Who Uses This Product? QuickVue One-Step hCG Combo Test is used by healthcare professionals who are responsible for obtaining pregnancy results for women who are of childbearing age or haven’t had a hysterectomy.
Why They Love It: The quick test results facilitate the answer needed to move forward with a medical procedure. The combo test means that either blood serum or urine collection may be added to the cassette test. Each box contains 50 individually wrapped tests with pipettes to perform each test.
QuickVue One-Step hCG Combo Test Overview
The Quidel QuickVue hCG Combo Test is a quick and essential part of everyday patient care for the identification of human chorionic gonadotropin (hCG) for early detection of pregnancy. This test is part of standard healthcare for women undergoing sedation before a surgical procedure or colonoscopy to mitigate risks to the fetus. This professional use pregnancy test kit provides one-step testing for fast and easy pregnancy detection using one cassette and pipette. After adding the sample, results display within 3 to 5 minutes, providing the green or red light for the patient to be cleared for anesthesia.
Quidell hCG Pregnancy Test Features and Benefits
- Test Supports Urine or Serum Collection
- Test Results in 3 to 5 Minutes
- Simple One-Step Procedure
- Clear, Easy-To-Interpret Test Results
- Clean and Safe Testing
- Ready-To-Use Tests
- No Meter or Equipment Needed To Test or Interpret the Results


Test Using Blood Serum or Urine
The QuickVue hCG Combo Pregnancy Test is an immunoassay for the detection of human chorionic gonadotropin hormone in either blood or urine. Since human chorionic gonadotropin is already found in very low levels in women’s blood and urine, the assay test requires an hCG level above 25 mIU/mL, as hCG rises post-conception.1 Urine is the most common sample type because it’s fast and easy to retrieve over a blood draw. The benefit of a combo test is that the blood serum provides a backup sample type when the patient cannot provide a urine sample.
Easy One-Step Test
The self-contained QuickVue hCG Combo One Step Test requires only three drops into the cassette. It doesn’t require additional equipment, making the testing fast, efficient, and safe. The serum test results display within five minutes and urine results within three minutes. After testing, the cassette and pipette are disposed of using facility protocols.
What Comes in the Box?
- (50) Individually wrapped test cassettes
- (50) Disposable pipettes
- (1) Package insert
- (1) Procedure card
Simple Test Interpretation
- Positive Result: A positive detection of hCG is indicated with double lines. The top blue control line (C) and the bottom blue test line (T) and one blue line for the Test line (T) and blue
- Negative Result: Only the top blue control line (C) is visible to indicate no detection of human chorionic gonadotropin.
- Invalid Result: A completely blank window or missing blue control line (C) indicates an invalid test. Retest with a new test and sample.


Frequently Asked Questions (FAQ)
What is the shelf life for the QuickVue kit and control sets?
The shelf life is 18 months when stored at room temperature.
How soon does this test detect pregnancy?
The test detects hCG as early as six days following conception with concentrations doubling every 32-48 hours.
Are there any known substances that interfere with the test?
Substances such as birth control pills and other metabolites, analytes, and chemicals have been studied and do not affect the test except for biotin. This hair, skin, and nail supplement may cause interference at concentrations of 1,000 µg and higher.
Can plasma detect hCG with this QuickVue test?
No. Plasma is not a sample specimen that is FDA-approved.
What volume of sample is dispensed with the dropper?
The pipette dropper dispenses three drops or 125 microliters µL.
Product Specifications
- Manufacturer: Quidel
- Product Number: 20110 US
- Box Quantity: 50 Tests
- Sample Size: 3 Drops
- Sample Type: Serum, Urine
- Test Results:
- Serum: 5 Minutes
- Urine: 3 Minutes
- Sensitivity: 99%
- Specificity Level: 25 Milli-International Units per Milliliter (mlU/mL)
- Shelf Life: 18 Months from Manufacturer Date
Manuals and Documents
User Manual provides setup and assembly instructions for the use and cleaning and storing of the unit.
Procedure Card Instructions illustrate steps with images of the indicator window to understand test results.
Package Insert outlines the materials, warnings, storage, test interpretation, and known compounds that may cause interference.
Footnotes
1 "Human Chorionic Gonadotropin." Cleveland Clinic. Accessed 17 Nov. 2022.
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