Now Available

Coronavirus
Testing

Why Antibody Testing?

The primary application of antibody testing, also known as serology testing, is the identification of individuals who have previously been infected with SARS-CoV-2. This knowledge can be used to guide epidemiology and seroprevalence studies, as well as facilitate contact tracing. Some individuals infected with the virus never experienced any major symptoms, which makes antibody testing one of the only methods capable of identifying asymptomatic cases.

Additionally, testing provides valuable information on the body’s immune response to the disease in people with different medical histories and conditions. These statistics can aid clinicians and researchers in vaccine development.

Coronavirus Disease (COVID-19) Antibody Testing
Overview
  • Whole blood, plasma, or serum sample
  • Test results will be reported as positive, negative, or indeterminate
  • The option to retest if indeterminate is available
TAT
Results are typically available within 1-2 days of your sample being received by the lab
Performance Measure Estimate Performance
Sensitivity (PPA) 97.1%
Sensitivity (NPA) 87.5%
Test Description

The Fulgent COVID-19 IgM/IgG DR Test is a solid phase immunochromatographic assay for the rapid, qualitative, and differential detection of human IgG and IgM antibodies against SARS-Cov-2 from whole blood, plasma, or serum samples.

The presence of these antibodies is indicative of an adaptive immune response to COVID-19, indicating recent or prior infection. The test uses anti-human IgM and IgG antibodies immobilized on separate nitrocellulose membrane strips to capture and detect antibodies against COVID-19 antigens. IgM antibodies are produced during the early phase of infection (first few days), whereas IgG antibodies are typically detectable during the active, late, and recovery phase of infection (7-10 days post-infection). Fulgent’s Antibody Test screens for both markers to maximize the detection of antibodies against SARS-CoV-2.

* This test has not been cleared or approved by the FDA. Fulgent’s laboratory is regulated under CLIA and is qualified to perform high-complexity testing for investigational or research purposes. This test should not be used as a diagnostic test. Since systematic and technical factors can affect the accuracy of testing, the results of testing should always be interpreted in the context of clinical and familial data.

Sample Types & Limitations

Sample Type
  • Human whole blood, plasma, or serum
  • Purple top EDTA tubes or Yellow top ACD tubes
Please see “how to order” for instructions on sample preparation and ordering processes.
Limitations

This test is only valid for the detection of the anti-SARS-CoV-2 IgM&IgG antibody. Efforts have been made in the design of this test to minimize the chances of a false positive result due to the presence of other infectious agents, but this cannot be ruled out. False negative results may occur if the antibody is not present in the tested specimen or is present at a very low level.


How to Order

If you require a sample collection kit, please contact us at clientservices@fulgentgenetics.com.

PLEASE NOTE: Orders may only be placed by physicians and medical institutions
Instructions for Submitting

Whole Blood, Plasma, or Serum Samples

ORDER FORM
Download and complete the appropriate Test Requisition Form (TRF)
Sample Requirements:
  • 3-4 mL whole blood, plasma, or serum specimens (Purple top EDTA tubes or Yellow top ACD tubes)
  • Express delivery is recommended such that the sample arrives at Fulgent within 24-48 hours from collection.
    • Specimens must be stored at 2-8°C prior to shipping.
    • Whole blood specimens can be sent at ambient temperature if shipped overnight, but cold packs are recommended.
    • Serum and plasma samples must be shipped with a cold pack.
  • Specimens must be labeled with two patient identifiers.
  • Specimens must be placed in a biohazard bag.
  • All specimens must be accompanied by a completed TRF (insert into outer pocket of specimen bags).
Send Completed TRF and Collected Sample to:

Fulgent Genetics
4978 Santa Anita Ave
Temple City, CA 91780


More about the Coronavirus

For more information on COVID-19, visit the CDC’s website and/or WHO’s website.
DOWNLOAD OUR COVID-19 RT-PCR & ANTIBODY INFORMATION FLYER