Description
Status hCG Combo Cassette extends the Status hCG family to serum as well as urine, in a one-step cassette for the qualitative detection of hCG in either specimen. It is CLIA waived for urine, carries 25 mIU/mL sensitivity, and suits settings that draw blood for the pregnancy question.
- Urine or Serum – One cassette covers both specimens, so the format follows the sample the setting already collected.
- 25 mIU/mL Sensitivity – The early-detection threshold matches the rest of the Status hCG family.
- One-Step Procedure – The cassette format keeps handling to a single application step for either specimen.
Combo Cassette for Urine and Serum hCG Testing
Laboratories and hospital settings often hold a serum sample when the pregnancy question arrives, and this cassette answers from either specimen. It qualitatively detects hCG in urine or serum at 25 mIU/mL through the family's one-step procedure. LifeSign lists the CLIA waiver for urine, with serum testing in the moderate complexity category. The family design carries minimal susceptibility to the hook effect from excess hCG beta core fragment. Each box holds 35 tests. Settings that test urine only can choose the urine-only cassette from the same family, while this combo covers mixed-specimen programs in one stocked format.
Features and Benefits
Specimen Flexibility
- Two Specimens, One Format – Urine and serum both run on the cassette, matching however the sample reached the bench.
- Family Threshold – Sensitivity stays at 25 mIU/mL, consistent with the strip and urine cassette formats.
Compliance Notes
- Waiver Scope – The CLIA waiver covers urine testing, while serum runs as moderate complexity.
- Hook-Effect Resistance – The family is designed for minimal susceptibility to interference from hCG beta core fragment.
Product Specifications
Test Details
- Analyte: Human chorionic gonadotropin (hCG)
- Specimen: Urine or serum
- Sensitivity: 25 mIU/mL
- Procedure: One-step cassette immunoassay
- CLIA Category: Waived for urine, moderate complexity for serum
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 Combo Cassette
Stocking separate urine and serum pregnancy formats splits inventory for one clinical question. This combo cassette answers from whichever specimen the setting collected, at the family's standard threshold. For mixed-specimen programs, that consolidation is the difference.
- One Stocked Format – A single cassette covers urine and serum programs, simplifying inventory and training.
- Bench-Ready for Serum Workflows – Laboratories holding serum samples answer without a second collection.
- Consistent Family Performance – The 25 mIU/mL threshold and one-step procedure match the rest of the Status hCG line.
Frequently Asked Questions
What specimens does the combo cassette use?
It tests urine or serum for hCG. The CLIA waiver applies to urine, and serum testing is moderate complexity.
What sensitivity does it have?
The cassette detects hCG at 25 mIU/mL. That matches the strip and urine-only cassette in the family.
How does it differ from the urine cassette?
The urine cassette tests urine only and is fully CLIA waived. This combo adds serum for laboratory and hospital workflows.
What is the hook effect note?
LifeSign states the family has minimal susceptibility to the hook effect caused by excessive hCG beta core fragment. The design addresses a known high-dose interference.
How many tests come in each box?
Each box holds 35 tests. Boxes are sold individually.
