Pro FAR Celiac Self-diagnostic Test

Pro FAR Celiac Self-diagnostic Test - Medical Device

Rapid lateral flow immunochromatographic test on whole blood.
Sample volume required for the test: 30 mcl.
Volume of diluent required: 3 drops.
Reading time: 10 minutes.
Test Interpretation: Visual (Negative 1 line - Positive 2 lines)
Cut-off: ≥20 U / ml IgA - IgG anti DGP (Deamidated Gliadin Peptide)
Reference methods: ELIA (enzyme linked immunoassay); FIA (fluorescent immunoassay); PHADIA (ThermoFisher); Chemiluminescent (Menarini).

• Sensitivity: ≥81%
• Specificity: ≥94%
• Accuracy: 90%

Warnings

Interference and Cross-reactivity
No interference or cross-reactivity was observed with the following substances at the indicated concentrations:

Bilirubin: 4.74 mg / dl and 21.11 mg / dl; Cholesterol: 480 mg / dl and 1,248 mg / dl; Glucose: 459 mg / dl; Immunoglobulins: IgA: 6.1 g / l and 9.45 g / l; IgG: 48.8 g / l and 33.65 g / l; IgM: 2.75 g / l and 4.5 g / l; Triglycerides 443 mg / dl and 868 mg / dl; Isopropanol 70%; Ethanol 12%; Hand creams; Helicobacter pylori.

storage

Store at a temperature between 4 ° C and 30 ° C.
Validity in unopened package: 24 months.

Format

Components:

• Antiseptic cleansing gauze;
• 2 Hands;
• Dropper vial containing the diluent;
• Hermetically sealed aluminum pouch containing the cassette + desiccant pouch;
• Capillary pipette for blood sampling;
• Instructions for Use.