CLAIDIA TB-IGRA - CLIA&DLCM - Products - Zhuhai Livzon Diagnostics Inc.

CLAIDIA TB-IGRA

Intended Use

This product is used for in vitro qualitative detection of the T cell irmmune response specific to

Mycobacterium tuberculosis in fresh human peripheral venousanticoagulated blood.

This product is intended for the auxiliary diagnosis of tuberculepsis.

Features

• 32-Hour Sample Stability

Extended room-temperature storage for worry-free sample transportation.

• High Cost-Efficiency

Optimized 3-tube assay delivers premium accuracy at a more accessible cost.

• Fully Automated CLIA

"Sample in, result out" with continuous loading and random access.

• High Sensitivity and Specificity

LoD <0.03 IU/mL, with RD1-specific antigens minimizing interference from BCG vaccination.

Parameters

Product Name	Tuberculosis Interferon-Gamma Release Assay (TB-IGRA) Diagnostic Kit (CLIA)
Methodology	Chemiluminescence Immunoassay (CLIA)
Sample Volume	20 μL per test (per tube)
Limit of detection	≤0.03 IU/mL
Linear range	0.04-12 IU/mL
Storage	2-8°C
Shelf Life	12 months
Compatible Platforms	Shine i1900/Shine i2900/PATHVIZON X50

Ordering Information