ELISA Validation of Hypersensitive Rapid Diagnostic Test Results for Detection of P. Falciparum (ELISA)

July 2, 2018 updated by: University of Oxford

ELISA Validation of Hypersensitive Rapid Diagnostic Test Results for Detection of P. Falciparum Using Field Samples From Prevalence Surveys.

Elimination of P. falciparum (PF) malaria across a territory requires universal access to treatment of clinical cases for communities, and specific targeting of places or population groups where malaria transmission persists in spite of generalized access to treatment. In particular, a large prevalence of carriers of PF parasites is suspected to be one of the reasons for malaria persistence. The fact that these carriers are not developing symptoms allow them to harbour and transmit parasites over long periods of time. They are likely to contribute significantly the transmission in their community and even beyond it according to their movement patterns.

Identifying these pockets of high asymptomatic carriage is a key component of the malaria elimination strategy, as it allows targeting specific interventions, such as targeted mass-treatment, to quickly drain the asymptomatic reservoir.

Strategically to achieve this goal we need to be able to identify quickly and reliably the villages or groups of villages in which the asymptomatic reservoir is large and should be addressed by targeted mass drug administration (MDA).

There are no point of care tests currently available to detect asymptomatic carriers accurately. The available Rapid Diagnostic Tests (normal RDT) are designed to diagnose clinically relevant malaria infections. However their sensitivity for asymptomatic malaria carriers is low, since most of these individuals harbor parasitaemias below RDT detection thresholds. Currently, we are relying on high volume blood surveys, in which a small sample of the village population provides a 2mL venous blood sample that can be analysed by ultra-sensitive qPCR. This technique allows detecting very low parasitaemias. However it is a high cost test and technical requirements to use qPCR limit the number of samples that can be tested. In addition as the analysis must be done in a laboratory, the time needed for shipment and analysis results in delays of 4 to 8 weeks between survey and result. Surveying remote, poorly resourced areas adds to the challenge as the samples must be shipped from the field to the laboratory, on cold chain, within 24 to 48h from blood draw.

To ensure that asymptomatic individuals are diagnosed in a cost effect and feasible manner, it is vital that a more sensitive RDT is made available for use in the field. Depending on its performance, a sensitive RDT could be used for prevalence surveys to target MDA, or directly for interventions based on treatment of positive individuals (reactive case detection or mass screening and treatment).

A new hypersensitive RDT (hsRDT) has now been developed but before it can be utilised for elimination surveys we need to validate both its technical properties (sensitivity and specificity) and its usefulness in the field to detect PfHRP2 presence compared to a gold standard control ELISA (Enzyme Linked Immuno-Sorbent Assay) test. This will allow confirmation of false- and true- positive among samples.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1656

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
    • Tak
      • Mae Sot, Tak, Thailand
        • Shoklo Malaria Research Unit

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

No new participants required for this study. Samples are aliquots from anonymized blood samples for which consent already given from participants participated in TMT protocol.

Description

Inclusion Criteria:

  • Samples from participants who participated in TMT protocol with sufficient volume to perform ELISA (minimum40 µL) and for which an hsRDT result is already available.
  • Specimens have been stored at required temperature (-80 °C or below)

Exclusion Criteria:

• Specimen unsuitable for testing for any technical reasons

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Sensitivity of hsRDT compared to ELISA (gold standard) for detection of PfHRP2 antigen
Time Frame: 3 months
3 months
Specificity of hsRDT compared to ELISA (gold standard) for detection of PfHRP2 antigen
Time Frame: 3 months
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Oxford

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 24, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 24, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 27, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 5, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 2, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SMRU1701

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Conditions

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Dietary Supplements

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