SARS-CoV-2 S1 IgG ELISA Kit [CE-IVD]
(CE Marking: NL-CA002-2020-51026)
This assay has been calibrated with WHO International Standard (NIBSC Code: 20/136).
SUPPLIED REAGENTS AND MATERIALS
- SARS-CoV-2 S1 coated ELISA plate: 12 strips of 8 wells (96 wells in total) in a white strip holder and sealed in a foil bag with desiccant. Each well contains recombinant S1 of SARS-CoV-2. The microwell strips can be used separately. Place unused wells or strips in the provided plastic sealable storage bag together with the desiccant and return to 2-8°C. Once opened, stable for 4 weeks at 2-8°C.
- 5x Assay Buffer: 1 x 20 ml
- 10x Wash Buffer: 1 x 40 ml
- 100x Detection Antibody Solution: 1 x 0.12 ml
- Substrate Solution: 1 x 12 ml
- Stop Solution: 1 x 12 ml
- 10x Standard Solution: 1 x 0.06 ml, 27.2 IU/ml (Humanized anti-S1RBD monoclonal antibody, calibrated with WHO International Standard (NIBSC Code: 20/136) and expressed as International Unit (IU))
SARS-CoV-2 S1 IgG ELISA kit is a highly sensitive and specific enzyme-linked immunosorbent assay (ELISA) for the detection and qualitative measurement of IgG class antibodies against the spike protein S1 of SARS-CoV-2 virus in human blood.
This product is intended for the diagnosis of coronavirus disease 2019 (COVID-19).
This product is intended for use by professional persons only.
In December 2019, a novel coronavirus, now officially named as severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), has been identified in Wuhan China, which caused the outbreak of a coronavirus-associated acute respiratory disease called coronavirus disease 19 (COVID-19). Signs and symptoms of COVID-19 may occur 2 to 14 days after infection, which include fever, cough, shortness of breath or difficulties in breathing, pain in the muscle and tiredness. In severe cases, the infection can further lead to pneumonia, severe acute respiratory syndrome (SARS), kidney failure and death.
The spike protein (S) is an envelope-anchored protein that mediates the recognition and binding of SARS-CoV-2 to host cells. S comprises two functional subunits responsible for binding to the host cell receptor (S1 subunit) and fusion of the viral and cellular membranes (S2 subunit). The distal S1 subunit comprises the receptor-binding domain(s) and contributes to stabilization of the prefusion state of the membrane-anchored S2 subunit that contains the fusion machinery.
ImmunoDiagnostics SARS-CoV-2 S1 IgG ELISA kit is a two-step incubation immunoassay kit. Recombinant spike protein S1 of SARS-CoV-2 pre-coated onto the polystyrene microwell strips can specifically recognize anti-S1 antibodies in human serum or plasma specimen. After a 1-hour incubation, anti-S1 antibodies are captured by immobilized S1 protein while the unbound components are washed away. Afterwards, a detection solution containing HRP-conjugated anti-human IgG is added for another 1-hour incubation, wherein HRP-conjugated anti-human IgG binds to the IgG class antibodies previously bound to S1 protein on the plate. After removal of nonspecific bindings, a 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 signals, which is quantified by an absorbance microplate reader at 450nm. The color intensity is proportional to the amount of anti-S1RBP antibodies captured inside the wells.
STORAGE AND PREPARATION OF TEST SAMPLES
- Test samples are suggested to be assayed immediately after separation of serum or plasma, or preferably stored frozen (-200C or below) in aliquots. Multiple freeze-thaw cycles should be avoided. Duplicate test is recommended.
- Serum or plasma specimens with EDTA, sodium citrate or heparin can be tested. Highly lipaemic, icteric, or hemolytic specimens are not recommended. Specimens with visible microbial contamination should not be used.
- When required, vortex test serum or plasma samples at room temperature to ensure homogeneity. Then centrifuge samples at 10,000 to 15,000 rpm for 5 minutes prior to assay to remove particulates. Please do not omit this centrifugation step if samples are cloudy and containing particles.
STORAGE AND STABILITY
- The kit is stable until the expiry date only when stored at 2-8°C in sealed foil pouches. The expiry date is the last day of the month stated on the foil pouch and kit container.
- The kit should be stored at 2-8°C upon receipt, and all reagents should be equilibrated to room temperature before use. Remove any unused antigen-coated strips from the microplate, return them to the foil pouch and re-seal. Once opened, the strips may be stored at 2-8°C for up to one month. To assure maximum performance, protect the reagents from contamination with microorganism or chemicals during storage.
- Store the cut-off and positive control at 4°C, up to 3 months.