Quidel QuickVue™ hCG Combo Test Kit

Uses a monoclonal antibody specific to the beta subunit of hCG in a single-step technology

Supplier:  Quidel 20110

Catalog No. 23-043-053

Includes: Individually wrapped test cassettes, disposable pipets, procedure card, and package insert

Description

• CPT Codes: 81025 (urine), 84703 (serum)
• CLIA Complexity: Waived (urine), Non-waived (serum)
• For the qualitative detection of human chorionic gonadotropin (hCG) in serum or urine for the early detection of pregnancy
• Sensitivity: >99%
• Specificity: >99%
• Agreement: >99%
• Results in three minutes for urine, five minutes for serum
• Positive results: pink-to-red Test (T) line along with a blue procedural Control (C) line; negative results: only a blue procedural Control line. Specimens containing as low as 25mIU/mL (calibrated against the WHO 4th IS 75/589) hCG will yield positive results.
• For in vitro diagnostic use

Specifications

• Accuracy: >99%
• Clia Complexity: Waived, Non-waived
• Sample Type: Serum, Urine
• Includes: Individually wrapped test cassettes, disposable pipets, procedure card and package insert
• Sample Size: 3 Drops

• CPT Code: 81025, 84703
• Detectable Analytes: hCG
• Type: hCG Combo Test Kit
• Quantity: 50 Tests
• Test Time: 3 min. for urine, 5 min. for serum