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Specialty Diagnostics, Inc.
Clinical Genetics Center
A State Licensed High Complexity Laboratory

Our RAPID Antigen Test has undergone clinical validation studies in our high-complexity CLIA certified laboratory. It has also undergone independent validations in other 3rd party labs. Please make sure all regulatory documents are executed. 

SDI’s 15 Minute SARs-CoV-2 Antigen Test Device is a laboratory-based Antigen Test (LDT) and is Made in the USA. It is legally approved to be administered in the USA through only our high complexity laboratory channel. Our laboratory clinically validated the 15 Minute SARs-CoV-2 Antigen Test using the Laboratory Developed (LDT) pathway which is governed by the U.S. Dept. of Health and Human Services (HHS) and permits the use of our SARs-CoV-2 Antigen Test in the USA.

This pathway was approved by HHS mid-August 2020 and then on December 5th, 2020 was referenced by the CDC when the FDA “authorized laboratory-based antigen tests”. This guidance is very detailed and is an essential requirement to help guide employer groups, healthcare institutions and states to conduct front line testing via Antigen Tests.

New packaging coming soon!

Our laboratory will handle all software and regulatory components of the LDT pathway. There is an urgent need for a robust system which can provide the world’s first POC solution to track and report results of serological, molecular, Antigen, Vaccine (neutralizing antibodies), and contact tracing identifying the viral reservoir and furthering critical epidemiological studies:

  1. 1. Every single test picture is uploaded and our laboratory director (and his team) formally reviews every test result and provides test result diagnosis and clearance for school, work or travel.
  2. 2. We ensure a signed contract for HIPAA compliance is electronically executed, reported and on file.
  3. 3. We also execute a staffing agreement. 
  4. 4. All our testing personnel are trained by our high complexity laboratory ensuring the appropriate use of this device under a full regulatory framework.
Our software will do the following for YOU

A. Ensure the reporting of all applicable results to local and federal authorities.
B. All patients can be easily scheduled and load balanced based on the number of providers and number of patients or employees saving countless needless scheduling hours.

C. Critical data can be transferred to local healthcare departments  in order to initiate Contact Tracing (in process).

 

D. Positive or inconclusive tests can easily be scheduled for PCR testing

E. All CPTS codes are present, and insurance can be billed in conjunction with the laboratory

F. Our system is programmed to handle all aspects of Antibody, Antigen, Vaccination testing (in process) and contact tracing (in process).

If you would like to read up on additional information on the Laboratory Developed Test pathway (LDT) please refer to the following links provided by the FDA:


You can find acceptance by the FDA & CDC for Laboratory Developed Tests here

https://www.cdc.gov/coronavirus/2019-ncov/lab/resources/antigen-tests-guidelines.html