RevoDx MTBC qPCR Kit
Intended Use
RevoDx MTBC qPCR Kit is a real-time RT-PCR test intended for qualitative detection of M. tuberculosis complex (M. tuberculosis, M. africanum, M. bovis, M. bovis BCG, M. canettii, M. microti, M. pinnipedii) DNA in clinical specimens of sputum, bronchoalveolar lavages or bronchial secretion using RevoDx DNA Purification Kit from Respiratory Samples and BIO-RAD CFX96 Real-Time PCR Detection System for amplification, detection and analysis. RevoDx MTBC qPCR Kit is intended to assist in the management of patients with MTBC infection and to form a strategy for antibacterial therapy in conjunction with all relevant clinical and laboratory findings.
Negative results do not preclude MTBC infection and should not be used as the sole basis for patient management decisions. Negative results must be combined with clinical observations, patient history, and epidemiological information.
RevoDx MTBC qPCR Kit is intended for use by qualified and trained clinical laboratory personnel specifically instructed and trained in the techniques of real-time PCR and in vitro diagnostic procedures.
Instruments
The RevoDx MTBC qPCR Kit is to be used with BIO-RAD CFX96 and Tianlong Gentier 96 Real-Time PCR Detection Systems. But the RevoDx MTBC qPCR Kit may also be compatible with most real-time PCR detection systems with the channels FAM and HEX
Features
- Validated for use with clinical specimens of sputum, bronchoalveolar lavages or bronchial secretion
- Exogenous internal control
- The Limit of Detection (LoD) value is 0.22 copies/μL
- Diagnostic specificity is ≥ 99 %
- Whole system failure rate is ≤1 %
- For in vitro diagnostic use.
Ordering Information