Respiratory & Tuberculosis
MoiM MDR-TB Detection Kit
MDR-TB (MTB, RIF, INH) detection kit in a single cartridge, which will support both sputum,
sputum swab and tongue swab samples
Research Use Only
Category
| Intended Use | The MoiM MDR-TB Detection Kit for use with the MoiM Dx system, is a real-time PCRbased in vitro diagnostic test for the qualitative detection of Mycobacterium tuberculosis complex (MTBC) DNA in raw sputum, sputum swabs, and tongue swabs. Additionally, the assay detects mutations in the rpoB gene associated with rifampin resistance and the katG/inhA promoter regions associated with isoniazid resistance, specifically using sputum specimens. The test is intended for use with samples from individuals suspected of tuberculosis (TB) as an aid in the diagnosis of TB and the identification of multidrug resistant TB (MDR-TB). This assay is designed for use by trained laboratory personnel or healthcare professionals in clinical and near-patient | |||||
| Target Genes | IS6110, MPT64 (MTBC detection) rpoB (Rifampin resistance detection) katG, inhA (Isoniazid resistance detection) | |||||
| Sample Types | Sputum, sputum swab, Tongue swab | |||||
| Target Sensitivity | MTB | RIF-Resistance | INH-Resistance | |||
| Sputum | 95 % | Sputum | 95 % | Sputum | 95 % | |
| Sputum swab | 90 % | |||||
| Tongue swab | 90 % | |||||
| Target Specificity | Sputum | 95 % | Sputum | 99 % | Sputum | 99 % |
| Sputum swab | 90 % | |||||
| Tongue swab | 90 % | |||||
| Turnaround Time | 60mins | |||||