Description

Product Overview

The COVID‑19 IgM/IgG Antibody Test Kit is designed for detection of immune response antibodies against SARS‑CoV‑2. This assay helps in infection screening, epidemiological surveillance and post‑infection immune response evaluation.

Intended Use

For in vitro qualitative detection of IgM and IgG antibodies to novel coronavirus (SARS‑CoV‑2) in human blood samples as an aid in diagnosis and clinical assessment of COVID‑19 infection.

Clinical Significance

Supports infection screening, immune status evaluation, serological surveillance and laboratory confirmation in combination with nucleic acid testing.

Test Principle

Fluorescence immunoassay where recombinant viral antigens bind specific antibodies present in sample forming immune complexes detected by analyzer.

Sample Type

Whole Blood / Serum / Plasma

Test Time

Approximately 10 minutes

Technology

Fluorescence Immunoassay

Compatible Analyzers

GETEIN 1100
GETEIN 1160

Applications

Hospitals, diagnostic laboratories, infectious disease screening programs and epidemiological monitoring studies.