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 healthcare professionals in the diagnosis of early pregnancy.
Pregnancy tests detect 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 earlier than urine-based tests with a single drop of whole blood, serum, or plasma.
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:): Human venous whole blood, fingerstick whole blood, plasma, and serum
What are the benefits of the ADEXUSDx® hCG Test?
- ‘Touch to test’: No sample collection tool or pipette; transfer device not required
- Rapid and self-contained: 10 minutes to result; no buffer, diluents, reagents
- Easy to use: Simple instructions, fewer steps than competitor tests, no equipment
- Secure: Protected by large patent portfolio and trade secrets
- Volume controlled separation of plasma from cells: Membrane will absorb 17.5 uL of plasma from drop of blood
- ‘Our lab at the tip of your finger’: Yields laboratory quality results
- Samples are not diluted: Driving improved sensitivity
- Made in the USA: Tests manufactured in Northwest Arkansas
How accurate is the test?
- 99% sensitive and specific
What is the reimbursement code for the ADEXUSDx® hCG Test?
- CPT Code 0167U gonadotropin chorionic (hCG), immunoassay with direct optical observation, blood
What size lancet is recommended?
What sample anticoagulants are FDA cleared for use?
What are the sample storage specifications?
- Venous blood samples may be stored for up to 4 hours at room temperature. Plasma or serum may be stored up to 72 hours refrigerated 2℃ to 8℃.
Is it possible to underfill the device?
- Underfilling can occur, although if inadequate volume is obtained, a control line will not appear.
Is it possible to overfill the device?
- No, the test has automatic volume controls that prevent overfilling.
Is a lab analyzer or reader required to perform the test?