Description
Status hCG Urine Cassette is the urine-only cassette in the Status hCG family, a one-step immunoassay for the qualitative detection of hCG in urine. It is CLIA waived with 25 mIU/mL sensitivity for early pregnancy detection at the point of care.
- One-Step Cassette Procedure – Urine drops into the cassette well and the result develops without further handling.
- 25 mIU/mL Sensitivity – The threshold supports early detection in routine point-of-care pregnancy testing.
- CLIA Waived for Urine – The waived urine format fits offices, clinics and urgent care without laboratory complexity.
Cassette hCG Testing for Routine Point-of-Care Use
The cassette is the default pregnancy test format in most clinics, and this is the urine-only member of the Status family. It qualitatively detects hCG in urine through a simple one-step procedure, at 25 mIU/mL sensitivity. LifeSign notes the family's minimal susceptibility to the hook effect caused by excess hCG beta core fragment, a known interference in pregnancy testing. The CLIA waived status for urine keeps it usable anywhere pregnancy status gates a decision, from imaging to medication starts. Each box holds 35 tests. Programs that also test serum use the combo cassette from the same family, listed separately.
Features and Benefits
Assay Design
- Hook-Effect Resistance – LifeSign notes minimal susceptibility to the hook effect from excess hCG beta core fragment in this family.
- One-Step Format – A single application step keeps the procedure teachable and repeatable across staff.
Setting Fit
- CLIA Waived Urine Testing – The waived category covers the office and clinic settings where pregnancy status is checked.
- 35-Test Box – The count suits stocked point-of-care programs rather than occasional use.
Product Specifications
Test Details
- Analyte: Human chorionic gonadotropin (hCG)
- Specimen: Urine
- Sensitivity: 25 mIU/mL
- Procedure: One-step cassette immunoassay
- CLIA Category: Waived for urine
Packaging
- Tests per Box: 35
- Packaging: Sold by the box, each
Browse the full Pregnancy Tests range, or shop everything from LifeSign.
Why Choose the Status hCG Urine Cassette
Pregnancy status gates imaging, procedures and prescriptions all day, and the checking tool has to be foolproof at any staffing level. This cassette's one-step format and waived status keep it that way, with the family's hook-effect resistance behind the result. For routine point-of-care testing, that reliability is the difference.
- Decision-Grade Convenience – A waived one-step cassette puts pregnancy answers wherever care decisions happen.
- Interference Awareness – The family is designed for minimal hook-effect susceptibility from hCG beta core fragment.
- Consistent Threshold – The 25 mIU/mL sensitivity matches the strip and combo formats in the same family.
Frequently Asked Questions
What does this cassette detect?
It qualitatively detects hCG in urine at 25 mIU/mL sensitivity. It is a pregnancy test for point-of-care use.
Is it CLIA waived?
Yes, this urine cassette is CLIA waived. The combo cassette in the family adds serum, with the waiver applying to urine only.
What is the hook effect note?
LifeSign states the hCG family has minimal susceptibility to the hook effect caused by excessive hCG beta core fragment. That interference can mask very high hCG levels in some assays.
How many tests come in a box?
Each box holds 35 tests. Boxes are sold individually for stocked programs.
Strip or cassette?
Cassettes take dropped urine in a contained device, while strips dip into the specimen. Programs pick per workflow, and both formats share the 25 mIU/mL threshold.
