As part of our response to the COVID-19 pandemic, the scientific team at FirmaLab laboratories developed the FirmaLab SARS-CoV2 Molecular Assay, a laboratory developed test (LDT).
The FirmaLab SARS-CoV-2 Molecular Assay is a real-time RT-PCR test intended for the presumptive qualitative detection of nucleic acid of SARS-CoV-2 from upper and lower respiratory specimens. PCR (polymerase chain reaction) is a method to analyze a short sequence of DNA (or RNA) even in samples containing only minute quantities of DNA or RNA. PCR is used to reproduce (amplify) selected sections of DNA or RNA. PCR is highly efficient in that untold numbers of copies can be made of the DNA. Moreover, PCR uses the same molecules that nature uses for copying DNA. Positive results are indicative of the presence of SARS-CoV-2 RNA; clinical correlation with patient history and other diagnostic information is necessary to determine patient infection status. Positive results do not rule out a bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease.
By rapidly adding capacity, instrumentation, equipment and staff to meet the unprecedented demand for testing. FirmaLab will have the capacity to do 10,000 tests per day with a 24-hour turnaround time.
FirmaLab serology test identifies the presence of antibodies that indicate that a person had an immune response to COVID-19 (also known as coronavirus or SARS-CoV-2). A positive result of this antibody (IgG) test indicates previous exposure to COVID-19 and the body has developed antibodies. Although It may take up to 14 days after the onset of symptoms for antibodies to be developed within the body, 91% of people develop such antibodies within the first 8-13 days. Some people infected with COVID-19 will never exhibit symptoms but will have a detectable antibody response. While there is a belief that the presence of antibodies may provide immunity to future infections, there is not yet enough data to state this conclusively. These tests can give greater detail into the
prevalence of a disease in a population by identifying the individuals who have developed these antibodies.
As part of our ongoing commitment to bring health surveillance solutions to the market, FirmaLab has secured the latest technology from Abbot Laboratories to detect SARS-CoV2 IgG antibodies with testing capacity for over 60,000 patient samples per month. This FDA authorized testing platform.
This certification indicates that the FDA has reviewed the data submitted on this IgG testing platform and it has met the criteria for use with sensitivity and specificity.
COVID-19 Antibody test cannot confirm the presence of the virus in your system at the present day. It can only tell whether you have been exposed in the past or if you have never been exposed to SARS-CoV-2. Consequently, it should only be used alone as a screening test and should be used in tandem with a genetic-based test to determine a complete status.
Write the patient name, date and time of collection on the specimen container. Place the specimen in the Bio-hazard bag along with your FirmaLab Test Requisition Form.
While serological tests are becoming more widely available, there are important considerations for how serological tests should, and should not, be used. A clear understanding of the limitations of current serological tests is critical for appropriate interpretation of test results. No serologic tests are currently approved by the FDA for diagnosis of COVID-19. Detection of viral RNA remains the preferred test for the diagnosis of active COVID-19 in individual patients. Given our current understanding of COVID-19 serology:
It is important to select a serology test that has been fully validated using plasma or serum from confirmed COVID-19 infected individuals or well-characterized reference samples. For a list of FDA approved tests, see this link: