Product Overview

A rapid chromatographic immunoassay for qualitative detection of anti-TB antibodies (IgG/IgM/IgA) in whole blood, serum, or plasma. Designed for professional in vitro diagnostics to aid in tuberculosis screening and management.

Disease Background

Tuberculosis (TB), caused by Mycobacterium tuberculosis, remains a global health crisis. According to WHO's 2023 Global TB Report, 10.8 million new cases were reported worldwide in 2023, with a 4.6% rise in incidence rates since 2020. The disease is among the top 10 causes of death globally, particularly in low- and middle-income countries where 95% of cases occur.

TB is primarily an airborne infectious disease. Transmission occurs when individuals with active pulmonary TB cough, sneeze, or speak, releasing tiny respiratory droplets containing M. tuberculosis into the air.

Product Specification

Intended use	Detection of anti-TB antibodies
Principle	Fluorescence Immunochromatography
Storage	4-30°C
Shelf Life	24 Months
Reading Time	10~15 Minutes
Materials Provided	Test device Package insert Desiccant Dropper Buffer

Ordering Information

Product Name	Catalog No.	Specimen	Format	Pack	Certification
Tuberculosis (TB) Rapid Test Device	TB-3012	Serum/Plasma	Cassette		CE
	TB-4011	Whole Blood/Serum/Plas	Strip		CE
	TB-4012	Whole Blood/Serum/Plas	Cassette		CE

Product Advantages

High Accuracy: 93.2% sensitivity and 98.9% specificity for reliable results.

Fast Diagnosis: Results ready in 15 minutes for rapid clinical action.

Sample Flexibility: Works with whole blood, serum, or plasma.

Room Temperature Storage: Stable at 4–30°C with long shelf life.

User-Friendly: Simple workflow for healthcare professionals.

product-750-750

Operation Steps & Interpretation

product-750-750

FAQ

Q: What specimens are invalid?

A: Samples with visible clots or hemolysis may affect results.

Q: How to handle expired kits?

A: Discard expired devices per local biohazard regulations.

Q: Does medication affect results?

A: No known cross-reactivity with common medications.

Q: Can it differentiate IgG/IgM/IgA?

A: No-It provides a combined qualitative result.

Q: What's the minimum sample volume?

A: 50 μL for whole blood; 10 μL for serum/plasma.

Q: How is quality ensured?

A: We follow strict quality control processes: pre-production samples for approval and final inspection before shipment. All products meet CE, ISO, and GMP standards.

Q: What products do you offer?

A: We specialize in:
Drugs of Abuse Tests
Women Health Tests
Infectious Diseases Tests
Cardiac Markers Tests
Tumor Markers Tests