Clinical Study Report of SARS-CoV-2 Antigen Rapid Test (nasopharyngeal swab) INCP-502 Performance Evaluation Study

SARS-CoV-2 Antigen Rapid Test (nasopharyngeal swab) INCP-502 Performance Evaluation Study - SARS-CoV-2 Antigen Rapid Test (nasopharyngeal swab) INCP-502 Performance Evaluation Study

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000048027

Enrollment

100

Registered

2022-06-10

Start date

2022-06-01

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

COVID-19

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: The subjects must fulfill the following inclusion criteria: A:Inclusion Criteria for Subjects 1.Subjects with suspected respiratory tract infection (SARS-CoV-2 infection) symptoms including fever, throat pain, dyspnea and ranging from minor to serious symptoms. B:Inclusion Criteria for Samples 1.Remaining samples that can be used to confirm definite diagnosis. 2.Uncontaminated samples.

Exclusion criteria

Exclusion criteria: The presence of any of the following excludes a subject from study enrollment: 1.Overdue and deteriorated samples that were not collected, processed or stored as required. 2.Samples of patients with repeated enrolment (only valid samples of the first enrolment of the patient are retained). 3.Other samples that can be proved not to be operated according to the requirements of the scheme.

Design outcomes

Primary

Measure	Time frame
1. Comparison with approved antigen quantitation test. 2. To evaluate the results of a correlational study based on comparisons with an approved quantitative test for antigens using nasal swabs (Espline SARS-CoV-2, Fujirebio).	—

Countries

Japan

Contacts

Public ContactYoshinobu Oikawa

APO PLUS STATION CO., LTD. CRO Business Div.

y-oikawa@apoplus.co.jp0363868800

Outcome results