人 IgM、SARS-CoV-2 核衣壳蛋白 (NP) EL

人 IgM、SARS-CoV-2 核衣壳蛋白 (NP) ELISA 测定详细如下：
Product 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 H-₂SO₄, 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.

• Application(s) ELISA
• Application Details ELISA. For the detection of SARS-CoV-2 Nucleocapsid protein, Human IgM (NP) in Serum, Plasma (Citrate), Plasma (EDTA), Plasma (Heparin). Please download the detailed product insert for complete instructions for the successful use of this ELISA. Use only as directed.
  
  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.
• Target SARS-CoV-2 Nucleocapsid protein, Human IgM (NP)
• 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 specimen s 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.
• Target Host Species Human
• Species Reactivity Human
• Sample Type Plasma (Citrate), Plasma (EDTA), Plasma (Heparin), Serum
• Detection Method Colorimetric
• Kit Components The ELISA kit box contains 96-well pre-coated strip plate(s), blank control sample, detection reagents, wash and sample buffers, substrate buffer and detailed protocols.
• Storage Instructions 2-8°C. Product ships on ice packs and is stable from ambient to refrigerated temperatures for 1 week.
• Storage Temperature 2-8°C
• Batch Number Please see item label.
• Expiration Date The unopened kit is stable for 6 months from date of receipt when stored at 2-8°C. Once opened, store reagents at 2-8°C for up to 1 month.