Vela Diagnostics has received clearance from the Food and Drug Administration for the Sentosa SA201 HSV-1/2 PCR test, a herpes simplex virus (HSV) nucleic acid amplification assay. This test uses real-time polymerase chain reaction (PCR) to qualitatively detect and differentiate HSV-1 and HSV-2 DNA from swabs of anogenital or oral skin lesions. Performed on an automated workflow, the assay contains reagents and enzymes for specific amplification of a 104 base pair fragment of the UL30 gene common to both HSV-1 and HSV-2, as well as specific probes for the direct detection and differentiation of HSV-1 and HSV-2 amplicons, respectively. The test’s limit of detection is defined as the lowest HSV titer (TCID50/mL) detected with a probability of 95% or greater and is 40 TCID50/mL for HSV-1 and 4 TCID50/mL for HSV-2. A reproducibility study also examined the performance of the Vela Sentosa SA201 HSV-1/2 PCR test using simulated samples across multiple sites, instruments, operators, and lots, and found a coefficient of variation of 5.25% or less across all samples.