For purposes of COVID 19 Surveillance and Deterrence, we sell to any facility or organization suffering from the pandemic:
Under the current schema (please check with your local Health Boards and Relevant Agencies for accurate advisory):
a. In California, the regulation for COVID19 DTK testing is covered by National CLIA guidelines. Four states do not go through CLIA but through their respective state’s Department of Health (NY, FL, MA, and NV).
b. Therefore, our product should first be validated by a high complexity CLIA lab in your vicinity. The current standard if we use the RT-PCR FDA guidance as a reference example is to test 30+ and 30 – RT-PCR COVID19 blood samples. Additional control studies of class specificity and cross reactivity are required as well, please consult your local agency requirements for updated protocols.
c. If validation is consistent with testing requirements for sensitivity and specificity demanded by the local guidelines then that laboratory is authorized to perform COVID19 serology testing using the DTK they have validated.
d. The high complex laboratory is then also able to validate moderate and low complexity environments in their community such as POC under their CLIA umbrella using +/- sample testing under their review.
e. Once a Covid19 DTK receives a POC designation for COVID19 diagnosis by the FDA then the above CLIA schema would not have to be followed for that DTK. At this point, no DTK has received that approval by the FDA.
For Hospital inpatients