Acquired Immunodeficiency SyndromeNCT02396355
Accuracy Evaluation of the BD FACS Presto System
An observational study of Acquired Immunodeficiency Syndrome, run by Becton, Dickinson and Company at 6 sites in 4 countries.
Trial summary
The enumeration of T lymphocytes positive for the CD4 antigen is used to determine the immune status of patients with, or suspected of developing, immune deficiencies such as AIDS. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Acquired Immunodeficiency Syndrome
- What is being tested?
- Investigational BD FACSPresto System, BD FACSCalibur flow cytometer and Sysmex hematology analyzer KX-21
- Type of treatment
- Medical device
- How many people
- 583 participants
- Where
- 6 sitesin 4 countries
- Study dates
- Feb 2015to May 2015
- 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
- No healthy volunteers
- Child, Adult, Older adult
Study population: The study will enroll specimens from children 0-12 years and adolescent or adult patients 13 years of age or greater. Enrolment of children in the study is expected to satisfy the binning (stratification) requirements since relative lymphocytosis and higher CD4+ lymphocyte counts are normal in children less than 5 years of age.
Who may be able to join
- Subject has been infected with HIV and willing to provide informed consent to draw venous and capillary blood
- Specimen: Venous blood must be collected in blood collection tube with EDTA anticoagulant and stored at room temperature (20-25 °C) according to tube manufacturer's instructions
- Specimen: post enrolment staining within 24 hours
- venous blood of acceptable quality for flow cytometry, e.g. no hemolysis or clots and acceptable pre analytical handling)
- venous blood sample > 1 mL for sample preparation
- capillary blood applied to the investigational CD4/%CD4/Hb cartridge
Who cannot join
- Subject unwilling to disclose medical information regarding previous CD4 test results
- Subject unwilling to discuss medical information regarding co-morbid conditions and current medications
Trial locations and contacts
6 sites in 4 countries.
6 sites in 4 countries
United States3 sites
Children's Hospital Los Angeles
Los Angeles, California, 90027
San Francisco General Hospital and Trauma Center
San Francisco, California, 94111
Becton Dickinson MedLab
San Jose, California, 95131
About this study
Official title: Accuracy Evaluation of the BD FACS Presto System: Instrument, Software and BD CD4/%CD4/Hb Cartridge Assay
The enumeration of T lymphocytes positive for the CD4 antigen is used to determine the immune status of patients with, or suspected of developing, immune deficiencies such as AIDS. The BD FACS Presto™ is an investigational automated system for in vitro diagnostic use in performing the direct enumeration of CD4 absolute count, CD4 percentage of lymphocytes, and hemoglobin (Hb) concentration in human whole blood.
This is a prospective study to determine the relative bias between the investigational BD FACS Presto system and the predicate BD FACS Calibur with BD Tritest system in their determination of absolute CD4, % CD4, and Hb concentrations.
- Conditions
- Acquired Immunodeficiency Syndrome
- Being tested
- Investigational BD FACSPresto System, BD FACSCalibur flow cytometer, Sysmex hematology analyzer KX-21
- Keywords
- flow cytometry
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Investigational BD FACSPresto SystemDevice
Blood samples will be tested on the BD FACSPresto system for CD4 absolute count (CD4Abs), %CD4, and Hb concentration.
BD FACSCalibur flow cytometerDevice
Blood samples will be tested on the predicate, currently marketed device. For CD4Abs and %CD4 measurement, the BD FACSCalibur flow cytometer will be used with BD Multiset software version 1.1 or later and BD Tritest CD3/CD4/CD45 reagent with Trucount tubes.
Sysmex hematology analyzer KX-21Device
Blood samples will be tested for hemoglobic concentration on the predicate, currently marketed Sysmex hematology analyzer KX-21
| Study group | Role | What they receive |
|---|---|---|
| All subjects | This is a single arm study. Samples from each subject will be tested with the Investigational BD FACSPresto System, the BD FACSCalibur flow cytometer, and the Sysmex hematology analyzer KX-21. Receives: Device: Investigational BD FACSPresto System; Device: BD FACSCalibur flow cytometer; Device: Sysmex hematology analyzer KX-21 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Method bias between BD FACSPresto System vs. Predicate in venous blood (AbsCD4 and %CD4)
The primary endpoint is the bias (expected difference) between the investigational vs. predicate system measured as absolute CD4 lymphocyte count and %CD4 in peripheral venous blood from a minimum of 400 specimens with valid results tested at three or more external sites.
Measured: assayed upon sample collection
Secondary outcomes (2)
Method bias between BD FACSPresto System vs. Predicate in Capillary Blood (AbsCD4 and %CD4)
The bias (expected difference) between the investigational vs. predicate system measured as absolute CD4 lymphocyte count and %CD4 in capillary blood from a minimum of 400 specimens with valid results tested will be determined at three or more external sites.
Measured: assayed upon sample collection
Method bias between BD FACSPresto System vs. Predicate for Hemoglobin
The bias (expected difference) between the investigational BD FACSPresto system vs. predicate (Sysmex KX-21 hematology analyzer) will be determined for hemoglobin concentration using venous blood and capillary blood.
Measured: assayed upon sample collection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2015 (estimated)
- Study startFeb 2015
- Primary completionMay 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acquired Immunodeficiency SyndromeStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 583 participants (actual)
Sponsor and investigators
- Lead sponsor
- Becton, Dickinson and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kevin Judge, MD, Study chair, Becton, Dickinson
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02396355
- Sponsor's protocol ID
- CAS-PCACC1
- Status last verified
- Feb 2017
- First submitted
- 18 Mar 2015
- Last updated
- 9 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Angira F, Akoth B, Omolo P, Opollo V, Bornheimer S, Judge K, Tilahun H, Lu B, Omana-Zapata I, Zeh C. Clinical Evaluation of the BD FACSPresto Near-Patient CD4 Counter in Kenya. PLoS One. 2016 Aug 2;11(8):e0157939. doi: 10.1371/journal.pone.0157939. eCollection 2016.
PubMed 27483008
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accuracy Evaluation of the BD FACS Presto System: Instrument, Software and BD CD4/%CD4/Hb Cartridge Assay
- ClinicalTrials.gov ID
- NCT02396355
- Acronym / sponsor ID
- CAS-PCACC1
- Conditions
- Acquired Immunodeficiency Syndrome
- Keywords
- flow cytometry
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 583 participants (actual)
- Lead sponsor
- Becton, Dickinson and CompanyIndustry (pharma, biotech, devices)
- Study start
- Feb 2015
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 24 Mar 2015 (estimated)
- 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 enumeration of T lymphocytes positive for the CD4 antigen is used to determine the immune status of patients with, or suspected of developing, immune deficiencies such as AIDS. The BD FACS Presto™ is an investigational automated system for in vitro diagnostic use in performing the direct enumeration of CD4 absolute count, CD4 percentage of lymphocytes, and hemoglobin (Hb) concentration in human whole blood.
This is a prospective study to determine the relative bias between the investigational BD FACS Presto system and the predicate BD FACS Calibur with BD Tritest system in their determination of absolute CD4, % CD4, and Hb concentrations.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All subjects | – | Device: Investigational BD FACSPresto System, Device: BD FACSCalibur flow cytometer, Device: Sysmex hematology analyzer KX-21This is a single arm study. Samples from each subject will be tested with the Investigational BD FACSPresto System, the BD FACSCalibur flow cytometer, and the Sysmex hematology analyzer KX-21. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study will enroll specimens from children 0-12 years and adolescent or adult patients 13 years of age or greater. Enrolment of children in the study is expected to satisfy the binning (stratification) requirements since relative lymphocytosis and higher CD4+ lymphocyte counts are normal in children less than 5 years of age.
Key inclusion criteria (6 listed)
- Subject has been infected with HIV and willing to provide informed consent to draw venous and capillary blood
- Specimen: Venous blood must be collected in blood collection tube with EDTA anticoagulant and stored at room temperature (20-25 °C) according to tube manufacturer's instructions
- Specimen: post enrolment staining within 24 hours
- venous blood of acceptable quality for flow cytometry, e.g. no hemolysis or clots and acceptable pre analytical handling)
- venous blood sample > 1 mL for sample preparation
Key exclusion criteria (2 listed)
- Subject unwilling to disclose medical information regarding previous CD4 test results
- Subject unwilling to discuss medical information regarding co-morbid conditions and current medications
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 |
|---|---|---|
| Investigational BD FACSPresto SystemBlood samples will be tested on the BD FACSPresto system for CD4 absolute count (CD4Abs), %CD4, and Hb concentration. | Device | All subjects |
| BD FACSCalibur flow cytometerBlood samples will be tested on the predicate, currently marketed device. For CD4Abs and %CD4 measurement, the BD FACSCalibur flow cytometer will be used with BD Multiset software version 1.1 or later and BD Tritest CD3/CD4/CD45 reagent with Trucount tubes. | Device | All subjects |
| Sysmex hematology analyzer KX-21Blood samples will be tested for hemoglobic concentration on the predicate, currently marketed Sysmex hematology analyzer KX-21 | Device | All subjects |
Primary outcome
Method bias between BD FACSPresto System vs. Predicate in venous blood (AbsCD4 and %CD4)
Time frame: assayed upon sample collection
The primary endpoint is the bias (expected difference) between the investigational vs. predicate system measured as absolute CD4 lymphocyte count and %CD4 in peripheral venous blood from a minimum of 400 specimens with valid results tested at three or more external sites.
2 secondary outcomes
Method bias between BD FACSPresto System vs. Predicate in Capillary Blood (AbsCD4 and %CD4)
Time frame: assayed upon sample collection
Method bias between BD FACSPresto System vs. Predicate for Hemoglobin
Time frame: assayed upon sample collection
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 9 Feb 2017.
- Derived from this study: PubMed 27483008Angira F, Akoth B, Omolo P, Opollo V, Bornheimer S, Judge K, Tilahun H, Lu B, Omana-Zapata I, Zeh C. Clinical Evaluation of the BD FACSPresto Near-Patient CD4 Counter in Kenya. PLoS One. 2016 Aug 2;11(8):e0157939. doi: 10.1371/journal.pone.0157939. eCollection 2016.
- Individual participant dataSharing planned: No
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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.
Kevin Judge, MD study chair
Becton, Dickinson
6 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acquired Immunodeficiency Syndrome, run by Becton, Dickinson and Company at 6 sites in 4 countries.
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 6 inclusion and 2 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 9 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States, India, Kenya, Thailand. 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?
Method bias between BD FACSPresto System vs. Predicate in venous blood (AbsCD4 and %CD4) (time frame: assayed upon sample collection). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02396355, which also lists 1 linked publication.
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 9 Feb 2017.