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Completed

NCT Number: NCT04959760

BinaxNow COVID-19 IgG Rapid Test Device and Antibody Self Test

Performance evaluation of the BinaxNOW™ COVID-19 IgG Rapid Test Device (Professional Use) and with BinaxNOW™ COVID-19 Antibody Self Test wehn used with fingerstick capillary whole blood and plasma samples. The BinaxNOW™ Antibody Tests are lateral flow tests that measure SARS-CoV-2 IgG antibodies.

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Key information

Conditions

COVID-19 Respiratory Infection

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rush University Medical Center, Chicago, Illinois, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Participant is 18 years of age or older.
  • Evaluable individuals with a prior confirmed SARS-CoV-2 infection with prior COVID-19 symptoms with symptoms onset > 14 days prior to the study, or symptoms onset 8-14 days prior to the study, or symptoms onset 0-7 days prior to study.OR

Evaluable individuals confirmed negative by SARS-CoV-2 RT-PCR using a sample obtained within 7 days prior to or on the day of the study.

  • Participant agrees to complete all aspects of the study.

Exclusion criteria

  • Participant has already participated in this study on a previous occasion.
  • Participant is enrolled in a study to evaluate a new drug.
  • Participant has a visual impairment that cannot be restored using glasses or contact lenses.
  • Participant is unable or unwilling to provide informed consent.
  • Participant is a vulnerable person as deemed unfit for the study by the Principal Investigator.
  • Participant has a condition deemed unfit to safely perform the test by the investigator.
  • Participant is a practising health-care professional or laboratory scientist / technician.

Treatment and study plan

The BinaxNOW™ Antibody Tests measure IgG antibodies against SARS-CoV-2.

Diagnostic Test

The BinaxNOW™ Antibody Tests measure IgG antibodies against SARS-CoV-2 in fingestick capillary blood and plasma samples.

Primary outcomes

  1. Clinical performance of the BinaxNOW™ COVID-19 IgG Rapid Test

    Time frame: Through study completion, an average of 6 months

    to evaluate the clinical performance of the BinaxNOW™ COVID-19 IgG Rapid Test Device when used by a professional user.

  2. Clinical performance of the BinaxNOW™ COVID-19 Antibody Self-Test

    Time frame: Through study completion, an average of 6 months

    to evaluate the clinical performance of the BinaxNOW™ COVID-19 Antibody Self-Test when used by a lay person.

Secondary outcomes

  1. Professional user usability

    Time frame: Through study completion, an average of 6 months

    Evaluation of the usability of the BinaxNOW™ COVID-19 IgG Rapid Test Device when used by a Professional User

  2. Self Test user usability

    Time frame: Through study completion, an average of 6 months

    Evaluation of the usability of the BinaxNOW™ COVID-19 Antibody Self-Test when used by a lay person.

  3. Matrix Equivalence Professional Use

    Time frame: Through study completion, an average of 6 months

    Validation of the Matrix Equivalence between the Fingerstick Whole Blood and Plasma samples when used with the BinaxNOW COVID-19 IgG Rapid Test Device.

  4. Diagnostic sensitivity and specificity

    Time frame: Through study completion, an average of 6 months

    To determine the diagnostic sensitivity, specificity and overall agreement of the BinaxNOW™ COVID-19 Antibody Self Test as performed by lay users in comparison with the BinaxNOW™ COVID-19 IgG Rapid Test Device as performed by professional user.

Sponsors and collaborators

Lead sponsor

Abbott Rapid Diagnostics Jena GmbH

Industry

Registry information

Official study title

Clinical Evaluation of the BinaxNOW™ COVID-19 IgG Rapid Test Device and the BinaxNOW™ COVID-19 Antibody Self Test Clinical Study Protocol

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jul 13, 2021
Registry last updated
May 9, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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