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OUR RESPONSE TO THE COVID -19 PANDEMIC
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).
COVID -19 RT- PCR TESTING MOLECULAR TEST
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 SARS-CoV2 Molecular Assay validation exceeds the minimum recommendation put forth by the FDA guidance and has been determined to be 100% specific and sensitive.
- FACT SHEET FOR HEALTHCARE PROVIDERS Molecular Laboratory Developed Test (LDT) COVID-19 Authorized Tests.
- FACT SHEET FOR PATIENTS Molecular Laboratory Developed Test (LDT) COVID-19 Authorized Tests.
COVID -19 IgG ANTIBODY TEST SEROLOGY TEST
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.
- FACT SHEET FOR HEALTHCARE PROVIDERS SARS-CoV-2 IgG assay - Abbott Laboratories Inc.
- FACT SHEET FOR RECIPIENTS SARS-CoV-2 IgG assay - Abbott Laboratories Inc.
- VALIDATION SUMMARY FOR ALINITY PLATFORM - Abbott Laboratories Inc.
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.
Clinical Significance of Utilizing the PCR (swab) test along with the Antibodies (blood) test
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.
REAL TIME PCR TEST
IgG ANTIBODY TEST
CLINICAL SIGNIFICANCE
NOT DETECTED
NOT DETECTED
PATIENT WAS MOST LIKELY NOT EXPOSED TO SARS-CoV2
DETECTED
NOT DETECTED
PATIENT MAY BE IN EARLY STAGE OF INFECTION
DETECTED
DETECTED
PATIENT MAY BE IN EARLY STAGE OF INFECTION
NOT DETECTED
DETECTED
PATIENT MAY BE IN EARLY STAGE OF INFECTION
FirmaLab Specimen Collection, Handling and Processing Protocol For Samples Collected from Persons Under Investigation (PUI) for COVID- 19 or with Confirmed COVID-19.
Specimen Labeling For PUI or Persons with COVID-19
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.
Oropharyngeal (Throat)
- Take a swab, insert into mouth, and swab the posterior pharynx and tonsillar areas. (Avoid the tongue.)
- Place tip of swab into the viral transport medium tube and cut off the applicator tip.
Nasopharyngeal (Nose)
- Tilt patient’s head back 70 degrees.
- While gently rotating the swab, insert swab into nostril (until resistance is met at turbinates).
- Rotate the swab several times against nasal wall and repeat in other nostril using the same swab. Place in viral transport medium tube and bend and cut off the applicator tip.
COVID-19 Serology Testing: Indications
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:
WHAT SHOULD COVID-19 SEROLOGY TESTING BE USED FOR?
Determine prevalence
Yes
Surveillance studies to determine population-level estimates of exposure to SARS-CoV-2 (i.e., prevalence) in a community, typically through a serologic survey. A positive serology test cannot distinguish between ongoing (active) or past COVID-19 infection.
Identify Convalescent Plasma Donors
Possible
Individuals who have recovered from COVID-19 infection (viral RNA negative) and are COVID-19 serology positive can potentially donate plasma.
Identify false negative PCR
Possible
As an indicator of SARS-CoV-2 infection when viral RNA test is negative. If there is high clinical suspicion for COVID-19 and SARS CoV-2 viral RNA test is negative, a positive serology test would provide support for COVID-19 infection. However, a negative serology result does not exclude COVID-19 infection since it can take 2-3 weeks after symptom onset for antibodies to develop.
Determine prevalence
Possible
Given the limited availability of COVID-19 viral RNA testing, many individuals who had symptoms suggestive of COVID-19 could not be tested at the time. A positive serology test would provide support for a prior COVID-19 infection.
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:
WHAT SHOULD COVID-19 SEROLOGY NOT BE USED FOR?
REAL TIME PCR TEST
IgG ANTIBODY TEST
COVID-19 serology should not be used for the following:
Diagnose COVID
Yes
NO
As the sole basis to diagnose or exclude SARS CoV-2. COVID-19 viral RNA testing is the gold standard for diagnosing COVID-19 infection.
Identify asymptomatic shedders
Yes
NO
To screen for asymptomatic shedders. COVID-19 viral RNA testing is the best method for screening asymptomatic individuals for an unsuspected active COVID-19 infection.
Prior to hospital admission
Yes
NO
To determine if an individual is protected against future COVID-19 infections. It is not known at this time if the antibodies are protective against future COVID-19 infection or how long the antibodies will last.
Prior to high- infectivity risk procedure**
Yes
NO
To guide PPE use or infection control measures. COVID-19 serology testing should not be used to make decisions about the use of personal protective equipment (PPE) or infection control measures. It is not known at this time if the antibodies are protective against future COVID-19 infection or how long the antibodies will last.
COVID-19 Serology Testing Guidelines for Use
YES
Epidemiologic studies to determine the prevalence of COVID-19 in a community (serologic survey)
MAYBE
- Identify potential convalescent plasma donors
- Identify false negative COVID-19 viral RNA results
- Evaluate individuals with prior COVID-19 symptoms who could not be tested at the time they were ill
DO NOT USE COVID-19 SEROLOGY
NO
- Sole basis to diagnose or exclude COVID-19
- Screen for asymptomatic shedders
- Determine COVID-19 immunity
- Guide PPE use or infection control measures
- Return to congregant setting
- Make decisions about employment, i.e. return-to-work, hiring, duty assignment, etc.