Cancer test kit TAF-402

oncologyAFPserum

Product overview
The AFP Rapid Test Device (Serum/Plasma) is a rapid visual immunoassay for the qualitative presumptive detection of human Alpha-fetoprotein (AFP) in human serum or plasma specimens. The test provides a quick screening result to support clinical decision-making in oncology settings.

Intended use
The AFP Rapid Test Device is intended for the qualitative presumptive detection of human Alpha-fetoprotein (AFP) in human serum or plasma specimens and is an aid in the diagnosis and monitoring of certain cancers.

Operating steps

• Bring tests, specimens, buffer and controls to room temperature (15-30°C) before use.
• Remove the test from its sealed pouch and place it on a clean, level surface. Label the device. Perform the assay within one hour after opening.
• Transfer 3 drops (≈75 μl) of specimen to the specimen well (S) using the disposable pipette provided, then start the timer.
• Avoid trapping air bubbles in the specimen well and do not dispense solution into the observation window.
• As the assay runs, colored reagent will migrate across the membrane.
• Wait for the colored band(s) to appear. Read the result at 15 minutes. Do not interpret results after 20 minutes.

Performance and product data
Product: AFP Rapid test kit
Specimen: Whole blood, plasma, serum
Components: Individually packed test devices, disposable pipettes, buffer, package insert
Cutoff: 10 ng/ml
Sensitivity: 99.3%
Specificity: 99.1%
Overall agreement: 99.2%
Storage: 2-30 ℃
Validity: 24 months

Technical specifications

• Type: Rapid visual immunoassay (serum/plasma)
• Target analyte: Human Alpha-fetoprotein (AFP)
• Supported specimen types: Whole blood, plasma, serum
• Sample volume: ~75 μl (3 drops)
• Result read time: 15 minutes (do not read after 20 minutes)
• Analytical cutoff: 10 ng/ml
• Clinical performance: Sensitivity 99.3%; Specificity 99.1%; Overall agreement 99.2%
• Storage conditions: 2-30 ℃
• Shelf life: 24 months
• Kit contents: Individually packed test devices, disposable pipettes, buffer, package insert