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Description

HemoCue America . A simple immunoassay for the qualitative detection of hCG in the serum or urine for the early detection of pregnancy. A one-step, rapid, combination serum/urine test (urine CLIA Waived) designed to aid the physician to rule out pregnancy in addition to detecting early pregnancy. Detects hCG as low as 10 mIU/mL sensitivity for serum, 20 mIU/mL for urine. ICON 20 requires only 3 drops of sample with results in just 3 to 5 minutes.

Frequently asked questions

Does the ICON 20 HCG provide rapid pregnancy results?

Yes, the HemoCue ICON 20 HCG is a highly sensitive immunoassay designed to provide qualitative results for early pregnancy screening rapidly.

Key features that highlight its speed and accuracy include:

  • Fast Results: Provides results in just 3 to 5 minutes.
  • High Sensitivity: Detects Human Chorionic Gonadotropin (hCG) at low concentrations:
    • Serum Sensitivity: 10 mIU/mL
    • Urine Sensitivity: 20 mIU/mL
  • Dual Sample Use: The test is compatible with both serum and urine samples.
  • Efficiency: The test requires only 3 drops of sample volume, and it is CLIA Waived for use with urine samples, making it ideal for point-of-care environments.
How quickly are the results delivered by this rapid assay?

The HemoCue ICON 20 HCG is designed for rapid performance, providing qualitative results in just 3 to 5 minutes. This fast turnaround time applies to testing both serum and urine samples, enabling swift, early detection in clinical settings.

What is the sensitivity of the HemoCue ICON 20 HCG test?

The HemoCue ICON 20 HCG test is highly sensitive, designed for the rapid and early qualitative detection of hCG. It can detect concentrations as low as:

  • 10 mIU/mL when testing a serum sample.
  • 20 mIU/mL when testing a urine sample (this application is CLIA Waived).

This high sensitivity allows for rapid screening, providing results in just 3 to 5 minutes.

Is the ICON 20 hCG test CLIA waived?

Yes, the HemoCue ICON 20 hCG test is CLIA Waived specifically when used for urine testing. This status simplifies regulatory requirements, making it ideal for rapid, point-of-care pregnancy screening in various clinical settings.

Which sample types can the HemoCue ICON 20 HCG test use?

The HemoCue ICON 20 HCG test is designed for versatility, utilizing both serum and urine samples for the rapid, qualitative detection of hCG.

Key features related to sample use include:

  • Sample Volume: Only 3 drops of the specimen are required for testing.
  • Urine Classification: The urine test procedure is CLIA Waived.
  • High Sensitivity: The test detects low levels of hCG, specifically down to 10 mIU/mL in serum and 20 mIU/mL in urine, providing results within 3 to 5 minutes.
Does the test require minimal sample drops?

Yes, the HemoCue Icon 20 HCG test requires a very small sample volume, enhancing its utility for rapid point-of-care testing. You only need 3 drops of either the serum or urine sample to perform the immunoassay and obtain qualitative results quickly.

Does this test have high sensitivity?

Yes, the HemoCue Icon 20 HCG offers high analytical sensitivity, crucial for the rapid and early qualitative detection of pregnancy in clinical settings.

This test is designed to detect Human Chorionic Gonadotropin (hCG) at the following concentrations, depending on the sample type:

  • Serum Samples: Detects hCG levels as low as 10 mIU/mL.
  • Urine Samples: Detects hCG levels as low as 20 mIU/mL.

This high sensitivity allows for reliable results, which are typically available quickly, within 3 to 5 minutes of running the test.

What components are included in this test kit?

The HemoCue ICON 20 hCG kit is comprehensive and includes everything necessary to perform 25 complete rapid tests.

The following components are provided in each kit:

  • 25 Test Devices
  • 25 Disposable Sample Droppers (for collecting the sample)
  • 1 Product Instruction
  • 1 Procedure Card (for quick, convenient reference)
Does this product have a good expiry lead time?

Yes, the product is guaranteed to have a minimum expiry lead time of 90 days, ensuring sufficient shelf life for clinical use.

What is the typical lead time for shipping this product?

The typical lead time for shipping the HemoCue Icon 20 HCG is 1-2 weeks from the time of order. This product ships directly from the manufacturer or MFI Medical.