PrimeScreen™ MTB

 

 

 

 

 

 

 

 

PrimeScreen™ MTB is a TB triage oral screening kit that detects MTB DNA in the oral cavity for further diagnostic and clinical evaluation.  The complete kit has been tested on over 700 individuals with additional participants receiving screening each week.  Results are consistent across studies on three continents (Africa, Asia, and Europe).

 

Approximately 1/4 of the world's population has latent tuberculosis. Latent TB tests determine that the individual has been exposed to TB and the individual's immune system generated a response.  In some countries, latent TB is treated with a 6-9 month course of antibiotics. Multi-Drug Resistant MTB (MDR-TB) is increasingly common in many countries.  Latent TB tests cannot distinguish between drug sensitive and MDR-TB.

PrimeScreen™MTB provides a new way to screen patients with latent TB or individuals that are actively exposed to MTB infected individuals and symptomatic patients that cannot produce sputum or adequate sputum for standard testing. Individuals that have TB in their oral cavity are likely to be spreaders and should be further evaluation to prevent further transmission. 

 

PrimeScreen™MTB - The First Commercial Collection to Identification kit with no containment facilities required for safe handling.

Accurate and timely screening of active and subclinical TB infection with referral for approved diagnostic evaluation and determination of optimal treatment on a patient-by-patient basis is the key to reducing the spread of MDR TB and Extensively Drug-Resistant TB (XDR TB).

 

Current molecular testing systems have improved the speed of testing for active infection, but continue to miss significant numbers of sub-clinical and clinical cases.  Current systems also lack quality drug resistance determination.

Articles supporting TB triage by oral screening for referral for diagnostic testing:

Noninvasive Detection of Tuberculosis by Oral Swab Analysis

PrimeStore® MTM opens Sputum-free Molecular Screening for M. tuberculosis Infection

PrimeScreen™MTB is a clinically validated end-to-end solution for sub-clinical and active tuberculosis infection screening.  It works on most open platform Real-time PCR platforms and can be integrated with many high throughput extraction systems. 

 

PrimeScreen™MTB 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.
     

  • FDA cleared 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. PrimeStore®MTM can also be used as the front end of the Xpert MTB/RIF test improving sensitivity in low copy samples. 
     

  • 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.