Can Wondfo® SARSCoV-2 IgM/IgG Rapid Tests Deliver Reliable COVID-19 Diagnosis

Introduction

Rapid diagnostic testing played a major role during the early stages of the COVID-19 pandemic, offering the promise of quick detection and timely isolation. The featured study evaluates the accuracy and clinical usefulness of the Wondfo® SARS-CoV-2 IgM/IgG immunochromatographic assay a widely used rapid test marketed as a fast screening tool. This assessment helps determine whether such rapid kits can truly support public health decisionmaking.

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Understanding the Study: What Was Evaluated?

Researchers analyzed 97 human serum samples across four laboratories in Brazil to evaluate the performance of the Wondfo® lateral-flow test. Results were compared against fluorescence immunoassay (FIA)considered a far more reliable technique for SARS-CoV-2 antibody detection.

Key Findings From the Study

• FIA detected 72 out of 97 (74.22%) antibody-positive samples.
• Wondfo® IC detected only 9 out of 97 (9.3%) positives.
• The rapid test achieved 100% specificity, meaning no false positives.
• However, sensitivity was extremely low at 11.12%, resulting in 88.89% false-negative results.
• These findings indicate a very weak correlation between Wondfo® rapid test results and the reference standard (FIA).

Read the full study at: https://doi.org/10.29328/journal.abb.1001017
A more detailed analysis is also available in our main journal article URL, discussing diagnostic accuracy and laboratory performance.

Clinical Implications: Why Accuracy Matters

Accurate diagnosis is critical for preventing transmission and optimizing treatment strategies. According to the World Health Organization (WHO), reliable testing supports outbreak controlespecially when dealing with a virus that spreads silently among asymptomatic carriers.

Beyond WHO guidance, the Centers for Disease Control and Prevention (CDC) highlights that false-negative results may delay isolation protocols, increase community transmission, and compromise patient management.

The evidence shows that Wondfo® rapid tests should not be used as a standalone diagnostic tool, especially in clinical environments where precision is essential.

Diagnostic Reliability: What External Medical Bodies Suggest

Global organizations emphasize strong test performance:

• The American College of Radiology (ACR) stresses that any diagnostic tool must deliver consistent, validated results to support clinical decisions.
• Similarly, the European Centre for Disease Prevention and Control (ECDC) recommends that rapid serological assays undergo rigorous validation before being used for population screening.

This aligns with the study’s conclusion that Wondfo® IC kits lack sufficient sensitivity for dependable COVID-19 detection.

When Can Rapid Tests Still Be Useful?

Although the Wondfo® test performed poorly as a diagnostic tool, the study suggests limited use cases:

• Epidemiological surveys, where correction factors or large sample sizes may help adjust data.
• Resource-poor settings, where molecular testing is inaccessible though accuracy limitations must be clearly communicated.

Key Takeaways

• Low sensitivity (11.12%) makes Wondfo® unreliable for identifying active or past infection.
• High specificity (100%) indicates no false positives but this alone is not enough for clinical deployment.
• Rapid tests must be validated against gold-standard methods like RT-PCR or FIA.
• External authorities (WHO, CDC, ACR, ECDC) all emphasize the importance of robust diagnostic accuracy.
• The study clearly concludes that Wondfo® IC tests are not suitable for clinical COVID-19 screening.

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