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SARS-CoV-2 Nucleocapsid Protein (NP) IgM ELISA Kit (1 Plate)

$497.00USD


Catalogue No. BEK-1001-1P
Description The SARS-CoV-2 NP IgM ELISA kit is a highly sensitive and specific enzyme-linked immunosorbent assay (ELISA) for the detection and qualitative measurement of IgM class antibodies against the nucleocapsid protein (NP) of SARS-CoV-2 virus (causing Covid-19) in human blood.

The Biosensis SARS-CoV-2 NP IgM ELISA kit is a two-step incubation immunoassay kit. Recombinant nucleocapsid protein (NP) of SARS-CoV-2 pre-coated onto the polystyrene microwell strips can specifically recognize anti-NP antibodies in human serum or plasma specimens. After a 1 hour incubation, anti-NP antibodies are captured by immobilized NP protein while the unbound components are washed away. Afterwards, a detection solution containing HRP-conjugated anti-human IgM is added for another 1 hour incubation, wherein HRP-conjugated anti-human IgM binds to the IgM class antibodies previously bound to NP protein on the plate. After removal of nonspecific bindings, an HRP substrate solution containing 3,3′,5,5′-Tetramethylbenzidine (TMB) is added, resulting in the formation of a blue color. Color reaction is stopped by 2M H2SO4, transforming the blue color to yellow, which is quantified by an absorbance microplate reader at 450 nm. Microplate wells with increased color intensity indicate presence of higher amount of anti-NP antibodies in the tested samples.

This product is intended for use by professional persons only.† For research use only. Not for use in clinical & diagnostic procedures. In line with FDA guidelines, test reports must include the following statements:

(1) This test has not been reviewed by the FDA.
(2) Negative results do not rule out SARS-CoV-2 infection, particularly in those who have been in contact with the virus.
(3) Follow-up testing with a molecular diagnostic should be considered to rule out infection in these individuals.
(4) 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.
(5) Positive results may be due to past or present infection with non-SARS-CoV-2 coronavirus strains, such as coronavirus HKU1, NL63, OC43, or 229E.
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Batch No. Refer to the product label
Unit size 1 x 96 wells (12 strips of 8 wells)
Antigen Nucleocapsid protein (NP) is the most abundant protein on the helical nucleocapsid of coronaviruses, which envelopes the entire genomic RNA. NP also interacts with other viral structural proteins to play important roles during host cell entry and virus particle assembly and release. Anti-NP antibodies have been shown to be the earliest and the most predominant antibodies detectable in patientís blood samples after coronavirus infection.
Other Names Nucleocapsid phosphoprotein [Severe acute respiratory syndrome coronavirus 2]
Accession GenBank: QIV14980.1
Applications Human blood samples, including serum, EDTA-, sodium citrate- and heparin-plasma.
Specificity Clinical validation study of Biosensis SARS-CoV-2 NP IgM ELISA was conducted in 2020 in Shenzhen, China. Samples were collected from COVID-19 confirmed cases with clinical symptoms, laboratory abnormalities or pulmonary imaging manifestations. No tests have been performed on specimens from latent infections or patients in the incubation period. The kit showed higher positive detection rate in specimens from patients with delayed onset. Therefore, the interpretation of the test results should consider the specimenís collection time. It is highly recommended that each laboratory establishes its own normal and pathological reference range for anti-NP IgM level. Furthermore, it is also recommended that each laboratory includes its own panel of control samples in the assay.
Storage Store at 2-8C.
Expiry Date The unopened kit is stable for 6 months from date of receipt when stored at 2-8C. Once opened, store reagents at 2-8C for up to 1 month.
Kit components The ELISA kit box contains 1 x 96-well pre-coated strip plate, blank control sample, detection reagents, wash and sample buffers, substrate buffer and detailed protocols.
Kit protocol Click to download the kit protocolBEK-1001_as_at_April2020.pdf
MSDS Click to download the Material Safety Data SheetBiosensis SARS_CoV-2_ELISA ASSAY MSDS 5-2020.pdf
Images (click to zoom)
SARS-CoV-2 Nucleocapsid Protein (NP) IgM ELISA Kit (1 Plate) Performance Characteristics

PDF Data Sheet

Click to download the data sheet - Click to download the Data Sheet

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