Description
The Clarity hCG Combo Cassette tests for pregnancy in urine or serum on one cassette platform, with a 20 mIU/mL urine cutoff and a 10 mIU/mL serum cutoff. The manufacturer reports 99 percent overall accuracy and 100 percent specificity for the combination cassette.
- Format – Urine and serum hCG combination cassette.
- Cutoffs – 20 mIU/mL in urine (CLIA waived), 10 mIU/mL in serum (moderate complexity).
- Accuracy – 99 percent overall accuracy, as reported by the manufacturer.
- Packaging – 50 cassettes per box with 24 month dating.
About This hCG Combo Cassette
Laboratories and clinics that test both urine and serum for hCG usually keep two different products on the shelf. This combination cassette covers both specimen types, running urine at a 20 mIU/mL cutoff under CLIA waived status and serum at a 10 mIU/mL cutoff at moderate complexity. The manufacturer reports 99 percent overall accuracy and 100 percent specificity for the cassette.
A built in quality control line confirms each cassette ran correctly, and room temperature storage with 24 month dating simplifies stocking. The format suits emergency departments, fertility clinics and laboratories that want one hCG platform across specimen types.
Features and Benefits
Specimen Flexibility
- Urine and serum – One cassette platform handles the quick urine screen and the more sensitive serum test.
- Two cutoff levels – Urine reads at 20 mIU/mL and serum at 10 mIU/mL, matching the clinical role of each specimen.
Quality Design
- Built in control – An internal quality control line validates every cassette run.
- Long dating – Twenty four month dating at room temperature reduces expiry waste.
Product Specifications
Product Details
- Manufacturer: Clarity Diagnostics
- Test type: hCG pregnancy test cassette, urine and serum
- Urine cutoff: 20 mIU/mL (CLIA waived)
- Serum cutoff: 10 mIU/mL (CLIA moderate complexity)
- Overall accuracy: 99 percent (manufacturer reported)
- Specificity: 100 percent (manufacturer reported)
- Storage: Room temperature
- Shelf life: 24 month dating
Packaging
- Box contents: 50 test cassettes, package insert
- Sold as: 1 box of 50 cassettes
Browse related categories: pregnancy tests and Clarity Diagnostics products.
Why Choose the Combo Cassette for Urine and Serum hCG
One cassette for both specimen types cuts the hCG shelf in half and removes the wrong box problem at busy benches. The dual cutoffs match how urine and serum testing are actually used.
- One platform – Staff learn and stock a single hCG cassette for two specimen workflows.
- Serum sensitivity – The 10 mIU/mL serum cutoff supports earlier detection when the clinical question demands it.
- Visit ready urine testing – The waived urine path keeps routine pregnancy screens at the point of care.
Manuals and Troubleshooting Guides
Frequently Asked Questions
Can this cassette test both urine and serum?
Yes, it is a combination cassette for urine and serum hCG testing. Urine runs at a 20 mIU/mL cutoff and serum at a 10 mIU/mL cutoff.
Is the test CLIA waived?
Urine testing with this cassette is CLIA waived, while serum testing is moderate complexity. Run each specimen under the certificate your site holds.
What accuracy does the manufacturer report?
The manufacturer reports 99 percent overall accuracy and 100 percent specificity for the cassette. Those figures come from the manufacturer evaluation.
How many cassettes come in a box?
Each box contains 50 cassettes with the package insert. The box carries 24 month dating at room temperature storage.
Does the cassette have a control line?
Yes, a built in quality control feature validates each run. External hCG controls are available separately for documented quality programs.
