Clinical Investigation for 2019-nCoV Antigen Saliva Rapid Test Kit and V-CHEK SARS-CoV-2 Antigen Detection Kit to Detect COVID-19

Covid19 Clinical Trial

— Reliable  

Official title:

Clinical Investigation for 2019-nCoV Antigen Saliva Rapid Test Kit and V-CHEK SARS-CoV-2 Antigen Detection Kit to Detect COVID-19

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04940195
• Other study ID #: PRO00040834
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 1, 2021
• Est. completion date: June 1, 2022

Study information

• Verified date: May 2021
• Source: Medical College of Wisconsin
• Contact: Matthew L Faron, PhD
• Phone: 414-805-6967
• Email: mfaron[@]mcw.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Study staff will collect three swabs and one saliva specimen from the same participant.

Description:

This study is designed to analyze the agreements between the Investigational Device and an FDA approved SARS-CoV-2 NAATs and ensure that the Investigation Device is comparable to the reference method comparator. Clinical site staff will evaluate patients who exhibit COVID-19 symptoms and ask them if they would like to participate in this clinical study. Patients must meet the inclusion and exclusion criteria and be confirmed eligible to participate in the study. A minimum of two clinical sites is required for this study. Each site will enroll as many participants as possible to meet the initial screening criteria so that there are at least 30 positive COVID-19 results obtained when using the Investigational Device. Participants will be screen and those found acceptable will be asked to sign a consent form. After signing the consent form, each participants will be subjected to the standard COVID-19 test which will be sent to the lab for test results. Afterwards, study staff will collect another three specimens from the same participant. Collection include one nasopharyngeal swab (NP), one nasal swab (NS), and one saliva sample. The sample collected for NAAT testing should be transported according to the instructions suitable to the test to the testing laboratory. The NP swab can be collected from either nostril. Patient cannot eat, drink, smoke or chew gum for 30 minutes before giving saliva specimen. All collected samples should be tested immediately on the Investigational Device test cassette per the Instructions of Use (IFU). If an invalid result is observed, study group must repeat the test with a new cassette and use the same extraction tube. Staff must drip three drops of the extraction specimen on the well of the new cassette. All test results included those who are invalid must be recorded on the Case Report Form (CRF).

For each new shipment of products, new lot of products or each new operator an external control swab should be tested prior to participant testing and all result should be recorded.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 500
• Est. completion date: June 1, 2022
• Est. primary completion date: June 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• at least 18 years old

• exhibiting COVID-19 symptoms within the 7 days of enrollment

• Provision of signed and dated informed consent form or assent form

• stated willingness to comply with all study procedures and availability for the duration of the study

Exclusion Criteria:

• minors age less than 18

• have been administered COVID-19 vaccines (one shot or two shots)

• unable to collect nasal swab or saliva specimen

Related Conditions & MeSH terms

• Covid19

Intervention

Device:
• V-CHECK SARS-CoV-2 Antigen Detection Kit and 2019-nCoV Antigen Saliva Rapid Test Kit
Participants will have already been subjected to the standard COVID-19 test. Each site will receive about 100-200 Investigational Devices. For each participant, the operator will obtain additional test specimens in accordance with the Instructions for use. The test specimens for the Investigational Device will be tested immediately on site using the Investigation Device test cassettes following the instruction for use. Minimum of 5 operators at each site are required to conduct separate testing. Should an invalid result be observed, the operator must repeat the test with a new test cassette and still use the same extraction tube. The operator will then drip three drops of the extraction specimen into the sample well of the new cassette. All test results should be recorded on the CRFS. Each new shipment of products, new lots of products, or for each new operator external control swabs should be tested prior to participant testing and all results should be recorded on the CRF.

Locations

Country	Name	City	State
United States	Froedtert Health WAC	Wauwatosa	Wisconsin

Sponsors (2)

Lead Sponsor	Collaborator
Medical College of Wisconsin	Reliable, LLC.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluate clinical Accuracy of V-Check SARS-CoV-2 assay using midturbinate swabs compared to NP PCR standard of care.	Mid-turbinate swabs collected from patients will be tested on the V-check assay and compared to NP specimens tested on a EUA approved RT-PCR test. Results will be reported as positive percent agreement, negative percent agreement, and 95% Confidence intervals.	Approximately 4-8 weeks with a minimum total of 30 positive results
Primary	Evaluate clinical Accuracy of V-Check SARS-CoV-2 assay using Nasal swabs compared to NP PCR standard of care.	Nasal swabs collected from patients will be tested on the V-check assay and compared to NP specimens tested on a EUA approved RT-PCR test. Results will be reported as positive percent agreement, negative percent agreement, and 95% Confidence intervals.	Approximately 4-8 weeks with a minimum total of 30 positive results
Primary	Evaluate clinical Accuracy of V-Check SARS-CoV-2 assay using saliva compared to NP PCR standard of care.	Saliva collected from patients will be tested on the V-check assay and compared to NP specimens tested on a EUA approved RT-PCR test. Results will be reported as positive percent agreement, negative percent agreement, and 95% Confidence intervals.	Approximately 4-8 weeks with a minimum total of 30 positive results
Primary	Evaluate clinical Accuracy of the 2019-nCoV antigen saliva rapid test using saliva compared to NP PCR standard of care.	Saliva collected from patients will be tested on the 2019-nCoV antigeten Saliva rapid test kit and compared to NP specimens tested on a EUA approved RT-PCR test. Results will be reported as positive percent agreement, negative percent agreement, and 95% Confidence intervals.	Approximately 4-8 weeks with a minimum total of 30 positive results