Oropharyngeal Collection – 36 patients.


Statistical Analysis of Oral Rapid vs RT-PCR

True Positives


True Negative


False Negatives


False positive






James Chao, MD – Spectrum Diagnostics, California. USA

The study was conducted by James Chao, MD, California, at Spectrum Diagnostics and showed performance of 100% sensitivity and 100% specificity at a Ct count of 30.9 and below (Ct counts are the number of times a PCR instrument must cycle through to amplify enough genetic material of the SARS-CoV-2 virus for it to be detectable. 

DAYTONA BEACH, F.L., April 11, 2021 – North American Diagnostics (NAD) – a leading manufacturer of SARS-CoV-2 Rapid Antigen and Saliva tests – next week plans to submit an EUA to the Food and Drug Administration (FDA) for U.S. approval for inclusion in the Emergency Use Authorization program for distribution and use in the U.S. At this time, deployment will be overseas under a C.E. Mark until the EUA is authorized by the FDA.

Oral Rapid is The First Antigen Rapid Test which reveals a 100% sensitivity within the asymptomatic population.” Most importantly, this has been accomplished in a Double-blind Manner within the Southern California scientific community which makes North American Diagnostics the first manufacturer in the world, and the only USA-based company, to accomplish this feat.

This simple and affordable, 15-minute test is performed by taking a sample from the mouth to determine if it contains viral genetic material, giving results immediately without special equipment. According to the chairman, Paul Singh, “We actually have data supporting 100% sensitivity and 100% specificity, but conservatively are indicating sensitivity as > 95% and specificity as > 95%”. This makes it possible to test people quickly and conveniently within a variety of settings, including schools, workplaces, and doctor’s offices without the need for additional equipment.

An additional EUA will be filed for home based over-the-counter use towards the end of the month. The Oral Rapid Antigen Test was recently found to yield accurate results in conjunction with individuals who have been fully or partially vaccinated and is now undergoing the process of scientifically validating with the variants of SARS-CoV-2, which will be a key part of bringing the virus and its transmission under control. The test was entirely developed and manufactured in Daytona Beach, Florida. For distribution worldwide, and will be distributed from its Daytona Beach, Florida plant.

North American Diagnostics is a global leader in developing, manufacturing, and distributing diagnostic testing for infectious diseases and fertility Lateral flow assays. NAD has collaborated with leading Hospitals and high complexity laboratories to develop its SARS-CoV-2 devices.

Headquartered in Daytona Beach, Florida, North American Diagnostics is striving to become a worldwide leader in developing cost-effective point-of-care rapid tests.

For additional information, please contact: info@NorthAmericanDiagnostics.com.

For press inquiries, please contact Paul Singh at Paul@NorthAmericanDiagnostics.com

SOURCE North American Diagnostics, LLC, 618 Ridgewood Ave, Daytona Beach, FL 32117

Contact Detail:

Company Name: North American Diagnostics
Contact Person: Paul Singh
Email: Send Email
Address: 618 Ridgewood Ave, Daytona Beach, FL 32117
Country: United States
Website Url: http://www.northamericandiagnostics.com/

Source: www.PRExhibition.com