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Manufacturing

Components are manufactured under strict supervision and quality control/quality assurance protocols, with built-in redundancy of supply chain through component manufacturers in multiple countries including the USA, UAE, China, India, and South Korea.

Risk mitigation has been considered at every step.

  • Not dependent on one source
  • Manufactured under ISO-13485 certified protocols
  • Raw materials are checked through strict quality assurance protocols
  • All reagents are guaranteed to be of the highest purity to assure superior test performance

Our initial immediate production capacity is 100,000 test kits per day. With current supply chain allocations, we are able to ramp up manufacturing capacity to 300,000 test kits per day within 30 days, and 1,000,000 test kits per day within 60 to 90 days using existing infrastructure.

USA_C-Sync

Packaging

Packaging will be done under strict temperature and humidity controls.

  • Packaging can be adapted and customized to the customer’s need.  This includes languages, certification and other required symbols.
  • Labeling can be co-branded (in certain controlled circumstances) where permitted by regulatory bodies.
  • Right from concept to manufacturing, C-Sync™ is scientifically and ergonomically designed for ease-of-use and quality control.
  • Current Professional Use box configuration: 20 tests per box.
  • Future family packs: 10 tests / 5 tests / 2 tests per box for serial testing of individuals, and other configurations available as may be required by our clients.

Quality Control

Our senior QC/QA team members oversaw quality and risk mitigation for global Fortune 500 companies.

  • The test cassette manufacturing is fully automated, with high-quality robotic lines.
  • We have “feet on the ground” in China, India, and Korea, with additional QC assurance through SGS.
  • Manufacturing is not dependent on a large, unpredictable workforce.
  • The manufacturing process is ISO-13485 certified and compliant with all required risk mitigation standards and protocols.
  • Quickly scalable from current 100,000 units daily to 1,000,000 units daily in 60 to 90 days using the existing infrastructure.
Quality Control

Performance Testing

Testing was Testing was conducted by a respected Lab in Rockville MD, whose CEO is the immediate past President of the Washington Academy of Science. Clinical testing was conducted under strict FDA protocols at Ochsner Health in New Orleans and corroborated by both the Ochsner Health Lab as well as by Louisiana State University (LSU), the official lab for genetic sequencing of the SARS-CoV-2 virus for the State of Louisiana.

  • In clinical testing in the USA, C-Sync™ has demonstrated a sensitivity of 96.7% and a specificity of 100%.
  • In clinical testing in Europe, C-Sync™ has demonstrated a sensitivity of 98.7% and a specificity of 100%.

To date, in over 1100 clinical trials, there have been zero false positives in patients tested within 7 days of the onset of symptoms in our clinical studies in patients tested within 7 days of the onset of symptoms. Asymptomatic patients have also been verified.

In December, 2021, and January, 2022, in testing in clinical settings in the USA and UAE, C-Sync™ was verified to be able to detect the highly infectious SARS-CoV-2 OMICRON variant.

Design

Simple, Easy, and Intuitive
  • The product was designed to be non-invasive and simple to use.
  • It uses a comfortable shallow nasal swab – no need for a deep, brain-shocking poke or blood draw.
  • A step-by-step pictorial is included in the test box which provides the user with simple and user-friendly instructions.
  • A small dripless elution tube vial is easy to use to apply 4 drops to the test cassette.
  • As soon as the specimen is added to the sample well of one test cassette, a visual test reaction begins in less than 10 seconds. Positive results are often confirmed in as little as 2 to 3 minutes in high viral load patients. Negative results are confirmed at 10 minutes.
Designer
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