Full Name: COVID-19 (SARS-CoV-2) IgM ELISA Kit
Reactivity: Human
Sample Type: Plasma, Serum
Sensitivity: Cut-Off Point



A novel respiratory disease which later was called Coronavirus disease 19 (COVID-19) emerged from the city of Wuhan (China) and this rapidly spread within the country and also throughout the rest of the world. The genetic sequences for this virus displayed similarities to SAR-CoV and many other coronaviruses found in bats. It is made up of several proteins which included; a nucleocapsid (N), spike (S), membrane (M) and an envelope (E). The transmission from one human to another human is through the generation of respiratory droplets via close contacts, coughing and sneezing.

Transmission to humans occurs through the inhalation of aerosols containing infected droplets and is a concern for health in hospitals. Fruit bats (suborder Pteropodiformes) have been implicated in transmitting this virus to humans. The virus is associated with corneal ulcerations, conjunctivitis, another respiratory disease and pneumonia. The molecular diagnostics for this disease are immunohistochemistry, PCR or RT-PCR on nasal swabs or nasal lavage fluids and serology via an ELISA assay.

Symptoms of mild infection are difficulty in breathing, fever, loss of taste, shortness of breath and coughing. For more serious infection this could lead to death, kidney failure and severe acute respiratory syndrome (SARS). Due to the nature of the virus it is extremely critical to use an effective detection procedure for analysing coronavirus. IgM represents the first immunoglobulin that is produced following a response to an antigen and is also predominately present during the early onset period of the disease.


Human COVID-19 (SARS-CoV-2) IgM ELISA kit is ideal for detecting amounts of human IgM antibodies to SARS-CoV-2 (COVID-19 IgM) using serum and plasma samples. Positive results have been shown to correspond to a 100% specificity.


All reagents supplied need to be stored at 2 °C – 8 °C, unopened reagents will retain reactivity until expiration date. Do not use reagents beyond this date.

  • SARS-CoV-2 Antigens Coated Microtiter Strips (IgM).
  • Positive Control (Calibrator C).
  • Cut-Off Standard (Calibrator B).
  • Negative Control (Calibrator A).
  • Enzyme Conjugate.
  • Sample Dilution Buffer.
  • Washing Buffer (20x Conc.).
  • TMB Substrate Solution.
  • Stop Solution.


The minimum detection sensitivity level of human IgM against SARS-CoV-2 (COVID-19-IgM) using this COVID-19 IgM ELISA kit was to a specific cut-off point and a positive result was indicated by a 100% specificity.


– Negative: < 9 U
– Positive: > 11 U
– Cut-Off: 10 U
– Equivocal: 9 – 11 U
– Diagnostic Specificity: 100%
– Cross Reactivity: No significant evidence of false-positive results due to cross-reactions. However, cross reactions with antibodies to Respiratory syncytial virus cannot be excluded.


  1. Delayed specific IgM antibody responses observed among COVID-19 patients with severe progression. Emerg Microbes Infect. (2020) 9 (1): 1096-1101. Shen L., et al.
  2. Serum IgM against SARS-CoV-2 correlates with in-hospital mortality in severe/critical patients with COVID-19 in Wuhan, China. Aging (Albany NY). (2020) 12 (13): 12432-12440. Liu X., et al.
  3. Rapid Detection of IgM Antibodies against the SARS-CoV-2 Virus via Colloidal Gold Nanoparticle-Based Lateral-Flow Assay. ACS Omega. (2020) 5 (21): 12550-12556. Huang C., et al.


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