HIGH COMPLEXITY MADE SIMPLE
CLIA Certification: License #05D2183167
We have established a CLIA certified high complexity molecular testing laboratory to provide prompt and accurate testing to medical providers and clinical researchers. In response to the national public health emergency with the COVID-19 pandemic, we quickly our operations to perform COVID-19 testing utilizing RT-PCR technology. We are currently providing testing services to local hospitals and are in daily communication with California Department of Public Health regarding validation testing and reporting. Recognizing the challenge and needs of increasing testing in the national fight against COVID-19, we are expanding our testing services nationwide through designated specimen collection sites.
CLIA WORKFLOW FOR COVID-19 TESTING
HIGH COMPLEXITY TESTING
According to the CDC, CLIA High Complexity Testing refers to non-waived testing. Laboratories or sites that perform these tests need to have a CLIA certificate, be inspected, and must meet the CLIA quality standards described in 42 CFR Subparts H, J, K and M. Currently, all COVID-19 molecular specimen testings are required to be performed at a CLIA certified high complexity testing laboratory.
SPECIMEN COLLECTION PROCESS
What is RT-PCR?
Reverse transcription polymerase chain reaction (RT-PCR) is a laboratory technique combining reverse transcription of RNA into DNA followed by amplification of specific DNA targets using polymerase chain reaction (PCR). It is primarily used to measure the amount of a specific RNA via amplification using fluorescence, a technique called real-time PCR or quantitative PCR (qPCR). Combining RT-PCR and qPCR we are able to quantify viral RNA [COVID-19] for diagnoses.
Validation Data [Coming Soon]