Biocartis Clinical Performance Evaluation Study in Sierra Leone of the Biocartis Idylla System with the Rapid Ebola Virus Triage Test

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

PACTR

Registry ID

PACTR201501001002391

Enrollment

300

Registered

2015-01-19

Start date

2015-02-02

Completion date

Unknown

Last updated

2026-08-03

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

Conditions

Ebola Ebola

Interventions

RT-PCR Rapid Ebola Diagnostic test

RT-PCR Rapid Ebola Diagnostic Test

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Inclusion criteria: ¿ Samples can be used for investigational purposes according to the applicable laws ¿ Whole blood samples of patients with symptoms of Ebola infection Exclusion criteria: ¿ Patient objected to providing his/her sample to third parties for research purposes or samples not released for research purposes

Exclusion criteria

Exclusion criteria: Non Ebola , Non Suspect patient

Design outcomes

Primary

Measure	Time frame
Percentage of overall agreement at the first level i.e. with respect to the dichotomous level Ebola Virus detected or not detected and at the second level, i.e. with respect to the specific Ebola virus strain (Zaire or Sudan). Confidence interval on the diagnostic agreement will be used to evaluate the study acceptance criteria; Percentage positive and the negative agreemtn will be included in the calculation;Percentage overall agreement as defined by the percentage of valid Ebola Test results in agreement with the valid Ebola Reference results	—

Measure

Time frame

Percentage of overall agreement at the first level i.e. with respect to the dichotomous level Ebola Virus detected or not detected and at the second level, i.e. with respect to the specific Ebola virus strain (Zaire or Sudan). Confidence interval on the diagnostic agreement will be used to evaluate the study acceptance criteria; Percentage positive and the negative agreemtn will be included in the calculation;Percentage overall agreement as defined by the percentage of valid Ebola Test results in agreement with the valid Ebola Reference results

—

Countries

Sierra Leone

Contacts

Public ContactLuc Van Hove Luc Van Hove

Chief Medical Officer

lvhove@biocartis.com+32476960 I 53

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Aug 9, 2026