Seegene Allplex HSV-1&2/VZV/MPXV Assay

Seegene USA received emergency use authorization from the US Food and Drug Administration in July 2026 for its Allplex HSV-1&2/VZV/MPXV Assay. It is a syndromic real-time polymerase chain reaction test that simultaneously detects herpes simplex virus types 1 and 2, varicella-zoster virus and mpox clades I and II. All of these viruses are associated with skin and mucosal lesions.

Because these four viruses produce skin lesions that are difficult to distinguish by visual appearance alone, conventional single-pathogen testing can lead to missed diagnosis. According to a study presented at the 2024 Clinical Virology Symposium, researchers reanalyzed 966 samples that had tested negative using single-target assays with multiplex PCR testing. They detected previously unidentified HSV, VZV and MPXV infections in 54 cases, highlighting the potential for false negatives when testing for only one pathogen.

The Allplex HSV-1&2/VZV/MPXV Assay amplifies and detects viral DNA targets from MPXV clade I/II, MPXV clade II HSV-1, HSV-2, and VZV in three main steps: Nucleic Acid Extraction, Nucleic Acid Amplification/Detection, and Data Export & Analysis. 

Samples undergo nucleic acid extraction using the Seegene STARlet automated extraction system. Following nucleic acid extraction, 5μL of purified nucleic acid is automatically transferred to the PCR plate for amplification using MOM (MuDT Oligo Mix) and EM4 (DNA polymerase, Uracil-DNA glycosylase, and buffer containing dNTPs). After automated PCR plate setup, nucleic acid is amplified and detected using the Bio-Rad CFX OPUS 96 Dx Real-Time PCR System.

For multiplex target amplification and detection with maximum accuracy in a single reaction well, the assay utilizes a combination of TaqMan probe technology and Seegene’s innovative & proprietary DPO (Dual Priming Oligonucleotide), TOCE (Tagging Oligonucleotide Cleavage and Extension), and MuDTTM (Multiple Detection Temperatures) technologies.

The test is performed on swabs of pustules or vesicular rash. 

References

Seegene, Inc. Seegene USA receives FDA emergency use authorization for multiplex PCR assay, advancing differential diagnosis of HSV-1&2, VZV, and monkeypox virus for ulcerative skin lesions. Published July 21, 2026.

Seegene Allplex HSV-1&2/VZV/MPXV Assay Instructions for Use.