FUJIFILM Wako Diagnostics

AFP-L3 & AFP

μTASWako® AFP-L3

For In Vitro Diagnostic Use

Intended Use

The μTASWako AFP-L3 Immunological Test System is an in vitro device that consists of reagents used with the μTASWako i30 Immunoanalyzer to quantitatively measure, by immunochemical techniques, AFP-L3% in human serum. The device is intended for in vitro diagnostic use as an aid in the risk assessment of patients with chronic liver disease for development of hepatocellular carcinoma (HCC) in conjunction with other laboratory findings, imaging studies and clinical assessment. Patients with elevated AFP-L3% values (>= 10%) have been shown to be associated with an increase in the risk of developing HCC within the next 21 months and should be more intensely evaluated for evidence of HCC according to the existing HCC practice guidelines in oncology.

Basic Procedure

Operation on μTASWako® i30 Immunoanalyzer

Ordering Information

Catalog No. Product Name Pkg Size Storage Condition
999-60601 μTASWako AFP-L3 100 tests 2-10°C
Calibrator
997-60901 μTASWako AFP-L3 Calibrator Set 1 x 3 conc. x 2 mL 2-10°C
Control
997-61001 μTASWako AFP-L3 Control L 4 x 1 conc. x 2 mL 2-10°C
997-61101 μTASWako AFP-L3 Control H 4 x 1 conc. x 2 mL 2-10°C
Related Products
997-61501 μTASWako AFP-L3 Sample Dilution Buffer 3 x 10 mL 2-10°C
Consumables
991-60801 μTASWako Wash Solution 4 x 60 mL Room Temperature
991-61601 μTASWako Chip Cassette 100 chips Room Temperature
452-00501 Sample Cup S 1000 cups Room Temperature

Materials

Package Insert

PDFμTASWako AFP-L3