COVID-19 IgG ANTIBODY TEST
ZRT’s COVID-19 IgG S1 Spike Antibody Test is a highly specific laboratory-based test for the antibodies your body makes in response to an infection with the SARS-CoV-2 virus, which is responsible for the disease known as COVID-19.
Antibody testing is commonly referred to as “serology” testing (a test done in blood serum collected by a blood draw from a vein). To circumvent the need for a venipuncture blood draw in a clinic or blood draw station, ZRT Laboratory has developed a simple and convenient method that allows blood drops to be collected from the fingertip, deposited onto a filter card, dried, and shipped directly to ZRT Laboratory for testing of COVID-19 antibodies. ZRT has shown excellent concordance of COVID 19 IgG antibodies from serum collected by venipuncture and by fingerstick capillary dried blood spots (DBS) (see our peer-reviewed paper in the journal Future Science - Bioanalysis). The advantage of DBS is that the sample can be collected with health care professional assistance and shipped directly to ZRT Laboratory.
ZRT Laboratory’s COVID-19 IgG S1 Spike Antibody Test assesses IgG antibodies against the S1 subunit of the SARS-CoV-2 spike protein which includes the receptor binding domain (RBD). The S1 subunit of the spike protein allows the virus to attach to the host cell receptor.
- People who have recently had an infection with SARS-CoV-2 (COVID-19) that was confirmed by PCR (molecular) nasal/mouth swab testing and have had no symptoms for at least 7 days
- People who have recently had a flu-like respiratory illness that may or may not have been COVID-19 because it was not confirmed by virus testing, and have had no symptoms for at least 7 days
- People who want to see if they might have been exposed to COVID-19 and carry antibodies to the SARS-CoV-2 virus, but have had few or no symptoms
Note: Patients with an active respiratory infection should not test until at least 20 days after the start of symptoms. During early infection when symptoms are present, the immune system may not be making anti-COVID-19 IgG antibodies in sufficient quantity to be detected by the test.
There are many serology (antibody) tests currently on the market. Some point-of-care (POC) lateral flow cassette IgM/IgG tests are showing lower sensitivity and specificity than is required for population studies. While lateral flow cassettes are fast, convenient, and can use finger stick blood samples, they produce an unacceptable number of false positives and false negatives for population studies. Serum/plasma testing for COVID-19 antibodies using enzyme linked immunosorbent (ELISA) or chemiluminescent assays has high sensitivity and specificity and allows for simultaneous testing of positive and negative controls run in concert with the patient samples.
An ideal solution for antibody testing combines the simplicity of finger stick blood collection with the high sensitivity and specificity of ELISA to detect a prior COVID-19 infection, which may indicate immunity to future infections. The COVID-19 IgG S1 Spike Antibody Test offered by ZRT is exceptionally sensitive and specific for SARS-CoV-2 IgG antibodies against the viral S1 spike protein. ZRT is a CLIA-certified high complexity testing facility with >17 years’ experience working with dried blood spot, and the COVID-19 IgG S1 Spike Antibody Test was stringently validated in-house.
ZRT Laboratory has submitted the COVID-19 IgG S1 Spike Antibody Test for FDA Emergency Use Authorization (EUA).
ZRT has had extensive expertise in finger stick dried blood spot analysis for over 15 years. The advantages are:
- Easy to collect – see our sample collection instructions and videos
- Safe – finger stick DBS collection has been safely performed for decades
- Stable – there are no requirements for freezing or refrigerating samples for transportation, as DBS samples being tested for COVID-19 IgG antibodies are stable for at-least 30 days across all expected shipping temperatures
- Sample is visible – unlike molecular (PCR) testing using nasal or mouth swabs, which has shown to have high false negative rates due to improperly collected samples, it is very easy to see blood on filter paper and determine the quality of collection
- Easy to ship – according to the CDC, DBS are exempt human specimens for shipping purposes
- Low viral risk for sample handlers – most viruses are not viable once dried, making DBS safer to work with than liquid whole blood or serum, or respiratory or fecal samples. Live virus doesn’t last more than 24 hours on cardboard, resulting in minimal risk to mail carriers and specimen receivers
Test results are reported as:
- Positive – you have likely been exposed to the SARS-CoV-2 virus and your body has developed antibodies in response to the infection, whether or not you experienced symptoms or were sick with COVID-19
- Negative – the test did not detect antibodies to the SARS-CoV-2 virus, suggesting that you likely have not been exposed to the virus; however, a negative result does not absolutely rule out exposure
- Indeterminate – you may carry antibodies, but they were not present in sufficient quantity to be detected as a strong positive result on the test. Retesting in 2 weeks may help differentiate an indeterminate result from a true positive or negative.
- ZRT tests many other analytes in blood spot to help you understand your overall health and wellbeing. Hormonal imbalances (estradiol, progesterone, testosterone, cortisol), essential mineral deficiencies (iodine, selenium, zinc, magnesium), vitamin D deficiency, and imbalances in cardiometabolic markers of insulin resistance (insulin, hemoglobin A1c, triglycerides) are all showing a strong link to susceptibility to COVID-19 and disease outcome, including risk for death. Imbalances in these markers are emerging as important risk factors for worse outcomes with COVID-19 infection.
FDA Required disclaimer
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- This test has not been FDA cleared or approved
- 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 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