CLIA DIVISION

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. 

RT-PCR TESTING 
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]

SEROLOGY TESTING 
SPECIMEN COLLECTION PROCESS 

What is Serology?

Serological tests for SARS-CoV-2 are intended for individuals who may have been exposed to COVID-19 and either had symptoms but are no longer symptomatic, or were asymptomatic. The tests analyze serum in blood samples to determine the presence of antibodies (IgG, IgM).  A positive serologic result indicates that an individual has likely produced an immune response to the SARS-CoV-2 virus. A negative serologic result indicates that an individual has not developed detectable antibodies at the time of testing. 

What is FDA’s guideline on Serology? 

Considering that serology tests are less complex than molecular tests and are solely used to identify antibodies to the virus, FDA does not intend to object to the development and distribution by commercial manufacturers or development and use by laboratories of serology tests to identify antibodies to SARS-CoV-2, where  test have been validated, notification is provided to FDA. CELLUM BioMedical is disclosing the following information pertaining serology testing.  

  • This test has not been reviewed by the FDA. 

  • Negative results do not rule out SARS-CoV-2 infection, particularly in those who have been in contact with the virus. Follow-up testing with a molecular diagnostic should be considered to rule out infection in these individuals. 

  • Results from antibody testing should not be used as the sole basis to diagnose or exclude SARS-CoV-2 infection or to inform infection status. 

  • Positive results may be due to past or present infection with non-SARS-CoV-2 coronavirus strains, such as coronavirus HKU1, NL63, OC43, or 229E. 

Validation Data [Coming Soon]

CONTACT US

44045 Margarita Rd, Suite 102

Temecula, CA 92591

1(951) 302-1144

D©2020 by CELLUM BioMedical Inc