Architect AFP, Alinity i AFP
by Abbott Laboratories PMA
Active
PMA P120008
Overview
The Architect AFP, Alinity i AFP is a chemiluminescent microparticle immunoassay (CMIA) kit designed for the quantitative determination of alpha-fetoprotein (AFP) in human serum, plasma, and amniotic fluid. It is classified as a Kit, Test, Alpha-Fetoprotein for Neural Tube Defects and supports monitoring disease progression in nonseminomatous testicular cancer and screening for fetal open neural tube defects (NTD) during gestation.
This device is intended for use on the ARCHITECT i and Alinity i immunoassay systems, requiring calibration with Architect AFP Calibrators and quality control via Architect AFP Controls. Supplied as a single-use reagent kit, it is approved under FDA_PMA (PMA P120008) and adheres to Device Class 3 regulatory standards. Storage and handling follow manufacturer guidelines to maintain assay integrity.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA PMAAPPR | NumberP120008 | Date28 Nov 2012 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA PMA Active
Specification
- Trade Name
- Abbott Architect Afp Assay
- Generic Name
- KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS
- PMA Number
- FDA Product Code
- LOK
- Device Class
- Class III
- Advisory Committee
- Immunology
- FDA Decision
- APPR Approved
Other devices from Abbott Laboratories
Questions
What types of biological samples can the **ARCHITECT AFP, Alinity i AFP** assay analyze, and how does this differ from other AFP tests?
The **ARCHITECT AFP, Alinity i AFP** is designed to quantitatively measure alpha-fetoprotein (AFP) in **human serum, plasma, and amniotic fluid**. This distinguishes it from assays limited to serum or plasma alone, as it also supports testing of amniotic fluid—critical for detecting fetal open neural tube defects (NTD) during gestation (specifically between 15–21 weeks). The assay is optimized for use on the **ARCHITECT i** and **Alinity i** systems, requiring dedicated calibrators and controls for accurate results.
Is the **ARCHITECT AFP, Alinity i AFP** kit intended for single-use, and if so, what does this mean for workflow efficiency?
Yes, the **ARCHITECT AFP, Alinity i AFP** is supplied as a **single-use reagent kit**, meaning each kit is designed for one assay run. This ensures consistency and reduces cross-contamination risk but may require planning to maintain workflow efficiency, especially in high-volume settings. The kit’s single-use nature aligns with the **chemiluminescent microparticle immunoassay (CMIA)** technology, which relies on precise reagent integrity per use.
What clinical scenarios is this assay primarily used for, and how does it integrate with other diagnostic tools?
The assay aids in **two key clinical scenarios**: (1) monitoring disease progression in **nonseminomatous testicular cancer** by quantifying AFP levels in serum/plasma, and (2) screening for **fetal open neural tube defects (NTD)** in amniotic fluid between 15–21 weeks gestation. It is **not intended as a standalone diagnostic tool** but is used **in conjunction with ultrasonography or amniography** to improve detection accuracy for NTDs. For cancer monitoring, it supports treatment decision-making by tracking AFP trends over time.
Are there specific storage or handling requirements for the **ARCHITECT AFP, Alinity i AFP** kit to ensure assay validity?
While the exact storage conditions aren’t detailed in the data, the kit’s **chemiluminescent microparticle immunoassay (CMIA)** technology and single-use nature imply adherence to standard immunoassay storage protocols—typically **refrigerated (2–8°C) and protected from light** until use. The manufacturer’s guidelines (not specified here) likely outline shelf-life and handling to preserve assay integrity, particularly for calibrators and controls, which are critical for system accuracy on the **ARCHITECT i** or **Alinity i** platforms.