Longhorn

PrimeStore® MTM | Longhorn Vaccines & Diagnostics (lhnvd.com)

The first molecular transport device for storing and stabilizing microbial nucleic acid. PrimeStore® Molecular Transport Medium (MTM), is a patented, FDA approved, state-of-the-art ambient temperature molecular diagnostic collection and transport device. It was designed to help governments, global health organizations and drug manufacturers improve the diagnosis and treatment of highly infectious diseases.

Unlike standard devices for collecting and transporting biological samples, PrimeStore® MTM begins to inactivate pathogens, proteins and enzymes immediately upon insertion, allowing the sample to be tested right away or shipped at ambient temperature to a testing facility anywhere in the world. In one independent study, it showed stability for a 117-day average from sample collection to extraction.

SARS-CoV-2 Specimen Collection Supplies

PrimeStore® MTM is the only media on the FDA preferred list that inactivates SARS-CoV-2 during the collection and transit stage. Over 30 million tubes of PrimeStore® MTM have been sold to clients around the world during the SARS-CoV-2 pandemic.

The FDA has identified PrimeStore® MTM as a Class II microbial nucleic acid storage and stabilization device. FDA 510(k) clearance is a worldwide recognized standard in stringent, unbiased, and transparent regulatory review for medical devices, and is crucial to instilling confidence in new products and technologies.

PrimeStore® MTM was designed with the belief that nucleic acid quality begins at the moment of collection. Its unique characteristics can accelerate efforts to identify and control seasonal, endemic, and pandemic diseases such as coronavirus, influenza, and M. tuberculosis, opening up timely, accurate testing to billions of people in the U.S. and around the world. To truly impact highly infectious and rapidly evolving pathogens, the use of point of care, hospital-based, and centralized high throughput laboratory testing are absolutely necessary.

Spectrum Saliva Collection MTM

SDNA Whole Saliva Collection Devices » Spectrum Solutions

How you collect saliva makes a big diagnostic difference. To incorporate the use of saliva into COVID-19 diagnostic testing protocols or implement actual real-world mass-testing in scalable scenarios requires an authorized, proven, validated, and supported system that actually mitigates risk of exposure and a device engineered to increase testing accuracy.

A validated and authorized process saves time and money. The SDNA saliva collection system has been engineered to lead the saliva collection market in molecular diagnostic applications. This self-contained saliva collection system provides critical sample consistency while suspending and neutralizing viral RNA transcripts post collection for sensitive and specific analysis completely inactivating the live virus at ambient temperatures.

Spectrum’s CV3 patented blue preservation chemistry is 100% bacteriostatic, preserves both DNA and viral RNA transcripts, and offers over 10 days of post-collection stability with no degradation in sample efficacy. The SDNA saliva collection kit ships with verified, unique barcode serialization for biosample physical and digital chain-of-custody. Additionally, customized packaging, kitting, and fulfillment options are available to solve any special project or testing workflow requirements.

Choosing the wrong saliva collection device can introduce and increase critical failure points. As the first saliva collection device to be authorized for COVID-19 testing, the SDNA-1000 mitigates any risk of infection throughout the testing process and doesn’t require any special UN3373 designation for USPS, FedEx, or UPS sample shipping.

Spectrum is the manufacturer and supplier of the first FDA EUA authorized saliva collection kit used for COVID-19 testing. Under the current COVID-19 state of emergency, the FDA has granted special authorization (EUA202432) and device use for COVID-19 testing beyond research only applications to additionally include clinical diagnostics. This first-of-its-kind device authorization not only validates the technically-superior device capabilities but effectively paves the way for easy device integration and the addition of saliva-based testing into existing EUA authorized clinical diagnostic testing protocols.

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