The COVID-19 swab test is for the qualitative detection of nucleic acid from SARS-CoV-2 in upper and lower respiratory specimens.
Results are for the identification of SARS-CoV-2 RNA. The SARS-CoV-2 RNA is generally detectable in respiratory specimens during the acute phase of infection. 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 bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease. Laboratories within the United States and its territories are required to report all positive results to the appropriate public health authorities. The COVID-19 RT-PCR is only for use under the Food and Drug Administration’s Emergency Use Authorization.
It is a convenient method and highly specific test to detect the presence of SARS-CoV-2. Our At-Home Self-Collection kit is shipped directly to the comfort of your home and will contain everything needed for you to collect a nasal swab sample. The test is run at Access, a CLIA accredited and CAP accredited High Complexity laboratory. The ACCESS COVID-19 SELF-COLLECTION KIT is authorized by the FDA under the Emergency Use Authorization.
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. Previously, amplification of DNA involved cloning the segments of interest into vectors for expression in bacteria, and took weeks. But now, with PCR done in test tubes, it takes only a few hours. 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.
The RT-PCR,DNA test determines if the individual is infected with SARS-CoV-2 and considered to be able to transmit the disease (a positive test) or is negative for the virus. This test cannot tell whether a person is immune from past infection or has yet to be exposed and is still in danger.
The IgG & IgM antibodies test is based on the quantitative detection of IgM and IgG that are specifically generated by the body in response to SARS-CoV-2 infection. This can be used to determine recent & past exposure.
Researchers said having the IgG antibodies gives you protection from the virus -- but it doesn’t mean you’re immune for the rest of your life. You could get sick again. Still, they’re calling the test a milestone towards getting life back to normal.
Antibody tests for COVID-19 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.
|COVID-19 Real Time TR-qPCR(swab)||IgM Antibody (blood)||IgG Antibody (blood)||Clinical Significance|
|Not Detected||Not Detected||Not Detected||Patient was most likely not exposed to SAR-CoV-2|
|Detected||Not Detected||Not Detected||Patient may be in window period of infection|
|Detected||Detected||Not Detected||Patient may be in early stage of infection|
|Detected||Not Detected||Detected||Patient may be in later or recurrent stage of infection|
|Detected||Detected||Detected||Patient is in active stage of infection|
|Not Detected||Detected||Detected||Patient may be in the reovery stage of infection|
|Not Detected||Detected||Not Detected||Patient may be in early stage of infection|
|Not Detected||Not Detected||Detected||Patient may have had past infection, recovered and possibly immune|
You simply go to accessmedlab.com/selfcollection and select “At-Home Self-Collection”. Access prioritizes to First Responders and Healthcare workers. If you qualify after taking our clinical survey, you will be able to purchase the test and it will ship out the same day if placed by 5pm EST. After you perform the sample collection, simply drop the kit off at a UPS drop box or UPS store & we will receive it the next morning. Results will be delivered by a HIPAA encrypted email within 24hrs. If you are Positive, you will have access to an AML Health Physician via a Tele-health session at no charge.
Our PCR swab testing is performed in our CLIA High Complexity specialty lab on dedicated, automated instrumentation which is authorized by the FDA under the Emergency Use Authorization.
Clinical Sensitivity: 100%
Clinical Specificity: 95%