The assay kit is to qualitatively detect antibodies specifically against SARS-CoV-2 virus proteins in human blood, in the format of enzyme-linked immunosorbent assay (ELISA) that can be applied to plate reader systems in standard hospitals.

The incubation immunoassay kit was made by pre-coating recombinant nucleocapsid protein (NP) of SARS-CoV-2 onto the polystyrene microwell strips. The sensitivity and specificity for detecting SARS-CoV-2 virus infection is 94.59 % and 95.24% respectively.

SARS-CoV-2 NP Ab ELISA kit is an enzyme-linked immunosorbent assay (ELISA) for the qualitative detection of total antibodies against the recombinant nucleocapsid protein (NP) of SARS-CoV-2 virus in serum or plasma samples from individuals with signs and symptoms of infection who are suspected of COVID-19.

Results are for the identification of antibodies against the recombinant nucleocapsid protein (NP) of SARS-CoV-2 virus. The anti-NP antibodies is generally detectable in plasma or serum samples during and even after the phase of SARS-CoV-2 virus infection.

Samples with positive results should be retested in duplicate using SARS-CoV-2 NP Ab ELISA kit before data interpretation. Only repeatable positive results in the same sample can be finally considered as the successful detection of total antibodies to NP of SARS-CoV-2 and can be used as serological indications of COVID-19 currently or in the past. Laboratories within the United States and its territories are required to report all positive results to the appropriate public health authorities.

Negative results do not preclude 2019-nCoV infection and should not be used as the sole basis for patient management decisions. Negative results must be combined with clinical observations, patient history, and epidemiological information.

The SARS-CoV-2 NP Ab ELISA kit is intended for use by trained clinical laboratory personnel specifically instructed and trained in the techniques of ELISA and in vitro diagnostic procedures. The SARS-CoV-2 NP Ab ELISA kit is only for use under the Food and Drug Administration’s Emergency Use Authorization.


  • FactSheet Fact Sheet for Healthcare Providers
  • Fact Sheet Fact Sheet for Patients

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