C-Sync® COVID-19 Antigen Test – BioSynchronicity Corporation

Fast-Easy-Reliable Results in Minutes

The C-Sync® COVID-19 Antigen Test for point of care (POC) use is a lateral flow immunoassay intended for the qualitative detection of nucleocapsid protein and spike protein antigens from SARS-CoV-2 in direct anterior nasal (nares) swab specimens collected by a healthcare worker from individuals who are suspected of COVID-19 within the first seven days of symptom onset or for screening of individuals without symptoms or other epidemiological reasons to suspect COVID-19 infection, when tested twice over three days with at least 24 hours and no more than 48 hours between tests.

What sets the C-Sync® COVID-19 Antigen Test Apart?

Ultra-Rapid Results

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.

Accuracy and Reliability

Our clinical testing has demonstrated unprecedented results, with zero false positives for low viral loads with Ct. values up to 36 (100% specificity) when testing patients within seven days of symptom onset.

Simple to Use

Comfortable, and Painless. The ultra-rapid C-Sync® Antigen Test uses a painless shallow nasal swab, easy to use even on children, without the need for the highly unpopular and usually uncomfortable deep nasal (nasopharyngeal) swab. A saliva-based swab system is in development which is simply “licked like a lollipop” (Lollypop™).

Affordability

From the onset of our project, it has been our goal to offer universal availability of high quality frequent rapid testing to everyone, addressing testing inequity, and effectively overcoming pricing boundaries to widespread use. C-Sync® is well-priced to be accessible to all populations and significantly less costly than the time consuming and traditionally high-cost PCR tests.

Availability

Given its low price point, C-Sync® can be used in countless venues where regular testing is critical for a vigilant and well protected society, including businesses, schools, sports and recreation venues, houses of worship, nursing homes, community centers, restaurants, bars, theatres, and transportation services. Testing which allows quick screening results provides confidence in the safety of each of these environments.

Applicability

While the technology can be used now for COVID-19, the principle of the technology will be leveraged to test for other current and future critical medical needs, such as seasonal influenza, dengue fever, chikungunya virus, tuberculosis, pneumonia, syphilis, HIV, diabetes, and the detection of restricted drugs such as opioids.

C-Sync® Test Kit Components

The Professional Use box contains

20 test cassettes in individual sealed pouches
20 nasal swabs
20 sample elution tubes with dropper cap
1 Instruction for Use (IFU) leaflet
1 Quick Instruction for Use (IFU) leaflet

FOR USE UNDER FDA EMERGENCY USE AUTHORIZATION (EUA) ONLY

This product has not been FDA cleared or approved, but has been authorized by FDA under an EUA for use by authorized laboratories; use by laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C §263a, that meet the requirements to perform moderate, high, or waived complexity tests. This product is authorized for use at the Point of Care (POC), i.e., in patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation. The emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked sooner.