Clinical Performance Evaluation of Detection Kit for Monkeypox Virus DNA (PCR-Fluorescence Probing)

Clinical Performance Evaluation of Detection Kit for Monkeypox Virus DNA (PCR-Fluorescence Probing) - REQA_22023_DaAn

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00030899

Enrollment

500

Registered

2023-02-02

Start date

2023-02-09

Completion date

Unknown

Last updated

2025-04-07

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

Conditions

Monkeypox infection status

Interventions

Group 1: Testing of left-over samples for monkeypox with the subject device under investigation Group 2: Testing of left-over samples for monkeypox with the comparator methods: PCR test: BioeXsen Monk

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Having at least one symptom of monkeypox at the time of sampling 2. Diagnostic result: (previous) diagnostic results will be used for the determination of the groups (positive, negative) in the study.

Exclusion criteria

Exclusion criteria: 1. Insufficient sample amount 2. Insufficient sample quality: Samples that cannot be processed with the comparator and subject device

Design outcomes

Primary

Measure	Time frame
Positive Percent Agreement (PPA) in lieu of Diagnostic Sensitivity (DSens), Negative Percent Agreement (NPA) in lieu of Diagnostic Specificity (DSpec)	—

Secondary

Measure	Time frame
Positive Predictive Value (PPV), Negative Predictive Value (NPV), Likelihood ratio (LR)	—

Countries

Germany

Contacts

Public ContactHakan Inan

Requalite GmbH

Hakan@requalite.com+498932800304

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026