ELISA IgM test for SARS-CoV2

The SARS-CoV-2 IgM ELISA kit is an in vitro diagnostic test for the qualitative detection of IgM antibodies to SARS-CoV-2 in human serum.

The kit is intended for use as an aid in identifying individuals with an adaptive immune response to SARSCoV-2, indicating recent or prior infection.

At this time, it is unknown for how long antibodies persist following infection and if the presence of antibodies confers protective immunity.

The SARS-CoV-2 IgM ELISA KIT should not be used to diagnose acute SARS‑CoV‑2 infection. Results are for the detection of IgM SARS-CoV-2 antibodies.

IgM antibodies to SARS-CoV-2 are generally detectable in the blood several days after initial infection, although the duration of time antibodies are present post-infection is not well characterized. Individuals may have a detectable virus present for several weeks following seroconversion.

The sensitivity of SARSARS-CoV-2 IgM ELISA early after infection is unknown. Negative results do not preclude acute SARS-CoV-2 infection. If the acute infection is suspected, direct testing for SARS-CoV-2 is necessary.

False positive results for SARS-CoV-2 IgM ELISA may occur due to cross-reactivity from pre-existing antibodies or other possible causes.

MADE IN ITALY

Kit content

  • SARS-CoV-2 Antigen Coated Microtiter Plate: 1×96 well

Strip holder in a resealable foil pouch, containing 96 polystyrene microtiter wells coated with SARS-CoV-2 antigen in each well.

  • Sample dilution Buffer (DIL): 2×15,5 mL

Sample Dilution Buffer will be used for the dilution of test samples and controls. Phosphate buffer pH 7.40, NaCl, KCl, Proclin 300, Interference masking agent

  • 100X Secondary Conjugate Ab: 12 mL

Horseradish peroxidase-labeled secondary antibody. Phosphate buffer pH 7.40, NaCl, KCl, Proclin 300.

  • Secondary Ab dilution Buffer: 1×12 mL

Phosphate buffer pH 7.40, NaCl, KCl, Proclin 300 Stable at 2-8°C until the expiration date.

  • 5X Wash Buffer (WS): 1×100 mL

5X concentrated buffer. Phosphate buffer pH 7.40, NaCl, KCl, Tween 20, Proclin 300

  • TMB Substrate: 1×12 mL

TMB chromogenic substrate. 3,3,5,5′-Tetramethylbenzidine.

  • Stop Solution: 1×12 mL

Stop Solution. Sulfuric Acid 1 – 4%

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