TEMECULA, Calif., June 10, 2020 /PRNewswire/ -- CELLUM BioMedical, a CLIA licensed laboratory and bio technology company, announced today that it will begin offering specimen (RT-PCR) & serological antibody testing for SARS-CoV-2, the virus that causes COVID-19, to hospitals, healthcare organizations and businesses looking to reopen throughout the nation. The company is licensed to perform high complexity assay testing along with COVID-19 testing.
"It is critical to understand that we are not merely offering distribution of serology kits to clinics who may or may not be certified to perform SARS-CoV-2 testing. We are offering a complete testing service that includes both serology and RT -PCR specimen testing. Our service allows physicians to validate serological tests with RT-PCR testing" Dr. Richard Jin., MD., PhD., President of CELLUM BioMedical Inc.
CELLUMS's focus on making COVID-19 testing available was expedited due to the need for clinics and hospitals to reopen in a safe transitional manner.
"During these uncertain times, the ability to have a trusted network to turn to and help you navigate through reopening is something I think every business needs, especially clinics and medical workers such as myself. We are right now getting ramped up to offering again our elective noninvasive and surgical procedures, and I think a main reason we are able to admit patients and offer procedures at this time is due greatly to our COVID-19 testing through CELLUM BioMedical", Dr. Diane Duncan, Medical Director of Plastic Surgery Associates in Ft. Collins, Colorado.
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. According to the FDA and CDC, "Serology tests are solely used to identify antibodies to the virus, and FDA does not intended to object to the development and use by laboratories of serology tests…".The final confirmation of infection with SARS-CoV-2, according to the FDA, must be made through a combination of clinical evaluation and RT-PCR specimen testing. RT-PCR testing is a real-time reverse transcription polymerase chain reaction (RT-PCR) test for the qualitative detection of nucleic acid from SARS-CoV-2 in upper and lower respiratory specimens (such as nasopharyngeal or oropharyngeal swabs) collected from individuals suspected of COVID-19 by their healthcare provider. Positive results are indicative of the presence of SARS-CoV-2 RNA with 99% sensitivity and specificity; clinical correlation with patient history and other diagnostic information is necessary to determine patient infection status. Negative results must be combined with clinical observations, patient history, and epidemiological information.
Beginning Monday (June 9, 2020), CELLUM will be offering three CELLUM COVID-19 Testing & Concierge Service Packages with two Additional Testing Options, where clinics will operate as 'collection sites' of testing under CELLUMS CLIA license.
Silver Package | Combination of Serology & RT-PCR Testing
20 Qty Serology Test [Validated Test]. 5 Qty RT-PCR Tests [Validated Test], FDA & CDC Requirements on Reporting, Diagnose & Result Analysis, Testing Results in 24-48 Hours, On Call Concierge Service [Mon-Fri], Access To Online Backend Open 24/7, 5 Qty Clinical Pak [Return Shipping for Specimen]
Gold Package | Combination of Serology & RT-PCR Testing
40 Qty Serology Test [Validated Test]. 10 Qty RT-PCR Tests [Validated Test], FDA & CDC Requirements on Reporting, Diagnose & Result Analysis, Testing Results in 24-48 Hours, On Call Concierge Service [Mon-Fri], Access To Online Backend Open 24/7, 10 Qty Clinical Pak [Return Shipping for Specimen]
RT-PCR Package | RT-PCR Testing
20 Qty Serology Test [Validated Test]. 5 Qty RT-PCR Tests [Validated Test], FDA & CDC Requirements on Reporting, Diagnose & Result Analysis, Testing Results in 24-48 Hours, On Call Concierge Service [Mon-Fri], Access To Online Backend Open 24/7, 5 Qty Clinical Pak [Return Shipping for Specimen.
In the case of Serology Testing Healthcare providers can collect whole blood specimens and take an initial reading of the serology test, however, tested serology cassettes, both positives and negatives, are to be shipped back to CELLUM for final analysis and reporting. RT-PCR is recommended for serology validation purposes, and for those clinics whom are looking for assurance prior to any treatment or surgery that the patient does not carry COVID-19. CELLUMs' COVID19 testing and concierge services, allow healthcare workers to collect nasopharyngeal specimens from the patient with the provided UTM swab kit and send it for RT-PCR testing and receive the results within 24-48 hours. "Having a regular testing regimen consisting of both serology and specimen tests which are reviewed by a licensed CLIA lab for all staff and patients, along with proper use of PPE offers an invaluable tool to welcome both new and old patients," said Dr. Randy Miller, M.D., F.A.C.S, Medical Director of Miller Plastic Surgery, in Miami, Florida.
"We pride ourselves in our ability to offer this type of concierge support to medical networks, and we thank our partner BENEV Company Inc for their tremendous support in this endeavor," said Dr. Richard Jin, MD., PhD., President of CELLUM BioMedical Inc. We hope that everyone stays safe and healthy and that in time we can all get back to a sense of normal, and until then we will be here for our community, continuing in the fight against COVID-19.
Updates related to CELLUM's COVID-19 response are available on CELLUM BioMedical's website
Healthcare providers can collect whole blood specimens and take an initial reading of the serology test, however, tested serology cassettes, both positives and negatives, are to be shipped back to CELLUM for final diagnostic and reporting.
SOURCE CELLUM BioMedical