The Most Sensitive Molecular Solution in the Tuberculosis Diagnostic Market, Opening Access to Billions of People
Multi-drug resistant Tuberculosis, (MDR TB) and Extensively Drug-Resistant Tuberculosis (XDR TB) are growing problems Worldwide. The World Health Organization reports that in some areas of the World up to 25% of people infected with tuberculosis have MDR TB or XDR TB. The cost of drugs alone for treating MDR is over a 100 times more than standard treatment and the cost for treating XDR TB is many times more then MDR TB.
Accurate and timely diagnosis of TB and determination of optimal treatment on a patient-by-patient basis is the key to reducing the spread of MDR TB and XDR TB.
Current molecular testing systems have improved the speed of diagnosis, but continue to miss significant numbers of infections. Current systems also lack quality drug resistance determination.
PrimeSuite TB™ is a clinically validated end-to-end solution of detection of Tuberculosis and genetic analysis of drug resistance. It works on most open platform Real-time PCR platforms and Next Generation sequencers, and can be integrated with many high throughput extraction systems. In a May 2016 publication, PrimeSuite TB was demonstrated to be statistically superior to Xpert MTB/RIF in culture negative samples.
PrimeSuite TB™ consists of:
- PrimeSwab™ is made from the finest polyester materials available worldwide. The unique microstructure of HydraFlock®’s multi-length fibers are designed to enhance rapid absorption and release of biological specimens into transport medium.
- PrimeStore MTM® for the safe, cost effective, and efficient collection and transport of tuberculosis samples. All tuberculosis must be considered hazardous, but MDR TB and XDR TB must be treated with extreme care. With PrimeStore MTM® the sample is rendered non-infective on site of collection. Transport and testing can be done with no concern for cold chain or infectivity. Multiple tests can be run from the same sample and the sample can survive multiple freeze/thaw cycles if long term storage is desired.
- PrimeXtract™ is a simplified total nucleic extraction system (silica-based spin column extraction) for sensitive purification of RNA/DNA for downstream PCR, real-time PCR, and Next-Generation Sequencing.
- PrimeMix TB® is a highly sensitive, tuberculosis specific, all-inclusive, PCR reagent mixture that reduces costly labor-intensive preparation, is easy to use and stable for weeks at room temperatures. (For use outside of the United States)
PrimeSeq™ portfolio of products includes ten resistance gene reagents for TB gene sequencing. Each tube contains primers and enzymes necessary for sequencing the TB gene of interest (50 sequences per tube). The reagents can be used with current leading gene-sequencing platforms.