COVID-19 IgM and IgG antibody Rapid Test
Over 6 million tests currently available
Over 6 million currently available
When Speed and Precision are Essential
Our lateral flow immuno-assays rapid test provides a much easier and faster way to determine previous exposure to the virus that causes COVID-19. Unlike other antibody tests, our test does not require extensive laboratory operations and can be performed on site, under the supervision of a health care professional, consistent with the terms of our FDA Authorization for these tests (download FDA EUA letter of authorization here) .
Orders under 100,000 shipped next day from either our Pennsylvania or Nevada facilities.
Our organization strictly adheres to FDA policies and regulations covering the sale of diagnostic testing supplies for COVID-19. While personal protective equipment (PPE) may be purchased without restriction, our FDA EUA authorization indicates that these tests are intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection. Emergency use of this test is limited to authorized laboratories.
Always verify FDA Authorization Status Before Purchasing COVID-19 Testing Supplies. You may verify the current status of our products (and any other manufacturer’s products on the FDA website: FDA Listing for In Vitro Diagnostics EUA’s)
News and Research Updates
Corroboration of the Accuracy of the Biohit SARS-CoV-2 IgM/IgG LFA test kitThe human immune response to a COV/0-19 infection encompasses the host synthesis of anti-SARS-CoV-2 lgM antibodies that are detectable after about 5 to 7 days of infection which, in turn, is...
COVID-19 Testing and Detection: How It Works [Transcript of Video] Dr. Frederick Schaffer Explains COVID-19 Testing and Detection Hello, I'm Dr. Fred Schaffer, and I'm a board-certified allergist immunologist and a former university associate professor. We're here...
qby Frederick M. Schaffer, M.D., Paul V. Holland, M.D. and James D. Strader, D.C. Introduction: COVID-19 cases have been documented in over 188 countries. Unfortunately, many high risk patients develop significant morbidity which in turn may result in death. Both...
A Comparison of The Biohit SARS-CoV-2 LFA IgM/IgG Antibody assay and the RT-qPCR and Antigen Assays for detecting SARS-CoV-2 Virus
There are 3 common forms of detecting SARS-CoV-2 virus infection in patients. Specifically, real- time PCR (RT-qPCR), Rapid Antibody Laminar Flow Immuno-Assays (LFA) and viral Antigen Assays.
1. RT-qPCR assay– in this assay viral RNA is acquired via nasal swabs and after RNA extraction, the RNA undergoes reverse transcription to yield complementary DNA (cDNA). Then the cDNA is amplified (i.e. copied) millions of times to derive enough cDNA to analyze. This method requires a sophisticated lab, expensive equipment, and well-trained lab technicians. Its procedure (once RNA is extracted) takes up to 4 hours to run; however, with sample back logs in some areas, reporting results take a week or longer. Test sensitivity (an association of positive test results with patients who accurately have disease) is initially good. Up to 30% of these assays may produce false negative results because of early collection/processing of samples and poor adherence of virus to the nasal swabs and/or the techniques (pre-RT-qPCR) utilized (1). The graph below shows the forms of testing vs. time since onset of symptoms (please note that symptom onset occurs on average 5 days after virus exposure/acquisition), as depicted below the viral load rapidly diminishes to very low levels by 8 to 9 days after symptom onset (or 13 to 14 days after the virus infection began).
In fact, because of the resultant lower RT-qPCR (and Antigen Assay) test sensitivity, the FDA recommends that for samples collected after 8 days of symptoms, that the additional use of an antibody assay would significantly increase detection test sensitivity (2). The benefits of combined testing were also evident in studies promulgated by Zhao and colleagues and Xie et al. (3,4). Specifically, Zhao and colleagues showed that for the period of 1 to 7 days post symptom onset (pso) the results of combined antibody and RT-qPCR assays yielded a combined sensitivity of 78.7% in comparison to a sole RT-qPCR assay sensitivity of 66.7% (3). Furthermore, for the period of 8 to 14 days pso the combined sensitivity was 97 % compared to a sole RT-qPCR sensitivity of 54%. In a similar manner, Xie et al. demonstrated that combined assay detection sensitivity was more than 3 fold increased in comparison to the results of a RT-qPCR assay alone (4). Similar improvement in detection accuracy and sensitivity is evident in the results of combining an antibody assay with RT-qPCR as published by Wang (5). Wang demonstrated that PCR positive detection occurred in 89% of COVID-19 patients tested during day 0 to 10 pso, in 20% of patients tested from day 11 to 20 pso and in 8% of patients tested more than 20 days pso. This decreasing positive response is most likely due to decreasing viral loads with time and concomitant decreasing test sensitivities. When calculating in the results of antibody assays, Wang reported that the total RT-qPCR sensitivity of 92.2% for all periods studied plus the Antibody assay sensitivity of 95.7% for all periods yielded a combined sensitivity of 98.6% sensitivity. In a similar manner Guo et al. demonstrated that by combining the results of IgM and RT-qPCR assays, the positive detection rate was significantly increased to 98.6% from 51.9% if one relied on a single RT-qPCR assessment only (6). Thus, the clinical utilization of 2 different testing assays would significantly improve testing sensitivity and accuracy.
2. Biohit SARS-CoV-2 LFA IgM/IgG Antibody assay– this assay can demonstrate the presence of anti-SARS-CoV-2 IgM and IgG antibodies within 15 minutes. It is a low cost, rapid, simple and a point of care assay that is one of the few authorized after extensive testing by the FDA ( 7 ). In addition, it demonstrates excellent test detection sensitivity and specificity as demonstrated by the FDA, a corroborative study from Yale University and the antibody kit manufacturers ( please see table below).2. The Biohit SARS-CoV-2 LFA IgM/IgG Antibody assay- this assay can demonstrate the presence of anti-SARS-CoV-2 IgM and IgG antibodies within 15 minutes. It is a low cost, rapid, simple and a point of care assay that is one of the few authorized after extensive testing by the FDA ( 7 ). In addition, it demonstrates excellent test detection sensitivity and specificity as demonstrated by the FDA, a corroborative study from Yale University and the antibody kit manufacturers ( please see table below). The authors of the Yale study contrasted their study results with that of one completed by the University of California at San Francisco (UCSF) in which 10 alternative LFA antibody assays were assessed ( 8 ). The Yale study authors point out that the Biohit test IgM and IgG sensitivities were better than the comparable best performing assays in the UCSF study ( 9 ).
IgM detection, as detected by a laminar flow immunoassay (LFA) kit is detectable as early as 5 days pso. IgG is detectable shortly after IgM (see above graph). Of note, both IgM and IgG assays have high sensitivities throughout the time period specified for assay use (post 8 days pso) for combined testing as per the FDA to improve testing sensitivity and accuracy.
3. Antigen Assays- These tests detect specific viral protein antigens; however, unlike PCR methods, no amplification step is incorporated. Therefore, Antigen tests are very specific for the virus, but are not as sensitive as molecular PCR tests. This means that positive results from antigen tests are highly accurate, but there is a higher chance of false negatives, so negative results do not rule out infection. With this in mind, negative results from an antigen test may need to be confirmed with a PCR test prior to making treatment decisions or to prevent the possible spread of the virus due to a false negative result. Antigen assays usually provide results within 7 days pso (see above graph) which is a shorter diagnostic time span than RT-qPCR. In addition, as the viral load falls so does viral protein content which contributes to the lower Antigen assay sensitivities over time (see graph above). 3. Antigen Assays- These tests detect specific viral protein antigens; however, unlike PCR methods, no amplification step is incorporated. Therefore, Antigen tests are very specific for the virus, but are not as sensitive as molecular PCR tests. This means that positive results from antigen tests are highly accurate, but there is a higher chance of false negatives, so negative results do not rule out infection. With this in mind, negative results from an antigen test may need to be confirmed with a PCR test prior to making treatment decisions or to prevent the possible spread of the virus due to a false negative result. Antigen assays usually provide results within 7 days pso (see above graph) which is a shorter diagnostic time span than RT-qPCR. In addition, as the viral load falls so does viral protein content which contributes to the lower Antigen assay sensitivities over time (see graph above). Antigen tests are very specific for the virus, but are not as sensitive as molecular PCR tests. This means that positive results from antigen tests are highly accurate, but there is a higher chance of false negatives, so negative results do not rule out infection (10). The Quidel Sofia SARS Antigen FIA is a FDA authorized Antigen Assay kit whose instructions contain the following statement, ” Negative results, from patients with symptom onset beyond five days, should be treated as presumptive and confirmation with a molecular assay, if necessary, for patient management, may be performed. Negative results do not rule out COVID-19 and should not be used as the sole basis for treatment or patient management decisions, including infection control decisions. Negative results should be considered in the context of a patient’s recent exposures, history and the presence of clinical signs and symptoms consistent with COVID-19 (11).”
Reinvigorating Society, One Test at a Time
For rapid point of care assays, the Biohit SARS-CoV-2 LFA IgM/IgG Antibody assay is FDA authorized, cost effective, reliable, simple to use and results are displayed within 15 minutes. This assay has definite positive roles in confirming testing results (e.g. combined testing with RT-qPCR) particularly after 8 days post onset of disease symptoms, to assess previous presence of SARS-CoV-2 virus in patients with a possible asymptomatic or questionable history, and to play a role in the screening selection of putative convalescent plasma donors.
The Biohit SARS-CoV-2 LFA IgM/IgG Antibody assay is less expensive than RT-qPCR or Antigen testing and unlike Antigen and RT-qPCR assays, its effective detection spans from 5 days after symptom onset to several months after disease recovery.
How The COVID-19 Antibody Rapid Test Works
The One-Step SARS-CoV2 (COVID-19) IgG and IgM Antibody Rapid Test is a lateral flow immunochromatographic assay. This means that the test is easy to administer and does not require a lab, and can provide a positive, negative, or invalid result in a matter of minutes.
The test works by washing a sample of blood or serum (liquid part of blood) over a nitrocellulose strip that the antibodies can bind to. If the IgM and/or IgG antibodies are present, a burgundy-colored band(s) will appear. A colored line appearing in the control region (C) is an internal procedural control and confirms sufficient specimen volume as well as correct procedural technique. Absence of a colored band in the test region indicates a negative test result, while a complete absence of bands in the control line indicates that the test is invalid. For more detailed information, visit our FAQs.
Interpretation of Results:
POSITIVE: A test is positive when the control line and at least one test line appear on the test screen. The appearance of T1 test line indicates the presence of COVID-19 specific IgM antibodies, while the appearance of T2 test line indicates the presence of COVID-19 specific IgG antibodies. If both T1 and T2 lines appear, it indicates the presence of both COVID-19 specific IgG and IgM antibodies. The lower the antibody concentration is, the weaker the result line is*.
*The intensity of the color in the test line regions may vary depending on the concentration of SARSCoV-2 antibodies present in the specimen. Therefore, any shade of color in the test line region should be considered positive.
NEGATIVE: A test is negative if one colored line appears in the control region, while no apparent colored line(s) appear in the test line region.
INVALID: A test is considered invalid when the control line fails to appear. Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for control line failure. If this happens, review the procedure and repeat the test with a new test device. If the problem persists, discontinue using the test kit immediately and contact your local distributor.
QUALITY CONTROL: A colored line appearing in the control region (C) is an internal procedural control. It confirms sufficient specimen volume and correct procedural technique.
We have been using Avriogenetics biohit Covid 19 rapid antibody test for a few months. We have found it to be accurate, sensitive and specific. This test can be used to assess IGM and IGG status on suspected patients. It can be used to assess recent exposure and allows rapid screening in a cost effective manner. This is not a replacement or in lieu of the PCR test. PCR testing has its place in the testing suspected Covid 19 patients. With this rapid test we have been able to screen large populations and we are very happy with the test. Sam Najmabadi M.D.
Accurate, Reliable COVID-19 Testing at Scale is Within Reach
Flexible order volumes and shipping terms available.