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Noninvasive Determination of CMV Serostatus From Dried Buccal Swab Samples: Assay Development, Validation, and
Geoffrey A Behrens1, Michael Brehm1, Rita Groß1
1DKMS Life Science Lab, Dresden, Germany.
Insights
This study presents a new method to determine cytomegalovirus immunoglobulin G (CMV IgG) serostatus using noninvasive buccal swabs. This assay offers a reliable alternative to blood draws for CMV antibody testing in large-scale studies.
Area of Science:
- Immunology
- Virology
- Biotechnology
Background:
- Buccal swabs offer a noninvasive alternative to blood draws for antibody serostatus assays.
- Cytomegalovirus immunoglobulin G (CMV IgG) serostatus determination is crucial for various medical applications.
Purpose of the Study:
- To develop and validate a method for determining CMV IgG serostatus from dried buccal swab samples.
- To establish CMV prevalence statistics in different populations using this novel assay.
Main Methods:
- CMV IgG was quantified from solubilized buccal swabs using an adapted ELISA assay.
- Assay parameters were optimized, and CMV titers were normalized against total protein concentration.
- The assay was validated on a large number of samples and compared to blood-based testing.
Main Results:
- The assay accurately determined CMV IgG serostatus in over 80% of participants.
- High specificity (98.6%) and sensitivity (99.1%) were achieved during validation.
- Age- and sex-stratified CMV prevalence data were generated for Germany, Poland, the UK, and Chile.
Conclusions:
- The developed assay provides an accurate, noninvasive method for CMV IgG serostatus determination from buccal swabs.
- This method is suitable for large-scale population studies and donor screening, such as for hematopoietic stem cell transplantation.
- It offers a practical alternative to plasma-based CMV monitoring for non-diagnostic purposes.
Background:
Buccal swab sampling constitutes an attractive noninvasive alternative to blood drawings for antibody serostatus assays. Here we describe a method to determine the cytomegalovirus immunoglobulin G (CMV IgG) serostatus from dried buccal swab samples.
Methods:
Upon solubilization, CMV IgG is determined by an ELISA assay specifically adapted to cope with low IgG concentrations. The derived CMV titer is normalized against the total protein concentration to adjust for incorrectly or less efficiently sampled buccal swabs. Assay parameters were optimized on a set of 713 samples.
Results:
Validation with 1784 samples revealed distinct results for > 80% of samples with 98.6% specificity and 99.1% sensitivity. Based on the analysis of 1.2 million samples we derived age- and sex-stratified CMV prevalence statistics for Germany, Poland, United Kingdom, and Chile. To confirm accuracy of the assay in routine operation, the CMV status of 6518 donors was reassessed by independent laboratories based on conventional blood samples revealing 96.9% specificity and 97.4% sensitivity.
Conclusions:
The assay accurately delivers the CMV IgG serostatus from dried buccal swab samples for > 80% of the participants. Thereby it provides a noninvasive alternative to plasma-based CMV monitoring for nondiagnostic purposes such as hematopoietic stem cell transplantation donor screening or population studies.
