BELTEST-IT FIBRO

The BELTEST-IT FIBRO Rapid Test is intended to detect YKL-40 (CHI3L1) protein in whole blood (fingerstick or venous), plasma, or serum. It is a non-invasive solution to help assess stages of liver fibrosis. This point-of-care test is intended for use by trained healthcare professionals in primary care settings where laboratories are not available.

PRODUCT INFORMATION

MethodImmunochromatographic assay
Sample TypeHuman whole blood (fingerstick or venous), plasma, serum
Sample Size50 μL
Time to Results20 minutes
Storage Conditions2°C to 30°C (35°F to 86°F)
Shelf Life12 months

KIT CONTENTS

  • Test cassette

  • Pipette for transferring blood from the fingertip to the test cassette

  • Desiccant packet

  • Lancet

  • Vial containing buffer solution

  • Plastic bag for disposal of used test materials

  • Pouch with label

  • Instructions for use

TEST PERFORMANCE

BIOMARKER: YKL-40 (CHI3L1)

SENSITIVITY

96.6%

SPECIFICITY

93.4%

ACCURACY

95.0%

*NOTE: Results from this test should not be used as the sole basis to diagnose or exclude hepatic disease. As with all diagnostic assays, the results obtained with this test must only be used as an adjunct to other information available to the healthcare professional. Treatment of patients should be based on a combination of symptoms, clinical signs, medical history, other laboratory tests and therapeutic responses.