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

Organizational Data

DRKS-ID:
DRKS00030899
Recruitment Status:
Recruiting planned
Date of registration in DRKS:
2023-02-02
Last update in DRKS:
2023-02-02
Registration type:
Prospective

Acronym/abbreviation of the study

REQA_22023_DaAn

URL of the study

No Entry

Brief summary in lay language

The aim of this study is to evaluate the clinical performance of the Detection Kit for Monkeypox Virus DNA (PCR-Fluorescence Probing). This study will use left-over samples that are not needed for diagnostic purposes anymore. The samples will be analyzed at three clinical study sites. Each site will conduct testing with Detection Kit for Monkeypox Virus DNA (PCR-Fluorescence Probing). A CE-marked comparator device (BioeXsen Monkeypox Virus qPCR Kit) will be used to determine true positive and true negative results. Furthermore, all samples will be sequenced by Sanger Method. 30 positive and 30 negative samples will be cultured (with successful cultivation on true positive samples).

Brief summary in scientific language

The aim of this study is to evaluate the clinical performance of the Detection Kit for Monkeypox Virus DNA (PCR-Fluorescence Probing). This study will have a cross-sectional, observational design with retrospective samples. Retrospective oropharyngeal (OP) swabs and skin lesion materials will be used in three clinical study sites and each site will conduct testing with Detection Kit for Monkeypox Virus DNA (PCR-Fluorescence Probing). Primary endpoints of the study are diagnostic performance parameters of the device (sensitivity and specificity). Secondary endpoints of the study are predictive values and likelihood ratios. A CE-marked comparator device BioeXsen Monkeypox Virus qPCR Kit will be used to determine true positives and true negatives. All samples will be sequenced by Sanger Method. 30 positive and 30 negative samples will be cultured with successful cultivation on positive samples.

Health condition or problem studied

Free text:
Monkeypox infection status
Healthy volunteers:
No

Interventions, Observational Groups

Arm 1:
Testing of left-over samples for monkeypox with the subject device under investigation
Arm 2:
Testing of left-over samples for monkeypox with the comparator methods: PCR test: BioeXsen Monkeypox Virus qPCR Kit and Sanger sequencing

Endpoints

Primary outcome:
Positive Percent Agreement (PPA) in lieu of Diagnostic Sensitivity (DSens), Negative Percent Agreement (NPA) in lieu of Diagnostic Specificity (DSpec)
Secondary outcome:
Positive Predictive Value (PPV), Negative Predictive Value (NPV), Likelihood ratio (LR)

Study Design

Purpose:
Diagnostic
Retrospective/prospective:
Prospective
Study type:
Non-interventional
Longitudinal/cross-sectional:
Cross-sectional study
Study type non-interventional:
No Entry

Recruitment

Recruitment Status:
Recruiting planned
Reason if recruiting stopped or withdrawn:
No Entry

Recruitment Locations

Recruitment countries:
  • Germany
Number of study centers:
Multicenter study
Recruitment location(s):
  • University medical center Institut für Virologie der Technischen Universität München München
  • University medical center Institut für Virologie der Uniklinik Köln Köln

Recruitment period and number of participants

Planned study start date:
2023-02-09
Actual study start date:
No Entry
Planned study completion date:
2023-03-15
Actual Study Completion Date:
No Entry
Target Sample Size:
500
Final Sample Size:
No Entry

Inclusion Criteria

Sex:
All
Minimum Age:
no minimum age
Maximum Age:
no maximum age
Additional 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

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

Addresses

Primary Sponsor

DaAn Gene Co., Ltd.
No.19 Xiangshan Road, Science Park, High & New Technology Development District
510700 Guangzhou
China
Telephone:
No Entry
Fax:
No Entry
Contact per E-Mail
URL:
No Entry
Investigator Sponsored/Initiated Trial (IST/IIT):
No

Contact for Scientific Queries

Requalite GmbH
Dr. Hakan Inan
Jahnplatz 4
82166 Gräfelfing
Germany
Telephone:
+498932800304
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Contact for Public Queries

Requalite GmbH
Dr. Hakan Inan
Jahnplatz 4
82166 Gräfelfing
Germany
Telephone:
+498932800304
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Principal Investigator

Pfützner Science & Health Institute
Prof. Dr. Dr. Andreas Pfützner
Haifa-Allee 20
55128 Mainz
Germany
Telephone:
+49 6131 5884640
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Sources of Monetary or Material Support

No Entry

Ethics Committee

Address Ethics Committee

Ethik-Kommission bei der Landesärztekammer Rheinland-Pfalz
Deutschhausplatz 3
55116 Mainz
Germany
Telephone:
+49-6131-288220
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Vote of leading Ethics Committee

Date of ethics committee application:
2022-11-25
Ethics committee number:
2022-16829-BO - erstvotierend
Vote of the Ethics Committee:
Approved
Date of the vote:
2023-01-24

Other Address Ethics Committee

Ethikkommission der Fakultät für Medizin der Technischen Universität München
Ismaninger Str. 22
81675 München
Germany
Telephone:
+49-89-41404371
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Vote of the Ethics Committee

Vote of the Ethics Committee:
Approved
Date of the vote:
2023-01-31

Other Address Ethics Committee

Ethikkommission der Medizinischen Fakultät der Universität zu Köln
Gleueler Str. 269
50935 Köln
Germany
Telephone:
+49-221-478 82900
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Vote of the Ethics Committee

Vote of the Ethics Committee:
Pending/not yet approved
Date of the vote:
2022-11-25

Further identification numbers

Other primary registry ID:
No Entry
EudraCT Number:
No Entry
UTN (Universal Trial Number):
No Entry
EUDAMED Number:
No Entry

IPD - Individual Participant Data

Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
No
IPD Sharing Plan:
No Entry

Study protocol and other study documents

Study protocols:
No Entry
Study abstract:
No Entry
Other study documents:
No Entry
Background literature:
No Entry
Related DRKS studies:
No Entry

Publication of study results

Planned publication:
No Entry
Publikationen/Studienergebnisse:
No Entry
Date of first publication of study results:
No Entry
DRKS entry published for the first time with results:
No Entry

Basic reporting

Basic Reporting / Results tables:
No Entry
Brief summary of results:
No Entry