The imperative for quality control programs in Monkeypox virus DNA testing by PCR: CIBERINFEC quality control.

Area of Science:

• Clinical Microbiology
• Infectious Diseases
• Molecular Diagnostics

Background:

• Mpox (formerly monkeypox) diagnosis relies on molecular assays, necessitating evaluation of their performance in clinical settings.
• Quality control (QC) is crucial for ensuring the accuracy and reliability of diagnostic tests, especially for emerging viral threats.

Purpose of the Study:

• To assess the performance of molecular diagnostic assays for Mpox and other orthopoxviruses used in Spanish clinical microbiology laboratories.
• To evaluate the concordance of results obtained through a quality control program involving multiple participating centers.

Main Methods:

• A quality control study was conducted with 14 clinical microbiology centers across Spain.
• Participating centers received spiked serum samples and nucleic acid extracts for Mpox and orthopoxvirus detection.
• Laboratories reported results using their routine molecular assays, with data on methods and outcomes collected.

Main Results:

• Seven different commercial assays were utilized, with LightMix Modular Orthopox/Monkeypox (Mpox) Virus (Roche®) being the most common.
• Concordance for Mpox detection ranged from 62.5% to 100% for eluates and 75.0% to 100% for serum.
• False negatives for Orthopoxvirus were reported in serum samples, and false positives for Mpox were observed due to cross-reactivity with Vaccinia virus.

Conclusions:

• The study highlights variability in the performance of molecular Mpox diagnostic assays across different laboratories.
• False results underscore the importance of assay standardization, validation, and continuous quality control in microbiological diagnostics.
• Robust QC measures are essential for accurate diagnosis of emerging infectious diseases like Mpox.