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COVID -19 RT- PCR TESTING MOLECULAR TEST
The UDX 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. UDX will have the capacity to do 10,000 tests per day with a 24-hour turnaround time.
- UDX 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.
- UDX LISTING ON FDA WEBSITE AS EUA AUTHORIZED
COVID -19 IgG ANTIBODY TEST SEROLOGY TEST
UDX 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, UDX 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 received Emergency Use Authorization by the FDA.
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 RECOVERY /RECOVERD STAGE OF INFECTION |
UDX 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 UDX 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.
https://www.fda.gov/medical-devices/emergency-situations-medical-devices/eua-authorized-serology-test-performance
What should COVID-19 serology NOT be used for?
- COVID-19 TEST Viral RNA: Yes
- COVID-19 TEST Serology: No
- COVID-19 serology should not be used for the following:
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.
- COVID-19 TEST Viral RNA: Yes
- COVID-19 TEST Serology: No
- COVID-19 serology should not be used for the following:
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.
- COVID-19 TEST Viral RNA: Yes
- COVID-19 TEST Serology: No
- COVID-19 serology should not be used for the following:
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.
- COVID-19 TEST Viral RNA: Yes
- COVID-19 TEST Serology: No
- COVID-19 serology should not be used for the following:
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 TEST Viral RNA: Yes
- COVID-19 TEST Serology: No
- COVID-19 serology should not be used for the following:
To determine return to congregant setting. COVID-19 viral RNA testing should be used to determine if the individual has an active COVID-19 infection.
- COVID-19 TEST Viral RNA: Yes
- COVID-19 TEST Serology: No
- COVID-19 serology should not be used for the following:
- Unknown if antibodies are protective against future COVID-19 infection
- Unknown how long antibodies will last
- Cross-reactivity can lead to false-positive results, meaning the individual may not have COVID-19 antibodies even though the serology test is positive
- The likelihood that the individual has COVID-19 antibodies depends on the serology test used and the prevalence of COVID-19 in their community, e.g. in a population with a 5% prevalence of SARS CoV-2 infection, a serologic test with 95% sensitivity and 95% specificity will have 50% positive predictive value (i.e. only 50% of individuals who test positive will actually have or have had COVID-19)
- COVID-19 TEST Viral RNA: Yes
- COVID-19 TEST Serology: No
- COVID-19 serology should not be used for the following:
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.
- COVID-19 TEST Viral RNA: Yes
- COVID-19 TEST Serology: No
- COVID-19 serology should not be used for the following:
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.
- COVID-19 TEST Viral RNA: Yes
- COVID-19 TEST Serology: No
- COVID-19 serology should not be used for the following:
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.
- COVID-19 TEST Viral RNA: Yes
- COVID-19 TEST Serology: No
- COVID-19 serology should not be used for the following:
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 TEST Viral RNA: Yes
- COVID-19 TEST Serology: No
- COVID-19 serology should not be used for the following:
To determine return to congregant setting. COVID-19 viral RNA testing should be used to determine if the individual has an active COVID-19 infection.
- COVID-19 TEST Viral RNA: Yes
- COVID-19 TEST Serology: No
- COVID-19 serology should not be used for the following:
- Unknown if antibodies are protective against future COVID-19 infection
- Unknown how long antibodies will last
- Cross-reactivity can lead to false-positive results, meaning the individual may not have COVID-19 antibodies even though the serology test is positive
- The likelihood that the individual has COVID-19 antibodies depends on the serology test used and the prevalence of COVID-19 in their community, e.g. in a population with a 5% prevalence of SARS CoV-2 infection, a serologic test with 95% sensitivity and 95% specificity will have 50% positive predictive value (i.e. only 50% of individuals who test positive will actually have or have had COVID-19)
| COVID-19 TEST Viral RNA | COVID-19 TEST Serology | 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. |
Return to
congregant
setting | Yes | NO | To determine return to congregant setting. COVID-19 viral RNA
testing should be used to determine if the individual has an active
COVID-19 infection. |
Return-to-Work | Yes | NO | To make decisions about employment. COVID-19 serology testing should not be used to make decisions about return-to-work, hiring, duty assignment, etc.
- Unknown if antibodies are protective against future COVID-19 infection
- Unknown how long antibodies will last
- Cross-reactivity can lead to false-positive results, meaning the individual may not have COVID-19 antibodies even though the serology test is positive
- The likelihood that the individual has COVID-19 antibodies depends on the serology test used and the prevalence of COVID-19 in their community, e.g. in a population with a 5% prevalence of SARS CoV-2 infection, a serologic test with 95% sensitivity and 95% specificity will have 50% positive predictive value (i.e. only 50% of individuals who test positive will actually have or have had COVID-19) |
| COVID-19 Serology Testing Guidelines for Use | |
|---|---|
Yes |
|
Maybe |
|
| DO NOT USE COVID-19 SEROLOGY | |
|---|---|
No |
|
Precise Diagnostic Solutions
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- 870 Vine St, Los Angeles, CA 90038
- +1(800) 799-7248
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