Description
The Quidel QuickVue hCG Urine Test is the single purpose pregnancy test for sites that only ever test urine. This sensitive immunoassay detects human chorionic gonadotropin (hCG) in urine for the early detection of pregnancy, and it is CLIA waived, so waived sites can run it under a certificate of waiver.
- Three Minute Read – Results are ready in 3 minutes, fast enough to share before the patient leaves.
- Two Color Result – A clear two color endpoint keeps interpretation simple for any staff member.
- One Step Procedure – Fewer steps mean fewer procedural errors and minimal training time.
- 25 Test Kit – A right sized box for lower volume sites and satellite locations.
Waived Urine Pregnancy Testing Without the Extra Steps
Urine pregnancy testing is often the first test of the visit, and this cassette keeps it that simple. The manufacturer states the assay can detect low hCG levels as early as two to three days before expected menses, at a sensitivity of 25 mIU/mL. Three drops of urine start the test, internal controls are included, and accuracy above 99 percent is reported in the package insert. External controls are available separately for sites that include them in quality checks. For waived clinics, urgent care centers and school health offices, it is a complete urine only answer in one small box.
Features and Benefits
Ease of Use
- One Step Format – Add the sample and read, which shortens training for new and float staff.
- Two Color Readout – The two color result window is easy to read and interpret under normal room light.
Assay Facts
- 25 mIU/mL Sensitivity – Supports early detection, including before a missed period in many patients.
- Internal Controls Included – Every cassette carries its own control, so each run is validated.
- Room Temperature Storage – No refrigeration is needed, which suits small exam room storage.
Product Specifications
Test Details
- Manufacturer: Quidel (QuidelOrtho)
- Test Type: One step hCG immunoassay
- Sample Type: Urine
- Sample Size: 3 drops
- Time to Results: 3 minutes
- 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
- Quantity Per Pack: 25 tests/kit
- Sold As: 1 kit
Shop the wider range of diagnostic test kits or view every item under Quidel products.
Why Choose a Urine Only Kit
Combo kits earn their keep in mixed labs, but a urine only site pays for flexibility it never uses. This kit strips the product back to the single specimen those sites run, in a smaller box with a waived status that matches their certificate. The procedure stays at one step, so nothing about the workflow gets harder.
- Right Sized Box – Twenty five tests suit sites that run a handful of pregnancy tests each week.
- Waived Simplicity – CLIA waived status fits certificate of waiver sites without added complexity.
- Same Visit Answers – A 3 minute read keeps the result inside the appointment.
Manuals and Troubleshooting Guides
Frequently Asked Questions
Is this test CLIA waived?
Yes. The urine test is CLIA waived, so it can be run by sites holding a certificate of waiver.
How long until the result is ready?
Read the cassette at 3 minutes after adding three drops of urine.
How many tests are in the box?
The kit contains 25 tests and is sold as one kit.
What sensitivity does the manufacturer state?
Sensitivity is 25 mIU/mL, and the manufacturer states the test can detect low hCG levels as early as two to three days before expected menses.
Are external controls required?
Internal controls are included in every cassette. External controls are available separately if your quality program uses them.
How should kits be stored?
Store at room temperature, 15 to 30 °C (59 to 86 °F), with an 18 month shelf life from the date of manufacture.
