Clinical Performance Evaluation of Monkeypox Virus Nucleic Acid Diagnostic Kit (Fluorescence PCR)

Clinical Performance Evaluation of Monkeypox Virus Nucleic Acid Diagnostic Kit (Fluorescence PCR) - REQA_22025_SNSR

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00031194

Enrollment

Registered

2023-02-21

Start date

2023-02-27

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 status of infection

Interventions

Group 1: Testing of left-over samples for monkeypox with test device Group 2: Testing of left-over samples for monkeypox with comparator device (PCR test): Bosphore® Monkeypox Virus Detection Kit v1 a

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Having at least one symptom of monkeypox at the time of sampling 2. Diagnosis result: The (previous) diagnostic results are used to classify the groups (positive, negative).

Exclusion criteria

Exclusion criteria: 1. Insufficient sample amount 2. Insufficient sample quality: samples that cannot be used with the test or comparator 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