Tuberculosis and mycobacteria
From specimen preparation to molecular analysis
The Amplitub system brings together successive stages of mycobacterial laboratory testing: specimen preparation, DNA extraction, and real-time PCR for detection of Mycobacterium tuberculosis complex (MTBC) DNA, analysis of genetic markers associated with drug resistance, and detection and differentiation of nontuberculous mycobacteria (NTM). Intended use and permitted interpretation are defined by the instructions for each product.
This page helps laboratories select products by analytical stage and laboratory objective. The focus is the Amplitub family: specimen preparation, manual or automated DNA extraction, and dedicated real-time PCR kits for distinct analytical tasks.
Laboratory tasks
- prepare specimens for mycobacterial DNA extraction;
- perform manual or documented automated DNA extraction;
- detect MTBC DNA and, with the relevant kits, perform quantitative assessment;
- detect markers associated with rifampicin and isoniazid resistance;
- detect markers associated with fluoroquinolone resistance;
- detect MTBC and NTM DNA and perform NTM differentiation where specified by the kit;
- use research products separately for M. tuberculosis complex differentiation and Beijing genotype analysis.
Analytical sequence
Specimen preparation
For specimen types covered by the instructions, testing may begin with Amplitub-Prep.
DNA extraction
Manual magnetic-particle products and documented automated configurations are available.
Real-time PCR
The kit is chosen by objective: MTBC detection/quantitative assessment, rifampicin/isoniazid resistance-associated markers, fluoroquinolone resistance-associated markers, or MTBC/NTM detection with NTM differentiation.
Interpretation
Permitted conclusions are defined by the specific product instructions and applicable laboratory procedures.
SYNTOL offers products for several connected stages: Amplitub-Prep for specimen preparation, M-Sorb-Tub for magnetic DNA extraction, Amplitub-RT configurations for MTBC DNA detection and quantitative assessment, dedicated kits for resistance-associated markers, and products for detection/differentiation of nontuberculous mycobacteria.
The principal methods are specimen preparation, magnetic DNA extraction and real-time PCR. Some resistance-marker kits use allele-specific real-time PCR within their documented scope.
Products for key stages
Core solutions include Amplitub-Prep, the Amplitub-RT family, Amplitub-MDR-RT (OM-600), Amplitub-FQ-RT (OM-800), Amplitub-NTM-Differentiation (OM-700), M-Sorb-Tub, and automated DNA-extraction configurations. Research products such as Amplitub-Differentiation, Amplitub-Beijing, and Express-Tub are presented separately from IVD products.
Pretreatment reagent for samples suspected of containing mycobacterial DNA
"Amplitub-RT" reagent kit for mycobacterial DNA isolation from clinical samples and cell cultures using magnetic sorbent, kit No. 1; sorbent dispensed into 1.5 mL tubes
Reagent kit "Amplitub-RT"for isolation of DNA mycobacteria from clinical samples and cell cultures (on magnetic sorbent) (TECAN, Automatic-48)
"Amplitub-RT" reagent kit for manual isolation, detection, and quantification of Mycobacterium tuberculosis complex DNA by real-time PCR
Reagent kit "Amplitub-RT"for isolation of on automated stations, detection of and quantitative determination of DNA Mycobacterium tuberculosis complex by real-time PCR
Reagent kit "Amplitub-RT"for isolation of on automated stations, detection of and quantitative determination of DNA Mycobacterium tuberculosis complex by real-time PCR
"Amplitub-MDR-RT" reagent kit for detection of Mycobacterium tuberculosis complex DNA markers associated with rifampicin and isoniazid resistance by real-time PCR
"Amplitub-FQ-RT" reagent kit for detection of DNA markers of Mycobacterium tuberculosis complex associated with fluoroquinolone resistance by real-time PCR
"Amplitub-NTM-Differentiation" reagent kit for detection of DNA markers of Mycobacterium tuberculosis complex and nontuberculous mycobacteria, with differential identification of…
Reagent kit "Amplitub-differentiation"for differentiation of mycobacterial species, included in M. tuberculosis complex (M. tuberculosis, M. bovis, M. bovis BCG)
"Amplitub-Beijing" reagent kit for determination of the Beijing genotype of Mycobacterium tuberculosis
Reagent kit "express-Tub"for express isolation of DNA mycobacteria from samples cell cultures (without magnetic sorbent)
Move from the task to concrete resources
Amplitub-Prep registration document
Open document↗Amplitub-FQ-RT registration document
Open document↗Real-time PCR publication on reserve-line drug resistance
Open material↗Real-time PCR publication on drug-resistant M. tuberculosis
Open material↗Reagent kits for tuberculosis diagnostics
Open material↗User Training
Practical user training for working with reagents, protocols and laboratory scenarios.
Open service↗Scope and limitations
Sensitivity and specificity values, time to result, DNA-extraction characteristics, and other performance parameters belong to the specific assay and its current instructions. This section is not intended for assessing infectiousness, treatment effectiveness, or treatment selection and adjustment.
Select a solution
Primary action: “Select an Amplitub configuration for your laboratory task.” The request can specify MTBC; rifampicin + isoniazid markers; fluoroquinolone markers; MTBC + NTM; or automated DNA extraction. Secondary action: “Request training.”
Start a request