Validation of SDS-EDTA-Treated Chromatography Paper Strips for Mpox Sampling and Transport in DRC

Use of SDS/EDTA-Treated Chromatography Strips for Sampling, Transportation and Laboratory Confirmation of Mpox Virus Infection

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07634081

Enrollment

150

Registered

2026-06-08

Start date

2026-05-01

Completion date

2026-07-31

Last updated

2026-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mpox

Brief summary

The objective of this prospective paired diagnostic comparison study is to evaluate the diagnostic yield and field applicability of SDS-EDTA-treated chromatography paper strips for the collection, transport, and laboratory detection of mpox virus compared with the routine swab-based sampling method under field conditions in the Democratic Republic of the Congo (DRC). The study is conducted among patients with suspected mpox infection presenting to healthcare facilities in South Kivu, DRC. For each participant, paired samples are collected simultaneously using the standard swab method and the SDS-EDTA strip method. Samples are analyzed using locally available molecular diagnostic platforms.

Interventions

DIAGNOSTIC_TESTSDS-EDTA-treated chromatography strip

Chromatography strip treated with a buffer containing SDS and EDTA. SDS inactivates the virus and reduces biosafety constraints during transport, while EDTA stabilizes nucleic acids and reduces dependence on cold-chain conditions.

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Inclusion criteria

* Patients presenting with clinical signs compatible with mpox infection according to national case definition. * Written informed consent obtained. * Presence of at least two skin lesions in a similar stage of evolution suitable for paired sampling.

Exclusion criteria

* Refusal or inability to provide informed consent. * Presence of only one suitable lesion for sampling. * Lesions at markedly different stages of evolution. * Inability to safely obtain paired samples.

Design outcomes

Primary

Measure	Time frame
Paired difference in mpox positivity between SDS-EDTA strip samples and routine swab samples.	Laboratory analysis of collected samples up to 6 months after collection

Countries

Democratic Republic of the Congo

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 12, 2026