PrimeScreen™ MTB
Screening for sub-clinical and active tuberculosis infection.
Overview
PrimeScreen MTB is a tuberculosis 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 1000 individuals with additional participants receiving screenings each week. Results are consistent across studies on three continents: Africa, Asia, and Europe.
This clinically validated end-to-end solution works on most open real-time PCR platforms and can be integrated into many high throughput extraction systems.
The first Commercial Collection to Identification kit with no containment facilities required for safe handling.
The Problem
Latent tuberculosis around the globe.
With so much of the world being affected with latent TB, testing has become essential. Latent TB tests determine if the individual has been exposed to TB and the individual's immune system generated a response. However, these tests cannot distinguish between drug sensitive and Multi-Drug Resistant TB (MTB), which is increasingly common in many countries. In some countries, latent TB is treated with a six-to-nine-month course of antibiotics.
PrimeScreen MTB provides a new way to screen patients with latent TB, individuals that have been 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, warranting further evaluation to prevent transmission.
About 1/4 of the world's population has latent tuberculosis.
Current Approaches
Existing molecular testing systems lack speed, quality and broad applicability.
Though current molecular testing systems have improved the speed of testing for active infection, many continue to miss significant numbers of sub-clinical and clinical cases. Current systems also lack quality drug resistance determination capabilities.
There is a need for 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. This is the key to reducing the spread of MDR TB and Extensively Drug-Resistant TB (XDR TB).
Our Solution
The components of PrimeScreen MTB.
PrimeSwab™
Designed to enhance rapid absorption and release of biological specimens into transport medium.
-
PrimeSwab™ is made from the unique microstructure of HydraFlock®’s multi-length fibers, which are considered the finest polyester materials available worldwide.
PrimeStore® MTM
FDA-cleared 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™
Designed for the sensitive purification of RNA/DNA for downstream PCR, real-time PCR, and Next-Generation Sequencing.
-
PrimeXtract™ is a simplified total nucleic extraction system (silica-based spin column extraction).
PrimeMix®TB
Reduces costly labor-intensive preparation, is easy to use and stable for weeks at room temperatures.
-
PrimeMix®TB is a highly sensitive, tuberculosis specific, all-inclusive, PCR reagent mixture.
