GEN-CHECK SARS –COVID-19 IgG/IgM RAPID TEST CASSETTE (Whole. Blood/Serum/Plasma) CE

           

GEN-CHECK™ SARS –COVID-19 IgG/IgM RAPID TEST CASSETTE (Whole. Blood/Serum/Plasma)

This novel coronavirus disease COVID-19 IgM Rapid Test Kit is based on double sandwich lateral flow immunoassay to detect total antibody of SARS-COV-2. It can be used as an aiding tool for RT-PCR testing. Clinical diagnosis shall be done according to the doctor.

Component of COVID-19 Total Antibody Rapid Test Kit

  • COVID-19 Total Antibody Rapid Test Card, 25pcs,
  • Sample buffer, 5ml, 2pcs
  • Disposable micropipette tips, 25pcs,
  • Kit instruction, 1 pc

Significance of Testing IgG/IgM in blood/serum/plasma

  • IgM is an antiody produced in the beginning of infection, which indicates an early stage of the disease
  • IgG is produced after a period of infection, which indicates the infection is ongoing or was infected.
  • Combination of IgG/IgM indicates the infection is ongoing
  • Clinical diagnosis shall be determined by RT-PCR/CT scanning.

How to use COVID-19 Total Antibody Rapid Test Kit

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.

The picture below describes the use of this kit:

COVID-19 IgM Rapid Test Kit

Precautions on the handling of sample and lab waste

  • This kit does not contain any contagious materials, it is safe to ship/use under normal situation.
  • All samples are contagious, please handle carefully according to local regulations, or following the guidelines of your local CDC or WHO.
  • Used test cards shall be handled carefully as biolab waste, which shall be treated carefully according to guidelines of CDC/WHO.

Limitations of this COVID-19 Total Antibody Rapid Test Kit

This kit is used as aiding tool for the testing of COVID-19, which shall be used in combination with RT-PCR/CT scanning. The results shall be determined by professionals. It is not a home use test. Before licensed by CDC, this kit can only used as research tool, which can not be used in clinical diagnosis of COVID-19.

Background of novel coronavirus and COVID-19

Coronaviruses (CoV) are a large family of viruses that cause illness, ranging from the common cold to more severe diseases such as Middle East Respiratory Syndrome (MERS-CoV) and Severe Acute Respiratory Syndrome (SARS-CoV). A novel coronavirus (nCoV, also known as SARS-CoV-2) is a new strain that has not been previously identified in humans. The disease caused by this novel coronavirus is then named Coronavirus Disease 2019(COVID-19) by WHO. 

Standard recommendations to prevent infection spread include regular hand washing, covering mouth and nose when coughing and sneezing, thoroughly cooking meat and eggs. Avoid close contact with anyone showing symptoms of respiratory illness such as coughing and sneezing.

More information can be found on WHO website, CDC website.