Table of Contents

1. Introduction
2. What is the IgG/IgM Combo Rapid Test Used For?
3. Mechanism of Action
4. Clinical Parameters and Numerical Analysis
5. Company Solutions
6. References

Introduction

The IgG/IgM Combo Rapid Test is a point-of-care immunoassay designed for the qualitative detection of Immunoglobulin G (IgG) and Immunoglobulin M (IgM) antibodies against specific pathogens in human specimens. This test is crucial in identifying acute and past infections, particularly for diseases where serology is a reliable marker.

What is the IgG/IgM Combo Rapid Test Used For?

The IgG/IgM Combo Rapid Test is primarily used for diagnosing infectious diseases such as COVID-19, Dengue, and Zika. It helps in determining the phase of infection—whether it’s a recent or past infection. By detecting IgM antibodies, the test identifies recent infections, while the presence of IgG antibodies signifies past exposure or infection.

Mechanism of Action

This lateral flow chromatographic immunoassay employs a colloidal gold-conjugated antigen and a series of capture antibodies to facilitate the binding of plasma or serum antibodies. The test results are typically available within 10-15 minutes, making it a convenient option for rapid screening.

Understanding Antibody Detection

IgM antibodies are usually the first to respond to an infection, making them important markers for early diagnosis. IgG antibodies, conversely, persist longer in the bloodstream and can indicate prior exposure, immunity, or later stages of infection.

Clinical Parameters and Numerical Analysis

Clinical validation studies have shown that the IgG/IgM Combo Rapid Test can achieve a sensitivity of approximately 88-94% and a specificity of around 95-98% for specific pathogens, depending on the disease and population tested. The predictive values, both positive and negative, are influenced by the prevalence of the disease in the test population.

Performance Metrics

• Sensitivity: 88-94%
• Specificity: 95-98%
• Time to Results: 10-15 minutes
• Sample Type: Serum, Plasma, or Whole Blood

Company Solutions

Several diagnostic companies offer IgG/IgM Combo Rapid Test kits tailored for different pathogens. Companies such as Abbott, Roche Diagnostics, and Cellex have developed reliable solutions that are widely used in clinical and point-of-care settings. These companies ensure that their test kits comply with regulatory standards and provide necessary certification for usage worldwide.

Key Industry Players

• Abbott: Offers a range of serological tests that are authorized for emergency use and provide high reliability and precision.
• Roche Diagnostics: Known for their Elecsys Anti-SARS-CoV-2 assays, which offer high sensitivity and specificity.
• Cellex: Was among the first to receive Emergency Use Authorization from the FDA for their rapid test kits during the COVID-19 pandemic.

References

• World Health Organization. (2020). Laboratory testing for coronavirus disease (COVID-19) in suspected human cases.
• Centers for Disease Control and Prevention. (2020). Interim Guidelines for COVID-19 Antibody Testing.
• Public Health England. (2020). Guidance on SARS-CoV-2 IgG/IgM Rapid Tests.
• Abbott Laboratories. (2021). Serology Test Performance Data.