The ADEXUSDx® hCG Test is an immunoassay used for the qualitative detection of human chorionic gonadotropin in human whole blood, plasma, or serum and is indicated as an aid for health care professionals in the diagnosis of early pregnancy. Learn more >
Product Specifications
The ADEXUSDx® hCG Test is an immunoassay used for the qualitative detection of human chorionic gonadotropin in human whole blood, plasma, or serum and is indicated as an aid for health care professionals in the diagnosis of early pregnancy. Pregnancy tests are based on the detection of human chorionic gonadotropin (hCG), a hormone produced by the placenta around the fourth day after conception. hCG levels rise rapidly and double approximately every two days. The ADEXUSDx® hCG Test can detect hCG in a single drop of whole blood, serum, or plasma without additional reagents or materials. The ADEXUSDx® hCG Test is a rapid chromatographic immunoassay that delivers results in ten minutes.
| Time to Result | 10 minutes |
| Result Window | 10-30 minutes |
| Storage Conditions | 4 ℃ – 30℃ (39℉ – 86℉ )
*Tests do not require refrigeration |
| Operating Temperature | 4 ℃ – 30℃ (39℉ – 86℉ )
*Tests do not require refrigeration |
| Test Shelf Life | 15 months- expiration dates printed on test pouches |
| Sample Type(s) | Capillary blood/whole blood/plasma/serum |
Test Method
Benefits
Detect sooner than urine-based hCG tests*
Accurate
- >99{2f5276604f3a1e7068efb98114168ce28194f73b7a09f2630b16ba5125f5ed77} sensitivity and specificity
1
- Reduced exposure to liability from false negatives
2
Efficient
- Results in 10 minutes, no waiting on urine samples
- Increased patient throughput
Easy-to-use
- No reagents or buffers
- Decreased potential for user error
- Uses capillary blood, plasma, or serum
FDA 510K Cleared
CLIA Waiver Pending
CE Mark
*Based on our cutoff, pregnancy can be detected at 10 mIU/mL. Depending on the woman and the pregnancy, this can be days earlier than urine-based hCG tests.
1 Capillary Blood Sensitivity >99{2f5276604f3a1e7068efb98114168ce28194f73b7a09f2630b16ba5125f5ed77} compared to clinically confirmed pregnancy diagnosis
Capillary Blood Sensitivity >99{2f5276604f3a1e7068efb98114168ce28194f73b7a09f2630b16ba5125f5ed77} compared to clinically confirmed non-pregnant women
2 In a March 2015 report in Clinical Chemistry, Robert N. Nerenz and Ann M. Gronowski detailed their evaluation of 11 common POC hCG urine-based devices and determined that 9 of the 11 were susceptible to false-negative results.
Resources
Instructional video for finger stick method:
Click here to watch video
Instructional video for pipetting method:
Click here to watch video
Product Insert:
Click here for PDF Product Insert
Sales Sheet
Click here for the PDF Sales Sheet
Reimbursement Code: 84703
Purchase Codes:
| Catalog # | Product Description | # of Tests |
| 8001-25 | ADEXUSDX hCG Assay, Box | 25 |
| 8001-1000 | ADEXUSDX hCG Assay, Case | 1000 |
For availability in your country, please contact our customer service department.