Antibody Test for COVID
Results in 10 Minutes

For businesses, organizations, nursing homes, small clinics, schools, and more.

Why is Antibody Testing for COVID Important?

Our antibody test for COVID determines if someone was previously exposed to the virus or has had a past infection. For organizations large and small, regularly monitoring this status for individuals provides the science-based knowledge necessary to make informed decisions.
On-site results are ready in 10 minutes. 

COVID-19 Instant Antibody Test Kits to Determine Past Infection

  • FDA Emergency Use Authorization (EUA)
  • Determines presence of IgM and IgG antibodies, indicating a past COVID infection or past exposure to the virus
  • This test does not determine if a person is currently infected with COVID
  • Fast results in just 10 minutes
  • Small blood sample required
  • Sold in packs of 25
  • Shelf life of up to 24 months from manufacture date
  • Test to be performed in a CLIA moderate- or high-complexity setting *

This test has been authorized only for the presence of IgM and IgG antibodies against SARS-CoV-2, and not for any other viruses or pathogens.

This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b) (1) of the Act, 21 U.S.C. $360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.

* The FDA has only granted this test emergency use authorization in a CLIA moderate- or high-complexity setting. Please refer to your local regulations, and download the FDA Fact Sheet: Antibody Test Oversight and Use For COVID-19.

To request more information about our Rapid Coronavirus (Covid-19) test kit, complete the form and submit it to DDC. One of our COVID experts will contact you as soon as possible to discuss your options.

Symptoms of COVID-19

Symptoms of COVID-19 can vary from mild to severe; those infected may present all or a combination of the most common symptoms below, although it is also possible to have COVID-19 with no symptoms at all. The typical symptoms of COVID-19 are present in other illnesses as well, which is why testing is essential. 

  • Cough
  • Fever or chills
  • Shortness of breath or difficulty breathing
  • Muscle or body aches
  • Sore throat
  • New loss of taste or smell
  • Diarrhea
  • Headache
  • Fatigue
  • Nausea or vomiting
  • Congestion or runny nose

Is a Fever Always a Symptom of COVID-19?

Many places of business, events, and venues have adopted the practice of checking people for fever before they are allowed to enter. Although this is a wise strategy, it is not foolproof. According to medical authorities, it is possible to not exhibit a fever at all with coronavirus infection. Only testing can help to definitively identify or rule out an infection.

DDC Offers Two Lab-Based Tests that Determine Current COVID Infection

  1. Learn about the DDC PCR COVID-19 saliva test to determine active infection
  2. Learn about the DDC PCR COVID-19 swab test to determine active infection

COVID-19 IgG/IgM Rapid Test Cassette

The Novel Coronavirus testing kit, manufactured by Healgen Scientific LLC and distributed by DDC, is conducted by using whole blood/serum/plasma and placing it in the center well of the cassette and then adding two drops of the buffer to the buffer well labeled “B.” Results should appear within 10 minutes and are invalid after 15 minutes. 

Product Facts:

  • Following the incubation period, IgM may appear in blood within 3-5 days. IgG will appear as soon as 1-2 weeks.
  • Sample: Test can work with whole blood, plasma and serum samples.
  • Storage: The kit can be stored at room temperature or refrigerated (2-30°C).
  • Shelf Life: Up to 24 months from manufacture date

More detailed results of ongoing clinical evaluations and test stability report for this coronavirus test kit are available upon request.

Clinical Evaluation Results

Study 1: Healgen Clinical Agreement Validation

The clinical performance of the COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) was evaluated by testing a total of 191 plasma (K2EDTA) clinical samples—90 positive samples and 101 negative samples) from individual patients exhibiting pneumonia, respiratory symptoms and fever etc. Testing was performed at two sites in China from January to mid-March 2020. COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) results for IgM and IgG detection were compared to the results of RT-PCR assays for SARS-CoV-2 from oropharyngeal swabs (Site #1) and sputum (Site #2). At Site #1, 61 retrospective specimens and 4 prospective specimens were included in the study. At Site #2, 95 retrospective specimens and 31 prospective specimens were included in the study. The time from RT-PCR result to collection of specimens (plasma) ranged from 15-45 days (Site #1) and 0-38 days (Site #2). The time from collection of specimens (plasma) from each individual to testing ranged from 12-23 days (Site #1) and 3-29 days (Site #2). Overall study results are shown in below (Table 1).

IgG:

Positive Percent agreement (PPA): 96.7% (87/90) (95%CI: 90.7%~98.9%) Negative Percent agreement (NPA): 98.0% (99/101) (95%CI: 93.1%~99.5%)

IgM:

Positive Percent agreement (PPA): 86.7% (78/90) (95%CI: 78.1%~92.2%) Negative Percent agreement (NPA): 99.0% (100/101) (95%CI: 94.6%~99.8%)

Overall (either IgG+ or IgM+):

Positive Percent agreement (PPA): 96.7% (87/90) (95%CI: 90.7%~98.9%) Negative Percent agreement (NPA): 97.0% (98/101) (95%CI: 91.6%~99.0%)

Study 2: Independent Clinical Agreement Validation

The test was validated against a panel of previously frozen samples consisting of 30 SARS-CoV-2 antibody-positive serum samples and 80 antibody-negative serum and plasma samples. Each of the 30 antibody-positive samples were confirmed with a nucleic acid amplification test (NAAT) and both IgM and IgG antibodies were confirmed to be present in all 30 samples. The presence of antibodies in the samples was confirmed by several orthogonal methods prior to testing with the COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma). The presence of IgM and IgG antibodies specifically was confirmed by one or more comparator methods. Antibody-positive samples were selected at different antibody titers.

All antibody-negative samples were collected prior to 2020 and include: i) Seventy (70) samples selected without regard to clinical status, “Negatives” and ii) Ten (10) samples selected from banked serum from HIV+ patients, “HIV+”. Testing was performed by one operator using one lot of the COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma). Confidence intervals for sensitivity and specificity were calculated per a score method described in CLSI EP12-A2 (2008).

For evaluation of cross-reactivity with HIV+, it was evaluated whether an increased false positive rate among antibody-negative samples with HIV was statistically higher than the false positive rate among antibody-negative samples without HIV (for this, a confidence interval for the difference in false positive rates was calculated per a score method described by Altman). The results and data analysis are shown in the tables below.

COVID-19 IgG/IgM Rapid Test Cassette

Instructions for use

  1. Remove the test cassette from the sealed foil pouch and use it as soon as possible. Best results will be obtained if the assay is performed within one hour.
  2. Place the test device on a clean and level surface.
  3. (For Whole Blood Specimen): Hold the 5 μL mini plastic dropper vertically and transfer 1 drop of whole blood (about 10 μL) to the specimen well(S) of the test device, then add 2 drops (about 80 μL) of sample buffer to the buffer well (B) immediately. Avoid air bubbles.(For Serum or Plasma Specimens): With a 5 μL mini plastic dropper provided, draw serum/plasma specimen to exceed the specimen line as showed in the following image and then transfer drawn serum/plasma specimen into the sample well (S). Then add 2 drops (about 80 μL) of sample buffer to the buffer well (B) immediately. Avoid air bubbles.
  4. Wait for the colored line(s) to appear. After 2 minutes, if the red color has not moved across the test window or if blood is still present in the specimen well (S), add 1 additional drop of the sample buffer to the buffer well (B).
  5. The result should be read in 10 minutes. Positive results may be visible as soon as 2 minutes. Do not interpret the result after 15 minutes.

Interpretation of Results:

Negative:

The colored line in the control line region (C) changes from blue to red. No line appears in the test line regions M or G. The result is negative.

IgM Positive:

The colored line in the control line region (C) changes from blue to red, and a colored line appears in test line region M. The test result indicates the presence of IgM anti-SARS-Cov-2 antibodies.

IgG Positive:

The colored line in the control line region (C) changes from blue to red, and a colored line appears in test line region G. The test result indicates the presence of IgG anti-SARS-CoV-2 antibodies

IgG and IgM Positive:

The colored line in the control line region (C) changes from blue to red, and two colored lines appear in test line regions M and G. The test results indicate the presence of IgM and IgG anti-SARS-CoV-2 antibodies.

Invalid:

Control line is partially red, and fails to completely change from blue to red. Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for control line failure. Review the procedure and repeat the test with a new test cassette. If the problem persists, discontinue using the test kit immediately and contact DDC.

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Fairfield, OH 45014

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