Coronavirus Disease 2019 (COVID-19) Rapid Serology Testing:
SYNOPSIS: Phamatech COVID-19 Antibody Rapid Test (also known as serologic test)
On March 16, 2020 the FDA updated its Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency. The updates include guidance that allows for serological tests that identify antibodies (e.g., IgM, IgG) to SARS- CoV-2 from clinical specimens, like Phamatech COVID-19 IgG/IgM Rapid Test, to be used in laboratories or by healthcare workers.
In the beginning of April, Dr. Anthony Fauci, a leading national expert on many domestic and global health issues, and particularly on COVID-19 pandemic, announced on CNN that “within a week or so, we are going to have a relatively large number of tests” to determine if recovered COVID-19 patients, including those who never showed symptoms, have evidence of immunity. Antibody tests (serologic test) examine the blood for the presence of antibodies, proteins produced by the immune system in response to infection. If present, that person has had a prior exposure to SARS-CoV-2 which is important, especially since many infections are mild or asymptomatic in severity. Among federal and state administration, there is a discussion whether results of this testing could be used to issue “certificates of immunity” that would allow return to normal life.
Phamatech COVID-19 IgG/IgM Rapid Test Information:
This test has been submitted for FDA Emergency Use Authorization. It has not been reviewed yet, but it is permitted for distribution and use under the public health emergency guidance issued by the FDA on March 16 (as above-mentioned).
This is a 10-minute point-of-care qualitative test that can detect antibodies in blood to confirm current or past exposure to COVID-19, the infection caused by the SARS-CoV-2 coronavirus.
The test detects immunoglobulin M and G (IgM and IgG) antibodies that are produced by the body in response to coronavirus infection. These antibodies are typically present in the middle to later stages of COVID-19 infection, but may remain present after exposure, which helps to determine who has been exposed to the coronavirus, even if a person didn't exhibit any symptoms of the COVID-19 disease.
This test has been used in California by other labs during the COVID-19 outbreak.
The test is simple and quick to complete. A few drops of blood, collected with a lancet from a finger prick, are transferred to a test cartridge, followed by two to three drops of a buffer. The results can be read in 15 minutes, similar to how over-the-counter pregnancy tests show multiple lines for positive results and a single line for negative (Control line) results.
FREQUENTLY ASKED QUESTIONS:
- 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 (nasal or throat swab) 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, cross reacting with antibodies for other viruses not tested for.
- This test is not for the screening of donated blood
- This test is for professional use.
- Confirmed COVID-19 infection and a negative antibody test: the nasal or throat swab test (diagnostic test), which directly detects the virus - was positive, while antibody test (serologic test) several weeks later is negative. Q: How does this make any sense? A: Either the test was wrong (either the test was done too early, or inherited quality of the test – what is called False Negative/or Relative Sensitivity) or the patient failed to develop protective immunity. The clinical performance of Phamatech COVID-19 IgG/IgM Rapid Test was evaluated in patients with confirmed COVID-19 infection. The study yielded 96.9% Relative Sensitivity
- Suspected COVID-19 infection and a positive antibody test: a patient had a mild cold-like symptoms (or no symptoms) a while ago and his antibody test returns positive. It should be noted that Phamatech COVID-19 IgG/IgM Rapid Test was also evaluated in patients with confirmed COVID-19 infection for Relative Specificity yielding 96.3%, which means that 96.3% are true positive for COVID-19 infection. The remaining 3.7% who would have positive serology – antibodies, are incorrectly identified as test positive (false positives) due to cross-reactivity with non-SARS-CoV-2 coronavirus strains.
- It should be clear, that while preliminary data is promising, recovery from the infection does not guarantee immunity. Furthermore, if true immunity develops, it is unclear how long it will last.
Common Scenarios in Interpretation of Serologic Testing:
All test results are presumptive and should be confirmed by clinical observation and/or by approved diagnostic testing.
- this is a general-population study for individuals who either previously sought medical care for COVID-19-like symptoms and tested negative in a diagnostic (nasal throat swab) test or had none or mild common-cold like symptoms without any prior testing.
- An additional group of eligible individuals would include those who tested positive for COVID-19 in a diagnostic (nasal throat swab) test. For COVID-19 positive patients, please note, in the early days of the infection, the immune response is still being developed and antibodies may not be detectable, so only individuals who have been symptoms-free for at least 14 days are eligible to be tested.
- Therefore, if you have recently been diagnosed with COVID-19 or have been having active common-cold like symptoms for less than two weeks, please do not do antibody - serologic test as your chances to have False Negative results are higher. It takes time to develop antibodies. Instead, please do a diagnostic (nasal throat swab) test first. Only when you are symptoms free for at least two weeks or more, come back and we will be happy to assist and to do antibody-serologic testing.
Key Scientific Considerations:
- At this time, there is a preliminary evidence that antibodies to SARS-CoV-2, the coronavirus that causes COVID-19 disease, will prevent reinfection. Several small-size group studies have shown that antibodies from donors who had recovered from COVID-19 infection were able to neutralize, or prevent reinfection, with SARS-CoV-2. Nonetheless, we do not yet know if all COVID-19 patients are able to mount effective immunity and prevent reinfection.
- There are reports of COVID-19 patients who recovered completely, and then developed new symptoms and tested positive for the virus a second time. It is not clear if this results from a reinfection (new infection) or if they had an unexplained reactivation, and relapse of previously infected state. It’s also possible that some of the tests have had false positive results, meaning that the test was positive, but the patient did not have COVID-19 infection.
- Another important question with COVID-19 immunity is how long it will last and whether the presence of antibodies prevents reinfection. While some other virus strains causing common cold show declining immunity weeks after infection, SARS-CoV, the causative agent of the 2003 SARS pandemic, is genetically more similar to SARS-CoV-2 and shows a more reassuring immunity data. The longer immunity duration can provide enough time to protect individuals until development and distribution of a vaccine.
- Immune testing for COVID-19 is valuable. It can help to understand the extent of the virus’s transmission in the population and true occurrence of SARS-CoV-2 infection across a population (prevalence). In addition, this data can help to answer questions about the true severity of the disease and its mortality rate.
- It can also help to identify individuals who are still vulnerable to the infection. How prevalent disease transmission is from people without symptoms may change and ease shelter-in-place restrictions.
- We are using a qualitative test that gives a YES/NO result for the presence of antibodies.
- The test is not faultless. It is 96.9% “sensitive,” meaning almost 97% of people who were infected with COVID-19 and have antibodies will test positive while remaining 3% will not. It has 96.3% “specificity,” which means that about 96% of tested individuals with positive antibodies have truly serologic evidence for the past COVID-19 infection.
- The reality is that many questions about COVID-19 right now don't have an answer. We're trying to figure it out.
PATIENT INFORMATION & CONSENT:
Occupation: Mobile Phone:
Previously diagnosed with COVID-19. Yes / No
Previous exposure to other individuals diagnosed as COVID-19 positive. Yes / No
Previous recent cold or flu-like symptoms (in 2020). Yes / No - If YES, when?
The patient reports that they do not have a fever.
The patient reports that they do not have a new or worsening cough or shortness of breath.
The patient reports that they do not have any cold or flu-like symptoms.
The patient reports that they do not have any change of smell or taste.
The patient reports that they do not have any new onset of diarrhea.
During your visit you are tested for COVID-19 antibodies/seropositivity. Results from this SARS-CoV-2 IgG/IgM Rapid Test should not be used as the sole basis for diagnosis. At this time, it is unknown for how long IgM or IgG antibodies may persist following infection and if seropositive state can prevent recurrent COVID-19 re-infection and protect you from re-infection if exposed to COVID -19 positive individuals.
Our Medical Office does not provide clinical observation and/or diagnostic (nasal-throat swab) testing. After Testing with Phamatech COVID-19 IgG/IgM Rapid Test today you are solely responsible to follow up with your health care provider or any type of medical facility for any clinical determination, additional testing and treatment if required.
The results will be reviewed by our medical staff and we will contact you with the results of your coronavirus test in 1-2 hours.
Patient acknowledged understanding of instructions as stated.
You should continue home quarantine, social distancing, interventions to decreased spread of disease, as instructed by your County, State or Federal medical officials and administration. The patient has been told, if there are any new symptoms please contact their Primary Care Provider or call 911 if medical emergency.
IMPORTANT NOTE!!! The test you had today is a first step for diagnosis of past coronavirus infection or for diagnosis of ongoing asymptomatic coronavirus infection. In case you are tested positive - You are STRONGLY advised to seek follow-up treatment or additional diagnostic testing offered by your regular medical provider (MD or NP). Such care may be important for your health safety.
Signature/Printed Name Date