BioPerfectus has been actively supporting global efforts in mpox testing and control, delivering real-time PCR kits to key health organizations, including Africa CDC, the African Union, and ASLM. Our monkeypox PCR kits have undergone evaluation, consistently proving their performance across multiple assessments:
✅WHO Assessment: The BioPerfectus Monkeypox Real-Time PCR Kit demonstrated exceptional sensitivity in WHO comparison studies, reliably detecting both Clade I and Clade II monkeypox virus DNA with sensitivity as low as 5 ge/rxn (Cq = 36).
✅Clinical Validation in France: At the Institute of Biomedical Research of the Armed Forces (IRBA) in France, our Monkeypox Virus Real-Time PCR Kit underwent comprehensive clinical validation. The results confirmed that our kit not only meets the required sensitivity and specificity standards for PCR laboratories. The inclusion of validated positive and negative controls further ensures that laboratories can trust the accuracy of their results.
✅Clinical Evaluation in the USA: In a clinical evaluation conducted at XYZ Laboratory, a CAP-accredited, CLIA-certified high-complexity clinical molecular diagnostic lab in Austin, Texas, the BioPerfectus Monkeypox Virus (MPXV) Fast Real Time PCR Kit stood out for its high sensitivity, rapid turnaround, and user-friendly design, including two target genes to prevent potential future mutations, ensuring a more accurate diagnosis of monkeypox. The kit achieved an impressive 97.43% Positive Percentage of Agreement (PPA) and 100% Negative Percentage of Agreement (NPA), reinforcing its reliability in clinical settings.
If you need more information about the evaluation report, don't hesitate to email us at marketing_global@bioperfectus.com.