Abstract
Abstract Background Enabling labs to rapidly respond to unexpected healthcare challenges is the kind of situations for which the BD MAX™ open system reagent suite is designed. Therefore, after the monkeypox outbreak in non-endemic countries on May 2022, development of a molecular assay for monkeypox detection on the BD MAXTM System was initiated. Methods VIASURE Monkeypox virus Real Time PCR Reagents for BD MAX™ System was designed for the qualitative detection of DNA from monkeypox virus in human skin lesion swabs in VTM/UTM obtained from individuals suspected of monkeypox infection. The Limit of Detection (LoD) was determined by testing a 3-fold dilution series across 5 concentrations. The lowest concentration with 100% detection was tested with an additional 20 replicates. The preliminary LoD was confirmed with a ≥95% detection with 20 replicates. Then, a fully contrived clinical evaluation was performed. Each contrived clinical specimen was prepared using a unique natural clinical specimen matrix (lesion swabs). Twenty (20) of the clinical specimens were prepared at 1-2X LoD, ten (10) were prepared at 3-5X LoD, and thirty (30) were tested as negative samples. Results The lowest detectable concentration of virus at which >95% of all replicates test positive (LoD) was 288 copies/mL. The results for the contrived clinical evaluation are shown in Table 1. 19/20 (≥95%) low positive specimens (1-2xLoD) and 20/20 (100%) moderate positive specimens (3-5x LoD) were detected demonstrating the functionality of the test. Conclusion VIASURE Monkeypox virus Real Time PCR Reagents for BD MAX™ System provides results in a short time and requires less than one minute of hands-on time per sample due to integration of fully automated extraction and thermocycling steps. An additional clinical testing of positive natural clinical specimens must be performed to complete evidence that this product is for the purpose and the population for which it is intended.
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