Description
The Quidel QuickVue hCG Combo Test answers the pregnancy question for clinics that work with whichever specimen the visit provides. This one step immunoassay detects human chorionic gonadotropin (hCG) in serum or urine for the early detection of pregnancy, in a self contained cassette that is clean to run and simple to dispose of.
- Two Color Result – A two color endpoint makes the cassette easy to read and interpret at a glance.
- Serum or Urine – One kit handles both specimen types, with reads at 5 minutes for serum and 3 minutes for urine.
- Early Detection – The assay detects low hCG levels as early as two to three days before expected menses.
- 50 Test Kit – A mid size box that suits steady clinic volume without overstocking.
A Self Contained Pregnancy Cassette for Clinics and Labs
Practices that confirm pregnancy during routine visits need a test that fits the pace of the room. This cassette uses a three drop sample and a one step procedure, so staff can start the test and read it minutes later without extra equipment. Sensitivity is 25 mIU/mL with accuracy above 99 percent reported by the manufacturer in the package insert. Internal controls are included in the cassette, and external controls are available separately for quality programs. For a front desk to bench workflow, the format keeps pregnancy testing quick, tidy and dependable.
Features and Benefits
Reading the Result
- Two Color Endpoint – The two color result removes guesswork when staff read the cassette window.
- Self Contained Cassette – The sealed cassette format is clean to handle and easy to dispose of after the read.
Assay Design
- 25 mIU/mL Sensitivity – The stated sensitivity supports detection of low hCG levels early in pregnancy.
- Built In Control – Internal controls are included, so each cassette validates its own run.
- Room Temperature Kits – Storage at room temperature keeps the kits on the bench instead of in the refrigerator.
Product Specifications
Test Details
- Manufacturer: Quidel (QuidelOrtho)
- Test Type: One step hCG immunoassay
- Sample Type: Serum or urine
- Sample Size: 3 drops
- Time to Results: 3 minutes (urine), 5 minutes (serum)
- Sensitivity: 25 mIU/mL
- Internal Controls: Included
- External Controls: Sold separately
Storage and Packaging
- Storage: Room temperature, 15 to 30 °C (59 to 86 °F)
- Shelf Life: 18 months from date of manufacture
- CLIA Complexity: Waived for urine, moderate for serum
- Quantity Per Pack: 50 tests/kit
- Sold As: 1 kit
See more from this line in diagnostic test kits and across all Quidel products.
Why Choose This Combo Cassette
Many sites keep separate urine cups and serum tubes workflows for the same clinical question. A combo cassette lets one stocked product serve both, which trims inventory and training. The two color read then keeps interpretation fast when the waiting room is full.
- Fewer Stocking Decisions – One 50 test kit covers serum and urine testing for the whole site.
- Fast Turnaround – Results inside five minutes keep the pregnancy answer in the same appointment.
- Proven Format – The QuickVue cassette design is a long standing point of care format from Quidel.
Manuals and Troubleshooting Guides
Frequently Asked Questions
What specimens can this test use?
It is intended for serum or urine. Read urine results at 3 minutes and serum results at 5 minutes.
How many tests come in a kit?
Each kit contains 50 tests, sold as one kit.
What is the sensitivity of the assay?
The manufacturer states a sensitivity of 25 mIU/mL, with accuracy above 99 percent reported in the package insert.
Does the cassette include controls?
Internal controls are included in the cassette. External controls are available separately for sites that run them.
How is the kit stored?
Store at room temperature, 15 to 30 °C (59 to 86 °F). Shelf life is 18 months from the date of manufacture.
Is it CLIA waived?
Urine testing is CLIA waived and serum testing is moderately complex, so match the specimen type to your certificate.
