The Alpha-1-Antitrypsin (A1AT) Immunological Test System is a diagnostic tool used to measure the levels of Alpha-1 Antitrypsin in blood samples. This test is critical for detecting Alpha-1 Antitrypsin Deficiency (A1ATD), a genetic condition that can lead to lung and liver disease.

Intended Use of Alpha-1-Antitrypsin Immunological Test System

An alpha-1-antitrypsin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the alpha-1-antitrypsin (a plasma protein) in serum, other body fluids, and tissues. The measurements aid in the diagnosis of several conditions including juvenile and adult cirrhosis of the liver. In addition, alpha-1-antitrypsin deficiency has been associated with pulmonary emphysema.

Intended Use

This is a qualitative DNA detection in vitro diagnostic test to be used in conjunction with a visualization instrument and its software. This test is for the simultaneous detection and identification of allelic variants found in the Alpha-1 antitrypsin (A1AT) codifying gene SERPINA1. This assessment system provides users with genetic information regarding genotypes of SERPINA1 allelic variants and is intended to be used in conjunction with clinical findings and other laboratory tests to aid in the diagnosis of individuals with A1AT deficiency.

Device Description

The Alpha-1 Antitrypsin (A1AT) Genotyping Test utilizes to analyze genomic DNA extracted from dry blood spots (DBS), EDTA-anticoagulated whole blood, or saliva collected via buccal swabs (ORAcollect·Dx OCD-100). The DNA is amplified, biotinylated, and hybridized to color-coded beads. The resulting signal is detected by the system, and data is processed using the A1AT Genotyping Test Analysis Software to generate a final report. The test kit includes four reagents (PCR Master Mix, Beads Master Mix, SAPE, and Dilution Buffer) and is available in configurations for 48 or 192 tests.

This device is a qualitative in vitro molecular diagnostic system designed to detect variants in the SERPINA1 gene from genomic DNA isolated from human specimens. The accompanying software analyzes genotype data, performs control checks, and generates a final genotype profile for each sample. Results should be interpreted alongside clinical findings and other tests to aid in diagnosing A1AT deficiency.

• Precision (Reproducibility and Repeatability)
• Specimen Stability
• Reagent Stability
• DNA Extraction Variability
• Cross-reactivity and Cross-contamination
• Interfering Substances
• Method Comparison
• Limit of Detection (LoD), Limit of Quantification (LoQ) and Limit of Blank (LoB)

Clinical Testing

No Guidance available  for 510k submission