Zika Virus InfectionNCT03776903
Evaluation of the Clinical Performance of the ZIKV Detect™ 2.0 IgM Capture ELISA
An observational study of Zika Virus Infection, run by InBios International, Inc. at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the performance of the ZIKV Detect™ 2.0 IgM Capture ELISA using archived confirmed ZIKV positive and confirmed ZIKV negative human serum samples. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Zika Virus Infection
- What is being tested?
- ZIKV Detect™ 2.0 IgM Capture ELISA
- How many people
- 600 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2018to 30 Sep 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Human males and females of varying ages and geographical locations where Zika virus is endemic and not endemic.
Who may be able to join
- Human males and females of varying ages and geographical locations where Zika virus is endemic and not endemic.
- Retrospective (archived) and prospective human serum samples. Archived samples will fall under the category of "leftover" specimens as described by FDA guidance.
Who cannot join
- Samples that are not de-identified.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to evaluate the performance of the ZIKV Detect™ 2.0 IgM Capture ELISA using archived confirmed ZIKV positive and confirmed ZIKV negative human serum samples.
Read the detailed description
The purpose of this study is to evaluate the performance of the ZIKV Detect™ 2.0 IgM Capture ELISA using archived confirmed ZIKV positive and confirmed ZIKV negative human serum samples. The FDA guidance document (ZIKA SEROLOGY DE NOVO/510(K) PRE-MARKET SUBMISSIONS - Recommended Analytical and Clinical Studies for Zika Virus IgM Assays; Dated 02Jun2017; FDA/CDRH/OIR/DMD) allows for the utilization of archival serum specimens to evaluate test performance. This study will follow this guidance. Test samples will be collected from endemic sites (both presumed positive and presumed negative samples) and from non-endemic sites (presumed negative samples). All samples will be shipped to the sponsor for randomization and will be tested at three sites in the United States.
- Conditions
- Zika Virus Infection
- Being tested
- ZIKV Detect™ 2.0 IgM Capture ELISA
- Medical subject headings
- Zika Virus Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZIKV Detect™ 2.0 IgM Capture ELISAOther
De-identified archive specimens are tested by ELISA and compared to reference testing (RT-PCR and CDC MAC-ELISA)
| Study group | Role | What they receive |
|---|---|---|
| endemic | Samples collected from areas endemic for zika. Subject specimens underwent testing with the study device and reference method. Receives: Other: ZIKV Detect™ 2.0 IgM Capture ELISA | |
| non-endemic | Samples collected from areas non-endemic for zika. Subject specimens underwent testing with the study device and reference method. Receives: Other: ZIKV Detect™ 2.0 IgM Capture ELISA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Positive Percent Agreement and Negative Percent Agreement
The positive percent agreement (PPA) and negative percent agreement (NPA) of the ZIKV Detect™ 2.0 IgM Capture ELISA versus the reference test.
Measured: From symptom onset to 12 weeks after symptom onset.
Secondary outcomes (1)
Duration of Positive Percent Agreement
The time period relative to onset of symptoms that a positive result can be identified and the time period after onset of symptoms that the positive percent agreement is maximized and the longest elapsed time after symptom onset that positive test results are observed.
Measured: From symptom onset to 12 weeks after symptom onset.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2018
- Study start1 Apr 2018
- Primary completion31 Aug 2018
- Study completion30 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Zika Virus InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 600 participants (actual)
Sponsor and investigators
- Lead sponsor
- InBios International, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Fast-Track Drugs & Biologics, LLC, Biomedical Advanced Research and Development Authority
- Responsible party
- Sponsor
- Investigators
- Frances Chu, PhD, Study director, InBios International
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03776903
- Sponsor's protocol ID
- ZIKV-2016-01
- Status last verified
- Dec 2018
- First submitted
- 12 Dec 2018
- Last updated
- 17 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Clinical Performance of the ZIKV Detect™ 2.0 IgM Capture ELISA
- ClinicalTrials.gov ID
- NCT03776903
- Acronym / sponsor ID
- ZIKV-2016-01
- Conditions
- Zika Virus Infection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 600 participants (actual)
- Lead sponsor
- InBios International, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Fast-Track Drugs & Biologics, LLC, Biomedical Advanced Research and Development Authority
- Study start
- 1 Apr 2018 (actual)
- Primary completion
- 31 Aug 2018 (actual)
- Study completion
- 30 Sep 2018 (actual)
- First posted
- 17 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the performance of the ZIKV Detect™ 2.0 IgM Capture ELISA using archived confirmed ZIKV positive and confirmed ZIKV negative human serum samples.
Detailed description
The purpose of this study is to evaluate the performance of the ZIKV Detect™ 2.0 IgM Capture ELISA using archived confirmed ZIKV positive and confirmed ZIKV negative human serum samples. The FDA guidance document (ZIKA SEROLOGY DE NOVO/510(K) PRE-MARKET SUBMISSIONS - Recommended Analytical and Clinical Studies for Zika Virus IgM Assays; Dated 02Jun2017; FDA/CDRH/OIR/DMD) allows for the utilization of archival serum specimens to evaluate test performance. This study will follow this guidance. Test samples will be collected from endemic sites (both presumed positive and presumed negative samples) and from non-endemic sites (presumed negative samples). All samples will be shipped to the sponsor for randomization and will be tested at three sites in the United States.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| endemic | – | Other: ZIKV Detect™ 2.0 IgM Capture ELISASamples collected from areas endemic for zika. Subject specimens underwent testing with the study device and reference method. |
| non-endemic | – | Other: ZIKV Detect™ 2.0 IgM Capture ELISASamples collected from areas non-endemic for zika. Subject specimens underwent testing with the study device and reference method. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Human males and females of varying ages and geographical locations where Zika virus is endemic and not endemic.
Key inclusion criteria (2 listed)
- Human males and females of varying ages and geographical locations where Zika virus is endemic and not endemic.
- Retrospective (archived) and prospective human serum samples. Archived samples will fall under the category of "leftover" specimens as described by FDA guidance.
Key exclusion criteria (1 listed)
- Samples that are not de-identified.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ZIKV Detect™ 2.0 IgM Capture ELISADe-identified archive specimens are tested by ELISA and compared to reference testing (RT-PCR and CDC MAC-ELISA) | Other | endemic, non-endemic |
Primary outcome
Positive Percent Agreement and Negative Percent Agreement
Time frame: From symptom onset to 12 weeks after symptom onset.
The positive percent agreement (PPA) and negative percent agreement (NPA) of the ZIKV Detect™ 2.0 IgM Capture ELISA versus the reference test.
1 secondary outcome
Duration of Positive Percent Agreement
Time frame: From symptom onset to 12 weeks after symptom onset.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Frances Chu, PhD study director
InBios International
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Zika Virus Infection, run by InBios International, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Positive Percent Agreement and Negative Percent Agreement (time frame: From symptom onset to 12 weeks after symptom onset.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2018.