COVID-19 Antibody

Rapid Test

COVID-19 “CORONAVIRUS”
IGG/IGM RAPID TEST KIT

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.

Our easy-to-use COVID-19 test kit provides results in just 10 minutes

Cost-Effective
Fast
Accurate

Features

  • FDA Authorized (EUA)1
  • Rapid results within 10 minutes
  • Small sample sizes
  • Sold in packs of 25
  • Following the incubation period, IgM may appear in blood within 3-5 days. IgG will appear as soon as 1-2 weeks.
  • Shelf life of up to 24 months from manufacture date
  • Forensic / Medical Professional Use Only2
  • Tests should be conducted by a licensed phlebotomist or a medical
    professional
  • Test to be performed in a CLIA moderate- or high-complexity setting3

1 These tests are authorized by the FDA for emergency use as of May 29, 2020. Forensic/medical professional only: Tests should be conducted by a licensed phlebotomist or a medical professional.
2 Forensic/medical professional use only: Tests should be conducted by a licensed phlebotomist or a medical professional. Verification of use case prior to shipping is mandatory. Verification of use case prior to shipping is mandatory.
3 Please defer to your local regulations.

HOW ACCURATE IS THE CORONAVIRUS
(COVID-19) RAPID TEST?

Our test has shown in clinical evaluation to have a total agreement of 97.19% and a kappa value of 0.94.

  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):
    • a. 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.
    • b. 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.
Cat No.GCCOV-402a (CE)
Package Unit25 Tests/Kit
DescriptionCOVID-19 IgG/IgM Rapid Test
FormatCassette
SpecimenWhole Blood /Serum/Plasma