IgG/IgM Antibody Test in Patients Who Have Tested Negative or Positive for COVID-19 With the Standard Method of COVID19 Testing.

Evaluation and Correlation of SARS-Cov2 Virus IgG/IgM Rapid Test Cassette Clungene Test With the Standard Method of COVID19 Testing in Inpatients With or Without COVID19

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04402814

Enrollment

Registered

2020-05-27

Start date

2020-05-05

Completion date

2020-12-01

Last updated

2020-07-27

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

Conditions

SARS-CoV 2

Keywords

Coronavirus, COVID-19, Clungene, IgG/IgM antibodies

Brief summary

The purpose of this study is to evaluate point of care SARS-Cov2 Virus IgG/IgM rapid test cassette Clungene test and correlate it with the standard method of testing in inpatients who have tested positive or negative for COVID19.

Detailed description

This is a laboratory testing study using the SARS-Cov2 Virus IgG/IgM rapid test cassette Clungene test to determine the presence of IgM and IgG antibodies in subjects who have tested negative or positive for COVID-19. The study is observational and subjects will be assigned to one of two arms depending on the results of their nCOVID-19 test.

Interventions

DIAGNOSTIC_TESTClungene rapid test cassette

Blood will be tested for the presence of IgG and IgM antibodies using the Clungene rapid test cassette.

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Received confirmed COVID-19 positive or negative test from Sharp HealthCare's standard method of testing. * Age \>/=18 years old. * Access to a phone in the hospital room or an electronic device that is capable of receiving phone calls and/or video calls and/or e-mail. * Able to read/write/speak English or Spanish fluently. * Subjects must have the ability to understand the requirements of the study, provide informed consent, and provide authorization of use and disclosure of personal health information. * Hospitalized at the time of consent or recently discharged with leftover blood stored at hospital laboratory

Exclusion criteria

* Impaired cognitive or decision-making capacity (based on the clinical judgment of the PI or designee)

Design outcomes

Primary

Measure	Time frame	Description
IgG/IgM antibodies	from date of consent to date of test completion, up to 40 days	Presence of IgG and/or IgM antibodies

Countries

United States

Contacts

Primary ContactKathryn Miller

kathryn.miller@sharp.com858-939-7162

Backup ContactDivina Fanning, RN

divina.fanning@sharp.com(619)823-7347

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026