ADEXUSDx® hCG Test

FDA Cleared & CE Marked CLIA Waiver Pending

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

administering a test-generic

Benefits

Detect sooner than urine-based hCG tests*

Accurate

>99% 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% compared to clinically confirmed pregnancy diagnosis
Capillary Blood Sensitivity >99% 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.