Description
The Quidel QuickVue+ hCG Combo Test is the pregnancy test clinics reach for when a patient needs a dependable answer before she leaves the room. It detects human chorionic gonadotropin (hCG) in serum or urine for the early detection of pregnancy, so one kit covers both specimen workflows on a busy schedule.
- Two Specimen Types – Runs serum or urine in the same cassette format, which keeps one familiar procedure for every patient presentation.
- Three to Five Minute Results – Urine reads at 3 minutes and serum at 5 minutes, so the result lands inside the same visit.
- High Sensitivity – Detects hCG down to 10 mIU/mL in serum and 20 mIU/mL in urine, catching low levels early.
- Two Kit Sizes – Choose the 30 test kit for smaller sites or the 90 test kit for high volume benches.
Early Pregnancy Detection for Busy Point of Care Settings
This one step immunoassay was built for physician offices, clinics and laboratories that confirm pregnancy at the point of care. The manufacturer states it can detect low hCG levels as early as two to three days before expected menses, which makes it useful when a patient presents before a missed period. Each cassette carries positive and negative internal controls, so every run checks itself before the result is read. A four drop sample keeps the procedure short, and minimal steps mean minimal training for new staff. Altogether, the kit gives care teams a fast, self contained way to answer the pregnancy question and move the visit forward.
Features and Benefits
Assay Performance
- Low Level Detection – Sensitivity of 10 mIU/mL in serum and 20 mIU/mL in urine supports early detection of pregnancy.
- Reported Accuracy – The manufacturer reports accuracy above 99 percent for this immunoassay, per the package insert.
Workflow Fit
- One Step Procedure – A single step format with four drops of sample reduces handling errors at the bench.
- Built In Controls – Positive and negative internal controls ride in every cassette, validating each individual run.
- Room Temperature Storage – Kits store at room temperature, so no refrigerator space is given up to pregnancy testing.
Product Specifications
Test Details
- Manufacturer: Quidel (QuidelOrtho)
- Test Type: One step hCG immunoassay
- Sample Type: Serum or urine
- Sample Size: 4 drops
- Time to Results: 3 minutes (urine), 5 minutes (serum)
- Sensitivity: 10 mIU/mL (serum), 20 mIU/mL (urine)
- Internal Controls: Positive and negative
- External Controls: Low positive, high positive and negative set sold separately
Storage and Packaging
- Storage: Room temperature, 15 to 30 °C (59 to 86 °F)
- Shelf Life: 21 months from date of manufacture
- CLIA Complexity: Waived for urine, moderate for serum
- Kit Sizes: 30 tests or 90 tests
- Sold As: 1 kit per size selected
Browse related categories: diagnostic test kits and Quidel products.
Why Choose the QuickVue+ Combo Format
Sites that test with both serum and urine usually stock two different products and train two different procedures. This combo format collapses that into one cassette, one workflow and one inventory line. The result is a bench that stays simpler while patients still get an early, sensitive answer.
- Earlier Answers – Detection as early as two to three days before expected menses helps patients plan sooner.
- One Inventory Line – Two kit sizes under one product keep ordering and stocking straightforward.
- Self Checking Runs – Internal controls in every cassette mean each result carries its own validity check.
Manuals and Troubleshooting Guides
Frequently Asked Questions
Can this kit test both serum and urine?
The combo cassette is intended for both specimen types, with urine read at 3 minutes and serum read at 5 minutes.
How early can it detect pregnancy?
The manufacturer states the assay can detect low hCG levels as early as two to three days before expected menses, at 10 mIU/mL in serum and 20 mIU/mL in urine.
Are controls included in the kit?
Positive and negative internal controls are built into every cassette. A separate external control set with low positive, high positive and negative controls is sold separately.
How should the kits be stored?
Store kits at room temperature, 15 to 30 °C (59 to 86 °F). Shelf life is 21 months from the date of manufacture.
Is the test CLIA waived?
It is CLIA waived for urine testing and moderately complex for serum testing, so sites should run each specimen type under the matching certificate.
What sample volume does the test use?
Each cassette uses four drops of serum or urine.
