T) region (darker than, the same color as, or lighter than the control line) along with a red/purple line in the control (C) region is considered a positive result.
Q: A known hCG-negative specimen was tested and developed a test line in the (T) region after 1 hour. What does this mean?
A: The result is negative if there was no test line at the specified read time. The ICON® 25 hCG test is designed to detect 25 mIU/mL hCG at 3 minutes in urine and 5 minutes in serum specimens. If pregnancy is suspected, the test can be repeated in 2 to 4 days and/or supplemental tests can be performed.
Q: Will a positive result stay positive on the test?
A: A positive result (two distinct red/purple lines) usually does not change on the test. However, fading of the lines may occur several hours after the test is performed. According to the instructions, urine samples should be read at 3 minutes, and serum samples at 5 minutes.
Q: Can the result be read before the specified read time?
A: A positive result can be read earlier than the specified read time, when the C line is present and a T line appears. For a negative reading, read it at the specified read time and not earlier.
4. Storage
Q: How should the test kits be stored?
A: Store the tests as packaged in their sealed pouch at 2 to 30° C until use. Do not freeze the tests. If stored refrigerated (2 to 8°C), allow the test devices to equilibrate to room temperature (15 to 30°C) prior to use.
Q: If the foil pouch has been opened, should the test be used right away?
A: Because humidity in the air can affect the integrity of the test, it is recommended that the test be used immediately once the foil pouch has been opened. Likewise, if a pouch is found to be punctured or have a broken seal, do not use the test inside.
Q: Can the test be used beyond the expiration date on the foil pouch?
A: No. The test should not be used past its expiration date under any circumstances.
Q: What is the shelf life?
A: Until the expiration date labeled on the test pouch (which is the same as the one labeled on the kit box), when stored as indicated in the product instructions.
For technical assistance, contact Technical Marketing at 800-877-6242
or 650-845-3526 or e-mail
askpcd@beckman.com.
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