QuickVue hCG Combo Test

quickvue-hcg-combo

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QuickVue hCG Combo Test

Women’s Health

The QuickVue hCG Combo Test is a sensitive immunoassay that detects human chorionic gonadotropin (hCG) in serum or urine for the early detection of pregnancy.

INTENDED USE

The QuickVue One-Step hCG Combo test is a one-step immunoassay intended for the qualitative detection of human Chorionic Gonadotropin (hCG) in serum or urine for the early detection of pregnancy. The test is intended for use by healthcare professionals.

FEATURES & BENEFITS
Feature Benefit
One-step procedure Easy to use, fewer procedural errors
Results in 3 to 5 minutes Fast time to results
Two-color result Easy to read and interpret
High sensitivity Ability to detect low hCG levels as early as 2-3 days before expected menses
Self-contained test Cassette Clean, easy to use and dispose of
Pictorial Procedure Card Clear and simple illustrations to guide the hCG test procedure
All components included in kit Ready to use, no need for additional equipment
Internal controls included Provides verification of test strip functional integrity, increasing confidence in results
External controls included Facilitates internal laboratory quality control
Room temperature storage No refrigerator space needed. No need to wait for reagents to warm up.
PRODUCT SPECIFICATIONS
Sample type Serum, urine
Sample size 3 drops
Time to results Serum – 5 minutes; Urine – 3 minutes
Kit storage conditions Room temperature (15°C to 30°C/59°F to 86°F)
Internal Controls Included
External Controls Available separately
Sensitivity* 25 mIU/mL
Accuracy* > 99%
Shelf life 18 months from date of manufacture
CLIA complexity Waived for urine, moderate for serum
*Refer to Package Insert for additional performance claims.

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