Development Of A Rapid Diagnostic Test To Identify Crimean-Congo Haemorrhagic Fever At The Point-Of-Care

N/ANot Yet RecruitingNCT06624787

Liverpool School of Tropical Medicine492 enrolled

Overview

The goal of this medical device diagnostic evaluation study is to determine if this novel lateral flow device can detect Crimean-Congo Hemorrhagic Fever (CCHF) at the point of care in secondary health care clinics in Turkey. The main outcome is to determine the sensitivity and specificity of the tests for CCHF in samples of whole blood, serum and capillary blood compared to a gold-standard of PCR for participants that present at 4 endemic sites secondary health care clinics in Turkey in 492 adults who are suspected to have been infected with CCHF. The study aims to hopes to achieve at least the minimum required sensitivity of 90 % and specificity of 80 % as required by the WHO.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

492

Conditions

Crimean-Congo Haemorrhagic Fever

Interventions

The Liverpool School of Tropical Medicine (LSTM) in collaboration with Global Access Diagnostics (GADx) have achieved the development of the first RDT to detect CCHF viral antigens with a sensitivity and specificity that exceeds the minimum recommendation in the WHO target product profile (TPP)of \>80% and \>90% for sensitivity and specificity respectively for minimal performance in pre-clinical studies. The RDT is not only faster providing a test result within 20 minutes, but is also substantially cheaper than RT-PCR, and simpler to perform. A predicted price per test of around $5, whereas the current price of the RT-PCR test ranges from $1,000 to $1,200 for 96 reactions. The RDT does not require refrigeration or require specialist personnel to undertake, and the only additional apparatus needed is a stopwatch to monitor running time.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: Participants aged 18 years or older Suspected CCHF infection that requires a RT-PCR diagnosis and venous blood draw Willingness to comply with study procedures and consent to the study Presents at 1 of 4 listed sites Exclusion Criteria: * In the investigators opinion should not be enrolled onto study (e.g., medical prudence or capacity)

Outcomes

Primary Outcomes

Sensitivity and Specificity

To determine the sensitivity and specificity of RDT tests for CCHF in samples of whole blood, serum and capillary blood compared to a gold-standard of PCR for participants that present at 4 endemic sites secondary health care clinics in Turkey.

Time frame: From the date/time of blood draw of the first participant until all diagnostic results have been received (up to two weeks from blood draw)

Secondary Outcomes

Usability of RDT via questionnaires answered by end users.

To determine the ease of use of the RDT at the point of care in CCHF-endemic settings by end users answering a questionnaire designed with a 5-point Likert scale

Time frame: Once all questionnaires have been completed, and quality checked - this should occur upto a month after the last recruit

To determine the most suitable matrices that have the minimum TPP as required by the WHO for RDTs for CCHF detection.

Using the sensitivity, specificity, ease-of-use questionnaires, Positive predictive value, Negative predictive value and accuracy of RDT in all matrices to determine the most suitable matrix(ices) at the end-user setting.

Time frame: From the date/time of blood draw of the first participant until all diagnostic results and questionnaires have been received - this should be completed upto a month after the last recruit

Using the PPV, NPV and accuracy of the RDT in all matrices.

To determine the Positive predictive value (PPV), Negative predictive value (NPV) and Accuracy of the RDT in all matrices.

Time frame: From the date/time of blood draw of the first participant until all diagnostic results have been received (up to two weeks from first blood draw of database lock)

To determine the time taken for a CCHF result from blood draw.

Time from blood drawn to diagnostic result - (from upload to the MoH server, and from the site knowing the RT-PCR result)

Time frame: From the date/time of blood draw of the first participant until all diagnostic results have been received (this should occur unto a month after the last recruit)