QUIDEL
Genzyme
Description
Uses a monoclonal antibody specific to the beta subunit of hCG in a single-step technology.
Individually wrapped test cassettes
Disposable pipets
Procedure card
Package insert
CPT Codes: 81025 (urine), 84703 (serum)
CLIA Complexity: Waived (urine), Non-waived (serum)
For the qualitative detection of human chorionic gonadotropin (hCG) in serum or urine for the early detection of pregnancySensitivity: >99%.
Specificity: >99%Agreement: >99%
Results in three minutes for urine, five minutes for serum
Positive results: pink-to-red.
Test (T) line along with a blue procedural Control (C) line
Negative results: only a blue procedural Control line.
Specimens containing as low as 25mIU/mL (calibrated against the WHO 4th IS 75/589) hCG will yield positive results.
For in vitro diagnostic use.
