Solid Rapid Diagnostic Test for Tuberculosis (TB) – 25pcs

18,000.00

Specification Details
Product Name Solid Rapid Diagnostic Test for Tuberculosis (TB)
Test Type In vitro diagnostic (IVD) assay
Detection Principle Molecular or immunochromatographic method (e.g., PCR, NAAT, or antigen-antibody reaction)
Target Organism Mycobacterium tuberculosis complex (MTBC)
Specimen Type Sputum, blood, serum, plasma, or other clinical specimens
Detection Capability Qualitative detection of M. tuberculosis DNA or antigens; some models detect rifampin/multidrug resistance genes
Sensitivity ≥ 95% (depending on specimen type and test version)
Specificity ≥ 98%
Result Time Within 1–2 hours
Storage Conditions 2°C – 30°C (avoid sunlight and moisture)
Shelf Life 12–24 months (unopened, under proper storage)
Operating Temperature 15°C – 30°C
Sample Volume 50–100 µL (varies by kit type)
Test Format Single-use cassette or cartridge with ready-to-use reagents
Reading Method Visual line interpretation or automated reader (depending on model)
Certifications CE-IVD certified, WHO prequalified (for select models), ISO 13485 compliant manufacturing
Packaging Individually sealed test devices, buffer solution, droppers, and instruction manual
Intended Use For qualitative detection of Mycobacterium tuberculosis in human specimens to aid in the diagnosis of TB infection
The Solid Rapid Diagnostic Test for Tuberculosis (TB) provides fast and accurate in vitro detection of Mycobacterium tuberculosis. Designed for early diagnosis, drug resistance detection, and effective case management, this rapid TB test delivers results within hours—enhancing patient care, improving treatment outcomes, and supporting global TB control efforts.

18,000.00

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