COVID-19 Antibody (IgG/IgM) Test Cassettes


FDA Approved | Emergency Use Authorized (EUA) 

For Professional Use Only

EUA Authorized Covid-19 Antibody Test

COVID-19 Antibody (IgG/IgM) Rapid Test

The COVID-19 IgG/IgM (Whole Blood/Serum/Plasma) Rapid Test Device utilizes lateral flow technology for the qualitative, differential detection of both anti-SARS-CoV-2 IgM and IgG antibodies. In general, antibodies can be detected 1-3 weeks after infection. This test is intended to screen patients for SARS-CoV-2 antibodies.

Coronaviruses are enveloped RNA viruses that are distributed broadly among humans, other mammals and birds that cause respiratory, enteric, hepatic and neurologic diseases. Four viruses – 229E, OC43, NL63 and HKU1 are prevalent and typically cause common cold symptoms in immunocompromised individuals. Three other strains SARS-CoV, MERS-CoV and SARS-CoV-2 (COVID-19) can be transmitted from between non-human vertebrates to humans.

Instructions for Use

  1. Remove the test cassette from the sealed foil pouch and use it as soon as possible.
  2. Lay device on flat surface and add specimen (see specific instructions for each specimen type below):
    1.  For Serum or Plasma Specimen: With the plastic dropper provided, draw serum/plasma specimen to exceed the specimen line, as shown in the diagram below. Hold the dropper vertically and transfer drawn serum/plasma specimen into the sample well (S). Immediately add 2 drops (about 80 μL) of sample buffer to the buffer well (B) ensuring that buffer vial tip does not touch the sample. Avoid air bubbles.
    2. For Whole Blood Specimen: Hold the plastic dropper vertically and transfer 1 drop of whole blood (about 10 μL) to the sample well (S) of the test device. Immediately add 2 drops (about 80 μL) of sample buffer to the buffer well (B) ensuring that buffer vial tip does not touch the sample. Avoid air bubbles.
  3. Wait for the control line (C) to change from blue to a red color. If, after 2 minutes, the sample has not moved across the test window or if blood is still present in the sample well (S), add 1 additional drop of sample buffer to the buffer well (B).
  4. The results should be read in 10 minutes. Do not interpret the result after 15 minutes.
The COVID-19 IgG/IgM (Whole Blood/Serum/Plasma) Rapid Test Instructions
  • Detection Window (IgM): 3-5 days after incubation 

  • Dual band results for simple interpretation

  • Multivariable analysis of immunoglobin IgG & IgM

  • Room temperature storage or refrigerated (2-30⁰C / 36-86⁰F)

  • Procedural internal control included

  • Buffer included

Manufacturer # GCCOV-402A
Manufacturer Healgen Scientific Ltd
Country of Origin Unknown
Application Rapid Test Kit
Contents (25) Sealed Pouches each containing Test Casette, Dropper and a Dessicant, Buffer, Package Insert
Number of Tests 25 Tests
Reading Type Visual Read
Sample Type Whole Blood / Serum / Plasma Sample
Storage Requirements USP Controlled Room Temperature
Test Format Cassette Format
Test Method Lateral Flow Immunochromatographic Assay
Test Name COVID-19 IgG / IgM
Test Type Antibody Test
Time to Results 10 Minute Results
UNSPSC Code 41116205
  • Clinical Evaluation

    • Positive Percent Agreement (PPA): IgG 96.7%; IgM 86.7%; Overall 96.7%

    • Negative  Percent Agreement (NPA): IgG 98.0%; IgM 99.0%; Overall 97.0%

  • Clinical Agreement with Characterized Samples

    • Sensitivity: IgG 96.7%; IgM 100%; Combined 100%​

    • Specificity: IgG 97.5%; IgM 100%; Combined 97.5%​

  • Specimen: Whole Blood, Serum, Plasma

  • Time to Results: 10 minutes

  • Shelf Life: 24 months from the date of manufacture

Can I freeze the device for long-term storage?

The device should never be frozen. If refrigerated, allow the buffer, specimen and device to reach room temperature before use.

What is the significance of the various test results?

IgM negative, IgG negative: Patient not exposed or too early. A medical professional should observe symptoms and epidemiology of patients. Retesting should be considered if symptoms appear or persist.

IgM positive, IgG positive/negative: Acute or recent infection.

IgM negative, IgG positive: Previous, distant infection.

Our Pricing

COVID-19 Antibody  Rapid Test

25 tests per box (Order Min 1 box)

Simple Pricing

$475 per box ($17/test)

Simple Pricing

 $350 per box ($14/test)

Simple Pricing

$300 per box ($12/test)

Professional Rapid Covid-19 Test Kits