Spotlight to DRG's CMV IgG Buccal Swab ELISA

The cytomegalovirus (CMV) belongs to the human herpes viruses (human herpes virus 5). CMV is widespread worldwide and is considered the most common viral pathogen of congenital infection. Seroprevalence is dependent on age and socioeconomic factors of the population under study.^[1]
CMV is examined in prenatal diagnostics as part of TORCH serology, but CMV status also plays a major role in transplant medicine. In transplantation, the aim is for the donor to have the same CMV status as the patient. If the patient is CMV-negative, the donor should also be negative so that the patient is not reinfected with CMV. If, on the other hand, he is positive, the donor should also be positive, because the donor's immune system is then already CMV-experienced and trained accordingly.^[2]
Whereas in the past CMV IgG could only be detected in blood, DRG Instruments GmbH has already been offering a CMV IgG ELISA since 2018, for which buccal swab is used as a sample.

With DKMS Life Science Lab gGmbH, it could be shown on the basis of a large validation set that a CMV serostatus can be derived from dried swabs with good sensitivity (99.1%) and specificity (98.6%) in >80% of the samples. This is sufficient in the context of registering the potential donor. In case of transplantation all infectious disease markers are retested. Supporting our ELISA, a total protein assay was used (BCA) to identify swabs with insufficient or no sample material. ^[2,3]

UNIQUE      CMV IgG Buccal Swab ELISA (RUO)

Available in single kit version (SLV-6110) and as 300 plate kit (SLV-6084)

Assay Range 0 - 80 DU/mL Incubation Times       60 / 30 / 10 min Sample Buccal Swab (not included in kit) Controls Negative and Positive Control included in Kit Standards 3 Standards (Neg. Control is used as 0-Standard).    Processing Manual or automated possible  Protocols available for Dynex DS2 and DSX

[1] RKI-Ratgeber Zytomegalievirus-Infektionen
(https://www.rki.de/DE/Content/Infekt/EpidBull/Merkblaetter/Ratgeber_Zytomegalievirus.html)
[2] J Infect Dis. 2021 Oct 13;224(7):1152-1159; Non-invasive determination of CMV serostatus from dried buccal swab samples: assay development, validation and application to 1.2 million samples; Geoffrey A. Behrens, Michael Brehm, Rita Groß, Jana Heider, Jürgen Sauter, Daniel M. Baier, Tatjana Wehde, Santina Castriciano, Alexander H. Schmidt, Vinzenz Lange
[3] Transpl Immunol. 2022 Oct 14;75:101729.doi: 10.1016/j.trim.2022. Reanalysis of unclear CMV status results from buccal swab samples of potential stem cell donors is an efficient donor registry strategy; Stefanie N Bernas, Geoffrey A Behrens, Henning Baldauf Daniel M Baier, Heike Fischer, Jens Pruschke, Falk Heidenreich, Katja Ruhner, Jan A Hofmann, Jan Markert, Johannes Schetelig, Vinzenz Lange, Alexander H Schmidt