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ERBA Diagnostics Mannheim
ErbaLisa COVID-19 IgM

ErbaLisa COVID-19 IgM

Product catalog summary

Overview: Erba Mannheim and Calbiotech have developed an automation-friendly COVID-19 ELISA for IgM antibody assessment. The assay is designed for comprehensive and accurate detection using proven technology.

Specifications:

CE-marked Enzyme Immunoassay (ELISA) kit for detecting IgM antibodies to SARS-CoV-2 in human serum.
Number of tests: 96
Principle: Indirect ELISA using recombinant Spike (S) subunit and Nucleocapsid (N) antigens.
Tracer: HRP-Labelled Anti-human IgM
Assay format: Semi-quantitative
Total incubation time: 50 minutes
Sample type: Serum
Sample volume: 10 μL
Sample Size: 100 μL (1:21 Dilution)
Reading wavelength: 450nm
Storage: 2-8ºC

Performance:

Diagnostic sensitivity: 100.0%
Diagnostic specificity: 90.0%
No interference with Haemoglobin, Bilirubin, Biotin, or IgG.
Intra-assay precision CV: 8.10%
Inter-assay precision CV: 8.22%

Convenience Features:

Ready to use reagents
Removable strips and break-apart wells
All incubation steps at room temperature
Interchangeable reagents
Calibrator and Controls included
Ready for automation
1:21 sample dilution validated on microwell plate

Validation: Conducted in the USA with 30 serum samples from RT-PCR confirmed COVID-19 patients and 50 samples from healthy individuals collected before the outbreak. Results showed 30 confirmed positive and 45 confirmed negative.

Limitations: Negative results do not rule out SARS-CoV-2 infection, especially in those exposed to the virus. Antibody testing results should not be the sole basis for diagnosing or excluding SARS-CoV-2 infection.

Manufacturing: Developed and manufactured in the U.S.A.

Catalog excerpts

ErbaLisa covid-19 igM CE-marked Enzyme Immunoassay (ELISA) kit for the detection of IgM antibodies to SARS-CoV-2 in human serum. Erba Mannheim and Calbiotech have developed a reliable and automation-friendly COVID-19 ELISA, allowing for comprehensive and accurate IgM antibody assessment. Our solid phase assay uses proven technology, and total incubation time is 50 min at room temperature with a simple one step serum dilution. ErbaLisa COVID-19 assays are built for superior performance and reliable interpretation of results. Negative results do not rule out SARS-CoV-2 infection, particularly in those who have been in contact with the virus. Results from antibody testing should not be used as the sole basis to diagnose or exclude SARS-CoV-2 infection or to inform infection status.

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*Prices are pre-tax. They exclude delivery charges and customs duties and do not include additional charges for installation or activation options. Prices are indicative only and may vary by country, with changes to the cost of raw materials and exchange rates.

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