NovoPro
Cart 2

Novel Coronavirus Antibody, COVID-19 IgM/IgG Rapid Test Kit (CE & ISO Certificated)

Product Code
H100
Categories
Diagnostic Kits
Test Type
Single Test
Kit Principle
Rapid Test
Kit Size
40T/Box
Format
Cassette
SPECIFICATION
Sample Volume: 10μl
Fast Reaction: 15 minutes
For professional use only

Basic information on SARS-CoV-2 IgM/IgG Ab Rapid Test

The SARS-CoV-2 IgM/IgG Ab Rapid Test is a rapid chromatographic immunoassay for the qualitative detection of antibodies IgM and IgG to novel coronavirus-19 in human whole blood, serum and plasma.

This product has been certificated by CE and ISO 13485.

Component of the SARS-CoV-2 IgM/IgG Ab Rapid Test

  • COVID-19 Rapid Test Card, 40pcs/box,
  • Sample buffer, 1 bottle/box,
  • Kit instruction, 1 pc/box
  • 48 boxes/Carton

Intended Use

Used to detect the IgM and IgG antibodies to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in human serum, plasma or whole blood sample qualitatively. It is to be used as an aid in the diagnosis of coronavirus infection disease (COVID-19), which is caused by SARS-CoV-2.

Performance

* Note: Results compared to Molecular testing.

Significance of tesing 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 this SARS-CoV-2 IgM/IgG Ab Rapid Test

  • Take 10-20ul blood sample (serum, full blood or plasma), add into the sample well on the test card
  • Then add 2-3 drops(80-100ul) of sample buffer into the well.
  • Wait for 15-20min, determine the result according to the kit instruction, the result is invalid over 20 minutes..

View the operation video of SARS-CoV-2 IgM/IgG Ab Rapid Test

Operation Video

Interpretation of Results

  • POSITIVE:Two distinct red lines appear. One line should be in the control region (C) and another line should be in the T1 test region (T1),indicating the IgG positive.
  • POSITIVE:Two distinct red lines appear. One line should be in the control region (C) and another line should be in the T2 test region (T2),indicating the IgM positive.
  • POSITIVE:Three distinct red lines appear. One line should be in the control region (C) ,the T1 test region (T1) and the T2 test region (T2), indicating the IgG and IgM positive.
  • NEGATIVE:One red line appears in the control region(C). No red or pink line appears in the test region (T).
  • INVALID:No red lines appear or control line fails to appear, indicating that the operator error or reagent failure. Verify the test procedure and repeat the test with a new testing device.

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 cassettes shall be handled carefully as biolab waste, which shall be treated carefully according to guidelines of CDC/WHO.

Limitations of this SARS-CoV-2 IgM/IgG Ab Rapid Test

  • This reagent is designed for the qualitative screening test. Concentration of SARS-CoV-2 IgM/IgG antibody cannot be determined by this qualitative test. The depth of the T-line color is not necessarily related to the concentration of the antibody in the sample.
  • The results of the reagent are only for clinical reference, which is not the only basis for clinical diagnosis and treatment. A confirmed diagnosis and treatment should only be made by a physician after all clinical and laboratory findings have been evaluated.

ATTENTIONS

  • For IN VITRO diagnostic use only.
  • Reagents should be used as soon as possible after opened. This reagent cannot be reused for disposable.
  • The test device should remain in the sealed pouches until use. If sealing problem happens, do not test. Don’t use after the expiration date.
  • All specimens and reagents should be considered potentially hazardous and handled in the same manner as an infectious agent after use.

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.

BIBLIOGRAPHY

  • Nanshan Chen, Min Zhou, Xuan Dong, et al. (2020). Epidemiological and clinical characteristics of 99 cases of 2019 novel coronavirus pneumonia in Wuhan, China: a descriptive study. The Lancet, 395(10223), 507-513.
  • Chaolin Huang, Yeming, et al. (2020). Clinical features of patients infected with 2019 novel coronavirus in Wuhan, China. The Lancet, 395(10223), 497-506.
  • Chen Wang, Peter W Horby, Frederick G Hayden, George F Gao. (2020). A novel coronavirus outbreak of global health concern. The Lancet, 395(10223), 470-473.
  • Na Zhu, Ph.D., Dingyu Zhang, M.D., Wenling Wang, Ph.D., et al. (2020). A Novel Coronavirus from Patients with Pneumonia in China, 2019. The New England Journal of Medicine.
  • World Health Organization: Clinical management of severe acute respiratory infection when Novel coronavirus (nCoV) infection is suspected: Interim Guidance. 12 January, 2020.