AffiCHECK® Mycobacterium tuberculosis MTB RIF Resistant (SPUTUM) DNA PCR Quantitative Positive Control
AffiCHECK® Mycobacterium tuberculosis MTB INH Resistant (SPUTUM) DNA PCR Quantitative Positive Control is a high-quality reference standard containing defined quantities of Mycobacterium tuberculosis MTB INH (Isoniazid) Resistant DNA formulated to mimic clinical sputum specimens. Engineered using inactivated, non-infectious bacterial particles, this control is specifically designed to validate and monitor the entire workflow of molecular assays that detect gene mutations associated with isoniazid resistance.
INTENDED USE :
AffiCHECK® Mycobacterium tuberculosis MTB RIF Resistant (SPUTUM) DNA PCR Quantitative Positive Control supports validation and routine performance checks of PCR assays. It’s used for both qualitative detection and quantitative measurement of Mycobacterium tuberculosis MTB RIF Resistant (SPUTUM) DNA in clinical, research, and diagnostic workflows.
PRODUCT FEATURES :
Specificity & Sensitivity : Contains lyophilized DNA from the Mycobacterium tuberculosis MTB RIF Resistant (SPUTUM) for highly specific and sensitive detection, supporting both qualitative and quantitative PCR analysis.
Reproducibility : Delivers consistent and reproducible results, making it ideal for routine validation and assay performance checks.
- Intra-assay precision: Three vials were extracted under identical conditions and amplified in triplicate by the same operator using consistent qPCR settings. The coefficient of variation was below 15%.
- Inter-assay precision: One vial was extracted and amplified in triplicate by two different operators over three consecutive days. The coefficient of variation remained below 15%.
Convenience: Lyophilized format ensures easy storage, quick reconstitution, and reliable handling.
Compatibility : Works seamlessly with DNA-based platforms, including real-time PCR, for test development, optimization, and ongoing validation.
PACK CONTENT :
| Components | Pack Size | Note |
| Mycobacterium tuberculosis (MTB) RIF Resistant (531) (SPUTUM) Control Lyophilized | 5 Vials | Quantified by real-time PCR (2 × 10⁴ to 5 × 10⁴ copies/µL), containing the rpoB (S531L) mutation associated with rifampicin resistance. |
| Mycobacterium tuberculosis (MTB) RIF Resistant (531) (SPUTUM) Control Lyophilized | 5 Vials | Quantified by real-time PCR (2 × 10⁴ to 5 × 10⁴ copies/µL), containing the rpoB (H526D) mutation associated with rifampicin resistance. |