Immupass — SARS-CoV-2-NP-IgG

Enzyme immunoassay for the detection of IgG to SARS-CoV-2 coronavirus nucleocapsid antigen

Microplate, Conjugate concentrate, Positive control, Negative control, Washing solution concentrate, Specimen diluent, Conjugate diluent, TMB Substrate, Stop-reagent, Plate sealer, Instruction for use.

CONTEINS:

On customer request kit can additionally be supplied with vials for reagent preparation and pipette tips.

CONFIGURATIONS AVAILABLE:

h X Description
Т1-26G01, Т1-26G01С* 192 (including controls) 1 stripplate, 12 test runs: 12×8 wells
Т1-26G02, Т1-26G02С* 192 (including controls) 2 stripplates, 12 test runs: 12×16 wells
Т1-26G05, Т1-26G05С* 480 (including controls) 5 stripplates, 15 test runs: 15×32 wells

* strips with breakable wells

We have also avaliable in production Immupass -SARS-CoV-2-NP-IgM and Immupass- SARS-COV-2 (IgG+IgM).

INTENDED USE:

Immupass-SARS-CoV-2-NP-IgG is an in vitro qualitative enzyme immunoassay for detection of IgG to SARS-CoV-2 nucleocapsid antigen human serum and plasma.

PRINCIPLE OF THE PROCEDURE:

Immupass-SARS-CoV-2-NP-IgG is an indirect ELISA.

When human plasma/serum is placed into well anti-SARS-CoV-2 IgG are bond to the immobilized recombinant SARS-CoV-2 nucleocapsid antigen forming antigen-antibody complexes. Such complexes are further detected with HRP conjugated monoclonal anti- human IgG antibodies. Unbound components are removed by washing and TMB substrate is added into wells. The enzymatic reaction is stopped by the stop-reagent adding and the optical density

(OD) is read at 450/620 nm. The colour intensity is defined by amount of anti-SARS-CoV-2 IgG.

WARNING: The assay is for in vitro diagnostic use by a laboratory professional and shall not be sold to general public. The assay can be performed using standard ELISA equipment.

STORAGE AND STABILITY: Store the kit at 2-8°C. Do not freeze. The kit shelf life is 14 months.

REAGENT PREPARATION:

Bring all reagents and specimens to room temperature (18-25°C) before use.

SAMPLE: Human serum or plasma.

SAMPLE VOLUME: 30 µl.

ASSAY DURATION: 2 hours.

LIMITATIONS OF THE ASSAY:

The false-negatives could be in the early stages of infection during the seroconversion window (1-6 days of disease), when the antibodies are absent or their concentrations are below the assay sensitivity limit. In this case, in the presence of clinical symptoms, it is recommended to re-examine the patient`s follow-up sample in a few days.

SHIPPING:

The kit should be shipped at 2-8°C. Do not freeze. It is allowed the transportation at 9- 25°С for 10 days.

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